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「阿米卡星」：修訂間差異

維基百科，自由的百科全書
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我把Amikacin翻譯為中文，用以補充原阿米卡星內容過短的遺憾。
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{{Infobox drug
{{Infobox drug
| Verifiedfields = changed
| Watchedfields = changed
| Watchedfields = changed
| verifiedrevid = 464364466
| verifiedrevid = 477165031
| image = Amikacin.svg
| type = mab
| width =
| image =
| alt =
| width =
| alt =
| image2 = Amikacin 3D ball-and-stick 4P20.png
| width2 =
| alt2 =
| caption =
| caption =

<!-- Monoclonal antibody data -->
| mab_type = mab
| source = zu/o
| target = {{le|血管內皮生長因子 A|Vascular endothelial growth factor A}}（VEGF-A）


<!-- Clinical data -->
<!-- Clinical data -->
| pronounce = {{IPAc-en|ˌ|b|ɛ|v|ə|ˈ|s|ɪ|zj|ʊ|m|æ|b}}<ref name="NIHp">{{cite web | title=Bevacizumab Injection: MedlinePlus Drug Information | url=https://www.nlm.nih.gov/medlineplus/druginfo/meds/a607001.html | agency=NLM.nih.gov | date=2014-02-28 | url-status=live | archive-url=https://web.archive.org/web/20140325065239/http://www.nlm.nih.gov/medlineplus/druginfo/meds/a607001.html | archive-date=2014-03-25 }}</ref>
| pronounce =
| tradename = Amikin、Amiglyde-V、Arikayce及其他
| tradename = Avastin及其他
| Drugs.com = {{drugs.com|monograph|amikacin-sulfate}}
| Drugs.com = {{drugs.com|monograph|bevacizumab}}
| MedlinePlus = a682661
| MedlinePlus = a607001
| DailyMedID = Amikacin
| DailyMedID = Bevacizumab
| pregnancy_AU = D
| pregnancy_AU = D
| pregnancy_AU_comment = <ref name="Drugs.com pregnancy">{{cite web | title=Amikacin Use During Pregnancy | website=Drugs.com | date= 2019-12-02 | url=https://www.drugs.com/pregnancy/amikacin.html | access-date=2020-03-13}}</ref>
| pregnancy_AU_comment = <ref name="Abevmy APM summary">{{cite web | title=Abevmy | website=Therapeutic Goods Administration (TGA) | date=2021-09-15 | url=https://www.tga.gov.au/apm-summary/abevmy | access-date=2021-09-17 | archive-date= 2021-09-16 | archive-url=https://web.archive.org/web/20210916174828/https://www.tga.gov.au/apm-summary/abevmy | url-status=live }}</ref><ref name="Drugs.com pregnancy">{{cite web | title=Bevacizumab Use During Pregnancy | website=Drugs.com | date=2019-07-30 | url=https://www.drugs.com/pregnancy/bevacizumab.html | access-date=2020-03-18 | archive-date= 2020-03-18 | archive-url=https://web.archive.org/web/20200318210058/https://www.drugs.com/pregnancy/bevacizumab.html | url-status=live }}</ref><ref name="Vegzelma APMDS" />
| pregnancy_category=
| pregnancy_category=
| routes_of_administration = [[肌肉注射]]、[[靜脈注射]]及口部吸入
| routes_of_administration = [[靜脈注射]]，{{le|玻璃體腔內注射|Intravitreal injection }}
| class =
| class = [[氨基糖苷類抗生素|胺基糖苷類抗生素]]
| ATC_prefix = L01
| ATCvet =
| ATC_prefix = D06
| ATC_suffix = FG01
| ATC_supplemental = {{ATC|S01|LA08}}
| ATC_suffix = AX12
| biosimilars = bevacizumab-adcd,<ref name="Vegzelma FDA label" /> bevacizumab-awwb,<ref name="Mvasi FDA label">{{cite web | title=Mvasi- bevacizumab-awwb injection, solution | website=DailyMed | date=2019-06-25 | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0a562b4e-67ce-4bab-852c-d9ee71e55fb8 | access-date=2020-03-18 | archive-date= 2020-07-27 | archive-url=https://web.archive.org/web/20200727174041/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0a562b4e-67ce-4bab-852c-d9ee71e55fb8 | url-status=live }}</ref> bevacizumab-bvzr,<ref name="Zirabev FDA label">{{cite web | title=Zirabev- bevacizumab-bvzr injection, solution | website=DailyMed | date=2020-01-27 | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=aa27acbd-d117-4350-aeee-17bc2e2c0ca4 | access-date= 2020 -03-18| archive-date=2020-07-27 | archive-url=https://web.archive.org/web/20200727174104/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=aa27acbd-d117-4350-aeee-17bc2e2c0ca4 | url-status=live }}</ref> bevacizumab-maly,<ref name="Alymsys FDA label">{{cite web | title=Alymsys- bevacizumab-maly injection, solution | website=DailyMed | date=2022-04-13 | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6b4040a2-a5c5-4ff0-ab45-935d7e49cf78 | access-date= 2022-04-20 | archive-date= 2022-06-10 | archive-url=https://web.archive.org/web/20220610024800/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6b4040a2-a5c5-4ff0-ab45-935d7e49cf78 | url-status=live }}</ref> bevacizumab-tnjn, Abevmy,<ref name="Abevmy EPAR" /> Alymsys,<ref name="Alymsys EPAR" /><ref name="Alymsys FDA label" /> Avzivi, Aybintio,<ref name="Aybintio EPAR" /> Bambevi,<ref name="Bambevi SBD" /> Bevacip,<ref name="AU biosimilar" /> Bevaciptin,<ref name="AU biosimilar" /> Equidacent,<ref name="Equidacent EPAR" /> Mvasi,<ref name="Mvasi EPAR" /> Onbevzi,<ref name="Onbevzi EPAR" /><ref name="Onbevzi APMDS" /> Oyavas,<ref name="Oyavas EPAR" /> Vegzelma,<ref name="Vegzelma FDA label" /><ref name="Vegzelma EPAR" /><ref name="Vegzelma APMDS" /> Zirabev<ref name="Zirabev EPAR" />
| ATC_supplemental = {{ATC|J01|GB06}}, {{ATC|S01|AA21}}, {{ATC|J01|RA06}}, {{ATCvet|D06|AX12}}, {{ATCvet|J01|GB06}}, {{ATCvet|S01|AA21}}, {{ATCvet|J01|RA06}}


<!-- Legal status -->
<!-- Legal status -->
| legal_AU = S4
| legal_AU = S4
| legal_AU_comment = <ref name="Abevmy APM summary" /><ref>{{cite web | title=AusPAR: Bevacizumab | website=Therapeutic Goods Administration (TGA) | date= 2022-02-02 | url=https://www.tga.gov.au/resources/auspar/auspar-bevacizumab-6 | access-date= 2022-06-12 | archive-date= 2022-05-31 | archive-url=https://web.archive.org/web/20220531202916/http://www.tga.gov.au/auspar/auspar-bevacizumab-6 | url-status=live }}</ref><ref name="Vegzelma APMDS">{{cite web | title=Vegzelma APMDS | website=Therapeutic Goods Administration (TGA) | date=2023-09-18 | url=https://www.tga.gov.au/resources/auspmd/vegzelma | access-date=2024-03-07 | archive-date=2024-01-02 | archive-url=https://web.archive.org/web/20240102021205/https://www.tga.gov.au/resources/auspmd/vegzelma | url-status=live }}</ref><ref name="Onbevzi APMDS">{{cite web | title=Onbevzi APMDS | website=Therapeutic Goods Administration (TGA) | date= 2024-02-06 | url=https://www.tga.gov.au/resources/auspmd/onbevzi | access-date=2024-03-07 | archive-date=2024-02-08 | archive-url=https://web.archive.org/web/20240208064548/https://www.tga.gov.au/resources/auspmd/onbevzi | url-status=live }}</ref><ref>https://www.tga.gov.au/resources/auspar/auspar-vegzelma</ref>
| legal_AU_comment = <ref>{{cite web | title=Prescription medicines: registration of new generic medicines and biosimilar medicines, 2017 | website=Therapeutic Goods Administration (TGA) | date=21 June 2022 | url=https://www.tga.gov.au/resources/publication/publications/prescription-medicines-registration-new-generic-medicines-and-biosimilar-medicines-2017 | access-date=2024-03-30}}</ref>
| legal_BR = <!-- OTC, A1, A2, A3, B1, B2, C1, C2, C3, C4, C5, D1, D2, E, F-->
| legal_BR = <!-- OTC, A1, A2, A3, B1, B2, C1, C2, C3, C4, C5, D1, D2, E, F-->
| legal_BR_comment =
| legal_BR_comment =
| legal_CA = <!-- OTC, Rx-only, Schedule I, II, III, IV, V, VI, VII, VIII -->
| legal_CA = Rx-only
| legal_CA_comment = /&nbsp;Schedule D<ref>{{cite web | title=Summary Basis of Decision for Vegzelma | website=[[Health Canada]] | date=2023-05-02 | url=https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1684869579695 | access-date= 2023-06-18 | archive-date=2024-03-10 | archive-url=https://web.archive.org/web/20240310055559/https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1684869579695 | url-status=live }}</ref><ref>{{cite web | title=Vegzelma Product information | website=[[Health Canada]] | date= 2023-01-03 | url=https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=102312 | access-date=2023-06-18 | archive-date=10 March 2024 | archive-url=https://web.archive.org/web/20240310055437/https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=102312 | url-status=live }}</ref>
| legal_CA_comment =
| legal_DE = <!-- Anlage I, II, III or Unscheduled-->
| legal_DE = <!-- Anlage I, II, III or Unscheduled-->
| legal_DE_comment =
| legal_DE_comment =
| legal_NZ = <!-- Class A, B, C -->
| legal_NZ = <!-- Class A, B, C -->
| legal_NZ_comment =
| legal_NZ_comment =
| legal_UK = <!-- GSL, P, POM, CD, CD Lic, CD POM, CD No Reg POM, CD (Benz) POM, CD (Anab) POM or CD Inv POM / Class A, B, C -->
| legal_UK = POM
| legal_UK_comment =
| legal_UK_comment = <ref>{{cite web | title=Amikacin 250 mg/ml Injection - Summary of Product Characteristics (SmPC) | website=(emc) | date=16 September 2015 | url=https://www.medicines.org.uk/emc/medicine/619 | access-date=2020-03-13}}</ref>
| legal_US = Rx-only
| legal_US = Rx-only
| legal_US_comment = <ref name="Arikayce FDA label" />
| legal_US_comment = <ref name="Avastin FDA label" /><ref name="Mvasi FDA label" /><ref name="Zirabev FDA label" /><ref name="Alymsys FDA label" /><ref name="Vegzelma FDA label" />
| legal_EU = Rx-only
| legal_EU = Rx-only
| legal_EU_comment = <ref name="Avastin EPAR" /><ref name="Mvasi EPAR" /><ref name="Zirabev EPAR" /><ref name="Aybintio EPAR" /><ref name="Equidacent EPAR" /><ref name="Alymsys EPAR" /><ref name="Onbevzi EPAR" /><ref name="Abevmy EPAR" /><ref name="Oyavas EPAR" /><ref name="Vegzelma EPAR" />
| legal_EU_comment = <ref name="Arikayce liposomal EPAR">{{cite web | title=Arikayce liposomal EPAR | website=European Medicines Agency | date=21 July 2020 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/arikayce-liposomal | access-date=2023-03-04}}</ref><ref>{{cite web | title=Arikayce liposomal Product information | website=Union Register of medicinal products | url=https://ec.europa.eu/health/documents/community-register/html/h1469.htm | access-date=2023-03-03}}</ref>
| legal_UN = <!-- N I, II, III, IV / P I, II, III, IV-->
| legal_UN = <!-- N I, II, III, IV / P I, II, III, IV-->
| legal_UN_comment =
| legal_UN_comment =
| legal_status = <!--For countries not listed above-->
| legal_status = Rx-only


<!-- Pharmacokinetic data -->
<!-- Pharmacokinetic data -->
| bioavailability = >90%<ref name="plumb"/>
| bioavailability = 100% (靜脈注射)
| protein_bound = 0–11%
| protein_bound =
| metabolism = 幾乎不會被代謝
| metabolism =
| metabolites =
| metabolites =
| onset =
| onset =
| elimination_half-life = 2–3小時
| elimination_half-life = 20天 (範圍: 11–50天)
| duration_of_action =
| duration_of_action =
| excretion = [[腎]]臟
| excretion =


<!-- Identifiers -->
<!-- Identifiers -->
| index2_label = as salt
| CAS_number_Ref = {{cascite|correct|??}}
| CAS_number_Ref = {{cascite|correct|??}}
| CAS_number = 37517-28-5
| CAS_number = 216974-75-3
| CAS_supplemental =
| CAS_supplemental =
| PubChem = 37768
| PubChem =
| IUPHAR_ligand =
| IUPHAR_ligand =
| DrugBank_Ref = {{drugbankcite|correct|drugbank}}
| DrugBank_Ref = {{drugbankcite|correct|drugbank}}
| DrugBank = DB00479
| DrugBank = DB00112
| ChemSpiderID_Ref = {{chemspidercite|correct|chemspider}}
| ChemSpiderID_Ref = {{chemspidercite|changed|chemspider}}
| ChemSpiderID = 34635
| ChemSpiderID = none
| UNII_Ref = {{fdacite|correct|FDA}}
| UNII_Ref = {{fdacite|correct|FDA}}
| UNII = 84319SGC3C
| UNII = 2S9ZZM9Q9V
| KEGG_Ref = {{keggcite|correct|kegg}}
| KEGG_Ref = {{keggcite|correct|kegg}}
| KEGG = D02543
| KEGG = D06409
| ChEBI_Ref =
| KEGG2_Ref = {{keggcite|correct|kegg}}
| ChEBI =
| KEGG2 = D00865
| ChEBI_Ref = {{ebicite|correct|EBI}}
| ChEMBL_Ref = {{ebicite|changed|EBI}}
| ChEBI = 2637
| ChEMBL = 1201583
| NIAID_ChemDB =
| ChEMBL_Ref = {{ebicite|correct|EBI}}
| ChEMBL = 177
| NIAID_ChemDB =
| PDB_ligand =
| PDB_ligand =
| synonyms =
| synonyms =


<!-- Chemical and physical data -->
<!-- Chemical and physical data -->
| IUPAC_name =
| IUPAC_name = (2''S'')-4-Amino-''N''-[(2''S'',3''S'',4''R'',5''S'')-5-amino-2-[(2''S'',3''R'',4''S'',5''S'',6''R'')-4-amino-3,5-dihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy-4-[(2''R'',3''R'',4''S'',5''R'',6''R'')-6-(aminomethyl)-3,4,5-trihydroxy-oxan-2-yl]oxy-3-hydroxy-cyclohexyl]-2-hydroxybutanamide
| C=22 | H=43 | N=5 | O=13
| C=6638 | H=10160 | N=1720 | O=2108 | S=44
| SMILES =
| SMILES = O=C(N[C@H]3[C@H](O[C@H]1O[C@@H]([C@@H](O)[C@H](N)[C@H]1O)CO)[C@@H](O)[C@H](O[C@H]2O[C@H](CN)[C@@H](O)[C@H](O)[C@H]2O)[C@@H](N)C3)[C@@H](O)CCN
| StdInChI =
| StdInChI_Ref = {{stdinchicite|correct|chemspider}}
| StdInChI_comment =
| StdInChI = 1S/C22H43N5O13/c23-2-1-8(29)20(36)27-7-3-6(25)18(39-22-16(34)15(33)13(31)9(4-24)37-22)17(35)19(7)40-21-14(32)11(26)12(30)10(5-28)38-21/h6-19,21-22,28-35H,1-5,23-26H2,(H,27,36)/t6-,7+,8-,9+,10+,11-,12+,13+,14+,15-,16+,17-,18+,19-,21+,22+/m0/s1
| StdInChI_comment =
| StdInChIKey =
| density =
| StdInChIKey_Ref = {{stdinchicite|correct|chemspider}}
| density_notes =
| StdInChIKey = LKCWBDHBTVXHDL-RMDFUYIESA-N
| density =
| melting_point =
| density_notes =
| melting_high =
| melting_point =
| melting_notes =
| melting_high =
| boiling_point =
| melting_notes =
| boiling_notes =
| boiling_point =
| solubility =
| boiling_notes =
| sol_units =
| specific_rotation =
| solubility =
| sol_units =
| specific_rotation =
}}
}}


'''貝伐珠單抗'''（{{lang-en|Bevacizumab}}）以Avastin（中文名稱有癌思停，或安維汀）商品名於市面銷售，是一種[[單株抗體]]藥物，用於治療一些類型的[[癌症]]和特定的眼部疾病。<ref name=AHFS2016/><ref name="Avastin FDA label">{{cite web | title=Avastin- bevacizumab injection, solution | website=DailyMed | date=2019 -06-28| url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=939b5d1f-9fb2-4499-80ef-0607aa6b114e | access-date= 2020-03-18 | archive-date=2020-07-27 | archive-url=https://web.archive.org/web/20200727174050/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=939b5d1f-9fb2-4499-80ef-0607aa6b114e | url-status=live }}</ref>透過緩慢注射到靜脈（[[靜脈注射]]）給藥，用於治療[[大腸癌]]、[[肺癌]]、[[卵巢癌]]、[[膠質母細胞瘤]]和{{le|腎細胞癌|Renal cell carcinoma}}。<ref>{{cite web | title=Bevacizumab | website=National Cancer Institute | date=2006-10-05 | url=https://www.cancer.gov/about-cancer/treatment/drugs/bevacizumab | access-date= 2023 -12-22| archive-date=2020-04-10 | archive-url=https://web.archive.org/web/20200410064746/https://www.cancer.gov/about-cancer/treatment/drugs/bevacizumab | url-status=live }}</ref>它是用於治療許多此類疾病的一線藥物。<ref name=AHFS2016/><ref name="Avastin FDA label" />對於老年性[[黃斑變性|黃斑部病變]]，係透過注射到眼睛（{{le|玻璃體腔內注射|Intravitreal injection }}）進行治療。<ref name=AHFS2016/>
'''阿米卡星'''（{{lang-en|Amikacin}}）是一種[[抗生素]]藥物，用於治療多種[[病原細菌]][[感染]],<ref name=AHFS2016>{{cite web|url=https://www.drugs.com/monograph/amikacin-sulfate.html|title=Amikacin Sulfate|publisher=The American Society of Health-System Pharmacists|access-date=2016-12-08|url-status=live|archive-url=https://web.archive.org/web/20161220231044/https://www.drugs.com/monograph/amikacin-sulfate.html|archive-date= 2016-12-20}}</ref>包括[[敗血性關節炎]]、{{le|腹腔內感染|intra-abdominal infection}}、[[腦膜炎]]、[[肺炎]]、[[敗血症]]和[[泌尿道感染]]。<ref name=AHFS2016/>它也用於治療{{le|多重抗藥性結核病|Multidrug-resistant tuberculosis}}。<ref name=WHO2008>{{cite book | title = WHO Model Formulary 2008 | year = 2009 | isbn = 9789241547659 | vauthors = ((World Health Organization)) | veditors = Stuart MC, Kouimtzi M, Hill SR | hdl = 10665/44053 | author-link = World Health Organization | publisher = World Health Organization | hdl-access=free |page=137}}</ref>此藥物經由[[靜脈注射]]、[[肌肉注射]]及口部吸入方式使用。<ref name=AHFS2016/>


於治療癌症時常見的副作用有[[流鼻血]]、[[頭痛]]、[[高血壓]]和[[皮疹]。<ref name=AHFS2016/>其他嚴重副作用有[[腸胃穿孔]]、出血、[[過敏反應]]、[[血栓]]和[[感染]]風險升高。<ref name=AHFS2016/>用於治療眼部疾病時，可能的副作用有[[視覺障礙]]和[[視網膜剝離]]。<ref name=AHFS2016/>貝伐珠單抗是一種單株抗體，具有{{le|血管生成抑制劑|angiogenesis inhibitor}}的作用。<ref name=AHFS2016/>它透過抑制{{le|血管內皮生長因子|Vascular endothelial growth factor A|血管內皮生長因子 A}} (VEGF-A) 來減緩[[血管新生]]，是一種{{le|抗血管內皮生長因子療法|Anti-VEGF}} 。<ref name=AHFS2016/>
阿米卡星與其他[[氨基糖苷类抗生素|胺基糖苷類藥物]]一樣，會導致聽力損失、身體平衡問題和[[腎功能衰竭]]。<ref name=AHFS2016/>其他的副作用有[[癱瘓]]（導致無法呼吸）。<ref name=AHFS2016/>如果個體在[[姙娠|懷孕]]期間使用，出生的後代可能會永久性失聰。<ref name=AHFS2016/><ref name="Drugs.com pregnancy" />阿米卡星是透過阻斷細菌[[30S核糖體亞基]]的功能，使其無法產生蛋白質而發揮作用。<ref name=AHFS2016/>

貝伐珠單抗於2004年在[[美國]]被批准用於醫療用途。<ref>{{cite web | title=Drug Approval Package: Avastin (Bevacizum) NDA #125085 | website=U.S. [[Food and Drug Administration]] (FDA) | date=2005-03-08 | url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/STN-125085_Avastin.cfm | access-date=2021-12-29 | archive-date=2021-04-08 | archive-url=https://web.archive.org/web/20210408212614/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/STN-125085_Avastin.cfm | url-status=live }}</ref><ref name=AHFS2016>{{cite web|title=Bevacizumab|url=https://www.drugs.com/monograph/bevacizumab.html|publisher=The American Society of Health-System Pharmacists|access-date=2016-12-08|url-status=live|archive-url=https://web.archive.org/web/20161220192620/https://www.drugs.com/monograph/bevacizumab.html|archive-date= 2016-12-20}}</ref>它已被列入[[世界衛生組織基本藥物標準清單]]之中，<ref name="WHO21st">{{cite book | vauthors = ((World Health Organization)) | title = World Health Organization model list of essential medicines: 21st list 2019 | year = 2019 | hdl = 10665/325771 | author-link = World Health Organization | publisher = World Health Organization | location = Geneva | id = WHO/MVP/EMP/IAU/2019.06. License: CC BY-NC-SA 3.0 IGO | hdl-access=free }}</ref><ref name="WHO22nd">{{cite book | vauthors = ((World Health Organization)) | title = World Health Organization model list of essential medicines: 22nd list (2021) | year = 2021 | hdl = 10665/345533 | author-link = World Health Organization | publisher = World Health Organization | location = Geneva | id = WHO/MHP/HPS/EML/2021.02 | hdl-access=free }}</ref><ref name="WHO23rd">{{cite book | vauthors = ((World Health Organization)) | title = The selection and use of essential medicines 2023: web annex A: World Health Organization model list of essential medicines: 23rd list (2023) | year = 2023 | hdl = 10665/371090 | author-link = World Health Organization | publisher = World Health Organization | location = Geneva | id = WHO/MHP/HPS/EML/2023.02 | hdl-access=free }}</ref>用於治療眼部疾病。<ref name="WHO21st" /><ref name="WHO22nd" />


==醫療用途==
==醫療用途==
===大腸癌===
阿米卡星最常用於治療嚴重性多重抗藥性與需氧[[革蘭氏陰性菌]]的感染，後者細菌特別指[[假單胞菌屬]]、[[不動桿菌屬]]、[[腸桿菌屬]]、[[大腸桿菌]]、[[變形桿菌屬]]、[[克雷伯氏菌屬]]和[[沙雷氏菌屬]]。<ref name="Amikacin sulfate FDA label">{{cite web | title=Amikacin sulfate injection, solution | website=DailyMed | date= 2019-4-10 | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c0f57839-1c9b-49e5-8c7a-708e2d16495d | access-date=2020-05-13}}</ref>少數會受阿米卡星強烈影響的[[革蘭氏陽性菌]]有[[葡萄球菌屬]]<ref name="Amikacin sulfate FDA label" />及[[諾卡氏菌屬]]兩種。 <ref>{{cite book | vauthors = Scholar EM, Pratt WB | title=The Antimicrobial Drugs | date=2000-05-22 | pages=15–19 | url=https://books.google.com/books?id=gACeB8XCnpgC&pg=PA15 | edition=2nd | publisher=Oxford University Press, USA | isbn=978-0-19-975971-2 | url-status=live | archive-url=https://web.archive.org/web/20170910172330/https://books.google.com/books?id=gACeB8XCnpgC&pg=PA15 | archive-date=2017-09-10 }}</ref>在第一線藥物無法控制非結核[[分枝桿菌屬]]感染和[[結核病]]感染（且如果是對阿米卡星效力敏感的菌株所引起）時，也可使用阿米卡星治療。<ref name=AHFS2016 />此種藥物在治療時很少會單獨使用。<ref name=cunha>{{cite journal | vauthors = Cunha BA | title = New uses for older antibiotics: nitrofurantoin, amikacin, colistin, polymyxin B, doxycycline, and minocycline revisited | journal = The Medical Clinics of North America | volume = 90 | issue = 6 | pages = 1089–1107 | date = November 2006 | pmid = 17116438 | doi = 10.1016/j.mcna.2006.07.006 | series = Antimicrobial Therapy | s2cid = 30373734 }}</ref>
貝伐珠單抗於2004年2月在美國獲得批准，於標準[[化學療法|化療]]時共同治療轉移性大腸癌（作為一線治療）。<ref name=":1">{{cite journal | vauthors = Cohen MH, Gootenberg J, Keegan P, Pazdur R | title = FDA drug approval summary: bevacizumab plus FOLFOX4 as second-line treatment of colorectal cancer | journal = The Oncologist | volume = 12 | issue = 3 | pages = 356–61 | date = March 2007 | pmid = 17405901 | doi = 10.1634/theoncologist.12-3-356 | s2cid = 21241228 | doi-access = free }}</ref>於2006年6月被核准與以[[5-氟尿嘧啶]]為基礎的療法，作為治療轉移性大腸癌的二線療法。<ref name=":1"/>


它於2005年1月被[[歐洲藥品管理局]]（EMA）批准用於治療大腸癌。<ref name="EMA_2005" /><ref name="Avastin EPAR">{{cite web | title=Avastin EPAR | website=[[European Medicines Agency]] (EMA) | date= 2020-03-11 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/avastin | access-date=2020-03-18 | archive-date=2020-03-18 | archive-url=https://web.archive.org/web/20200318210110/https://www.ema.europa.eu/en/medicines/human/EPAR/avastin | url-status=live }}</ref>
阿米卡星常用於治療下述疾病：<ref name=AHFS2016 />


貝伐珠單抗也被研究作為非轉移性結腸癌患者化療藥物的補充。兩項大型隨機研究的數據顯示在預防癌症復發方面未產生益處，且可能會造成傷害。<ref>{{cite journal | vauthors = Van Cutsem E, Lambrechts D, Prenen H, Jain RK, Carmeliet P | title = Lessons from the adjuvant bevacizumab trial on colon cancer: what next? | journal = Journal of Clinical Oncology | volume = 29 | issue = 1 | pages = 1–4 | date = January 2011 | pmid = 21115866 | doi = 10.1200/JCO.2010.32.2701 | doi-access = free }}</ref>
*[[支氣管擴張]]<ref name=medscape>{{cite web | work=Medscape | title=amikacin (Rx) | publisher=WebMD | access-date=2017-08-09 | url=http://reference.medscape.com/drug/amikin-amikacin-342516#0 | url-status=live | archive-url=https://web.archive.org/web/20170809083119/http://reference.medscape.com/drug/amikin-amikacin-342516 | archive-date=2017-08-09 }}</ref>
*骨骼和關節感染
*與[[替卡西林]]共同使用，治療[[癌症]]患者的[[粒細胞]]減少症<ref name="aronson">{{cite book |editor=Aronson J. K.| title=Meyler's Side Effects of Drugs | chapter=Amikacin | location=Oxford | date=2016 | edition=16th | publisher=Elsevier | isbn=978-0-444-53716-4 | pages=207–209}}</ref>
*作為其他藥物（如[[克林黴素]]、[[甲硝唑]]、{{le|哌拉西林/他唑巴坦|piperacillin/tazobactam}}或{{le|氨芐西林/舒巴坦|ampicillin/sulbactam}}）的輔助藥物，用於治療腹腔內感染（如[[腹膜炎]]）
*腦膜炎
*分枝桿菌屬感染，包括用作治療活動性結核病的二線藥物。<ref>{{cite book | vauthors = Vardanyan R, Hruby V | title=Synthesis of Best-Seller Drugs | chapter=Chapter 32: Antimicobacterial Drugs | location=Boston| date=2016| publisher=Academic Press | isbn=978-0-12-411492-0 | pages=669–675}}</ref>它也用於治療由{{le|鳥分枝菌群|Mycobacterium avium complex}}、{{le|膿腫分枝桿菌|Mycobacteroides abscessus}}、{{le|龜分枝菌群|Mycobacteroides chelonae}}和{{le|偶發分枝菌群|Mycobacterium fortuitum}}的感染。
*{{le|玫瑰紅球菌|Rhodococcus equi }}所引起類似結核病的感染
*呼吸道感染，包括作為[[β-內醯胺]]類或[[碳青黴烯]]類藥物的輔助藥物，用以治療{{le|院內型肺炎|hospital-acquired pneumonia}}
*敗血症，包括新生兒敗血症，<ref name="Amikacin sulfate FDA label" />作為β-內酰胺類或碳青黴烯類藥物的輔助藥物
*皮膚和手術縫合部位感染<ref name="Amikacin sulfate FDA label" />
*對毒性較低藥物具有抗藥性的細菌所引起的泌尿道感染（通常是[[腸桿菌科]]細菌或[[綠膿桿菌]]）


在歐盟，貝伐珠單抗與基於{{le|氟嘧啶|fluoropyrimidine}}的化療合併，可用於治療成人轉移性大腸癌。<ref name="Equidacent EPAR" />
阿米卡星可與β-內酰胺類抗生素聯合針對[[嗜中性白血球低下]]和[[發燒]]患者進行{{le|經驗治療|empiric therapy}}。<ref name=AHFS2016 />


===懸浮液吸入劑===
===眼部疾病===
許多眼部疾病，如老年性黃斑部病變和[[糖尿病視網膜病變]]都會損害[[視網膜]]。當視網膜周圍的血管異常生長並滲漏液體，而導致視網膜層剝離時，會導致失明。這種異常生長是由血管內皮生長因子（VEGF）所引起，由於貝伐珠單抗可成功抑制VEGF，而減緩這種生長。<ref name="pmid29398697"/>
[[美國]]<ref name="FDA PR">{{cite press release |title=FDA approves a new antibacterial drug to treat a serious lung disease using a novel pathway to spur innovation |url=https://www.fda.gov/news-events/press-announcements/fda-approves-new-antibacterial-drug-treat-serious-lung-disease-using-novel-pathway-spur-innovation |website=U.S. [[Food and Drug Administration]] (FDA) |access-date=2018-11-12 }} {{PD-notice}}</ref><ref name="Arikayce FDA label">{{cite web | title=Arikayce- amikacin suspension | website=DailyMed | date= 2018-09-30 | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=499ab990-2b21-474f-aaba-d86388965f40 | access-date= 2020-03-13}}</ref>和[[歐盟]]<ref name="Arikayce liposomal EPAR" />也批准使用含阿米卡星的[[脂質體]]懸浮液吸入劑，用於治療鳥分枝菌群感染。


貝伐珠單抗已被眼科醫生以[[仿單標示外使用]]，作為玻璃體腔內注射劑，以治療眼部血管增殖性疾病，特別是治療黃斑部病變中的{{le|脈絡膜新生血管|choroidal neovascular membrane}} (CNV)。將1.25–2.5毫克貝伐珠單抗注射入玻璃體腔內，並沒出現明顯的眼內毒性。<ref>{{cite journal | vauthors = Arevalo JF, Fromow-Guerra J, Sanchez JG, Maia M, Berrocal MH, Wu L, Saravia MJ, Costa RA | title = Primary intravitreal bevacizumab for subfoveal choroidal neovascularization in age-related macular degeneration: results of the Pan-American Collaborative Retina Study Group at 12 months follow-up | journal = Retina | volume = 28 | issue = 10 | pages = 1387–1394 | year = 2008 | pmid = 18827735 | doi = 10.1097/IAE.0b013e3181884ff4 | s2cid = 8694305 }}</ref>許多視網膜專家注意到在CNV、增殖性糖尿病視網膜病變、新生血管性[[青光眼]]、糖尿病[[黃斑水腫]]、[[早產兒視網膜病變]]<ref>{{cite journal | vauthors = Azad R, Chandra P | title = Intravitreal bevacizumab in aggressive posterior retinopathy of prematurity | journal = Indian Journal of Ophthalmology | volume = 55 | issue = 4 | pages = 319; author reply 320 | year = 2007 | pmid = 17595491 | doi = 10.4103/0301-4738.33057 | doi-access = free }}</ref>和於{{le|中心視網膜靜脈阻塞|Central retinal vein occlusion}}而繼發的黃斑水腫方面取得相當顯著的結果。<ref name="pmid29398697">{{cite journal | vauthors = Fogli S, Del Re M, Rofi E, Posarelli C, Figus M, Danesi R | title = Clinical pharmacology of intravitreal anti-VEGF drugs | journal = Eye | volume = 32 | issue = 6 | pages = 1010–1020 | date = June 2018 | pmid = 29398697 | pmc = 5997665 | doi = 10.1038/s41433-018-0021-7 }}</ref>
===特定人口群組===
對於老年人和兒童，由於老年人通常會出現隨年齡增長而有的腎功能下降，而兒童則為腎臟尚未發育完全，而應採小劑量治療方式。此藥物在美國和[[澳大利亞]]被歸類為妊娠類別D，表示有可能會傷害胎兒。<ref name="FDA PR" />


===卵巢癌===
阿米卡星於人體內的分布容積、清除率以及對特殊人群的影響如下述：
[[美國食品藥物管理局]]（FDA）於2018年核准貝伐珠單抗合併化療用於初次手術後的III期或IV期卵巢癌患者，然後再單獨使用貝伐珠單抗。前述核准是根據一項增加貝伐珠單抗與[[卡鉑]]和[[紫杉醇]]合併使用的研究結果。<ref name="FDA-ovarian cancer">{{cite web |url=https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-bevacizumab-combination-chemotherapy-ovarian-cancer |title=FDA approves bevacizumab in combination with chemotherapy for ovarian cancer |date=2018-06-13 |website=U.S. [[Food and Drug Administration]] (FDA) |access-date=4 August 2018 |archive-date=2020-03-18 |archive-url=https://web.archive.org/web/20200318201628/https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-bevacizumab-combination-chemotherapy-ovarian-cancer |url-status=live }} {{PD-notice}}</ref>患者無惡化存活期可從13個月延長至18個月。<ref name="FDA-ovarian cancer"/>


在歐盟，貝伐單抗與卡鉑和紫杉醇聯合適用於晚期上皮性卵巢癌、[[輸卵管瘤|輸卵管癌]]或原發性腹膜癌成人患者的一線治療。<ref name="Equidacent EPAR" />貝伐珠單抗與卡鉑和[[吉西他濱]]聯用，或與卡鉑和紫杉醇聯用，適用於治療鉑類敏感上皮性卵巢癌、輸卵管癌或原發性腹膜癌首次復發，且未接受過貝伐珠單抗，或其他VEGF抑制劑，或VEGF受體標靶藥物治療的成人患者。<ref name="Equidacent EPAR" />
*一般來說，應避免將阿米卡星用於嬰兒身上。<ref name=ettinger>{{cite book | vauthors = Ettinger SJ, Feldman EC | title=Textbook of Veterinary Internal Medicine | date=2009-12-24 | pages=1976, 523 | url=https://books.google.com/books?id=4Qzau1jagOYC&pg=PA1976 | publisher=Elsevier Health Sciences | isbn=978-1-4377-0282-8 | url-status=live | archive-url=https://web.archive.org/web/20170910172330/https://books.google.com/books?id=4Qzau1jagOYC&pg=PA1976 | archive-date=2017-09-10 }}</ref>嬰兒由於細胞外液濃度較高，其藥物分布容積也往往更大，會含有更多胺基糖苷類藥物。<ref name="plumb" >{{cite book | vauthors = Plumb DC | title=Plumb's Veterinary Drug Handbook | chapter=Amikacin Sulfate | location=Stockholm, Wisconsin; Ames, Iowa | date=2011 | edition=7th | publisher=Wiley | isbn=978-0-470-95964-0 | pages=39–43}}</ref>
*阿米卡星於老年人體內的停留時間往往更長。 20歲患者的阿米卡星平均清除率為每小時6升，而80歲患者則為每小時3升。<ref name=maire>{{cite book | vauthors = Maire P, Bourguignon L, Goutelle S, Ducher M, Jelliffe R | chapter=Chapter 20 – Individualizing Drug Therapy in the Elderly | veditors = Jelliffe RW, Neely M | title=Individualized Drug Therapy for Patients | location=Boston | date=2017 | publisher=Academic Press | isbn=978-0-12-803348-7 | pages=373–382}}</ref>
*[[囊腫性纖維化]]患者的清除率則更高。<ref name="eghianruwa">{{cite book | vauthors = Eghianruwa K | title=Essential Drug Data for Rational Therapy in Veterinary Practice | date=2014 | page=16 | url=https://books.google.com/books?id=h4zCAgAAQBAJ&pg=PA16 | publisher=Author House | isbn=978-1-4918-0000-3 | url-status=live | archive-url=https://web.archive.org/web/20170910172330/https://books.google.com/books?id=h4zCAgAAQBAJ&pg=PA16 | archive-date= 2017-09-10 }}</ref>
*對於患有肌肉疾患，如[[重症肌無力症]]或[[帕金森氏症]]等的患者，阿米卡星的神經肌肉銜接阻滯作用可能會加劇肌肉無力症状。<ref name=AHFS2016/>


FDA於2020年5月擴大[[奧拉帕利]]的適應症，加入貝伐珠單抗，作為一線{{le|維持治療|maintenance treatment}}成人晚期上皮性卵巢癌、輸卵管癌或原發性腹膜癌的藥物。 適用對象為接受一線鉑方案化療後，腫瘤完全緩解或部分緩解的患者，且癌症與同源重組修復缺陷 (homologous recombination deficiency) 陽性相關，由有害或疑似有害的 {{le|BRCA突變|BRCA mutation}}或基因組不穩定性所定義。<ref>{{cite press release | title=FDA approves olaparib plus bevacizumab as maintenance treatment for ovarian, fallopian tube, or primary peritoneal cancers | website=U.S. [[Food and Drug Administration]] (FDA) | date=2020-05-08 | url=https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-olaparib-plus-bevacizumab-maintenance-treatment-ovarian-fallopian-tube-or-primary | access-date=2020-10-12 | archive-date=2020-10-26 | archive-url=https://web.archive.org/web/20201026161721/https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-olaparib-plus-bevacizumab-maintenance-treatment-ovarian-fallopian-tube-or-primary | url-status=live }} {{PD-notice}}</ref>
==不良影響==
阿米卡星的副作用與其他胺基糖苷類藥物相似。{{le|腎毒性|Nephrotoxicity}}和{{le|耳毒性|ototoxicity }}（可導致聽力損失）是最重要的影響，會發生在1-10%的使用者身上。<ref name=medscape />腎毒性和耳毒性被認為是由於胺基糖苷類藥物容易在腎臟和[[內耳]]中累積所致。<ref name=plumb />
[[File:Gray920.png|thumb|人類內耳圖，阿卡米星會對[[耳蝸]]及[[耳前庭]]造成損害。|300x300px]]


===子宮頸癌===
如果使用較高劑量或使用時間超過建議時，可能會導致神經毒性。
在歐盟，貝伐珠單抗與紫杉醇和[[順鉑]]聯用，或在無法接受鉑類治療的患者中與紫杉醇和[[托普樂肯]]聯用，用於治療患有持續性、復發性或轉移性子宮頸癌的成人患者。<ref name="Equidacent EPAR" />


===老年黃斑部病變治療===
含阿米卡星脂質體懸浮液吸入劑的處方資訊中列有[[黑框警告]]，指出使用將涉及有關呼吸系統疾病風險增加，包括過敏性肺炎、支氣管痙攣、潛在肺部疾病惡化和[[咳血]]，且在某些情況下需住院治療。<ref name="FDA PR" /><ref name="Arikayce FDA label" />使用此類吸入劑的患者的其他常見副作用有[[聲音嘶啞]]、[[咳嗽]]、耳毒性、上呼吸道不適、肌肉骨骼疼痛、疲勞、[[腹瀉]]和[[噁心]]。<ref name="FDA PR" /><ref name="Arikayce FDA label" />
美國Philip Rosenfeld醫生開發貝伐珠單抗的仿單標示外使用，用於治療老年性黃斑部病變。<ref>{{cite journal | vauthors = Rosenfeld PJ, Reichel E | title = The Path to Intravitreal Bevacizumab. | journal = Retina Today | date = May–June 2009 | pages = 26–29 | url = https://retinatoday.com/articles/2009-may-june/0609_05-php | access-date = 21 September 2021 | archive-date = 2021-09-21 | archive-url = https://web.archive.org/web/20210921054455/https://retinatoday.com/articles/2009-may-june/0609_05-php | url-status = live }}</ref><ref name="pmid18785551">{{cite journal | vauthors = Sun XD, Xu WQ, Rosenfeld PJ | title = [Therapeutic efficacy and safety of off-label use of Bevacizumab for the treatment of neovascular diseases of the eye] | language = Chinese | journal = [Zhonghua Yan Ke Za Zhi] Chinese Journal of Ophthalmology | volume = 44 | issue = 3 | pages = 281–4 | date = March 2008 | pmid = 18785551 | doi = | url = }}</ref>貝伐珠單抗也同樣被仿單標示外使用，以治療新生血管性黃斑部病變。<ref name="pmid36358978">{{cite journal | vauthors = ElSheikh RH, Chauhan MZ, Sallam AB | title = Current and Novel Therapeutic Approaches for Treatment of Neovascular Age-Related Macular Degeneration | journal = Biomolecules | volume = 12 | issue = 11 | date = November 2022 | page = 1629 | pmid = 36358978 | pmc = 9688017 | doi = 10.3390/biom12111629 | doi-access = free }}</ref>


==禁忌症==
==不良影響==
貝伐珠單抗可抑制血管生長，而血管生長是身體正常癒合和維持的一個環節。身體在[[傷口癒合]]過程中會生長出新血管，作為受阻塞或[[動脈粥狀硬化]]血管周圍的{{le|側支循環|collateral circulation}}用途。因貝伐珠單抗會干擾這些正常過程，而引發會導致[[冠狀動脈疾病]]或[[週邊動脈阻塞]]病情惡化的擔憂。<ref>{{cite journal | vauthors = Semenza GL | title = A new weapon for attacking tumor blood vessels | journal = The New England Journal of Medicine | volume = 358 | issue = 19 | pages = 2066–7 | date = May 2008 | pmid = 18463385 | doi = 10.1056/NEJMcibr0800272 }}</ref>
對任何胺基糖苷類藥物敏感的患者應避免使用，因為阿米卡星會引發交叉過敏性。對[[亞硫酸鹽]]敏感的人也應避免使用（在氣喘患者中更為常見），<ref name="Amikacin sulfate FDA label" />因為大多數阿米卡星通常含有[[焦亞硫酸鈉]]，可能會引起過敏反應。<ref name=AHFS2016 />


主要副作用是[[高血壓]]和出血風險增加。有因而胃腸穿孔的報告。<ref>{{cite journal | vauthors = Sliesoraitis S, Tawfik B | title = Bevacizumab-induced bowel perforation | journal = The Journal of the American Osteopathic Association | volume = 111 | issue = 7 | pages = 437–41 | date = July 2011 | pmid = 21803880 }}</ref>疲勞和感染也很常見。<ref>{{cite web |url=http://www.gene.com/download/pdf/avastin_prescribing.pdf |title = AVASTIN (bevacizumab) injection, for intravenous use | publisher = Genentech, Inc. |access-date=e 2016-06-02 |url-status=live |archive-url=https://web.archive.org/web/20160429054035/http://www.gene.com/download/pdf/avastin_prescribing.pdf |archive-date=2016-04-29 }}</ref>
一般來說，阿米卡星不應與另一種可引起神經毒性、耳毒性或腎毒性的藥物一起使用，或在其之前/之後使用。此類藥物包括其他胺基糖苷類藥物、[[阿昔洛韋]]（抗病毒）、[[兩性黴素B]]（抗真菌）、[[桿菌肽]]（抗生素）、{{le|捲曲黴素|capreomycin}}、[[粘菌素]]、[[多粘菌素B]]和[[萬古黴素]]，以及用於[[化學療法]]的[[順鉑]]。<ref name=AHFS2016 />
在晚期肺癌患者中，接受貝伐珠單抗治療的患者中<ref>{{cite journal | vauthors = Velcheti V, Viswanathan A, Govindan R | title = The proportion of patients with metastatic non-small cell lung cancer potentially eligible for treatment with bevacizumab: a single institutional survey | journal = Journal of Thoracic Oncology | volume = 1 | issue = 5 | pages = 501 | date = June 2006 | pmid = 17409907 | doi = 10.1097/01243894-200606000-00023 }}</ref><ref>{{cite journal | vauthors = Vaughn C, Zhang L, Schiff D | title = Reversible posterior leukoencephalopathy syndrome in cancer | journal = Current Oncology Reports | volume = 10 | issue = 1 | pages = 86–91 | date = January 2008 | pmid = 18366965 | doi = 10.1007/s11912-008-0013-z | s2cid = 40332552 }}</ref>有{{le|鼻中隔穿孔|Nasal septum perforation}}和腎{{le|血栓性微血管病變|Thrombotic microangiopathy }}的報告。<ref>{{cite journal | vauthors = Eremina V, Jefferson JA, Kowalewska J, Hochster H, Haas M, Weisstuch J, Richardson C, Kopp JB, Kabir MG, Backx PH, Gerber HP, Ferrara N, Barisoni L, Alpers CE, Quaggin SE | title = VEGF inhibition and renal thrombotic microangiopathy | journal = The New England Journal of Medicine | volume = 358 | issue = 11 | pages = 1129–36 | date = March 2008 | pmid = 18337603 | pmc = 3030578 | doi = 10.1056/NEJMoa0707330 }}</ref>


[[羅氏]]公司於2013年宣布該藥物與1997年至2012年期間發生的52例[[壞死性筋膜炎]]有關，其中17名患者死亡。<ref>{{cite news|url=http://www.cbc.ca/news/health/story/2013/05/02/avastin-flesh-eating-disease.html|title=Cancer drug Avastin tied to 2 cases of flesh-eating disease in Canada|publisher=[[CBC News]]|date=2013-05-02|access-date=2013-05-02|url-status=live|archive-url=https://web.archive.org/web/20130502173839/http://www.cbc.ca/news/health/story/2013/05/02/avastin-flesh-eating-disease.html|archive-date=2013-05-02}}</ref>約2/3的病例涉及大腸癌患者、胃腸道穿孔或[[瘻]]管患者。
阿米卡星不應與[[神經肌肉阻滯藥]]一起使用，因為它們會加劇肌肉無力和癱瘓。<ref name=AHFS2016 />


於神經系統的不良事件包括[[可逆性后部脑病综合征|可逆性後部腦病變症候群]]。缺血性和出血性中風也有可能。<ref>{{cite journal | vauthors = Godfrey SE | title = Estrogen receptors | journal = American Journal of Clinical Pathology | volume = 91 | issue = 5 | pages = 629–30 | date = May 1989 | doi = 10.1215/15228517-2008-118 | pmid = 2718965 | pmc = 2718965 }}</ref>
==藥物交互作用==
阿米卡星可被其他β-內酰胺類藥物滅活，但程度不如其他胺基糖苷類藥物，而仍經常與[[青黴素]]（一種β-內酰胺類藥物）和碳青黴烯類藥物一起使用，以產生針對某些細菌的附加作用。已知抗生素[[氯黴素]]、克林黴素和[[四環黴素]]通常透過藥理拮抗作用讓胺基糖苷類藥物失去活性。<ref name=AHFS2016 />


大約有20%接受治療者會出現[[尿蛋白]]情況，但不需永久停藥。而有[[腎病症候群]]的患者則須永久停止用藥。<ref name="PrescribingInformation" />
阿米卡星的藥理拮抗劑作用會降低某些[[疫苗]]的效果，例如活的減毒[[卡介苗]]（用於預防結核病）、[[霍亂疫苗]]和口服減活[[傷寒疫苗]]。<ref name=medscape />


==藥理學==
==作用機轉==
貝伐珠單抗是一種重組人源化單株抗體，透過抑制血管內皮生長因子 A (VEGF-A) 來阻斷血管生成。<ref name=Los>{{cite journal | vauthors = Los M, Roodhart JM, Voest EE | title = Target practice: lessons from phase III trials with bevacizumab and vatalanib in the treatment of advanced colorectal cancer | journal = The Oncologist | volume = 12 | issue = 4 | pages = 443–50 | date = April 2007 | pmid = 17470687 | doi = 10.1634/theoncologist.12-4-443 | doi-access = free }}</ref>VEGF-A 是一種生長因子蛋白，可刺激多種疾病（尤其是癌症）的血管生成。貝伐珠單抗與VEGF-A結合，應在細胞外發揮作用，但在某些情況下（子宮頸癌和乳癌），它會經組成性包吞作用被細胞吸收。<ref>{{cite journal | vauthors = Karpinska A, Magiera G, Kwapiszewska K, Hołyst R |title=Cellular Uptake of Bevacizumab in Cervical and Breast Cancer Cells Revealed by Single-Molecule Spectroscopy |journal=Journal of Physical Chemistry Letters |date=2023 |volume=14 |issue=5 |pages=1272–1278 |doi=10.1021/acs.jpclett.2c03590|pmid=36719904 |pmc=9923738 }}</ref>注射進入眼部玻璃體腔內後，也被視網膜感光細胞吸收。<ref name="pmid17525217">{{cite journal | vauthors = Heiduschka P, Fietz H, Hofmeister S, Schultheiss S, Mack AF, Peters S, Ziemssen F, Niggemann B, Julien S, Bartz-Schmidt KU, Schraermeyer U | title = Penetration of bevacizumab through the retina after intravitreal injection in the monkey | journal = Investigative Ophthalmology & Visual Science | volume = 48 | issue = 6 | pages = 2814–23 | date = June 2007 | pmid = 17525217 | doi = 10.1167/iovs.06-1171 }}</ref>
===作用機制===
[[File:010 small subunit-1FKA.gif|thumb|原核生物30S核糖體亞基。圖中，橙色部分代表16S 核糖體RNA，藍色部分代表附着的各種蛋白質。]]


==化學==
阿米卡星不可逆地與[[16S 核糖體RNA]]和30S核糖體亞基的RNA結合S12蛋白結合，並透過改變[[核醣體]]的形狀來抑制蛋白質合成，使其無法正確讀取[[信使核糖核酸]]的[[遺傳密碼]]。<ref name="Amikacin sulfate FDA label" /><ref name="bauman">{{cite book | vauthors = Bauman RW | title=Microbiology: with diseases by body system | location=Boston | date=2015 | edition=4th | publisher=Pearson | isbn=978-0-321-91855-0}}</ref>它也干擾與[[轉運核糖核酸]]（tRNA）反遺傳密碼[[搖擺鹼基對]]相互作用的區域。<ref name="drugbank">{{cite web|url=https://www.drugbank.ca/drugs/DB00479|title=Amikacin|date=2017-08-02|work=DrugBank|access-date=2017-08-10|url-status=live|archive-url=https://web.archive.org/web/20170816150102/https://www.drugbank.ca/drugs/DB00479|archive-date=2017-08-16}}</ref>其作用有濃度依賴性，在鹼性環境下作用較佳。<ref name="plumb" />
貝伐珠單抗最初源自小鼠單株抗體，通過注射重組人血管内皮生長因子165個殘基形式來刺激小鼠免疫系統產生的抗體。為讓藥物更適合人體使用，科學家進行以下改造：保留關鍵片段、取代其他部分及進行額外修飾。然後將最終獲得的質粒 (攜帶外源基因的[[去氧核醣核酸|DNA]]片段) 轉染到[[CHO細胞]]中，再將這些細胞在大型發酵系統中培養，大量生產貝伐珠單抗。。<ref name="EMA_2005">{{cite web | work = European Medicines Agency | date = 2005 | url = http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Scientific_Discussion/human/000582/WC500029262.pdf | title = Bevacizumab Scientific Discussion | archive-url = https://web.archive.org/web/20150924012014/http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Scientific_Discussion/human/000582/WC500029262.pdf | archive-date = 2015-09-24 }}</ref>{{rp|4}}


==歷史==
在正常劑量下，會在24-48小時內對具有阿米卡星敏感性的細菌發生作用。<ref name="Amikacin sulfate FDA label" />
貝伐珠單抗是一種重組的人源化單株抗體，於2004年成為第一個臨床使用的血管生成抑制劑。<ref name=NYT2004>{{cite web | vauthors = Pollack A | work = The New York Times | date = 2004-02-27 | url = https://www.nytimes.com/2004/02/27/business/fda-approves-cancer-drug-from-genentech.html | title = F.D.A. Approves Cancer Drug From Genentech | archive-url = https://web.archive.org/web/20161024050313/http://www.nytimes.com/2004/02/27/business/fda-approves-cancer-drug-from-genentech.html | archive-date= 2016-10-24 }}</ref>其開發是根據於[[基因泰克]]工作的科學家[[納波萊奧內·費拉拉]]所發現的人類血管內皮生長因子 (VEGF）。<ref>{{cite journal | vauthors = Palmer AM, Stephenson FA, Williams RJ | title = Society for Medicines Research: 40th anniversary symposium | journal = Drug News & Perspectives | volume = 20 | issue = 3 | pages = 191–6 | date = April 2007 | pmid = 17520096 }}</ref><ref>{{cite journal | vauthors = Ferrara N | title = Anti-angiogenic drugs to treat human disease: an interview with Napoleone Ferrara by Kristin H. Kain | journal = Disease Models & Mechanisms | volume = 2 | issue = 7–8 | pages = 324–5 | year = 2009 | pmid = 19553691 | doi = 10.1242/dmm.002972 | s2cid = 22035397 | doi-access = }}</ref><ref name=Saga>{{cite journal | vauthors = Ribatti D | title = Napoleone Ferrara and the saga of vascular endothelial growth factor | journal = Endothelium | volume = 15 | issue = 1 | pages = 1–8 | year = 2008 | pmid = 18568940 | doi = 10.1080/10623320802092377 }}</ref>後來證明針對VEGF的抗體可抑制{{le|小鼠|Mouse}}體內腫瘤生長，<ref>{{cite journal | vauthors = Ferrara N | title = From the discovery of vascular endothelial growth factor to the introduction of avastin in clinical trials - an interview with Napoleone Ferrara by Domenico Ribatti | journal = The International Journal of Developmental Biology | volume = 55 | issue = 4–5 | pages = 383–8 | year = 2011 | pmid = 21858763 | doi = 10.1387/ijdb.103216dr | doi-access = free }}</ref>而為美國[[醫學]]專家[[猶大·福克曼]]在1971年提出的假設提供驗證，即停止血管生成可能有助於控制癌症生長。<ref name=Saga/>


===抗藥性===
===批准===
阿米卡星可避開所有抗生素失活酶的攻擊，而這些酶會導致細菌對抗生素產生抗藥性，但氨基乙醯轉移酶和核苷酸轉移酶兩者除外。<ref name=mudd>{{cite web | vauthors = Mudd E | title=O Aminoglycosides | work=Pharmacological Sciences | access-date= 2017-08-14 | date= 2017-08-07 | url=https://www.pharmacologicalsciences.us/pharmaceutical-chemistry/o-aminoglycosides.html | url-status=live | archive-url=https://web.archive.org/web/20170816105922/https://www.pharmacologicalsciences.us/pharmaceutical-chemistry/o-aminoglycosides.html | archive-date= 2017-08-16 }}</ref>
此藥物於2004年在美國首次獲得批准，與標準化療聯合用於治療轉移性結腸癌。<ref name=PrescribingInformation>{{cite web |title=Avastin full Prescribing Information - Genentech |url=http://www.gene.com/gene/products/information/pdf/avastin-prescribing.pdf |agency=Gene.com |date=2011 |url-status=live |archive-url=https://web.archive.org/web/20110714110417/http://www.gene.com/gene/products/information/pdf/avastin-prescribing.pdf |archive-date=14 July 2011 }}</ref>


FDA於2008年給予臨時核准，讓貝伐珠單抗用於治療轉移性乳癌，尚待進一步研究的結果。 FDA的顧問小組建議不予批准。<ref name=nytimesref>{{cite news |url=https://www.nytimes.com/2008/02/22/business/apee-drug.html |title=F.D.A. Approves Drug's Use for Breast Cancer |work=[[The New York Times]] |date=22 February 2008 |url-status=live |archive-url=https://web.archive.org/web/20170202064944/http://www.nytimes.com/2008/02/22/business/apee-drug.html |archive-date= 2017-02-02 }}</ref>迄2010年7月，在新研究未能顯示出顯著益處後，FDA顧問小組建議停止用於晚期乳癌的適應症。 基因泰克為此要求舉行聽證會，並於2011年6月舉行。FDA於2011年11月裁定撤回乳癌適應症。 基因泰克需FDA批准才能銷售該適應症的藥物。醫生有時可能會為此開立處方，但保險公司不太可能覆蓋此種費用。<ref name="NYT2011">{{cite news | vauthors = Pollack A |title=F.D.A. Revokes Approval of Avastin for Breast Cancer |newspaper=The New York Times |date=2011-11-18 |url=http://prescriptions.blogs.nytimes.com/2011/11/18/f-d-a-revokes-approval-of-avastin-for-breast-cancer/ |url-status=live |archive-url=https://web.archive.org/web/20111121024826/http://prescriptions.blogs.nytimes.com/2011/11/18/f-d-a-revokes-approval-of-avastin-for-breast-cancer/ |archive-date=2011-11-21 }}</ref>
===藥物動力學===
阿米卡星無法經由口服方式吸收，因此必須經由腸胃外給藥。於肌肉注射時，它在0.5-2小時內達到血清濃度的峰值。不到11%的阿米卡星會與血漿蛋白結合，分佈在[[心臟]]、[[膽囊]]、肺和[[骨骼]]中，以及[[膽汁]]、[[痰]]、組織液、胸膜液和[[滑液]]之中。


該藥物在其他國家（包括[[澳大利亞]]）仍被批准用於乳癌治療。<ref>{{cite news |url=http://www.abc.net.au/news/stories/2010/07/22/2960728.htm |title=Breast cancer drug 'still safe' for Aussie women |agency=[[Australian Broadcasting Corporation]] |date=2010-07-22 |url-status=live |archive-url=https://web.archive.org/web/20100723132712/http://www.abc.net.au/news/stories/2010/07/22/2960728.htm |archive-date=2010-07-23 }}</ref>使用此藥物的費用曾受[[英國]][[國民保健署]]{{le|癌症藥物基金|Cancer Drugs Fund}}的覆蓋，但在2015年1月受到剔除的提議。<ref>{{cite news|title=David Cameron's flagship Cancer Drugs Fund 'is a waste of NHS cash'|url=https://www.theguardian.com/politics/2015/jan/10/cancer-drugs-fund-waste-of-nhs-cash-david-cameron|access-date=11 January 2015|newspaper=[[The Guardian]]|date=2015-01-10|url-status=live|archive-url=https://web.archive.org/web/20150115065953/http://www.theguardian.com/politics/2015/jan/10/cancer-drugs-fund-waste-of-nhs-cash-david-cameron|archive-date=2015-01-15}}</ref>截至2023年3月，貝伐珠單抗仍保留於基金覆蓋費用的清單中。<ref>{{cite web |title=NHS England » National Cancer Drugs Fund list |url=https://www.england.nhs.uk/publication/national-cancer-drugs-fund-list/ |access-date=2023-03-09 |website=www.england.nhs.uk |archive-date=2023-03-09 |archive-url=https://web.archive.org/web/20230309153610/https://www.england.nhs.uk/publication/national-cancer-drugs-fund-list/ |url-status=live }}</ref>
==化學==
阿米卡星由卡那黴素衍生而來。<ref name=kawaguchi>{{cite journal | vauthors = Kawaguchi H, Naito T, Nakagawa S, Fujisawa KI | title = BB-K 8, a new semisynthetic aminoglycoside antibiotic | journal = The Journal of Antibiotics | volume = 25 | issue = 12 | pages = 695–708 | date = December 1972 | pmid = 4568692 | doi = 10.7164/antibiotics.25.695 | url = https://www.jstage.jst.go.jp/article/antibiotics1968/25/12/25_12_695/_pdf | url-status = live | doi-access = free | archive-url = https://web.archive.org/web/20170816105728/https://www.jstage.jst.go.jp/article/antibiotics1968/25/12/25_12_695/_pdf | archive-date = 2017-08-16 }}</ref><ref name=monteleone>{{cite book | vauthors = Monteleone PM, Muhammad N, Brown RD, McGrory JP, Hanna SA | title=Amikacin Sulfate | date=1983-01-01| doi=10.1016/S0099-5428(08)60163-X | issn=0099-5428 | volume=12 | pages=37–71| series=Analytical Profiles of Drug Substances | publisher=Academic Press | isbn=9780122608124 }}</ref>
[[File:Amikacin synthesis 2.svg|center|阿米卡星由卡那黴素衍生而來的過程|800x800px]]


==社會與文化==
==社會與文化==
===用於治療眼部黃斑部病變===
阿米卡星於1971年由[[禮來]]公司提出申請，於1972年獲得專利，並於1976年進入商業販售。<ref>{{cite book| vauthors = Fischer J, Ganellin CR |title=Analogue-based Drug Discovery|date=2006|publisher=John Wiley & Sons|isbn=9783527607495|page=507|url=https://books.google.com/books?id=FjKfqkaKkAAC&pg=PA507|url-status=live|archive-url=https://web.archive.org/web/20161220092307/https://books.google.ca/books?id=FjKfqkaKkAAC&pg=PA507|archive-date=2016-12-20}}</ref><ref>{{cite book|title=Oxford Handbook of Infectious Diseases and Microbiology|date=2009|publisher=OUP Oxford|isbn=9780191039621|page=56|url=https://books.google.com/books?id=5W-WBQAAQBAJ&pg=PT56|url-status=live|archive-url=https://web.archive.org/web/20151124232554/https://books.google.ca/books?id=5W-WBQAAQBAJ&pg=PT56|archive-date=2015-11-24}}</ref>它已被列入[[世界衛生組織基本藥物標準清單]]之中。<ref name="WHO21st">{{cite book | vauthors = ((World Health Organization)) | title = World Health Organization model list of essential medicines: 21st list 2019 | year = 2019 | hdl = 10665/325771 | author-link = World Health Organization | publisher = World Health Organization | location = Geneva | id = WHO/MVP/EMP/IAU/2019.06. License: CC BY-NC-SA 3.0 IGO | hdl-access=free }}</ref>
英國和其他歐洲國家於2015年就選擇貝伐珠單抗或[[蘭尼單抗]]（商品名Lucentis）以治療濕性黃斑部病變而展開激烈爭論。<ref name=BMJ2015pt1>{{cite news|title=Why have UK doctors been deterred from prescribing Avastin?|url=http://www.bmj.com/content/350/bmj.h1654|publisher=The British Medical Journal|date=2015-04-01|access-date=2015-04-02|archive-date=2015-04-04|archive-url=https://web.archive.org/web/20150404232028/http://www.bmj.com/content/350/bmj.h1654|url-status=live}}</ref>而[[諾華]]和羅氏公司（各擁有Avastin（貝伐珠單抗的商品名）的營銷權和所有權）尚未進行臨床試驗以取得用於治療濕性黃斑部病變的批准，它們也無意如此做。<ref name=BMJ2015pt1/>此外，兩家公司都透過遊說反對將Avastin在醫療指南中將其作為一線治療藥物，當政府資助的研究報告將Avastin與Lucentis進行比較時，兩家公司則發表文章，強調使用Avastin治療濕性黃斑部病變所具有的風險。<ref name=BMJ2015pt1/>


歐洲藥品管理局{{le|人用藥品委員會|Committee for Medicinal Products for Human}}（CHMP）於2024年3月採納正面意見，建議授予治療新生血管（濕性）年齡相關黃斑部病變（nAMD）的藥物（商品名Lytenava，含活性貝伐珠單抗成分）的上市許可。<ref name="Lytenava EPAR" />藥物申請者是總部設於美國[[紐澤西州]]的Outlook Therapeutics Limited。<ref name="Lytenava EPAR">{{cite web | title=Lytenava EPAR | website=European Medicines Agency | date= 2024-03-21 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/lytenava | access-date=2024-03-23}} Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.</ref>
==獸醫用途==
雖然阿米卡星獲得[[美國食品藥物管理局]]（FDA）批准，僅適用於治療狗和馬的子宮內感染，但它是[[獸醫學]]中最常使用的氨基糖苷類藥物之一，<ref name=forney>{{cite web | vauthors = Forney B | title=Amikacin for Veterinary Use | work=Wedgewood Pharmacy | access-date=2017-08-09 | url=http://www.wedgewoodpetrx.com/learning-center/professional-monographs/amikacin-for-veterinary-use.html | url-status=live | archive-url=https://web.archive.org/web/20170816110344/http://www.wedgewoodpetrx.com/learning-center/professional-monographs/amikacin-for-veterinary-use.html | archive-date=2017-08-16 }}</ref>並已用於狗、貓、[[豚鼠]]、[[絨鼠]]、[[倉鼠]]、{{le|小鼠|mouse}}、[[土撥鼠]]、[[家牛]]、[[鳥]]、[[蛇]]、[[龜鱉目|烏龜]]和[[陸龜]]、[[鱷魚]]、[[牛蛙]]和[[魚]]的治療。<ref name=plumb /><ref>{{cite book | vauthors = Riviere JE, Papich MG | title=Veterinary Pharmacology and Therapeutics | date=2013-05-13 | page=931 | url=https://books.google.com/books?id=xAPa4WDzAnQC&pg=PA931 | publisher=John Wiley & Sons | isbn=978-1-118-68590-7 | url-status=live | archive-url=https://web.archive.org/web/20170910172330/https://books.google.com/books?id=xAPa4WDzAnQC&pg=PA931 | archive-date=2017-09-10 }}</ref><ref>{{cite book | vauthors = Mader DR, Divers SJ | title=Current Therapy in Reptile Medicine and Surgery – E-Book | date=2013-12-12 | page=382 | url=https://books.google.com/books?id=2phWAgAAQBAJ&pg=PA382 | publisher=Elsevier Health Sciences | isbn=978-0-323-24293-6 | url-status=live | archive-url=https://web.archive.org/web/20170910172330/https://books.google.com/books?id=2phWAgAAQBAJ&pg=PA382 | archive-date=2017-09-10 }}</ref>它常用於治療蛇的呼吸道感染、烏龜的細菌性甲殼病和[[金剛鸚鵡]]的[[鼻竇炎]]。它通常禁用於家[[兔]]和野兔（但仍被使用），因為它會損害兔類[[腸道菌群]]的平衡。<ref name=plumb />


===核准治療乳癌===
對於狗和貓，阿米卡星通常用作外用抗生素，治療[[耳炎]]和角膜潰瘍，尤其是綠膿桿菌引起的。
[[歐盟執行委員會]]於2007年3月批准貝伐珠單抗合併紫杉醇用於轉移性乳癌的一線治療。<ref name="Austria-Codex">{{cite book |title=Austria-Codex |publisher=Österreichischer Apothekerverlag |year=2007 |isbn=978-3-85200-181-4 | veditors = Jasek W |edition=2007/2008 |location=Vienna |language=de }}{{Page needed|date=July 2011}}</ref>


FDA於2008年核准使用貝伐珠單抗治療乳癌。一個外部顧問小組於投票時以5比4反對，但此建議遭到否決。[[臨床試驗]]確實顯示貝伐珠單抗可減少腫瘤體積，並延長患者無惡化存活時間。FDA基於此而否決顧問小組的建議。FDA的決定受到患者權益團體和一些腫瘤學家的讚揚。而有其他腫瘤學家則認為批准無法延長或提高患者生活品質的晚期癌症療法，將導致藥廠在開發新的晚期癌症療法時會將此類重要基準忽略。<ref name="nytimesref" />
== 參考文獻 ==
{{reflist|2}}


===仿冒品===
{{模板:皮膚病用抗生素和化療藥}}
羅氏及其美國子公司基因泰克於2012年2月宣布已有仿冒的Avastin在美國銷售。<ref>{{cite news | url=https://www.reuters.com/article/us-counterfeits-cancer-drug-avastin-foun-idUSTRE81E1TK20120215 | work=Reuters | title=Counterfeits of cancer drug Avastin found in U.S | date=2012-02-15 | url-status=live | archive-url=https://web.archive.org/web/20150924162348/http://www.reuters.com/article/2012/02/15/us-counterfeits-cancer-drug-avastin-foun-idUSTRE81E1TK20120215 | archive-date=2015-09-24 }}</ref>調查仍在進行中，但因外包裝有差異，[[醫療衛生提供者|醫療服務提供者]]可輕易分辨。羅氏表示這些仿冒品中化學物質的含量並不一致，因此無法確定其是否達到有害濃度。仿冒品的源頭已追溯到[[埃及]]，然後經歐洲而進入美國合法供應鏈。<ref>{{cite news|url=http://uk.reuters.com/article/us-avastin-idUKTRE81Q29X20120227|title=Fake Avastin had salt, starch, chemicals:Roche| vauthors = Berkrot B |work=Reuters|date=2012-02-27|access-date=2012-02-28|url-status=live|archive-url=https://web.archive.org/web/20120303111906/http://uk.reuters.com/article/2012/02/27/us-avastin-idUKTRE81Q29X20120227|archive-date=2012-03-03}}</ref><ref>{{cite web|url=http://www.fiercepharma.com/story/phony-avastin-vials-contained-chemicals-no-drugs/2012-02-28|title=Phony Avastin vials contained chemicals, but no drugs| vauthors = Staton T |publisher=FiercePharma|date= 2012-02-28|access-date=2012-02-28|url-status=live|archive-url=https://web.archive.org/web/20120301191359/http://www.fiercepharma.com/story/phony-avastin-vials-contained-chemicals-no-drugs/2012-02-28|archive-date=2012-03-01}}</ref>
{{模板:蛋白質合成抑制劑類抗生素}}

===生物相似藥===
{{see also|生物相似藥}}

PlantForm和PharmaPraxis兩家製藥公司於2014年7月宣布計劃與[[弗劳恩霍夫協會]]的分子生物學中心合作，把透過[[菸草]]表達系統製造的貝伐珠單抗[[生物相似藥]]用商業化方式生產。<ref>{{cite web | vauthors = Brennan Z | title=Brazilian JV to tap plant-based manufacturing system for biosimilars | website=BioPharma-Reporter | date= 2014-07-23 | url=https://www.biopharma-reporter.com/Article/2014/07/23/Brazilian-JV-to-tap-plant-based-manufacturing-system-for-biosimilars | access-date=2020-03-18 | archive-url=https://web.archive.org/web/20160110103112/http://www.biopharma-reporter.com/Bio-Developments/Brazilian-JV-to-tap-plant-based-manufacturing-system-for-biosimilars |archive-date= 2016-01-10 | url-status=live }}</ref>{{update inline|date=September 2020}}

FDA於2017年9月核准[[安進]]製造的生物相似藥（通用名bevacizumab-awwb，商品名Mvasi）用於六種癌症適應症。<ref name="FDA PR 20170914">{{cite press release | title=FDA approves first biosimilar for the treatment of cancer | website=U.S. [[Food and Drug Administration]] (FDA) | date= 2017-09-14 | url=https://www.fda.gov/news-events/press-announcements/fda-approves-first-biosimilar-treatment-cancer | access-date=2020-10-12 | archive-date=2021-11-05 | archive-url=https://web.archive.org/web/20211105130151/https://www.fda.gov/news-events/press-announcements/fda-approves-first-biosimilar-treatment-cancer | url-status=live }} {{PD-notice}}</ref><ref>{{cite web | title=FDA approves first biosimilar for cancer treatment | website=U.S. [[Food and Drug Administration]] (FDA) | date=2017-09-14 | url=https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-first-biosimilar-cancer-treatment | access-date=2020-10-12 | archive-date= 2020-09-21 | archive-url=https://web.archive.org/web/20200921111204/https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-first-biosimilar-cancer-treatment | url-status=live }}</ref><ref>{{cite web | vauthors = Gever J | title=Avastin Clone OK'd — Biosimilar for bevacizumab approved for various cancers | website=MedPage Today | date=2017-09-14 | url=https://www.medpagetoday.com/hematologyoncology/othercancers/67911 | access-date=2020-03-18 | archive-url=https://web.archive.org/web/20170916225416/https://www.medpagetoday.com/HematologyOncology/OtherCancers/67911 | archive-date=2017-09-16 | url-status=live }}</ref>
2018年1月 - Mvasi獲准在歐盟作醫療用途。<ref name="Mvasi EPAR">{{cite web | title=Mvasi EPAR | website=[[European Medicines Agency]] (EMA) | date=2018-09-17 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/mvasi | access-date=2020-04-02 | archive-date= 2019-12-30 | archive-url=https://web.archive.org/web/20191230161123/https://www.ema.europa.eu/en/medicines/human/EPAR/mvasi | url-status=live }}</ref>

2019年2月 - Zirabev被批准在歐盟作醫療用途。<ref name="Zirabev EPAR">{{cite web | title=Zirabev EPAR | website=[[European Medicines Agency]] (EMA) | date=2018-12-11 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/zirabev | access-date=2 April 2020 | archive-date= 2019-12-30 | archive-url=https://web.archive.org/web/20191230160954/https://www.ema.europa.eu/en/medicines/human/EPAR/zirabev | url-status=live }}</ref>Zirabev於2019年6月在美國獲准用於醫療用途，<ref>{{cite web | title=Drug Approval Package: Zirabev | website=U.S. [[Food and Drug Administration]] (FDA) | date=2019-08-14 | url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/761099Orig1s000TOC.cfm | access-date=2021-12-29 | archive-date=2019-12-18 | archive-url=https://web.archive.org/web/20191218044943/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/761099Orig1s000TOC.cfm | url-status=live }}</ref>並於2019年11月在澳大利亞獲准用於醫療用途。<ref name="AU biosimilar" />

2020年6月 - Mvasi在澳大利亞核准用於醫療用途。<ref name="AU biosimilar" />

2020年8月 - Aybintio被批准在歐盟作醫療用途。<ref name="Aybintio EPAR">{{cite web | title=Aybintio EPAR | website=[[European Medicines Agency]] (EMA) | date=2020-05-26 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/aybintio | access-date=2020-09-09 | archive-date= 2020-12-29 | archive-url=https://web.archive.org/web/20201229221338/https://www.ema.europa.eu/en/medicines/human/EPAR/aybintio | url-status=live }}</ref>

2020年9月 - Equidacent獲准在歐盟使用。<ref name="Equidacent EPAR">{{cite web | title=Equidacent EPAR | website=[[European Medicines Agency]] (EMA) | date=2020-07-20 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/equidacent | access-date=2020-10-12 | archive-date=2020-10-13 | archive-url=https://web.archive.org/web/20201013000306/https://www.ema.europa.eu/en/medicines/human/EPAR/equidacent | url-status=live }} Text was copied from this source which is © European Medicines Agency. Reproduction is authorized provided the source is acknowledged.</ref>

歐洲藥品管理局人用藥品委員會採納積極意見，於2021年1月建議授予Alymsys上市許可，用於治療大腸癌、乳癌、非小細胞肺癌、腎細胞癌、上皮性卵巢癌、輸卵管癌或原發性腹膜癌以及子宮頸癌。<ref name="Alymsys EPAR" />Alymsys於2021年3月獲得歐盟核准用於醫療用途。<ref name="Alymsys EPAR">{{cite web | title=Alymsys EPAR | website=[[European Medicines Agency]] (EMA) | date= 2021-01-25 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/alymsys | access-date= 2021-05-19 | archive-date=2021-10-08 | archive-url=https://web.archive.org/web/20211008120839/https://www.ema.europa.eu/en/medicines/human/EPAR/alymsys | url-status=live }} Text was copied from this source which is © European Medicines Agency. Reproduction is authorized provided the source is acknowledged.</ref>

2021年1月 - Onbevzi在歐盟獲准用於醫療用途。<ref name="Onbevzi EPAR">{{cite web | title=Onbevzi EPAR | website=[[European Medicines Agency]] (EMA) | date=2020-11-09 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/onbevzi | access-date=2021-05-19 | archive-date=2021-11-05 | archive-url=https://web.archive.org/web/20211105130152/https://www.ema.europa.eu/en/medicines/human/EPAR/onbevzi | url-status=live }}</ref>

2019年6月和2021年6月 - Zirabev在加拿大獲准用於醫療用途。<ref>{{cite web | title=Summary Basis of Decision (SBD) for Zirabev | website=Health Canada | date=2014-10-23 | url=https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00449&lang=en | access-date=2022-05-29 | archive-date=2022-05-31 | archive-url=https://web.archive.org/web/20220531054646/https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00449&lang=en | url-status=live }}</ref><ref>{{cite web | title=Summary Basis of Decision (SBD) for Zirabev | website=Health Canada | date=2014-10-23 | url=https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00543&lang=en | access-date=2022-05-29 | archive-date= 2022-05-30 | archive-url=https://web.archive.org/web/20220530041510/https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00543&lang=en | url-status=live }}</ref>

Oyavas於2021年3月在歐盟獲准用於醫療用途。<ref name="Oyavas EPAR">{{cite web | title=Oyavas EPAR | website=European Medicines Agency | date= 2021-01-28 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/oyavas | access-date=2023-03-03 | archive-date= 2021-10-08 | archive-url=https://web.archive.org/web/20211008175537/https://www.ema.europa.eu/en/medicines/human/EPAR/oyavas | url-status=live }}</ref>

Abevmy於2021年4月在歐盟獲准用於醫療用途，<ref name="Abevmy EPAR">{{cite web | title=Abevmy EPAR | website=[[European Medicines Agency]] (EMA) | date=2021-02-24 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/abevmy | access-date= 2021-08-27 | archive-date=2021-08-28 | archive-url=https://web.archive.org/web/20210828061650/https://www.ema.europa.eu/en/medicines/human/EPAR/abevmy | url-status=live }}</ref>並於2021年9月在澳大利亞獲准。<ref name="Abevmy APM summary" /><ref name="AU biosimilar">{{cite web | title=Which biosimilar medicines are available in Australia? | url=https://www1.health.gov.au/internet/main/publishing.nsf/Content/biosimilar-which-medicines-are-available-in-australia | access-date=2021-12-29 | archive-date=2021-12-30 | archive-url=https://web.archive.org/web/20211230035404/https://www1.health.gov.au/internet/main/publishing.nsf/Content/biosimilar-which-medicines-are-available-in-australia | url-status=live }}</ref>

2021年9月 - Bambevi在加拿大獲准用於醫療用途。<ref name="Bambevi SBD">{{cite web | title=Summary Basis of Decision (SBD) for Bambevi | website=Health Canada | date=2014-10-23 | url=https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00568&lang=en | access-date=2022-05-29 | archive-date=2022-05-29 | archive-url=https://web.archive.org/web/20220529194052/https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00568&lang=en | url-status=live }}</ref>

Bevacip和Bevaciptin於2021年11月在澳大利亞獲准用於醫療用途。<ref name="AU biosimilar" /><ref>{{cite web | title=Bevacip/Bevaciptin | website=Therapeutic Goods Administration (TGA) | date=2021 -11-16| url=https://www.tga.gov.au/apm-summary/bevacipbevaciptin | access-date=2021-12-29 | archive-date= 2021-12-30 | archive-url=https://web.archive.org/web/20211230040027/https://www.tga.gov.au/apm-summary/bevacipbevaciptin | url-status=live }}</ref>

2021年11月 - Abevmy和Aybintio在加拿大核准用於醫療用途。<ref name="Abevmy SBD">{{cite web | title=Summary Basis of Decision (SBD) for Abevmy | website=Health Canada | date=2014-10-23 | url=https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00587&lang=en | access-date=2022-05-29 | archive-date= 2022-05-29 | archive-url=https://web.archive.org/web/20220529191500/https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00587&lang=en | url-status=live }}</ref><ref name="Aybintio SBD">{{cite web | title=Summary Basis of Decision (SBD) for Aybintio | website=Health Canada | date=2014-10-23 | url=https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00574&lang=en | access-date=2022-05-29 | archive-date= 2022-05-29 | archive-url=https://web.archive.org/web/20220529193156/https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00574&lang=en | url-status=live }}</ref>

2022年4月 - Alymsys（bevacizumab-maly）在美國獲准用於醫療用途。<ref name="Alymsys FDA label" />

2022年8月 - Vegzelma在歐盟獲准用於醫療用途。<ref name="Vegzelma EPAR">{{cite web | title=Vegzelma EPAR | website=[[European Medicines Agency]] (EMA) | date=2022-06-20 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/vegzelma | access-date=2023-03-03 | archive-date= 2023-01-28 | archive-url=https://web.archive.org/web/20230128020239/https://www.ema.europa.eu/en/medicines/human/EPAR/vegzelma | url-status=live }}</ref><ref>{{cite web | title=Vegzelma Product information | website=Union Register of medicinal products | url=https://ec.europa.eu/health/documents/community-register/html/h1667.htm | access-date= 2023-03-03 | archive-date=2023-03-04 | archive-url=https://web.archive.org/web/20230304053523/https://ec.europa.eu/health/documents/community-register/html/h1667.htm | url-status=live }}</ref>

2022年9月 - Vegzelma（bevacizumab-adcd）在美國獲准用於醫療用途。<ref name="Vegzelma FDA label">{{cite web | title=Vegzelma- bevacizumab-adcd injection, solution | website=DailyMed | date=2022-11-23 | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4cdcccda-7b9a-49d0-ac50-f4605a3c0ebe | access-date=2023-02-11 | archive-date=2023-02-11 | archive-url=https://web.archive.org/web/20230211065131/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4cdcccda-7b9a-49d0-ac50-f4605a3c0ebe | url-status=live }}</ref>

2023年6月 - 藥廠Enzene Biosciences在[[印度]]推出貝伐珠單抗生物相似藥。<ref>[https://chemindigest.com/enzene-biosciences-launches-bevacizumab Enzene Biosciences Launches Bevacizumab] {{Webarchive|url=https://web.archive.org/web/20240310055617/https://chemindigest.com/enzene-biosciences-launches-bevacizumab/ |date=2024-03-10 }} 2023-06-29</ref>

Avzivi（Bevacizumab-tnjn）於2023年12月在美國獲准用於醫療用途。<ref>{{cite web | title = Avzivi (bevacizumab-tnjn) injection, for intravenous use | work = Bio-Thera Solutions, Ltd. | publisher = U.S. Food and Drug Administration | date = 2020 | url = https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761198s000lbl.pdf | access-date = 2023 -12-10| archive-date = 2023-12-10 | archive-url = https://web.archive.org/web/20231210100524/https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761198s000lbl.pdf | url-status = live }}</ref><ref>{{cite web | title=Biosimilar Drug Information | website=U.S. Food and Drug Administration | date=2023-12-08 | url=https://www.fda.gov/drugs/biosimilars/biosimilar-product-information | access-date=2023-12-10 | archive-date= 2021-08-28 | archive-url=https://web.archive.org/web/20210828185647/https://www.fda.gov/drugs/biosimilars/biosimilar-product-information | url-status=live }}</ref>

==研究==
於2009年4月發佈的一項研究報告，提出貝伐珠單抗不能有效預防非轉移性結腸癌術後復發。<ref>{{cite news | vauthors = Reed K |title=Roche drug Avastin fails cancer study, shares fall |newspaper=Reuters |date=2009-04-22 |url=https://www.reuters.com/article/euRegulatoryNews/idUSLM27429520090422 |access-date=2009-04-22 |url-status=live |archive-url=https://web.archive.org/web/20090812201839/http://www.reuters.com/article/euRegulatoryNews/idUSLM27429520090422 |archive-date=2009-08-12 }}</ref>

貝伐珠單抗已在治療卵巢癌中進行測試，顯示其無惡化存活期有所改善，但整體存活期並未改善。<ref name="pmid27852039">{{cite journal | vauthors = Rossi L, Verrico M, Zaccarelli E, Papa A, Colonna M, Strudel M, Vici P, Bianco V, Tomao F | title = Bevacizumab in ovarian cancer: A critical review of phase III studies | journal = Oncotarget | volume = 8 | issue = 7 | pages = 12389–12405 | date = February 2017 | pmid = 27852039 | pmc = 5355353 | doi = 10.18632/oncotarget.13310 }}</ref>而在膠質母細胞瘤的測試，並未能提高整體存活率。<ref name="pmid28527008">{{cite journal | vauthors = Diaz RJ, Ali S, Qadir MG, De La Fuente MI, Ivan ME, Komotar RJ | title = The role of bevacizumab in the treatment of glioblastoma | journal = Journal of Neuro-Oncology | volume = 133 | issue = 3 | pages = 455–467 | date = July 2017 | pmid = 28527008 | doi = 10.1007/s11060-017-2477-x | s2cid = 4964000 }}</ref><ref name="pmid30119081">{{cite journal | vauthors = Kim MM, Umemura Y, Leung D | title = Bevacizumab and Glioblastoma: Past, Present, and Future Directions | journal = Cancer Journal | location = Sudbury, Mass. | volume = 24 | issue = 4 | pages = 180–186 | date = 2018 | pmid = 30119081 | doi = 10.1097/PPO.0000000000000326 | s2cid = 52033623 }}</ref>

貝伐珠單抗已被研究作為一種可能的胰臟癌治療藥物，補充化療之用，但研究顯示存活率並未改善。<ref>{{cite journal | vauthors = Rocha-Lima CM | title = New directions in the management of advanced pancreatic cancer: a review | journal = Anti-Cancer Drugs | volume = 19 | issue = 5 | pages = 435–46 | date = June 2008 | pmid = 18418211 | doi = 10.1097/CAD.0b013e3282fc9d11 | s2cid = 25507290 }}</ref><ref>{{cite book|pages=123–9 |doi=10.1007/978-3-540-71279-4_14 |pmid=18084954 |chapter=Antiangiogenic Strategies in Pancreatic Cancer |title=Pancreatic Cancer |series=Recent Results in Cancer Research |year=2008 | vauthors = Riess H |isbn=978-3-540-71266-4 |volume=177}}</ref>

該藥物也作為既定化療和手術的補充，用於治療兒童[[骨肉瘤]][<ref name="pmid28631382">{{cite journal | vauthors = Navid F, Santana VM, Neel M, McCarville MB, Shulkin BL, Wu J, Billups CA, Mao S, Daryani VM, Stewart CF, Kunkel M, Smith W, Ward D, Pappo AS, Bahrami A, Loeb DM, Reikes Willert J, Rao BN, Daw NC | title = A phase II trial evaluating the feasibility of adding bevacizumab to standard osteosarcoma therapy | journal = International Journal of Cancer | volume = 141 | issue = 7 | pages = 1469–1477 | date = October 2017 | pmid = 28631382 | pmc = 5812455 | doi = 10.1002/ijc.30841 }}</ref>和其他[[肉瘤]]，例如[[平滑肌肉瘤]]。<ref name="pmid29759566">{{cite journal | vauthors = Bogani G, Ditto A, Martinelli F, Signorelli M, Chiappa V, Fonatella C, Sanfilippo R, Leone Roberti Maggiore U, Ferrero S, Lorusso D, Raspagliesi F | title = Role of bevacizumab in uterine leiomyosarcoma | journal = Critical Reviews in Oncology/Hematology | volume = 126 | pages = 45–51 | date = June 2018 | pmid = 29759566 | doi = 10.1016/j.critrevonc.2018.03.019 | s2cid = 46890425 }}</ref>

貝伐珠單抗已被研究用於治療[[前庭神經鞘瘤]]。<ref>{{cite journal | vauthors = Plotkin SR, Merker VL, Halpin C, Jennings D, McKenna MJ, Harris GJ, Barker FG | title = Bevacizumab for progressive vestibular schwannoma in neurofibromatosis type 2: a retrospective review of 31 patients | journal = Otology & Neurotology | volume = 33 | issue = 6 | pages = 1046–52 | date = August 2012 | pmid = 22805104 | doi = 10.1097/MAO.0b013e31825e73f5 | s2cid = 205755932 | url = https://dash.harvard.edu/bitstream/1/33788498/2/Plotkin%20et%20al%202012%20-%20bevacizumab%20for%20progressive%20vestibular%20schwannoma%20in%20neurofibromatosis%20type%202%20-%20a%20retrospective%20review%20of%2031%20patients.pdf | access-date = 2019-08-02 | archive-date = 2024-03-10 | archive-url = https://web.archive.org/web/20240310055427/https://dash.harvard.edu/bitstream/handle/1/33788498/Plotkin%20et%20al%202012%20-%20bevacizumab%20for%20progressive%20vestibular%20schwannoma%20in%20neurofibromatosis%20type%202%20-%20a%20retrospective%20review%20of%2031%20patients.pdf?sequence=2 | url-status = live }}<!-- http://nrs.harvard.edu/urn-3:HUL.InstRepos:33788498 --></ref>

== 參見 ==
{{Reflist|2}}

== 延伸閱讀 ==
* {{cite news | vauthors = Berenson A |title=A Cancer Drug Shows Promise, at a Price That Many Can't Pay |newspaper=[[The New York Times]] |date=15 February 2006 |url=https://www.nytimes.com/2006/02/15/business/15drug.html |ref=none}}
* {{cite journal | vauthors = Sachdev JC, Jahanzeb M | title = Evolution of bevacizumab-based therapy in the management of breast cancer | journal = Clinical Breast Cancer | volume = 8 | issue = 5 | pages = 402–10 | date = October 2008 | pmid = 18952553 | doi = 10.3816/CBC.2008.n.048 |ref=none }}

== 外部連結 ==
* {{cite web | title=Bevacizumab | website=NCI Drug Dictionary | url=https://www.cancer.gov/publications/dictionaries/cancer-drug/def/bevacizumab }}

{{模板:細胞外化療藥物}}
{{模板:用於骨骼、肌肉骨骼、循環系統和神經系統的單株抗體}}
{{模板:生長因子受體調節劑}}
{{Portal bar | Medicine}}
{{Portal bar | Medicine}}
{{Authority control}}
{{Authority control}}


{{draft categories|
[[分類:氨基糖苷類抗生素]]
[[分類:抗結核藥物]]
[[分類:血管生成抑制劑]]
[[分類:眼科用藥]]
[[Category:Butyramides]]
[[分類:罕用藥]]
[[Category:Drugs developed by Genentech]]
[[Category:Drugs developed by Hoffmann-La Roche]]
[[Category:Monoclonal antibodies for tumors]]
[[Category:Specialty drugs]]
[[分類:世界衛生組織基本藥物]]
[[分類:世界衛生組織基本藥物]]
[[分類:RTT]]
[[分類:RTT]]
}}
[[分類:罕用藥]]

於 2024年4月9日 (二) 08:43 的修訂

阿米卡星
單株抗體
種類完整抗體
目標血管內皮生長因子 A（英語：Vascular endothelial growth factor A）（VEGF-A）
臨床資料
讀音/ˌbɛvəˈsɪzjʊmæb/[1]
商品名（英語：Drug nomenclature）Avastin及其他
生物相似藥bevacizumab-adcd,[2] bevacizumab-awwb,[3] bevacizumab-bvzr,[4] bevacizumab-maly,[5] bevacizumab-tnjn, Abevmy,[6] Alymsys,[7][5] Avzivi, Aybintio,[8] Bambevi,[9] Bevacip,[10] Bevaciptin,[10] Equidacent,[11] Mvasi,[12] Onbevzi,[13][14] Oyavas,[15] Vegzelma,[2][16][17] Zirabev[18]
AHFS/Drugs.comMonograph
MedlinePlusa607001
核准狀況
懷孕分級
給藥途徑靜脈注射，玻璃體腔內注射（英語：Intravitreal injection）
ATC碼
法律規範狀態
法律規範
藥物動力學數據
生物利用度100% (靜脈注射)
生物半衰期20天 (範圍: 11–50天)
識別資訊
CAS號216974-75-3  checkY
DrugBank
ChemSpider
  • none
UNII
KEGG
ChEMBL
CompTox Dashboard（英語：CompTox Chemicals Dashboard） (EPA)
ECHA InfoCard100.048.653 編輯維基數據鏈接
化學資訊
化學式C6638H10160N1720O2108S44
摩爾質量149,198.87 g·mol−1

貝伐珠單抗（英語：Bevacizumab）以Avastin（中文名稱有癌思停，或安維汀）商品名於市面銷售，是一種單株抗體藥物，用於治療一些類型的癌症和特定的眼部疾病。[27][25]透過緩慢注射到靜脈（靜脈注射）給藥，用於治療大腸癌、肺癌、卵巢癌、膠質母細胞瘤和腎細胞癌（英語：Renal cell carcinoma）。[28]它是用於治療許多此類疾病的一線藥物。[27][25]對於老年性黃斑部病變，係透過注射到眼睛（玻璃體腔內注射（英語：Intravitreal injection））進行治療。[27]

於治療癌症時常見的副作用有流鼻血、頭痛、高血壓和[[皮疹]。[27]其他嚴重副作用有腸胃穿孔、出血、過敏反應、血栓和感染風險升高。[27]用於治療眼部疾病時，可能的副作用有視覺障礙和視網膜剝離。[27]貝伐珠單抗是一種單株抗體，具有血管生成抑制劑（英語：angiogenesis inhibitor）的作用。[27]它透過抑制血管內皮生長因子 A (VEGF-A) 來減緩血管新生，是一種抗血管內皮生長因子療法（英語：Anti-VEGF） 。[27]

貝伐珠單抗於2004年在美國被批准用於醫療用途。[29][27]它已被列入世界衛生組織基本藥物標準清單之中，[30][31][32]用於治療眼部疾病。[30][31]

醫療用途

大腸癌

貝伐珠單抗於2004年2月在美國獲得批准，於標準化療時共同治療轉移性大腸癌（作為一線治療）。[33]於2006年6月被核准與以5-氟尿嘧啶為基礎的療法，作為治療轉移性大腸癌的二線療法。[33]

它於2005年1月被歐洲藥品管理局（EMA）批准用於治療大腸癌。[34][26]

貝伐珠單抗也被研究作為非轉移性結腸癌患者化療藥物的補充。兩項大型隨機研究的數據顯示在預防癌症復發方面未產生益處，且可能會造成傷害。[35]

在歐盟，貝伐珠單抗與基於氟嘧啶（英語：fluoropyrimidine）的化療合併，可用於治療成人轉移性大腸癌。[11]

眼部疾病

許多眼部疾病，如老年性黃斑部病變和糖尿病視網膜病變都會損害視網膜。當視網膜周圍的血管異常生長並滲漏液體，而導致視網膜層剝離時，會導致失明。這種異常生長是由血管內皮生長因子（VEGF）所引起，由於貝伐珠單抗可成功抑制VEGF，而減緩這種生長。[36]

貝伐珠單抗已被眼科醫生以仿單標示外使用，作為玻璃體腔內注射劑，以治療眼部血管增殖性疾病，特別是治療黃斑部病變中的脈絡膜新生血管（英語：choroidal neovascular membrane） (CNV)。將1.25–2.5毫克貝伐珠單抗注射入玻璃體腔內，並沒出現明顯的眼內毒性。[37]許多視網膜專家注意到在CNV、增殖性糖尿病視網膜病變、新生血管性青光眼、糖尿病黃斑水腫、早產兒視網膜病變[38]和於中心視網膜靜脈阻塞（英語：Central retinal vein occlusion）而繼發的黃斑水腫方面取得相當顯著的結果。[36]

卵巢癌

美國食品藥物管理局（FDA）於2018年核准貝伐珠單抗合併化療用於初次手術後的III期或IV期卵巢癌患者，然後再單獨使用貝伐珠單抗。前述核准是根據一項增加貝伐珠單抗與卡鉑和紫杉醇合併使用的研究結果。[39]患者無惡化存活期可從13個月延長至18個月。[39]

在歐盟，貝伐單抗與卡鉑和紫杉醇聯合適用於晚期上皮性卵巢癌、輸卵管癌或原發性腹膜癌成人患者的一線治療。[11]貝伐珠單抗與卡鉑和吉西他濱聯用，或與卡鉑和紫杉醇聯用，適用於治療鉑類敏感上皮性卵巢癌、輸卵管癌或原發性腹膜癌首次復發，且未接受過貝伐珠單抗，或其他VEGF抑制劑，或VEGF受體標靶藥物治療的成人患者。[11]

FDA於2020年5月擴大奧拉帕利的適應症，加入貝伐珠單抗，作為一線維持治療（英語：maintenance treatment）成人晚期上皮性卵巢癌、輸卵管癌或原發性腹膜癌的藥物。 適用對象為接受一線鉑方案化療後，腫瘤完全緩解或部分緩解的患者，且癌症與同源重組修復缺陷 (homologous recombination deficiency) 陽性相關，由有害或疑似有害的 BRCA突變（英語：BRCA mutation）或基因組不穩定性所定義。[40]

子宮頸癌

在歐盟，貝伐珠單抗與紫杉醇和順鉑聯用，或在無法接受鉑類治療的患者中與紫杉醇和托普樂肯聯用，用於治療患有持續性、復發性或轉移性子宮頸癌的成人患者。[11]

老年黃斑部病變治療

美國Philip Rosenfeld醫生開發貝伐珠單抗的仿單標示外使用，用於治療老年性黃斑部病變。[41][42]貝伐珠單抗也同樣被仿單標示外使用，以治療新生血管性黃斑部病變。[43]

不良影響

貝伐珠單抗可抑制血管生長，而血管生長是身體正常癒合和維持的一個環節。身體在傷口癒合過程中會生長出新血管，作為受阻塞或動脈粥狀硬化血管周圍的側支循環（英語：collateral circulation）用途。因貝伐珠單抗會干擾這些正常過程，而引發會導致冠狀動脈疾病或週邊動脈阻塞病情惡化的擔憂。[44]

主要副作用是高血壓和出血風險增加。有因而胃腸穿孔的報告。[45]疲勞和感染也很常見。[46] 在晚期肺癌患者中，接受貝伐珠單抗治療的患者中[47][48]有鼻中隔穿孔（英語：Nasal septum perforation）和腎血栓性微血管病變（英語：Thrombotic microangiopathy）的報告。[49]

羅氏公司於2013年宣佈該藥物與1997年至2012年期間發生的52例壞死性筋膜炎有關，其中17名患者死亡。[50]約2/3的病例涉及大腸癌患者、胃腸道穿孔或瘻管患者。

於神經系統的不良事件包括可逆性後部腦病變症候群。缺血性和出血性中風也有可能。[51]

大約有20%接受治療者會出現尿蛋白情況，但不需永久停藥。而有腎病症候群的患者則須永久停止用藥。[52]

作用機轉

貝伐珠單抗是一種重組人源化單株抗體，透過抑制血管內皮生長因子 A (VEGF-A) 來阻斷血管生成。[53]VEGF-A 是一種生長因子蛋白，可刺激多種疾病（尤其是癌症）的血管生成。貝伐珠單抗與VEGF-A結合，應在細胞外發揮作用，但在某些情況下（子宮頸癌和乳癌），它會經組成性包吞作用被細胞吸收。[54]注射進入眼部玻璃體腔內後，也被視網膜感光細胞吸收。[55]

化學

貝伐珠單抗最初源自小鼠單株抗體，通過注射重組人血管內皮生長因子165個殘基形式來刺激小鼠免疫系統產生的抗體。為讓藥物更適合人體使用，科學家進行以下改造：保留關鍵片段、取代其他部分及進行額外修飾。然後將最終獲得的質粒 (攜帶外源基因的DNA片段) 轉染到CHO細胞中，再將這些細胞在大型發酵系統中培養，大量生產貝伐珠單抗。。[34]:4

歷史

貝伐珠單抗是一種重組的人源化單株抗體，於2004年成為第一個臨床使用的血管生成抑制劑。[56]其開發是根據於基因泰克工作的科學家納波萊奧內·費拉拉所發現的人類血管內皮生長因子 (VEGF）。[57][58][59]後來證明針對VEGF的抗體可抑制小鼠體內腫瘤生長，[60]而為美國醫學專家猶大·福克曼在1971年提出的假設提供驗證，即停止血管生成可能有助於控制癌症生長。[59]

批准

此藥物於2004年在美國首次獲得批准，與標準化療聯合用於治療轉移性結腸癌。[52]

FDA於2008年給予臨時核准，讓貝伐珠單抗用於治療轉移性乳癌，尚待進一步研究的結果。 FDA的顧問小組建議不予批准。[61]迄2010年7月，在新研究未能顯示出顯著益處後，FDA顧問小組建議停止用於晚期乳癌的適應症。 基因泰克為此要求舉行聽證會，並於2011年6月舉行。FDA於2011年11月裁定撤回乳癌適應症。 基因泰克需FDA批准才能銷售該適應症的藥物。醫生有時可能會為此開立處方，但保險公司不太可能覆蓋此種費用。[62]

該藥物在其他國家（包括澳大利亞）仍被批准用於乳癌治療。[63]使用此藥物的費用曾受英國國民保健署癌症藥物基金（英語：Cancer Drugs Fund）的覆蓋，但在2015年1月受到剔除的提議。[64]截至2023年3月，貝伐珠單抗仍保留於基金覆蓋費用的清單中。[65]

社會與文化

用於治療眼部黃斑部病變

英國和其他歐洲國家於2015年就選擇貝伐珠單抗或蘭尼單抗（商品名Lucentis）以治療濕性黃斑部病變而展開激烈爭論。[66]而諾華和羅氏公司（各擁有Avastin（貝伐珠單抗的商品名）的營銷權和所有權）尚未進行臨床試驗以取得用於治療濕性黃斑部病變的批准，它們也無意如此做。[66]此外，兩家公司都透過遊說反對將Avastin在醫療指南中將其作為一線治療藥物，當政府資助的研究報告將Avastin與Lucentis進行比較時，兩家公司則發表文章，強調使用Avastin治療濕性黃斑部病變所具有的風險。[66]

歐洲藥品管理局人用藥品委員會（英語：Committee for Medicinal Products for Human）（CHMP）於2024年3月採納正面意見，建議授予治療新生血管（濕性）年齡相關黃斑部病變（nAMD）的藥物（商品名Lytenava，含活性貝伐珠單抗成分）的上市許可。[67]藥物申請者是總部設於美國紐澤西州的Outlook Therapeutics Limited。[67]

核准治療乳癌

歐盟執行委員會於2007年3月批准貝伐珠單抗合併紫杉醇用於轉移性乳癌的一線治療。[68]

FDA於2008年核准使用貝伐珠單抗治療乳癌。一個外部顧問小組於投票時以5比4反對，但此建議遭到否決。臨床試驗確實顯示貝伐珠單抗可減少腫瘤體積，並延長患者無惡化存活時間。FDA基於此而否決顧問小組的建議。FDA的決定受到患者權益團體和一些腫瘤學家的讚揚。而有其他腫瘤學家則認為批准無法延長或提高患者生活品質的晚期癌症療法，將導致藥廠在開發新的晚期癌症療法時會將此類重要基準忽略。[61]

仿冒品

羅氏及其美國子公司基因泰克於2012年2月宣佈已有仿冒的Avastin在美國銷售。[69]調查仍在進行中，但因外包裝有差異，醫療服務提供者可輕易分辨。羅氏表示這些仿冒品中化學物質的含量並不一致，因此無法確定其是否達到有害濃度。仿冒品的源頭已追溯到埃及，然後經歐洲而進入美國合法供應鏈。[70][71]

生物相似藥

參見：生物相似藥

PlantForm和PharmaPraxis兩家製藥公司於2014年7月宣佈計劃與弗勞恩霍夫協會的分子生物學中心合作，把透過煙草表達系統製造的貝伐珠單抗生物相似藥用商業化方式生產。[72][已過時]

FDA於2017年9月核准安進製造的生物相似藥（通用名bevacizumab-awwb，商品名Mvasi）用於六種癌症適應症。[73][74][75] 2018年1月 - Mvasi獲准在歐盟作醫療用途。[12]

2019年2月 - Zirabev被批准在歐盟作醫療用途。[18]Zirabev於2019年6月在美國獲准用於醫療用途，[76]並於2019年11月在澳大利亞獲准用於醫療用途。[10]

2020年6月 - Mvasi在澳大利亞核准用於醫療用途。[10]

2020年8月 - Aybintio被批准在歐盟作醫療用途。[8]

2020年9月 - Equidacent獲准在歐盟使用。[11]

歐洲藥品管理局人用藥品委員會採納積極意見，於2021年1月建議授予Alymsys上市許可，用於治療大腸癌、乳癌、非小細胞肺癌、腎細胞癌、上皮性卵巢癌、輸卵管癌或原發性腹膜癌以及子宮頸癌。[7]Alymsys於2021年3月獲得歐盟核准用於醫療用途。[7]

2021年1月 - Onbevzi在歐盟獲准用於醫療用途。[13]

2019年6月和2021年6月 - Zirabev在加拿大獲准用於醫療用途。[77][78]

Oyavas於2021年3月在歐盟獲准用於醫療用途。[15]

Abevmy於2021年4月在歐盟獲准用於醫療用途，[6]並於2021年9月在澳大利亞獲准。[19][10]

2021年9月 - Bambevi在加拿大獲准用於醫療用途。[9]

Bevacip和Bevaciptin於2021年11月在澳大利亞獲准用於醫療用途。[10][79]

2021年11月 - Abevmy和Aybintio在加拿大核准用於醫療用途。[80][81]

2022年4月 - Alymsys（bevacizumab-maly）在美國獲准用於醫療用途。[5]

2022年8月 - Vegzelma在歐盟獲准用於醫療用途。[16][82]

2022年9月 - Vegzelma（bevacizumab-adcd）在美國獲准用於醫療用途。[2]

2023年6月 - 藥廠Enzene Biosciences在印度推出貝伐珠單抗生物相似藥。[83]

Avzivi（Bevacizumab-tnjn）於2023年12月在美國獲准用於醫療用途。[84][85]

研究

於2009年4月發佈的一項研究報告，提出貝伐珠單抗不能有效預防非轉移性結腸癌術後復發。[86]

貝伐珠單抗已在治療卵巢癌中進行測試，顯示其無惡化存活期有所改善，但整體存活期並未改善。[87]而在膠質母細胞瘤的測試，並未能提高整體存活率。[88][89]

貝伐珠單抗已被研究作為一種可能的胰臟癌治療藥物，補充化療之用，但研究顯示存活率並未改善。[90][91]

該藥物也作為既定化療和手術的補充，用於治療兒童骨肉瘤[[92]和其他肉瘤，例如平滑肌肉瘤。[93]

貝伐珠單抗已被研究用於治療前庭神經鞘瘤。[94]

參見

  1. ^ Bevacizumab Injection: MedlinePlus Drug Information. NLM.nih.gov. 2014-02-28. （原始內容存檔於2014-03-25）. 
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延伸閱讀

外部連結

靶向治療/細胞外化療藥物/抗腫瘤藥（L01）
癌症免疫療法（CI）
單株抗體藥物
（英文後綴-mab）
受體酪氨酸激酶
其它實體瘤
淋巴瘤/白血病
免疫檢查點抑制劑（英語：Checkpoint inhibitor）
酪氨酸激酶抑制劑
（英文後綴-nib）
受體酪氨酸激酶

RET 抑制劑：恩曲替尼（也作用於ALK、ROS1、NTRK）, 拉羅替尼（也作用於NTRK）, 英菲格拉替尼, 培米替尼（也作用於FGFR）, 普拉替尼, 塞爾帕替尼（也作用於VEGFR和EGFR）, 凡德他尼（英語：Vandetanib）（也作用於VEGFR和EGFR）

c-MET 抑制劑：卡博替尼（英語：Cabozantinib）（也作用於VEGFR2）, 卡馬替尼, 克唑替尼（也作用於ALK）

非受體酪氨酸激酶（英語：Non-receptor tyrosine kinase）
其它
用於骨骼、肌肉骨骼、循環系統和神經系統的單株抗體
骨骼
人
人源化（英語：Humanized antibody）
肌肉骨骼
人
循環
人
小鼠
嵌合
人源化
神經
人
人源化
血管生成抑制劑（英語：Angiogenesis inhibitor）
人源化
生長因子
人
人源化
血管生成素（英語：Angiopoietin receptor）
CNTF（英語：Ciliary neurotrophic factor receptor）


 
EGF（ErbB）  
表皮生長因子受體
（EGF(ErbB1/HER1)）    
ErbB2/HER2
ErbB3/HER3（英語：HER3）
ErbB4/HER4（英語：HER4）
FGF
FGFR1（英語：Fibroblast growth factor receptor 1）
FGFR2（英語：Fibroblast growth factor receptor 2）
FGFR3（英語：Fibroblast growth factor receptor 3）
FGFR4（英語：Fibroblast growth factor receptor 4）
Unsorted
HGF (c-Met)（英語：Hepatocyte growth factor receptor）
IGF（英語：Somatomedin receptor）
IGF-1
IGF-2（英語：Insulin-like growth factor 2 receptor）
其他
LNGF (p75NTR)（英語：Low-affinity nerve growth factor receptor）
PDGF
RET (GFL)（英語：RET proto-oncogene）
GFRα1（英語：GFRα1）
GFRα2（英語：GFRα2）
GFRα3（英語：GFRα3）
GFRα4（英語：GFRα4）
Unsorted
SCF (c-Kit)（英語：CD117）
TGFβ（英語：Transforming growth factor beta receptor）
Trk
TrkA（英語：TrkA receptor）
  • Negative allosteric modulators: VM-902A
TrkB（英語：TrkB receptor）
TrkC（英語：TrkC receptor）
VEGF（英語：Vascular endothelial growth factor receptor）
其他
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