Effectiveness and safety of bedaquiline-containing regimens in the treatment of MDR- and XDR-TB: a multicentre study
Effectiveness and safety of bedaquiline-containing regimens in the treatment of MDR- and XDR-TB: a multicentre study
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DOI：
10.1183/13993003.00387-2017
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发表时间：
2017-05-01
影响因子：
24.3
通讯作者：
Migliori, Giovanni Battista
中科院分区：
文献类型：
--
作者：
Borisov, Sergey E.;Dheda, Keertan;Migliori, Giovanni Battista
关于贝达奎兰用于治疗多药耐药(MDR-)和广泛耐药结核病(XDR-TB)的大型研究缺乏。这项研究的目的是在五大洲的25个中心和15个国家进行一项大规模的回顾性观察性研究，以评估含有贝达奎林的方案的安全性和有效性。分析了428例经培养确认的耐多药结核病病例(61.5%为男性；22.1%为HIV阳性，45.6%为广泛耐药结核病)。耐多药结核病患者的住院时间中位数(四分位数范围)179(92-280)天，贝达奎林暴露168(86-180)天。治疗方案包括利奈唑胺、莫西沙星、氯胺酮和碳青霉烯类(分别占82.0%、58.4%、52.6%和15.3%)；耐多药肺结核患者的涂片转阴率和培养转换率分别为63.6%、81.1%和56.7%，90d分别为85.5%和88.7%、91.2%。中位(IQR)涂片和培养转换时间分别为34(30-60)天和60(33-90)天。在完成治疗的247例经培养确认的耐多药结核病病例中，71.3%获得成功(62.4%治愈；8.9%完成治疗)，13.4%死亡，7.3%违约和7.7%失败。在5.8%的病例中，贝达奎兰因不良事件而中断。1例死亡，其心电图异常可能与贝达奎兰无关。在不同的非实验条件下，含有贝达奎林的方案获得了较高的转换率和成功率。
Large studies on bedaquiline used to treat multidrug-resistant (MDR-) and extensively drug-resistant tuberculosis (XDR-TB) are lacking. This study aimed to evaluate the safety and effectiveness of bedaquiline-containing regimens in a large, retrospective, observational study conducted in 25 centres and 15 countries in five continents.428 culture-confirmed MDR-TB cases were analysed (61.5% male; 22.1% HIV-positive, 45.6% XDR-TB). MDR-TB cases were admitted to hospital for a median (interquartile range (IQR)) 179 (92-280) days and exposed to bedaquiline for 168 (86-180) days. Treatment regimens included, among others, linezolid, moxifloxacin, clofazimine and carbapenems (82.0%, 58.4%, 52.6% and 15.3% of cases, respectively).Sputum smear and culture conversion rates in MDR-TB cases were 63.6% and 30.1%, respectively at 30 days, 81.1% and 56.7%, respectively at 60 days; 85.5% and 80.5%, respectively at 90 days and 88.7% and 91.2%, respectively at the end of treatment. The median (IQR) time to smear and culture conversion was 34 (30-60) days and 60 (33-90) days. Out of 247 culture-confirmed MDR-TB cases completing treatment, 71.3% achieved success (62.4% cured; 8.9% completed treatment), 13.4% died, 7.3% defaulted and 7.7% failed. Bedaquiline was interrupted due to adverse events in 5.8% of cases. A single case died, having electrocardiographic abnormalities that were probably non-bedaquiline related.Bedaquiline-containing regimens achieved high conversion and success rates under different nonexperimental conditions.