肝爽颗粒联合恩替卡韦治疗乙型肝炎肝硬化有效性和安全性的系统评价

Systematic evaluation of the effectiveness and safety of GanShuang Granules combined with entecavir in the treatment of hepatitis B cirrhosis

目的系统评价肝爽颗粒联合恩替卡韦改善乙型肝炎肝硬化患者的有效性及安全性。方法计算机检索PubMed、中国知网、万方、维普等数据库,检索肝爽颗粒联合恩替卡韦治疗慢性乙型病毒性肝炎肝硬化的临床随机对照试验,由2名评价者独立评价纳入研究的方法学质量,应用RevMan 5.3软件进行Meta分析。结果共纳入25篇文献,Meta分析结果显示,肝爽颗粒联合恩替卡韦治疗乙型肝炎肝硬化,在e抗原转阴率[OR(95%CI)=3.08(1.84,5.16),P<0.01],乙型肝炎病毒-DNA[MD(95%CI)=-0.97(-1.38,-0.55),P<0.01];肝功能指标丙氨酸转氨酶[MD(95%CI)=-21.14(-28.38,-13.9),P<0.01],天冬氨酸转氨酶[MD(95%CI)=-2.1(-2.51,-1.69),P<0.01],白蛋白(ALB)[MD(95%CI)=5.23(4.47,6.00),P<0.01],总胆红素[MD(95%CI)=-10.75(-12.45,-9.05),P<0.01];肝纤维化指标透明质酸[MD(95%CI)=-40.68(-48.39,-32.97),P<0.01],层黏连蛋白[MD(95%CI)=-27.11(-31.99,-22.24),P<0.01],Ⅲ型前胶原[MD(95%CI)=-29.06(-32.64,-25.49),P<0.01],Ⅳ型胶原[MD(95%CI)=-27.74(-28.88,-19.64),P<0.01]等方面均优于恩替卡韦治疗,差异具有统计学意义(P<0.05)。2组患者不良反应发生率的差异无统计学意义(P>0.05)。结论肝爽颗粒联合恩替卡韦治疗慢性乙型肝炎肝硬化与单用恩替卡韦相比其疗效显著。

Objective To systematically evaluate the effectiveness and safety of GanShuang Granules combined with entecavir in improving patients with hepatitis B cirrhosis.Methods Computer-based searches were conducted in PubMed,CNKI,Wanfang Data,VIP,and other databases to retrieve clinical randomized controlled trials on the treatment of chronic hepatitis B cirrhosis with GanShuang Granules combined with entecavir.Two evaluators independently assessed the methodological quality of the included studies,and Meta-analysis was performed using RevMan 5.3 software.Results A total of 25 articles were included.The results of the Meta-analysis showed that the combination of GanShuang Granules and entecavir in the treatment of hepatitis B cirrho-sis was superior to entecavir alone in terms of HBeAg clearance rate[OR(95%CI)=3.08(1.84,5.16),P<0.01],HBVP DNA[MD(95%CI)=-0.97(-1.38,-0.55),P<0.01)],liver function indicators such as ALT[MD(95%CI)=-21.14(-28.38,-13.9),P<0.01],AST[MD(95%CI)=-2.1(-2.51,-1.69),P<0.01],ALB[MD(95%CI)=5.23(4.47,6.00),P<0.01],TBIL[MD(95%CI)=-10.75(-12.45,-9.05),P<0.01],and liver fibrosis indicators such as HA[MD(95%CI)=-40.68(-48.39,-32.97),P<0.01],LN[MD(95%CI)=-27.11(-31.99,-22.24),P<0.01],PC-Ⅲ[MD(95%CI)=-29.06(-32.64,-25.49)],P<0.01],Ⅳ-C[MD(95%CI)=-27.74(-28.88,-19.64),P<0.01]and other aspects were better than that of Entecavir treatment.The differences were statistically significant(P<0.05).There was no signifi-cant differ-ence in the incidence of adverse reactions between the two groups(P>0.05).Conclusion The combi-nation of GanShuang Granules and entecavir is significantly more effective than Entecavir alone in the treatment of chronic hepatitis B cirrhosis.