肝苏治疗慢性乙型肝炎的系统评价  

Gansu for Chronic Hepatitis B:A Systematic Review

作　　者：唐奇远[1] 何清[1] 白冰[1] 唐怡敏[1] 唐尉[1] 敖飞健[1] 

机构地区：[1]深圳市第三人民医院肝病科,深圳518020

出　　处：《中国循证医学杂志》2010年第8期978-984,共7页Chinese Journal of Evidence-based Medicine

摘　　要：目的系统评价肝苏治疗慢性乙型肝炎的疗效和安全性。方法计算机检索Cochrane图书馆临床对照试验数据库、PubMed、EMbase、CBM、CNKI、中文科技期刊数据库VIP和万方数据库等,检索时间从建库截至2009年12月按纳入排除标准选择文献,评价质量。在按测量指标和干预措施进行亚组分析后,对同质研究进行Meta分析。结果共纳入14个研究,合计1?755例慢性乙型肝炎患者。其中除2篇为半随机设计,其余12篇均未描述具体随机方法,所有文献均未描述分配隐藏方法,未实施盲法。Meta分析结果显示:①在降低ALT方面,肝苏+常规治疗组优于常规治疗组,差异有统计学意义;②在HBsAg阴转率方面,肝苏+常规治疗组与常规治疗组差异无统计学意义;③在HBeAg阴转率方面,治疗3个月时肝苏+常规治疗组与常规治疗组比较差异无统计学意义;④在HBV-DNA阴转率方面,无论治疗3个月或6个月时,肝苏+常规治疗组均优于常规治疗组,其差异有统计学意义,但肝苏+拉米夫定/阿德福韦与单用拉米夫定/阿德福韦比较,两组差异无统计学意义;⑤在降低肝纤维化指标方面,肝苏+常规治疗组优于常规治疗组,其差异有统计学意义。结论现有研究结果显示,肝苏治疗慢性乙型肝炎对ALT、病毒学指标、病毒学应答、肝纤维化的改善可能有效,且无严重不良反应。但本系统评价所纳入的文献多为较低质量的小样本研究,且用药时间不同,因此无法进行总体的效应合并分析,上诉结论尚需更多高质量研究支持。Objective To evaluate the effectiveness and safety of Gansu for chronic hepatitis B.Methods We searched The Cochrane Central Register of Controlled Trials（CCTR）,PubMed,EMbase,CBM,CNKI,VIP,and Wanfang databases up to Dce.2009.The methodological quality assessment and data extraction of the included studies were conducted by two reviewers independently according to the inclusion and exclusion criteria.Meta-analyses were performed for homogeneous studies using RevMan 4.2.10 software.Results A total of 14 studies involving 1 755 patients met the inclusion criteria.Of which,12 studies did not report randomization method,and the other two studies reported inadequate methods of randomization.None of the studies enforced allocation concealment and performed blinding.We conducted subgroup analyses based on the outcome measures and interventions.The results of meta-analyses showed：（1）In terms of reducing ALT,Gansu ＋ conventional therapy was superior to conventional therapy alone.（2）In terms of the HBsAg seroconversion rate,no significant difference was found between the two groups.（3）In terms of the HBeAg,no significant difference was found between the two groups at 3 months＇ follow-up.（4）In terms of the HBV-DNA,Gansu ＋ conventional therapy was superior to conventional therapy alone at 3 and 6 months＇ follow-up,but theses differences were not found between Gansu ＋ Lamivudine/Adefovir and Lamivudine/Adefovir alone.In terms of reducing the index of hepatic fibrosis,Gansu ＋ conventional therapy was superior to conventional therapy alone.Conclusion Gansu might be effective in normalizing ALT levels,clearing HBV DNA,achieving virus seroconversion and improving hepatic fibrosis,without any serious adverse effects.However,because the overall effects cannot be pooled for analysis,more evidence is needed to support this finding.

关 键 词：肝苏 慢性乙型肝炎 系统评价 随机对照试验 

分 类 号：R259[医药卫生—中西医结合]