复方鳖甲软肝片联合阿德福韦酯治疗慢性乙型肝炎肝纤维化的Meta分析

Systematic evaluation of Compound Biejia Ruangan Tablets combined with Adefovir Dipivoxil in treatment of chronic hepatitis B with liver fibrosis

系统评价复方鳖甲软肝片联合阿德福韦酯治疗慢性乙型肝炎肝纤维化的临床疗效,以期为临床使用提供循证参考。全面检索Cochrane Library、Pub Med、中国期刊全文数据库(CNKI)、万方数据在线知识服务平台、中文科技期刊全文数据库(VIP)已发表的复方鳖甲软肝片联合阿德福韦酯治疗慢性乙型肝炎肝纤维化随机对照试验(RCT),检索时间均从建库至2017年10月。提取数据并按照Cochrane系统评价员手册5.1.0评价质量后,使用Rev Man 5.3统计软件进行Meta分析。要求治疗组接受复方鳖甲软肝片联合阿德福韦酯治疗,对照组接受阿德福韦酯治疗。最终19篇文献,共计1 776名慢性乙型肝炎肝纤维化患者纳入研究。Meta分析结果显示,血清HA、IV-C、LN、PCIII、ALT、AST、TBIL水平治疗组均低于对照组,差异有统计学意义。HA[SMD=-1.72,95%CI(-2.26,-1.17),P=0.000 01];IV-C[SMD=-1.10,95%CI(-1.66,-0.54),P=0.000 10];LN[SMD=-1.18,95%CI(-1.64,-0.73),P=0.000 01];PCIII[SMD=-1.52,95%CI(-1.97,-1.07),P=0.000 01];ALT[SMD=-0.48,95%CI(-0.68,-0.28),P=0.000 01];AST[SMD=-1.19,95%CI(-2.08,-0.29),P=0.010 00];TBIL[SMD=-0.98,95%CI(-1.38,-0.58),P=0.000 01];血清HBV DNA、HBe Ag转阴率治疗组与对照组均无统计学意义,HBV DNA转阴率[RR=1.21,95%CI(0.97,1.50),P=0.09];HBe Ag转阴率[RR=1.05,95%CI(0.82,1.34),P=0.70]。临床总有效率治疗组明显优于对照组,差异有统计学意义[RR=1.25,95%CI(1.15,1.36),P=0.000 01]。与单用阿德福韦酯相比,复方鳖甲软肝片联合阿德福韦酯治疗慢性乙型肝炎肝纤维化疗效较好,可以明显改善患者肝功能,抑制肝纤维化,提高临床总有效率。

To evaluate the clinical curative effect of Compound Biejia Ruangan Tablets（CBRT） combined with Adefovir Dipivoxil in the treatment of chronic hepatitis B with liver fibrosis using Meta-analysis. Cochrane library, Pub Med, CNKI, Wanfang databases, and VIP were retrieved comprehensively to collect randomized controlled trials（RCTs） of CBRT combined with Adefovir Dipivoxil in the treatment of chronic hepatitis B with hepatic fibrosis from their inception to October 2017. treatment group was treated with CBRT combined with Adefovir Dipivoxil, and the control group was treated with Adefovir Dipivoxil. All the data were analyzed using Revman 5.3. A total of 19 RCTs and 1 776 patients were included. Meta-analysis results showed that the serum indexes including HA, IV-C, LN, PCIII, ALT, AST, and TBIL of the treatment group, were significantly lower than those of control group. HA [SMD =-1.72, 95% CI（-2.26,-1.17）, P = 0.000 01]; IV-C [SMD =-1.10, 95% CI（-1.66,-0.54）, P = 0.000 10]; LN [SMD =-1.18, 95% CI（-1.64,-0.73）, P = 0.000 01]; PCIII [SMD =-1.52, 95% CI（-1.97,-1.07）, P = 0.000 01]; ALT [SMD =-0.48, 95% CI（-0.68,-0.28）, P = 0.000 01]; AST [SMD =-1.19, 95% CI（-2.08,-0.29）, P = 0.010 00]; TBIL [SMD =-0.98, 95%CI（-1.38,-0.58）, P = 0.000 01]; There were no significant difference in serum HBV DNA, and Hbe Ag negative conversion rate treatment group compared with control group. HBV DNA [RR = 1.21, 95% CI（0.97, 1.50）, P = 0.09]; HBe Ag [RR = 1.05, 95% CI（0.82, 1.34）, P = 0.70]; The total clinical effective treatment group was significantly better than control group. [RR = 1.25, 95% CI（1.15, 1.36）, P = 0.000 01]. Compared with the single use of Adefovir Dipivoxil, the clinical curative effect of CBRT combined with Adefovir Dipivoxil in the treatment of chronic hepatitis B with liver fibrosis is better,which can significantly reduce the level of serum liver fiber markers and improve liver function in patients with biochemical indicators and the total clinical efficiency.