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PubMed、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。
Abstract
OBJECTIVE: To systematically review the efficacy of Compound danshen dripping pill or Compound danshen tablets for chronic hepatitis B complicated with hepatic fibrosis,and to provide evidence-based reference for clinical treatment. METHODS: Retrieved from PubMed, Cochrane Library, EMBase, Medline, Wanfang database, VIP, CJFD and CBM database, randomized controlled trials (RCTs) about Compound danshen dripping pills or tablets combined with entecavir(trial group) vs. entecavir 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 manual 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.