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奥他凡星:全球首次批准。

Oritavancin: first global approval.

机构信息

Springer, Private Bag 65901, Mairangi Bay, 0754, Auckland, New Zealand,

出版信息

Drugs. 2014 Oct;74(15):1823-8. doi: 10.1007/s40265-014-0295-4.

DOI:10.1007/s40265-014-0295-4
PMID:25239268
Abstract

Oritavancin (Orbactiv(®)) is a lipoglycopeptide antibacterial drug with activity against Gram-positive bacteria developed by The Medicines Company as a single-dose treatment for acute bacterial skin and skin structure infections (ABSSSI). The drug received its first global approval for this indication in the US in August 2014, and is under regulatory review in the EU. This article summarises the milestones in the development of oritavancin leading to this first approval for the treatment of ABSSSIs caused by Gram-positive bacteria.

摘要

奥利万星(奥他凡星(®))是一种糖肽类抗生素药物,对革兰氏阳性菌具有活性,由 The Medicines Company 开发,作为治疗急性细菌性皮肤和皮肤结构感染(ABSSSI)的单剂量疗法。该药于 2014 年 8 月在美国首次获得该适应证的全球批准,并正在欧盟接受监管审查。本文总结了奥利万星研发过程中的重要里程碑,这些里程碑使该药首次获批用于治疗革兰氏阳性菌引起的 ABSSSIs。

相似文献

1
Oritavancin: first global approval.奥他凡星:全球首次批准。
Drugs. 2014 Oct;74(15):1823-8. doi: 10.1007/s40265-014-0295-4.
2
Oritavancin: A Novel Lipoglycopeptide.奥利万星:一种新型脂糖肽类抗生素。
Consult Pharm. 2016 Feb;31(2):86-95. doi: 10.4140/TCP.n.2016.86.
3
Oritavancin, a single-dose, complete regimen, for the treatment of acute bacterial skin and skin structure infections.奥利万星,单剂量完整疗程,用于治疗急性细菌性皮肤及皮肤结构感染。
Expert Rev Anti Infect Ther. 2015 Apr;13(4):409-16. doi: 10.1586/14787210.2015.1012498. Epub 2015 Feb 9.
4
Oritavancin: a long-acting antibacterial lipoglycopeptide.奥利万星:一种长效抗菌脂糖肽。
Future Microbiol. 2016 Jul;11:843-55. doi: 10.2217/fmb-2016-0003. Epub 2016 May 10.
5
Oritavancin: a review in acute bacterial skin and skin structure infections.奥他万星:治疗急性细菌性皮肤和皮肤结构感染的综述。
Drugs. 2015 Nov;75(16):1891-902. doi: 10.1007/s40265-015-0478-7.
6
Activity of oritavancin against Gram-positive clinical isolates responsible for documented skin and soft-tissue infections in European and US hospitals (2010-13).奥塔万星对欧洲和美国医院有记录的皮肤和软组织感染的革兰阳性临床分离株的活性(2010-2013 年)。
J Antimicrob Chemother. 2015 Feb;70(2):498-504. doi: 10.1093/jac/dku421. Epub 2014 Oct 31.
7
Single-dose oritavancin versus 7-10 days of vancomycin in the treatment of gram-positive acute bacterial skin and skin structure infections: the SOLO II noninferiority study.单剂奥塔万古霉素与 7-10 天万古霉素治疗革兰阳性急性细菌性皮肤和皮肤结构感染:SOLO II 非劣效性研究。
Clin Infect Dis. 2015 Jan 15;60(2):254-62. doi: 10.1093/cid/ciu778. Epub 2014 Oct 6.
8
Antimicrobial development in the era of emerging resistance.耐药性不断出现时代的抗菌药物研发
Mini Rev Med Chem. 2009 Jul;9(8):938-55. doi: 10.2174/138955709788681564.
9
A comparative review of the lipoglycopeptides: oritavancin, dalbavancin, and telavancin.糖肽类抗生素的比较综述:奥他万古霉素、达巴万星和替拉万星。
Pharmacotherapy. 2010 Jan;30(1):80-94. doi: 10.1592/phco.30.1.80.
10
New lipoglycopeptides: a comparative review of dalbavancin, oritavancin and telavancin.新型糖肽类抗生素:达巴万星、奥他万星和替拉万星的比较综述。
Drugs. 2010 May 7;70(7):859-86. doi: 10.2165/11534440-000000000-00000.

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ACS Infect Dis. 2020 Aug 14;6(8):2169-2180. doi: 10.1021/acsinfecdis.0c00258. Epub 2020 Jul 14.
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本文引用的文献

1
Single-dose oritavancin in the treatment of acute bacterial skin infections.单剂量奥他万星治疗急性细菌性皮肤感染。
N Engl J Med. 2014 Jun 5;370(23):2180-90. doi: 10.1056/NEJMoa1310422.
2
Oritavancin: mechanism of action.奥利万星:作用机制。
Clin Infect Dis. 2012 Apr;54 Suppl 3:S214-9. doi: 10.1093/cid/cir920.
3
Oritavancin microbiologic features and activity results from the surveillance program in the United States.奥他万古霉素的微生物学特征和活性结果来自美国的监测计划。
C1-CBP-万古霉素:万古霉素C端三甲基铵阳离子对药理特性的影响及其新引入作用机制的见解
J Org Chem. 2020 Feb 7;85(3):1365-1375. doi: 10.1021/acs.joc.9b02314. Epub 2019 Oct 31.
4
Exploration of the site-specific nature and generalizability of a trimethylammonium salt modification on vancomycin: A-ring derivatives.对万古霉素A环衍生物上三甲基铵盐修饰的位点特异性性质及通用性的探索。
Tetrahedron. 2019 Jun 14;75(24):3160-3165. doi: 10.1016/j.tet.2019.02.008. Epub 2019 Feb 4.
5
N-Terminus Alkylation of Vancomycin: Ligand Binding Affinity, Antimicrobial Activity, and Site-Specific Nature of Quaternary Trimethylammonium Salt Modification.万古霉素的N端烷基化:配体结合亲和力、抗菌活性及季铵盐修饰的位点特异性本质
ACS Infect Dis. 2018 Oct 12;4(10):1468-1474. doi: 10.1021/acsinfecdis.8b00152. Epub 2018 Aug 8.
6
Nonribosomal Peptides from Marine Microbes and Their Antimicrobial and Anticancer Potential.海洋微生物产生的非核糖体肽及其抗菌和抗癌潜力。
Front Pharmacol. 2017 Nov 21;8:828. doi: 10.3389/fphar.2017.00828. eCollection 2017.
7
Peripheral modifications of [Ψ[CHNH]Tpg]vancomycin with added synergistic mechanisms of action provide durable and potent antibiotics.通过对[Ψ[CHNH]Tpg]万古霉素进行外围修饰,并增加协同作用机制,提供了持久而有效的抗生素。
Proc Natl Acad Sci U S A. 2017 Jun 27;114(26):E5052-E5061. doi: 10.1073/pnas.1704125114. Epub 2017 May 30.
8
Total Syntheses of Vancomycin-Related Glycopeptide Antibiotics and Key Analogues.万古霉素相关糖肽类抗生素及关键类似物的全合成
Chem Rev. 2017 Sep 27;117(18):11952-11993. doi: 10.1021/acs.chemrev.6b00820. Epub 2017 Apr 24.
9
New agents approved for treatment of acute staphylococcal skin infections.获批用于治疗急性葡萄球菌皮肤感染的新型药物。
Arch Med Sci. 2016 Dec 1;12(6):1327-1336. doi: 10.5114/aoms.2016.59838. Epub 2016 May 11.
10
Targeting Antibiotic Resistance.靶向抗生素耐药性。
Angew Chem Int Ed Engl. 2016 Jun 1;55(23):6600-26. doi: 10.1002/anie.201506818. Epub 2016 Mar 22.
Clin Infect Dis. 2012 Apr;54 Suppl 3:S203-13. doi: 10.1093/cid/cir923.
4
Comparison of the efficacy and safety of oritavancin front-loaded dosing regimens to daily dosing: an analysis of the SIMPLIFI trial.比较奥沙万古霉素前负荷剂量方案与每日剂量方案的疗效和安全性:SIMPLIFI 试验分析。
Antimicrob Agents Chemother. 2011 Jul;55(7):3476-84. doi: 10.1128/AAC.00029-11. Epub 2011 May 2.
5
Oritavancin, a new lipoglycopeptide antibiotic: results from a thorough QT study.奥利万星,一种新型糖肽类抗生素:一项全面 QT 研究的结果。
J Clin Pharmacol. 2010 Aug;50(8):895-903. doi: 10.1177/0091270009355449. Epub 2010 May 19.
6
New lipoglycopeptides: a comparative review of dalbavancin, oritavancin and telavancin.新型糖肽类抗生素:达巴万星、奥他万星和替拉万星的比较综述。
Drugs. 2010 May 7;70(7):859-86. doi: 10.2165/11534440-000000000-00000.
7
Oritavancin population pharmacokinetics in healthy subjects and patients with complicated skin and skin structure infections or bacteremia.奥利万星在健康受试者以及患有复杂皮肤和皮肤结构感染或菌血症患者中的群体药代动力学。
Antimicrob Agents Chemother. 2009 Oct;53(10):4422-8. doi: 10.1128/AAC.00231-09. Epub 2009 Jul 27.
8
Time-kill kinetics of oritavancin and comparator agents against Staphylococcus aureus, Enterococcus faecalis and Enterococcus faecium.奥利万星及对照药物对金黄色葡萄球菌、粪肠球菌和屎肠球菌的时间杀菌动力学
J Antimicrob Chemother. 2009 Jun;63(6):1191-9. doi: 10.1093/jac/dkp126. Epub 2009 Apr 15.
9
Pharmacokinetics of oritavancin in plasma and skin blister fluid following administration of a 200-milligram dose for 3 days or a single 800-milligram dose.给予200毫克剂量,持续3天或单次给予800毫克剂量后,奥利万星在血浆和皮肤水疱液中的药代动力学。
Antimicrob Agents Chemother. 2005 Jan;49(1):148-52. doi: 10.1128/AAC.49.1.148-152.2005.