异烟肼抗结核治疗致肝损伤的国内文献综合分析  

Systematic Review of Isoniazid Induced Liver Injury in China

作　　者：龙芳芳[1,2] 王以美[1] 于锋[2] 张天译[1] 张添光[1] 赵君[1] 彭双清[1] 

机构地区：[1]军事医学科学院疾病预防控制所,北京100071 [2]中国药科大学临床药学教研室

出　　处：《药物流行病学杂志》2016年第6期385-390,共6页Chinese Journal of Pharmacoepidemiology

基　　金：国家自然科学基金项目(编号:81273602)

摘　　要：目的：系统分析近10年异烟肼抗结核治疗致临床肝损伤的国内原始文献,了解国内异烟肼抗结核治疗导致临床肝损伤的发生情况,为临床安全使用异烟肼提供帮助。方法：系统检索2005年1月-2015年3月发表于中国知网、万方、维普等数据库的文献。制定相应的纳入及排除标准,对最终纳入的文献进行综合分析,对包括临床抗结核患者的异烟肼使用率,肝损伤的发生率、发生时间、影响因素等进行描述性分析。结果：共纳入27篇文献,81.5%的文献由专业机构或者综合医院完成。根据文献分析结果,92.4%的抗结核患者在治疗过程中使用了异烟肼;15.5%的抗结核患者发生了肝损伤,属于十分常见的不良反应（≥10%）,其中69.9%的肝损伤患者使用了异烟肼。排除无明确肝损伤病例的文献,有18篇文献报道男性较女性更易发生肝损伤,4篇文献报道女性较男性更易发生肝损伤。肝损伤主要发生在抗结核治疗15-30 d内,且患者转归大多为治愈。结论：我国抗结核患者的肝损伤发生率较高,与异烟肼的使用密切相关。在患者服用异烟肼期间,应嘱其密切观察肝功能变化,定期检测肝功能,并进行临床评估。Objective：To retrieve and analyze the domestic original articles in recent 10 years in the present study, in order to evaluate the occurrence of clinical liver injury induced by anti-tuberculosis treatment with isoniazid, provide to help the rational use of isoniazid in clinic. Methods ： All the publications systematically in CNKI, Wan Fang Data and VIP database from January 2005 to March 2015 were retrieved, inclusion and exclusion criteria were formulated to comprehensively analyze all accepted articles, The results were described as the utilization rate of isoniasid among tuberculosis patients in clinic, the incidence of liver injury, occurrence time, risk factors, etc. Results：The number of all accepted references was 27 articles, and 81.5% of data were from professional organizations or general hospitals. There were 19 general cohort studies, two cohort studies on risk factors, five prospective studies, and one piece of clinical trials. According to the results of literature analysis, 92.4% of patients used isoniazid in the process of anti-tuberculosis treatment, 15.5% of the patients suffered from liver injury in the process of anti-tuberculosis treatment, which belonged to the very common adverse reactions （ 10% or higher）. In the patients with liver injury, 69.9% of which were clearly caused by isoniazid or associated with isoniazid. There were 18 studies reported that the occurrence of liver injury among males was more than that of females, however, there were 4 articles reported the contrary results. In the process of anti-tuberculosis drug treatment, liver injury occurred mainly within 15 to 30 days. The outcome of these patients was cured in most. Conclusion：With a greater incidence of liver injury among tuberculosis patients in our country, it was closely related to isoniazid. During the patients treated with isoniazid, it should be necessary to monitor and evaluate the liver function in clinical tuberculosis patients.

关 键 词：异烟肼 抗结核药 药品不良反应 肝损伤 文献分析 

分 类 号：R978.3[医药卫生—药品]