扶正化瘀胶囊治疗慢性乙型肝炎肝纤维化有效性和安全性的系统评价

Effectiveness and Safety of Fuzheng Huayu Capsule for Liver Fibrosis of Chronic Hepatitis B: A Systematic Review

目的系统评价扶正化瘀胶囊治疗慢性乙型肝炎肝纤维化的有效性和安全性。方法采用Cochrane系统评价方法,电子检索MEDLINE、EMbase、Cochrane图书馆临床对照试验资料库、中国生物医学文献数据库、中国医院知识仓库,手工检索已发表与未发表的相关文献,检索时间截至2008年3月。纳入治疗组口服扶正化瘀胶囊,对照组口服其它药物的随机对照试验。由两名评价者独立选择试验、提取资料、交叉核对和进行方法学质量评估。统计分析采用RevMan4.2.10软件进行。结果最终纳入7个RCT,共590例慢性乙型肝炎肝纤维化患者。纳入研究质量1个为A级、1个为B级、其余5个为C级。按疗程和干预措施进行亚组分析:①在降低肝纤维化指标透明质酸方面,疗程为3个月时,与和络舒肝胶囊比较差异有统计学意义[WMD=–61.75,95%CI(–105.20,–18.30)],与其他药物比较差异均无统计学意义;疗程为6个月时,与安慰剂比较差异有统计学意义[WMD=–187.72,95%CI(–244.23,–31.21)],与和络舒肝胶囊比较差异也有统计学意义[WMD=–120.03,95%CI(–158.41,–81.65)]。②在降低Ⅳ型前胶原方面,除疗程为6个月时与肝泰乐等比较差异有统计学意义[WMD=–72.32,95%CI(–84.30,–60.34)]外,与其他药物比较差异均无统计学意义。③在改善肝脏病理纤维化分期S有效率方面,与肝泰乐等比较差异有统计学意义[RR=2.33,95%CI(1.37,3.96)],与和络舒肝胶囊比较差异也有统计学意义[RR=1.30,95%CI(1.03,1.65)]。④不良反应:主要为胃肠道反应,无其它不适。结论现有研究显示,扶正化瘀胶囊对血清纤维化指标透明质酸、及肝脏病理纤维化分期S有明显的改善作用。特别是当疗程由3个月延长至6个月时,该药对透明质酸及肝脏病理纤维化指标S的改善更为显著,且对Ⅳ-C也有一定的改善,并且无明显不良反应。由于本系统评价纳入RCT多为较低质量的小样本研究,需要更多高质量的研究进一步验证其疗效。

Objective To evaluate the effectiveness and safety of treatment with Fuzheng Huayu capsule for liver fibrosis of chronic hepatitis B （CHB）. Methods We searched MEDLINE, EMBASE, Cochrane Database of Controlled Trials （CCTR）, CBMweb and CNKI up to March 2008. The references of retrieved literature were also hand searched. Randomized controlled trials （RCTs） which compared Fuzheng Huayu capsule with placebo or other drugs were collected. Data extraction and quality assessment were performed by two reviewers independently. The Cochrane Collaboration＇ s software RevMan 4.2.10 was used for data analyses. Results Seven RCTs involving 590 cases of liver fibrosis of CHB were included. As for their methodological quality, one was graded A, one was graded B and the others were graded C. We carried out subgroup analyses based on treatment course and intervention measures. In terms of reducing haluronic acid, Fuzheng Huayu capsule was more effective than Huoluo Shugan capsule when the treatment course was 3 months （WMD= -61.75, 95%CI -105.20 to -18.30）; significant differences were also noted between Fuzheng Huayu capsule and placebo （WMD=-187.72, 95%CI -244.23 to -31.21） or Huoluo Shugan capsule （WMD=-120.03, 95% CI -158.41 to -81.65） when the treatment course was 6 months. In terms of reducing Ⅳ-C, Fuzheng Huayu capsule was more effective than Gantaile when the treatment course was 6 months （WMD= -72.32, 95%CI -84.30 to -60.34）. As for improving liver fibrosis at stage S, significant differences were observed between Fuzheng Huayu capsule and Gantaile （RR=2.33, 95%CI 1.37 to 3.96） or Huoluo Shugan capsule （RR=I.30, 95%CI 1.03 to 1.65）. Except a very small number of gastrointestinal reactions, no significant adverse reactions were reported. Conclusion Fuzheng Huayu capsule is effective in reducing haluronic acid and improving liver fibrosis at stage S, especially when the treatment course is prolonged from 3 months to 6 months. No significant adverse reactions are reported. Because most of the included trials are of poor quality and small sample size, more high-quality RCTs are needed.