中草药治疗慢性乙型肝炎随机对照试验的系统评价

Chinese medicinal herbs for chronic hepatitis B: a systematic review

目的 评价中草药治疗慢性乙型肝炎的疗效与安全性。设计Cochrane系统评价。研究的鉴定 检索Cochrane肝胆疾病组、Cochrane图书馆、Cochrane另证医学领域试验注册数据库,MEDLINE、EMBASE以及BIOSIS数据库。手工检索发表与未发表的中文文献。纳入标准 收集比较中草药与安慰剂、未治疗、非特异性治疗或干扰素治疗慢性乙型肝炎并随访达3个月以上的随机与半随机对照试验。中草药联用干扰素与单用干扰素比较的试验也予以纳入。试验无论是否使用盲法或发表语种均不受纳入限制。资料提取与统计方法 两名评价人员独立提取资料。纳入试验的方法学质量采用Jadad评分标准与随机分配隐藏。数据采用Cochrane协作网专用软件RevMan4.1版进行统计分析。结果 九篇随机对照试验共治疗936名病人满足纳入标准。其中仅一篇属于高质量的试验,双盲试验有二篇。回归分析表明存在发表偏倚,“倒漏斗”图(funnel plot)显示不对称图形(P=0.047)。与非特异性治疗或安慰剂比较,扶正解毒汤显示有清除乙型肝炎病毒血清表面抗原(HBsAg)、e抗原(HBeAg)及乙型肝炎病毒(HBV)DNA的疗效;猪苓多糖对清除血清HBsAg与HBV DNA有效;草药叶下珠对清除血清HBeAg有效。复方叶下珠和苦参碱对清除血清HBeAg及HBV DNA及恢复肝功能的效果与干扰素相当。试验?

Background Hepatitis B virus infection is a serious health problem worldwide. Traditional Chinese medicinal herbs have been widely used to treat chronic liver diseases, and many controlled trials have been done to investigate their efficacy. Objectives To assess the efficacy and safety of traditional Chinese medicinal herbs for chronic hepatitis B infection. Search strategy Searches were applied to the following electronic databases: the CHBG Trials Register, the Cochrane Complementary Medicine Field Trials Register, the Cochrane Library, MEDLINE, EMBASE and BIOSIS. Five Chinese journals and conference proceedings were handsearched. No language restriction was used. Selection criteria Randomised or quasi-randomised trials with at least three months follow-up. Trials of Chinese medicinal herbs (single or compound) compared with placebo, ho intervention, general non-specific treatment or interferon treatment were included. Trials of Chinese medicinal herbs plus interferon versus interferon alone were also included. Trials could be double-blind, single-blind or not blinded. Data collection and analysis Data were extracted independently by two reviewers. The methodological quality of trials was evaluated using the Jadad-scale plus allocation concealment. Intention-to-treat analyses were performed. Main Re- suits Nine randomised trials, including 936 patients, met the inclusion criteria. Methodological quality was considered adequate in only one trial. There was a significant funnel plot asymmetry (regression coefficient = 3.37, standard error 1.40,P = 0.047). Ten different medicinal herbs were tested in the nine trials. Compared to non-specific treatment or placebo, Fuzheng Jiedu Tang (compound of herbs) showed significantly positive effects on clearance of serum HBsAg, HBeAg, and HBV DNA; Polyporus umbellatus polysaccharide on serum HBeAg and HBV DNA; Phyllanthus amarus on serum HBeAg. Phyllanthus compound and kurorinone showed no significant effect on clearance of serum HBeAg and HBV DNA and on ala-nine aminotransferase normalisation compared to interferon treatment. There were no significant effects of the other examined herbs. Reviewer's conclusions Some Chinese medicinal herbs may work in chronic hepatitis B. However, the evidence is too weak to recommend any single herb. Rigorously designed, randomised, double-blind, placebo-controlled trials are required.