扶正化瘀胶囊联合核苷(酸)类药物治疗慢性乙型肝炎肝纤维化的初步系统评价

摘要

Objective:To systematically evaluate combinative efficacy of Fuzheng Huayu capsule with nucleotide analogues in treating liver fibrosis due to chronic hepatitis B based on randomized controlled trials ((R)CTs).Methods:Retrieval strategy RCT reports published until June 2012 were retrieved from databases,including SinoMed,CNKI,Wanfang database system,OVID,Springer and manually.Participants received treatments of Fuzheng Huayu capsule with nucleotide analogues were pooled into trial group,while nucleotide analogues monotherapy were into control group.Two reviewers screened the RCTs independently,extracted the information and cross-checked them.Jadad scale and the Cochrane risk of bias tool were used to assess the study quality of the included RCTs and the statistical software RevMan 5.1 was used for data analysis.Results:Eight RCTs with 608participants were included.One of the reports was scored 2 and the others was 1 evaluated by the Jadad scale.Compared to control group,there was a significant decease in serologic markers of liver fibrosis such as HA,laminin,P-Ⅲ-P and collagen Ⅳ in trial group.As for serum liver functions,greater improvement of serum ALT,AST and albumin was shown in trial group than that of control group.Trial group demonstrated a better efficacy in decreasing spleen thickness than control group.But there was no significant difference between the trial and control group in negative conversion rate of HBV DNA and HBeAg.Conclusion:This meta-analysis confirms that Fuzheng Huayu capsule with nucleotide analogues has better efficacy on alleviating serological markers of liver fibrosis and improving liver functions than nucleotide analogues monotherapy in patients with liver fibrosis or cirrhosis due to chronic hepatitis B.But the reliable efficacy should be confirmed by strict RCTs which use histologic pathology as the primary evaluation criteria.%目的:用Meta分析方法系统评价核苷(酸)类抗病毒药物与扶正化瘀胶囊联合应用对慢性乙型肝炎肝纤维化的疗效.方法:检索策略:①电子中文数据库:中国生物医学文献系统、中国博士学位论文全文数据库、中国知网、万方数据系统；②外文数据库:OVID数据库、Springer;③同时手工检索已发表和未发表的相关文献,检索时间截止于2012年6月.核苷(酸)类似物联合扶正化瘀胶囊纳入治疗组,核苷(酸)类似物单用纳入对照组.由两名评价者独立选择研究、提取资料、交叉核对后进行方法学质量评估.筛选检索到的随机临床对照实验(RCT)采用Jadad评分表和Cochrane偏倚风险评估量表进行质量评分,采用RevMan 5.1软件进行统计.结果:8个有关核苷(酸)类似物联合扶正化瘀胶囊治疗慢性乙型肝炎肝纤维化或肝硬化的RCT研究(合计608例)纳入评价系统.其中1篇Jadad量表得分为2分,7篇为1分.Meta分析显示:核苷(酸)类似物联合扶正化瘀胶囊治疗后患者血清HA、LN、P-Ⅲ-P、Ⅳ-C、ALT、AST、Alb以及脾脏厚度的改善程度与对照组比较,差异有显著性意义,联合用药优于单用核苷(酸)类药物,而两组患者治疗后HBV DNA阴转率和HBeAg阴转率等差异无显著性意义.结论:抗肝纤维化中药扶正化瘀胶囊与核苷(酸)类抗HBV药物联合应用,对肝纤维化或肝硬化患者的血清肝功能与肝纤维化指标改善优于单用核苷(酸)类似物,但其确切疗效尚需以组织学为最终疗效评价标准的严格的RCT证据加以证实.