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贝达喹啉:最新获得美国 FDA 批准的抗结核药物。

Pretomanid: The latest USFDA-approved anti-tuberculosis drug.

机构信息

Department of Pharmacology, Burdwan Medical College, Burdwan.

Department of Pharmacology, Burdwan Medical College, Burdwan.

出版信息

Indian J Tuberc. 2021 Apr;68(2):287-291. doi: 10.1016/j.ijtb.2020.09.003. Epub 2020 Sep 6.

DOI:10.1016/j.ijtb.2020.09.003
PMID:33845969
Abstract

Pretomanid is a nitroimidazooxazine drug which inhibits synthesis of mycolic acid. This leads to defective cell wall formation, ultimately causing bacterial cell death. It is active against both replicating and non-replicating M. tuberculosis. Following promising result in a phase III trial, pretomanid was approved by United States Food and Drug Administration in August 2019. This orally active drug has been approved as part of a combination regimen of bedaquiline, pretomanid and linezolid (BPaL regimen) to treat adults with pulmonary extensive drug resistant tuberculosis (TB) or treatment-intolerant or non-responsive multidrug resistant TB. Peripheral neuropathy and increased liver enzymes are some of the reported adverse events associated with pretomanid. However, more studies are required to confirm the role of pretomanid in paediatric, geriatric and HIV co-infection cases.

摘要

丙硫异烟胺是一种硝基咪唑恶嗪类药物,可抑制分枝菌酸的合成。这会导致细胞壁形成缺陷,最终导致细菌死亡。它对繁殖期和非繁殖期的结核分枝杆菌均有活性。在 III 期临床试验中取得了可喜的结果后,丙硫异烟胺于 2019 年 8 月获得美国食品和药物管理局的批准。这种口服活性药物已被批准作为贝达喹啉、丙硫异烟胺和利奈唑胺(BPaL 方案)联合方案的一部分,用于治疗患有广泛耐药性肺结核(TB)或不耐受或无反应的耐多药结核病的成年人。周围神经病和肝酶升高是与丙硫异烟胺相关的一些已报告的不良事件。然而,还需要更多的研究来证实丙硫异烟胺在儿科、老年和 HIV 合并感染病例中的作用。

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