A Review of the Evidence for Using Bedaquiline (TMC207) to Treat Multi-Drug Resistant Tuberculosis.
A Review of the Evidence for Using Bedaquiline (TMC207) to Treat Multi-Drug Resistant Tuberculosis.
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DOI：
10.1007/s40121-013-0009-3
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发表时间：
2013-12
影响因子：
5.4
通讯作者：
Menzies, Dick
中科院分区：
文献类型：
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作者：
Fox, Gregory J;Menzies, Dick
耐多药结核病（MDR-TB）的现有疗法在其有效性、副作用特征和给药复杂性方面具有很大的局限性。贝达喹啉是一种新型二芳基喹啉抗生素，最近被研究作为现有耐多药结核病疗法的辅助治疗。目前，有限的临床数据可用于评估药物的安全性和有效性。在两项小型随机对照临床研究中，贝达喹啉给药8周或24周已被证明可改善治疗反应的替代微生物标志物，但试验尚未评估其对临床失败和复发的影响。安全性问题包括一项研究中贝达喹啉组的死亡率增加、心电图QT段延长的发生率增加和肝毒性。在获得进一步的研究数据之前，贝达喹啉的使用应仅限于可以密切监测精心挑选的患者的环境。
Existing therapies for multi-drug resistant tuberculosis (MDR-TB) have substantial limitations, in terms of their effectiveness, side-effect profile, and complexity of administration. Bedaquiline is a novel diarylquinoline antibiotic that has recently been investigated as an adjunct to existing therapies for MDR-TB. Currently, limited clinical data are available to evaluate the drug’s safety and effectiveness. In two small randomized-controlled clinical studies, bedaquiline given for 8 or 24 weeks has been shown to improve surrogate microbiological markers of treatment response, but trials have not yet evaluated its impact on clinical failure and relapse. Safety concerns include an increased mortality in the bedaquiline arm of one study, an increased incidence of QT segment prolongation on electrocardiogram, and hepatotoxicity. Until further research data are available, the use of bedaquiline should be confined to settings where carefully selected patients can be closely monitored.