摘要
小柴胡汤是《伤寒论》中的经典方,广泛用于慢性肝病的治疗,尤其在日本每年有超过100万的慢性肝病病人使用。目的:运用循证医学系统综述方法评价小柴胡汤治疗慢性乙型肝炎的抗病毒及保肝疗效和安全性。检索策略:文献检索包括电子与手工检索。电子检索MEDLINE数据库、中国学术期刊全文数据库(CNKI)、中文科技期刊全文数据库(重庆维普)、中国生物医学文献数据库(Chinese Biomedical LiteratureDatabase,CBM)、中文生物医学期刊数据库(Chinese Medical Current Contents,CMCC)、中医药期刊文献数据库。检索日期截止至2009年11月8日。纳入标准:收集比较小柴胡汤与安慰剂、非特异性治疗、抗病毒药物治疗慢性乙肝的随机对照试验。小柴胡汤联用抗病毒药物与抗病毒药物比较的试验也予以纳入。资料提取与分析:两人独立提取资料,采用Cochrane协作网提供的软件RevMan 5.017进行资料分析。结局的效应指标为危险比率(risk ratio,RR)或均数差(mean difference,MD),均以95%可信区间表示。结果:16篇随机对照试验共治疗1601名慢性乙肝病人满足纳入标准。所纳入的1篇英文文献质量较高,其余15篇中文文献质量普遍偏低。在肝功能及抗病毒效应的综合疗效评价分析中,小柴胡汤联合抗病毒药物治疗优于单用抗病毒药物,小柴胡汤与安慰剂在改善肝功能和抗病毒效应方面的差异无统计学意义,小柴胡汤与丹参注射液联用在肝功能恢复上优于非特异性治疗。纳入试验未报告小柴胡汤的副作用,抗病毒治疗对个别患者有较严重的副作用。结论:纳入本系统评价的部分试验表明小柴胡汤联合抗病毒药物治疗慢性乙肝具有改善肝功能和清除血清标志物的作用。但是由于用中文发表的临床试验质量较低,对那些疗效较好的中药制剂需要作进一步的验证,试验的设计及报告应按照国际规范执行。
Background：Xiaochaihu Tang was a compound traditional Chinese herbal medicine recorded in ancient Chinese medical book Shanghanlun,and has been widely used for chronic liver diseases especially in Japan. Objective：To assess the beneficial effects and safety of Xiaochaihu Tang for chronic hepatitis B（CHB）. Search strategy：Electronic and manual searches were conducted and the search ended in November 2009. Inclusion criteria：We included randomized clinical trials testing Xiaochaihu Tang against placebo,nonspecific treatment,antivirals,or combined with antivirals against antivirals alone. Data extraction and analysis：Selection of trials for inclusion,assessment of methodological quality by Jadad score,data extraction and data syntheses were conducted according to the Cochrane Hepato-Biliary Group methods. Results：Sixteen randomized trials（involving 1 601 CHB patients） with various methodological quality were included.One trial published in English had good quality,while other trials published in Chinese were of poor quality.The pooled results showed that Xiaochaihu Tang combined with antiviral drugs was more effective in serum loss of hepatitis B viral markers and in improving liver function compared with antiviral drugs alone. Xiaochaihu Tang was not different from placebo in terms of viral clearance or improving liver function. However,Xiaochaihu Tang was superior to non-specific treatment in liver function improvement.There were no adverse effects reported in the trials regarding Xiaochaihu Tang,but adverse effects were reported in patients treated by interferon,and severe adverse effects occurred in few cases. Conclusion：Xiaochaihu Tang in this review appears to be effective in improving liver function and clearance of serum hepatitis B viral markers in patients with chronic hepatitis B.However,due to poor methodological quality in the majority of included trials the potential benefits need to be confirmed in rigorous clinical trials following international standards.
出处
《中西医结合学报》
CAS
2010年第4期312-320,共9页
Journal of Chinese Integrative Medicine
基金
国家重点基础研究发展计划(973计划)资助项目(No.2006CB504602)
关键词
小柴胡汤
慢性乙型肝炎
系统综述
随机对照试验
Xiaochaihu Tang
chronic hepatitis B
systematic review
randomized controlled trials
