国内抗结核药物不良反应发生率的综合分析

目的了解我国抗结核治疗导致各种药物不良反应尤其是肝损害的发生率情况。方法于2006年采用系统综述方法，以“结核＋药物”为关键词搜索国内发表于1996至2005年的文献，对文献的报道内容进行综合分析，包括抗结核治疗引起的各种不良反应的发生情况、发生率、可能的影响因素及不良反应预后等。结果根据检索结果、入选及排除标准，共纳入文献117篇。近10年文献报道抗结核药物引起的不良反应合计发生率为12．62％，其中以肝损害的报告发生率最高，合计发生率为11．90％。不同诊断标准、不同性质研究单位、不同研究类型报道的肝损害发生率有区别，但前两者无统计学意义。回顾性队列研究证明乙型肝炎病毒标志物阳性或曾有肝病史的结核病患者，其肝损害发生率明显高于一般结核病患者。肝损害的转归较好，在报告了转归的文章中，85．84％的患者不良反应治愈。结论我国抗结核治疗导致各种药物不良反应尤其是肝损害的发生率较高，应重视对不良反应的防治，以增强患者服药的依从性。

Systematic review of anti-tuberculosis drug induced adverse reactions in China

OBJECTIVE: To study the incidences of adverse reactions induced by anti-tuberculosis drugs in China. METHODS: Articles about adverse drug reactions (ADR) induced by anti-tuberculosis drugs published in 1996 - 2005 in China were searched. The incidences, possible risk factors, and prognoses of these ADR were analyzed. RESULTS: According to our searching strategy and including criteria, 117 studies were included. The overall incidence of anti-tuberculosis drug induced ADR of these studies was 12.62%, and the overall incidence of hepatic injury was 11.9%, which was the highest among all kinds of ADR induced by anti-tuberculosis therapy. For different types of study, different diagnostic standards of hepatic injury, and different study institutions, the reported incidences of hepatic injury varied. Retrospective cohort studies showed that HBV(+) tuberculosis patients had a significantly higher risk of hepatic injury than HBV(-) patients. The prognosis of hepatic injury was good; 85.84% patients were cured of hepatic injury according to the articles which reported outcomes. The whole study was finished by 2006. CONCLUSIONS: The incidence of adverse reactions induced by anti-tuberculosis drugs is high in China. Prevention and treatment of ADR are very important for improving the adherence of patients.