Meta analysis of efficacy and safety of the treatment containing bedaquiline for multidrug-resistant pulmonary tuberculosis

doi:10.19982/j.issn.1000-6621.20220012

Abstract

Abstract:

Objective: To systematically evaluate the efficacy and safety of the treatment containing bedaquiline for multidrug-resistant pulmonary tuberculosis (MDR-PTB). Methods: Randomized controlled trials (RCTs) of bedaquiline-containing regimens for the treatment of MDR-PTB were searched and collected from Chinese databases (China National Knowledge Infrastructure (CNKI), Wanfang Data, VIP and China Biomedical Literature Database (CBM)) and English databases (The Cochrane Library, PubMed, Embase). The retrieval time was from the establishment of the database to December 2021. Two researchers independently screened the literature, extracted data, and evaluated the quality of the literature. RevMan 5.4 software was used to analyze the heterogeneity of the included data, and the publication bias. Results: A total of 802 patients were included in 10 articles. Meta-analysis results showed that compared with conventional anti-tuberculosis regimens, bedaquiline-containing regimens in the treatment of MDR-PTB could increase the negative conversion rate of sputum at the end of 12 weeks after treatment (OR=3.17, 95%CI: 1.85-5.43, P<0.01), improve the negative rate of sputum bacteria at the end of 24 weeks after treatment (OR=4.09, 95%CI: 2.74-6.12, P<0.01), the cavity closure rate (OR=3.11, 95%CI: 1.68-5.74, P<0.01), the absorption rate of lesions (OR=4.44, 95%CI: 2.40-8.22, P<0.01) and clinical cure rate (OR=4.15, 95%CI: 2.27-7.58, P<0.01), and reduce the level of mortality (OR=5.22, 95%CI: 1.16-16.96, P<0.01). However, there was no significant difference in sputum negative conversion rate at the end of 8 weeks after treatment (OR=1.79, 95%CI: 0.98-3.26, P=0.06) and incidence of adverse drug reactions (OR=2.72, 95%CI: 0.61-12.19, P=0.19) at the end of 8 weeks after treatment with bedaquiline-containing regimens for MDR-PTB. Conclusion: Compared with conventional anti-tuberculosis treatment, the chemotherapy regimens containing bedaquiline for MDR-PTB help to accelerate the negative conversion of sputum bacteria and improve the clinical efficacy, with no increase in adverse reactions; however, ECG should be closely monitored to be alert to the cardiotoxicity of bedaquiline.

Key words: Tuberculosis, multidrug-resistant, Treatment outcome, Safety, Meta-analysis as topic, Bedaquiline

YU Chun-hong, LIU Xing, SHEN Ling-jun, LI Hai-wen, LI Xie, WU Rong-shuang, LI Xian-rui, FAN Hao. Meta analysis of efficacy and safety of the treatment containing bedaquiline for multidrug-resistant pulmonary tuberculosis[J]. Chinese Journal of Antituberculosis, 2022, 44(7): 660-668. doi: 10.19982/j.issn.1000-6621.20220012

Figures/Tables 13

References 24

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文献来源	样本量(男/女,例)		平均年龄(岁)		平均病程(年)		干预措施		疗程 (周)	观察指标
文献来源	C	T	C	T	C	T	C	T	疗程 (周)	观察指标
牟厚玲 2021^[6]	31 (24/7)	32 (21/11)	34.25± 2.01	34.35± 1.95	2.59± 0.51	2.61± 0.48	个体化治疗方案+Bdq	个体化治疗方案	24	③④⑦
常瑞霞 2021^[7]	45 (31/14)	45 (29/16)	51.6± 4.7	52.2± 4.4	7.0± 1.4	6.8± 1.6	个体化治疗方案+Bdq	个体化治疗方案	24	③⑤⑥⑦
任娜 2021^[8]	30 (19/11)	30 (17/13)	47.12± 12.33	46.85± 13.01	8.27± 5.57	8.08± 5.27	个体化治疗方案+Bdq	个体化治疗方案	24	③④⑤ ⑥⑦
凌慧琪 2021^[9]	32 (18/14)	32 (19/13)	45.35± 4.61	45.27± 4.59	1.19± 0.13	1.20± 0.12	个体化治疗方案+Bdq	个体化治疗方案	24	②③④ ⑤⑥⑦
陈艳 2021^[10]	69 (44/25)	60 (45/15)	34.6± 11.0	35.5± 13.82	-	-	个体化治疗方案+Bdq	个体化治疗方案	24	①②③⑧
班立芳 2020^[11]	53 (31/22)	52 (32/20)	42.65± 5.35	43.02± 5.40	2.96± 0.56	2.97± 0.58	个体化治疗方案+Bdq	个体化治疗方案	24	③
吴浩宇 2020^[12]	34 (19/15)	34 (20/14)	41.02± 3.55	40.11± 3.82	6.03± 2.15	5.97± 2.71	个体化治疗方案+Bdq	个体化治疗方案	24	②③④ ⑥⑦
Diacon 2009^[13]	23 (18/5)	24 (17/7)	33	33	-	-	个体化治疗方案+Bdq	个体化治疗方案	24	①⑧
Diacon 2012^[14]	21 (16/5)	23 (16/7)	33	33	-	-	个体化治疗方案+Bdq	个体化治疗方案	24	①⑧
Diacon 2014^[15]	66 (45/21)	66 (40/26)	32	34	-	-	个体化治疗方案+Bdq	个体化治疗方案	24	③⑧

纳入研究	随机方法	分配隐藏	盲法	结果数据的完整性	选择性报告研究结果	其他偏倚风险来源
牟厚玲2021^[6]	门诊单双号	不清楚	不清楚	是	是	不清楚
常瑞霞2021^[7]	患者意愿	不清楚	不清楚	是	是	不清楚
任娜2021^[8]	随机数字表	不清楚	不清楚	是	是	不清楚
凌慧琪2021^[9]	随机	不清楚	不清楚	是	是	不清楚
陈艳2021^[10]	入院时间	不清楚	不清楚	是	是	不清楚
班立芳2020^[11]	随机	不清楚	不清楚	是	是	不清楚
吴浩宇2020^[12]	数字随机表	不清楚	不清楚	是	是	不清楚
Diacon2009^[13]	随机	恰当	双盲	是	是	不清楚
Diacon2012^[14]	随机	恰当	双盲	是	是	不清楚
Diacon2014^[15]	随机	恰当	双盲	是	是	不清楚