和络舒肝胶囊治疗乙型肝炎肝纤维化疗效的系统评价

Heluo Shugan Capsule for Liver Fibrosis of Chronic Hepatitis B: A Systematic Review

目的系统评价和络舒肝胶囊治疗慢性乙型肝炎(CHB)肝纤维化的临床疗效及安全性。方法计算机检索Pub Med、The Cochrane Library、CBM、CNKI、VIP和Wan Fang Data数据库,搜集和络舒肝胶囊治疗CHB肝纤维化的相关随机对照试验(RCT),检索时限均从建库至2015年8月。由两名评价者独立筛选文献、提取资料和评价纳入研究的偏倚风险后,采用Rev Man 5.3软件进行Meta分析。结果最终纳入15个RCT,共计1 840例患者。Meta分析结果显示:1在降低血清HA水平方面,和络舒肝胶囊优于常规保肝治疗[MD=82.31,95%CI(37.44,127.19),P=0.000 3],但差于扶正化瘀胶囊[MD=–137.45,95%CI(–196.29,–78.62),P<0.000 01]、复方鳖甲软肝片[MD=–51.19,95%CI(–67.58,–34.81),P<0.000 01]和抗纤汤组[MD=–82.13,95%CI(–102.37,–61.88),P<0.000 01]。2在降低血清LN水平方面,和络舒肝胶囊优于常规保肝治疗[MD=36.83,95%CI(11.84,61.82),P=0.004],但差于复方鳖甲软肝片[MD=–36.00,95%CI(–64.29,–7.71),P=0.01]、肝复健胶囊[MD=–22.14,95%CI(–37.28,–7.00),P=0.004]和抗纤汤[MD=–38.64,95%CI(–75.00,–2.29),P=0.04]。3在降低血清PCⅢ水平方面,和络舒肝胶囊优于常规保肝治疗[MD=47.17,95%CI(32.68,61.66),P<0.000 01],但差于扶正化瘀胶囊[MD=–4.80,95%CI(–9.08,–0.51),P=0.03]、大黄蛰虫丸[MD=–53.77,95%CI(–105.01,–2.53),P=0.04]、肝复健胶囊[MD=–46.82,95%CI(–66.30,–27.34),P<0.000 01]和抗纤汤[MD=–28.68,95%CI(–55.59,–1.77),P=0.04]。4在降低血清Ⅳ-C水平方面,和络舒肝胶囊优于常规保肝治疗[MD=72.77,95%CI(47.65,97.89),P<0.000 01],但差于扶正化瘀胶囊[MD=–34.69,95%CI(–56.65,–12.73),P=0.002],大黄蛰虫丸[MD=–21.26,95%CI(–38.79,–3.73),P=0.02]、复方鳖甲软肝片[MD=–69.04,95%CI(–124.38,–13.69),P=0.01]、肝复健胶囊[MD=–19.84,95%CI(–37.41,–2.27),P=0.03]和抗纤汤[MD=–37.98,95%CI(–72.99,–2.96),P=0.03]。结论目前的证据表明,和络舒肝胶囊对主要的血清纤维化指标(HA、LN、PCⅢ、Ⅳ-C)有一定的改善作用,但不及复方鳖甲软肝片、扶正化瘀胶囊、大黄蛰虫丸、肝复健胶囊和抗纤汤。受纳入研究的数量和质量限制,上述结论尚需进一步开展更多高质量的RCT进行验证。

Objective To systematically review the efficacy and safety of Heluo Shugan capsule in the treatment of hepatitis B fibrosis. Method We searched PubMed, The Cochrane Library （Issue 8, 2015）, CBM, CNKI, VIP and WanFang Data from their inception to August 2015, to collect randomized controlled trials （RCTs） on Heluo Shugan capsule for hepatitis B fibrosis. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies. Then meta-analysis was performed using RevMan 5.3 software. Results A total of 15 RCTs involving 1 840 patients were included. The results of meta-analysis showed that： （1） As for reduced level of serum hyaluronic acid （HA）, Heluo Shugan capsule was superior to placebo （MD=82.31, 95%CI 37.44 to 127.19, P=0.O00 3）, but worse than Fuzheng Huayu capsule （MD= -137.45, 95%CI -196.29 to -78.62, P〈0.000 01）, Fufang Biejia Ruangan tablet （MD-- -51.19, 95%CI -67.58 to -34.81, P〈0.000 01） and Anti-fibrosis decoction （MD= -82.13, 95%CI-102.37 to -61.88, P〈0.000 01）. （2） As for reduced level of serum laminin （LN）, Heluo Shugan capsule was superior to placebo （MD=36.83, 95%CI 11.84 to 61.82, P=0.004）, but worse than Fufang Biejia Ruangan tablet （MD= -36.00, 95%CI -64.29 to -7.71, P=0.01）, Ganfujian capsule （MD= -22.14, 95%CI -37.28 to -7.00, P=0.004） and Anti-fibrosis decoction （MD= -38.64,95%CI -75.00 to -2.29, P=0.04）. （3） As for reduced level of serum procollagen type III peptide （PCIII）, Heluo Shugan capsule was superior to placebo （MD=47.17, 95%CI 32.68 to 61.66, P〈0.000 01）, but worse than Fuzheng Huayu capsule （MD-- -4.80, 95%CI -9.08 to -0.51, P=0.03）, Dahuang Zhechong pills （MD= -53.77, 95%CI -105.01 to -2.53, P=0.04）, Ganfujian capsule （MD= -46.82, 95%CI -66.30 to -27.34, P〈0.000 01） and Anti-fibrosis decoction （MD= -28.68, 95%CI -55.59 to -1.77, P=0.04）. （4） As for reduced level of serum type-IV-collagen （IV-C）, Heluo Shugan capsule was superior to placebo （MD=72.77, 95%CI 47.65 to 97.89, P〈0.000 01）, but worse than Fuzheng Huayu capsule （MD= -34.69, 95%CI -56.65 to -12.73, P=0.002）, Dahuang Zhechong pills （MD= -21.26, 95%CI -38.79 to -3.73, P=0.02）, Fufang Biejia Ruangan tablet （MD= -69.04, 95%CI -124.38 to -13.69, P=0.01）, Ganfujian capsule （MD= -19.84, 95%CI -37.41 to -2.27, P=0.03） and Anti-fibrosis decoction （MD= -37.98, 95%CI -72.99 to -2.96, P=0.03）. Conclusion Current evidence shows that, Heluo Shugan capsule was superior to placebo, but worse than Fufang Biejia Ruangan tablet, Fuzheng Huayu capsule, Dahuang Zhechong pills, Ganfujian capsule and Anti-fibrosis decoction in reducing the level of serum hepatic fibrosis. Due to the limited quantity and quality of included studies, more high-quality, large-scale RCTs are need to verify the above conclusion.