拉米夫定联合阿德福韦酯与恩替卡韦单药对慢性乙型肝炎初治患者疗效比较的Meta分析

摘要

目的：评价拉米夫定（LAM）联合阿德福韦酯（ADV）与恩替卡韦（ETV）单药对慢性乙型肝炎初治患者的疗效。方法计算机检索Cochrane图书馆、M EDLINE、Web of Science、CNKI全文数据库、万方中文期刊全文数据库、维普数据库，并追查了所有纳入文献的参考文献。检索年限均从建库到2012年3月6日。纳入LAM 联合ADV与ETV单药对慢性乙型肝炎初治患者疗效比较。用Cochrane协作网专用软件Rev M an 5．1进行统计分析。结果共有4项符合纳入标准的研究被纳入。M eta分析显示，在ALT复常率方面，12、24周时ETV单药组略高于联合组[OR＝0．52，95％ CI（0．28，0．97），Z＝2．04，P＝0．04]、[OR＝0．45，95％ CI（0．22，0．95），Z＝2．11，P＝0．04]，但36、48周后两组无明显差异[OR＝0．96，95％ CI（0．24，3．94），Z＝0．05，P＝0．96]、[OR＝0．66，95％ CI（0．28，1．59），Z＝0．93，P＝0．35]。 HBV DNA阴转率方面12、24、36、48周、18、24、30个月两组间均无明显差异（P＝0．22、P＝0．30、P＝0．86、P＝0．31、P＝0．93、P＝0．84、P＝0．83）。48周的 HBeAg阴转率两组无差异[OR＝0．93，95％ CI（0．29，2．95），Z＝0．13，P＝0．90]。结论 LAM联合ADV对慢性乙型肝炎初治患者其抗病毒疗效与ETV相似，但其长期疗效和安全性仍然有待研究。%Objective To analyse the efficacy of lamivudine(LAM) combined adefovir dipivoxil(ADV) and entecavir(ETV) in the treatment of naive patients with chronic hepatitis B (CHB) .Methods Cochrane Library ,MEDLINE ,Web of Science ,CNKI (China National Knowledge Infrastructure ) ,WANFANG database and VIP database were searched and the references of eligible studies were screened .All relevant literatures published before March 6th ,2012 were reviewed .Comparison of the efficacy of lami-vudine combined adefovir dipivoxil and entecavir in the treatment of naive patients with chronic hepatitis B was included and Rev Man 5 .1 software was used for Meta analysis .Results Four eligible studies (587 patients in all) were included for the analysis .In the entecavir monotherapy group ,the serum ALT normalization rate was a little higher at the 12 weeks and 24 weeks of the treat-ment compared to the combination group[OR=0 .52 ,95% CI(0 .28 ,0 .97) ,Z=2 .04 ,P=0 .04] ,[OR=0 .45 ,95% CI(0 .22 ,0 .95) , Z=2 .11 ,P=0 .04] ,respectively .But after 36 weeks there was no significance between the two groups .For HBV DNA undetect-able rate ,there were no significant differences between the two groups at the 12 weeks ,24 weeks ,36 weeks ,48 weeks ,18 months , 24 months and 30 months of the treatment (P=0 .22 ,P=0 .30 ,P=0 .86 ,P=0 .31 ,P=0 .93 ,P=0 .84 and P=0 .83 respectively) . At the 48 weeks ,HBeAg negative rate has no significant difference between the two groups [OR=0 .93 ,95% CI(0 .29 ,2 .95) ,Z=0 .13 ,P=0 .90] .Conclusion Both LAM+ADV combination therapy and ETV monotherapy are effective in the treatment of naive patients with CHB ,but further studies are still needed to obtain long term results and safety by high quality ,large scale randomized controlled trials .