贝达喹啉治疗耐多药结核病的安全性与有效性的系统评价

Systematic Evaluation of Safety and Effectiveness of Betaquinoline in the Treatment of Multidrug-Resistant Tuberculosis

目的探讨贝达喹啉治疗耐多药结核病的应用价值及安全性。方法检索百度学术数据库、中国期刊全文数据库、维普数据库、万方数据库、Embase数据库、PubMed数据库、the Cochrane Library数据库等,收集贝达喹啉治疗耐多药性结核病的相关临床试验(对照组采用常规治疗方案,观察组采用贝达喹啉联合常规治疗方案),由研究者按照纳入与排除标准选取文献、提取文献资料并采用Jadad量表和Cochrane系统评价员手册对文献进行方法学质量评价,后采用Rev Man 5.3软件对文献进行荟萃分析,观察贝达喹啉治疗耐多药结核病的应用价值及安全性。结果共纳入文献3篇,均为Ⅱ期临床试验,试验对象共179例。经Meta分析结果显示,观察组患者痰菌转阴时间明显短于对照组,痰菌转阴率明显高于对照组(P<0.05);两组患者治愈率、不良反应发生率对比无差异(P>0.05);经长期随访发现,观察组患者的病死率明显高于对照组(P<0.05),但由于死亡时间不同,因此不能说明病死率与应用贝达喹啉有关。结论贝达喹啉联合常规治疗可有效治疗耐多药结核病,但仍需临床试验的进一步验证。

Objective To study the value and safety of bedaquinoline in the treatment of MDR-TB.Methods The full-text database of Chinese journals,Weipu database,Wanfang database,Baidu academic database,PubMed,the Cochrane Library,Embase and so on were retrieved.The clinical trials of betaquinoline in the treatment of MDR-TB were collected(the control group was treated with routine treatment,while the observation group was treated with betaquinoline combined with routine treatment).The articles were selected by the researchers according to inclusion and exclusion criteria.Literature was collected and evaluated by Jadad scale and Cherane system evaluator's manual.Then meta-analysis was performed by Rev Man 5.3 software to observe the value and safety of betaquinoline in the treatment of MDR-TB.Results A total of 3 articles were included in the literature,all of which were phase Ⅱ clinical trials.A total of 179 subjects were tested.Meta analysis showed that after 24 weeks of treatment,the sputum negative conversion time of the observation group was significantly shorter than that of the control group,and the sputum negative conversion rate of the observation group was significantly higher than that of the control group,the difference was statistically significant(P<0.05).There was no significant difference in adverse reactions and cure rates between the two groups(P>0.05).In the long-term follow-up after treatment,the mortality rate of patients in the observation group was significantly higher than that in the control group,the difference was of far-sighted significance(P<0.05).However,due to the different time of death,it could not be explained that the mortality rate was related to the application of betaquinoline.Conclusion Bedaquinoline combined with conventional therapy can effectively treat MDR-TB,but it still needs further validation in clinical trials.