【作者】 武珊珊； 张越伦； 陈茹； 孙凤； 詹思延；

【Author】 WU Shan-shan, ZHANG Yue-lun, CHEN Ru, SUN Feng, ZHAN Si-yan. Department of Epidemiology and Biostatistics, School of Public Health, Peking University, Beijing 100191, China Corresponding author: ZHAN Si-yan, Department of Epidemiology and Biostatistics, School of Public Health, Peking University, Beijing 100191, China.

【机构】 北京大学公共卫生学院流行病与卫生统计学系；

【摘要】 目的:系统评价耐多药结核(MDR-TB)患者在使用二线抗结核药物治疗过程中肝损害的发生率情况。方法:以"tuberculosis"、"multidrug-resistant"、"MDR-TB"、"side effect"、"adverse"、"safety"、"tolerability"和"耐多药结核"、"副反应"、"不良反应"为关键词在Medline、Embase和The Cochrane Library三个英文数据库及VIP、CBMDisc、CNKI和万方四个中文数据库中(均从最早至2012年10月1日)系统检索MDR-TB患者在使用二线抗结核药物治疗过程中发生肝损害的随访研究,摘录有关信息,用随机效应模型进行Meta分析,并按照诊断标准、研究人群、研究类型、既往抗结核治疗史、HIV感染率和疗程进行亚组分析和敏感性分析。结果:根据入选及排除标准,共纳入25篇文献,3746名MDR-TB患者,其中353名发生了肝损害,各研究之间存在一定的异质性,采用随机效应模型加权合并的肝损害发生率为7.3%(95%CI:5.1%-10.5%)。亚组分析显示,肝损害在HIV感染率>0%、疗程≥18个月及非亚洲人群中发生率较高,但各亚组结果之间未见统计学差异(P>0.05)。25个研究中,只有9个研究报告了肝损害的诊断标准,但标准不统一。结论:MDR-TB患者在使用二线抗结核药物治疗过程中肝损害不良反应的发生率较高,且诊断标准不统一,应重视对肝损害的防治,并制定统一的诊断标准。更多还原

【Abstract】 Objective: To systematically evaluate the incidence of liver injury in multi-drug resistant tuberculosis (MDR-TB) patients with the treatment of second-line anti-TB drugs. Methods: Medline, Embase and the Cochrane library with four Chinese databases including VIP, CBMDisc, CNKI and wanfang, were systematically searched from inception through October 1st, 2012 with the Key words including "Tuberculosis", "multidrug-resistant", "MDR-TB", "side effect", "adverse", "safety" and "tolerability" for the follow-up studies of MDR-TB patients with liver injury during the treatment of second-line anti-TB drugs. Relevant information was extracted and data was analyzed using random-effects model. Subgroup and sensitivity analyses were performed based on diagnostic criteria, study population, study design, history of anti-TB treatment, HIV prevalence and treatment length. Results: A total of 25 articles with 3746 MDR-TB patients were included, of which 353 patients developed liver injury, and the weighted combined incidence of liver injury was 7.3% (95% CI: 5.1%-10.5%). There is some heterogeneity among the studies. Subgroup analyses showed that the incidence of liver injury was higher in groups with HIV prevalence> 0%, treatment length≥18 months and non-Asian populations, but there was no significant difference between groups (P>0.05). Among the 25 studies, only nine of them reported the diagnostic criteria of liver injury, while the criteria were not uniform. Conclusion: The incidence of liver injury during the treatment of second-line anti-TB drug in MDR-TB patients was high, and the diagnostic criteria were not uniform. We should pay attention to the prevention and treatment of liver injury, and develop standard diagnostic criteria for it.更多还原