恩替卡韦片单用或与异甘草酸镁注射液联用治疗慢性乙型肝炎的系统评价和Meta分析

Entecavir tablet combined with magnesium isoglycyrrhizinate injection for the treatment of chronic hepatitis B:a systematic review and Meta-analysis

目的系统评价恩替卡韦片单用或与异甘草酸镁注射液联用治疗慢性乙型肝炎(CHB)的疗效。方法使用中文检索词"恩替卡韦"、"异甘草酸镁"和"慢性乙型肝炎",英文检索词"entecavir"、"magnesium isoglycyrrhizinate"和"chronic hepatitis B"或"CHB"检索2015年9月12日前中国知网、万方数据库、维普网、PubMed和Central中的恩替卡韦和异甘草酸镁治疗CHB的随机对照临床研究文献。采用Review Manager 5.2软件通过Meta分析比较两种干预措施的疗效。结果共4项随机对照试验符合纳入标准。Meta分析结果显示,恩替卡韦联用异甘草酸镁在HBV-DNA转阴率(RR=1.04,95%CI:0.93~1.16)、HBe Ag转阴率(RR=1.17,95%CI:0.76~1.79)方面略高于恩替卡韦单用,但差异无统计学意义(P>0.05);而肝功能指标ALT(WMD=-13.45,95%CI:-22.97^-3.92)、AST(WMD=-12.58,95%CI:-22.77^-2.39)和Tbil(WMD=-7.34,95%CI:-12.93^-1.75)水平和肝纤维化指标HA(WMD=-44.91,95%CI:-52.59^-37.23)、Ⅳ-C(WMD=-27.18,95%CI:-33.59^-20.77)和LN(WMD=-17.78,95%CI:-24.21^-11.36)水平的改善均优于恩替卡韦单用,差异具有统计学意义(P<0.05)。结论恩替卡韦与异甘草酸镁联用在改善肝功能和血清肝纤维化水平方面优于恩替卡韦单用,但在HBV-DNA转阴率和HBeAg转阴率方面两者效果相似。

Objective To evaluate the effect of entecavir tablet combined with or not with magnesium isoglycyrrhizinate injection in the treatment of chronic hepatitis B （CHB）. Methods Correspondent datas from CNKI database, Wanfang database, VIP database, PubMed and Central before September 12, 2015 using the key words entecavir, magnesium isoglycyrrhizinate and chronic hepatitis B or CHB were retrieved. The randomized controlled clinical trials were collected. The statistical analysis was performed by Meta-analysis using Review Manager 5.2. Results Four randomized controlled trials met the inclusion and exclusion criteria. Meta-analysis showed that patients in entecavir combined with magnesium isoglycyrrhizinate group had higher rates of HBV-DNA （RR=1.04, 95%CI： 0.93, 1.16） and HBeAg （RR=1.17, 95%CI： 0.76, 1.79） negative conversion than entecavir used alone, but there were no significant differences （P〉0.05）. Better improvement of ALT（WMD=-13.45, 95%CI： -22.97, -3.92）, AST （WMD=- 12.58, 95%CI： -22.77, -2.39）, Tbil （WMD=-7.34, 95%CI： -12.93, -1.75） and HA （WMD=-44.91, 95%CI： -52.59, -37.23）, 1V-C （WMD=-27.18, 95%CI： -33.59, -20.77）, LN （WMD=- 17.78, 95%CI： -24.2 1, -11.36） in entecavir combined with magnesium isoglycyrrhizinate group, and the differences were significant （P〈0.05）. Conclusion Based on the Meta-analysis results, the entecavir combined with magnesium isoglycyrrhizinate is superior to entecavir used alone on improving liver function impairment and hepatic fibrosis. However, as for the negative conversion ratio of HBV-DNA and HBeAg, the efficacies of the two groups are similar.