College of Medicine Sulaiman Al Rajhi University, Bukayriyah, Al-Qassim, Saudi Arabia.
Department of Anesthesiology and Intensive Care Unit RSUD Pangeran Jaya Sumitra General Hospital, Kotabaru, South Kalimantan, Indonesia.
Pulm Med. 2024 Aug 9;2024:5542658. doi: 10.1155/2024/5542658. eCollection 2024.
The risks and benefits of bedaquiline (BDQ) for treatment of drug-resistant tuberculosis (DR-TB) have not been firmly established. We aimed to assess the safety and efficacy of BDQ-containing regimens for the treatment of DR-TB as evidenced in available randomized controlled trials (RCTs). In this systematic review and meta-analysis, five databases (i.e., ClinicalTrials.gov, Cochrane CENTRAL, PubMed, ScienceDirect, and SinoMed) were searched. RCTs among DR-TB patients that had a control arm were eligible. The safety endpoints were all-cause mortality and serious adverse effects (SAEs). Efficacy outcomes were sputum culture conversion rate at 8-12 weeks and 24-26 weeks, treatment success, and time to culture conversion. A total of 476 records were screened; 18 met the eligibility criteria. The pooled analysis included 2520 participants (55.8% received BDQ-containing regimens, = 1408). Pooled safety outcomes showed no significant reduction in all-cause mortality (relative risk [RR] [95%confidence interval (CI)] = 0.94 [0.41-2.20]) or SAEs (RR [95%CI] = 0.91 [0.67-1.23]) in the BDQ-regimen group. Pooled efficacy outcomes showed significantly superior culture conversion rates at 8-12 weeks (RR [95%CI] = 1.35 [1.10-1.65]) and 24-26 weeks (RR [95%CI] = 1.25 [1.15-1.36]), more treatment success (RR [95%CI] = 1.30 [1.17-1.44]), and a 17-day reduction in the time to culture conversion (standardized mean difference [SMD] [95%CI] = -17.46 [-34.82 to -0.11]) in the BDQ-regimen group (reference: non-BDQ regimen). Overall, BDQ regimens showed significant treatment effect against DR-TB but did not reduce mortality or SAEs.
巴喹替尼（BDQ）治疗耐药结核病（DR-TB）的风险和益处尚未得到明确证实。我们旨在评估在现有随机对照试验（RCT）中含 BDQ 方案治疗 DR-TB 的安全性和疗效。在这项系统评价和荟萃分析中，我们检索了五个数据库（即 ClinicalTrials.gov、Cochrane 中央、PubMed、ScienceDirect 和 SinoMed）。纳入了有对照臂的 DR-TB 患者的 RCT 符合入选标准。安全性终点为全因死亡率和严重不良事件（SAE）。疗效结局为 8-12 周和 24-26 周时痰培养转阴率、治疗成功率和培养转阴时间。共筛选出 476 条记录，其中 18 条符合入选标准。汇总分析纳入了 2520 名参与者（55.8%接受含 BDQ 方案治疗， = 1408）。汇总安全性结局显示，BDQ 方案组全因死亡率（相对风险[RR] [95%置信区间[CI] ] = 0.94 [0.41-2.20]）或 SAE（RR [95%CI] = 0.91 [0.67-1.23]）无显著降低。汇总疗效结局显示，BDQ 方案组 8-12 周（RR [95%CI] = 1.35 [1.10-1.65]）和 24-26 周（RR [95%CI] = 1.25 [1.15-1.36]）时痰培养转阴率显著更高，治疗成功率更高（RR [95%CI] = 1.30 [1.17-1.44]），培养转阴时间缩短 17 天（标准化均数差[SMD] [95%CI] = -17.46 [-34.82 至 -0.11]），BDQ 方案组获益更多（参照：非 BDQ 方案）。总体而言，BDQ 方案对 DR-TB 有显著治疗效果，但并未降低死亡率或 SAE。
