复方丹参滴丸/片对慢性乙型肝炎肝纤维化作用的系统评价

Effects of Compound Danshen Dripping Pills or Tablets on Chronic Hepatitis B Complicated with Hepatic Fibrosis:A Systematic Review

目的:系统评价复方丹参滴丸/片对慢性乙型肝炎肝纤维化的作用,为临床提供循证参考。方法:计算机检索Pub Med、Cochrane图书馆、EMBase、Medline、万方数据库、中文科技期刊数据库、中国期刊全文数据库、中国生物医学文献数据库,收集复方丹参滴丸/片联合恩替卡韦(试验组)对比恩替卡韦单用(对照组)治疗慢性乙型肝炎肝纤维化的随机对照试验(RCT),提取资料并按照Cochrane系统评价员手册5.1.0提供的偏倚风险评估工具进行质量评价后,采用Rev Man 5.3统计软件进行Meta分析。结果 :共纳入9项RCT,合计714例患者。Meta分析结果显示,试验组患者丙氨酸转氨酶水平[SMD=-0.44,95%CI(-0.86,-0.01),P=0.04]、透明质酸水平[SMD=-1.53,95%CI(-2.28,-0.79),P<0.001]、层黏连蛋白水平[SMD=-0.93,95%CI(-1.41,-0.46),P<0.001]、Ⅳ型胶原水平[SMD=-1.38,95%CI(-2.13,-0.63),P<0.001]和Ⅲ型前胶原水平[SMD=-1.42,95%CI(-1.60,-1.23),P<0.001]均显著低于对照组,乙肝病毒脱氧核糖核酸阴转率[OR=3.73,95%CI(2.14,6.49),P<0.001]显著高于对照组,差异均有统计学意义。结论:复方丹参滴丸/片能改善慢性乙型肝炎肝纤维化患者肝功能与肝纤维化情况,提高抗病毒效果。

OBJECTIVE： To systematically review the efficacy of Compound danshen dripping pill or Compound danshen tab- lets for chronic hepatitis B complicated with hepatic fibrosis, and to provide evidence-based reference for clinical treatment. METH- ODS： Retrieved from PubMed, Cochrane Library, EMBase, Medline, Wanfang database, VIP, CJFD and CBM database, ran- domized controlled trials （RCTs） about Compound danshen dripping pills or tablets combined with entecavir（trial group） vs. enteca- vir alone （control group） for chronic hepatitis B complicated with hepatic fibrosis were collected. Meta-analysis was performed by using Rev Man 5.3 statistical software after data extraction and quality evaluation according to Cochrane systematic evaluation man- ual 5.1.0. RESULTS： A total of 9 RCTs were enrolled, including 714 patients. The results of Meta-analysis showed that ALT [SMD= -0.44,95%CI（ -0.86, -0.01） ,P=0.04], HA [SMD=- 1.53,95%CI（ --2.28, -0.79） ,P〈0.001], LN [SMD=-0.93, 95%CI（- 1.41, -0.46）,P〈0.001], CIV [SMD=- 1.38,95%CI（-2.13, -0.63）,P〈0.001] and PCIII [SMD=- 1.42,95% CI （ - 1.60, - 1.23）, P〈 0.001] of trial group were significantly lower than those of control group; HBV-DNA negative rate [OR= 3.73, 95% CI（2.14, 6.49）, P〈0.001] was significantly higher than control group, with statistical significance. CONCLUSIONS： Compound danshen dripping pills or tablets can not only improve liver function and liver fibrosis in chronic hepatitis B patients with hepatic fibrosis, but also improve the antiviral effect.