扶正化瘀胶囊联合阿德福韦酯治疗慢性乙型肝炎肝纤维化的系统评价

Systematic evalution of Fuzheng Huayu Capsule combined with Adefovir Dipivoxil in treatment of chronic hepatitis B with hepatic fibrosis

系统评价扶正化瘀胶囊联合阿德福韦酯治疗慢性乙型肝炎肝纤维化的疗效和安全性。计算机检索万方、中国知网、维普、中国生物医学、Pub Med、Cochrane、Embase等数据库,搜集扶正化瘀胶囊联合阿德福韦酯治疗慢性乙型肝炎肝纤维化的随机对照试验(RCT),检索时间从建库至2017年3月。由2位研究者独立筛选文献、提取资料、评价文献质量。采用Rev Man 5.3软件对所提取的数据资料进行Meta分析。共纳入13项研究,1 400例研究对象。Meta分析结果显示,与单用阿德福韦酯相比,扶正化瘀胶囊联合阿德福韦酯不仅可以降低慢性乙型肝炎肝纤维化患者血清肝纤维化指标:HA[MD=-99.66,CI=-129.94^-69.37,P<0.000 01]、LN[MD=-40.99,CI=-58.56^-23.41,P<0.000 01]、PCIII[MD=-76.40,CI=-108.15^-44.66,P<0.000 01]、IV-C[MD=-55.24,CI=-79.19^-31.29,P<0.000 01];还能明显改善肝功能指标:ALT[MD=-21.05,CI=-22.58^-19.52,P<0.000 01]、AST[MD=-16.74,CI=-25.14^-8.33,P<0.000 1]、TBIL[MD=-10.38,CI=-14.17^-6.59,P<0.000 01]、ALB[MD=4.35,CI=-3.48~5.23,P<0.000 01],改善B超影像学结果,且无明显不良反应。扶正化瘀胶囊联合阿德福韦酯能显著改善肝功能,降低肝纤维化指标,且不良反应少,但尚需通过更多大样本、高质量的临床试验进一步验证其疗效。

To systemically review the efficacy and safety of Fuzheng Huayu Capsule（FHC） combined with Adefovir Dipivoxil in treatment of chronic hepatitis B with hepatic fibrosis. Wanfang, CNKI, VIP, CBM, Pub Med, Cochrane and Embase were retrieved by computers to collect the RCTs of FHC combined with Adefovir Dipivoxil in treatment of chronic hepatitis B with hepatic fibrosis from their inception to March 2017. After two reviewers separately screened literature according to the inclusion and exclusion criteria, extracted data and assessed the quality of the included studies, data were analyzed with Rev Man 5.3 sofware. Totally 14 RCTs were included with 1 400 patients involved. According to Meta-analysis, compared with Adefovir Dipivoxil alone, FHC combined with Adefovir Dipivoxil was more efficiently in reducing the liver fibrosis indexes HA [MD =-99.66, CI =-129.94 —-69.37], P〈0.000 01]; LN [MD =-40.99, CI =-58.56 —-23.41, P〈0.000 01]; PCIII [MD =-76.40, CI =-108.15 —-44.66, P〈0.000 01]; IV-C [MD =-55.24, CI =-79.19 —-31.29, P〈0.000 01], in improving the liver function ALT [MD =-21.05, CI =-22.58 —-19.52, P〈0.000 01]; AST [MD =-16.74, CI =-25.14 —-8.33, P〈0.000 1]; TBIL [MD =-10.38, CI = 14.17 — 6.59, P〈0.000 01]; ALB [MD = 4.35, CI =-3.48 — 5.23, P〈0.000 01], and improving the ultrasound imaging results. Also, no significant adverse reaction was reported. FHC combined with Adefovir Dipivoxil could significantly improve liver function, reduce liver fibrosis indexes, and had less adverse reactions, but more large sample, high quality clinical trial are required to verify the curative effect.