摘要
目的 系统评价与拉米夫定相关的乙型肝炎病毒YMDD区变异后不同抗病毒治疗方法的疗效和安全性。方法 计算机检索MEDLINE ( 1989～ 2 0 0 4 4 )、EMBASE ( 1989～ 2 0 0 4 4 )和中国生物医学文献数据库 ( 1989～ 2 0 0 4 4 ) ;手工检索未发表的中文学术会议文献。收集与拉米夫定相关的乙型肝炎病毒YMDD区变异后不同抗病毒疗法的临床随机与半随机对照试验 ,由两名评价者独立评价和提取资料 ,并采用Cochrane协作网专用软件RevMan 4 2进行统计分析。结果 共纳入 5篇随机和半随机对照研究 ,包括 6个试验组 2 84例病人。Meta分析结果显示 ,拉米夫定 +阿德福韦治疗对HBVDNA、HBeAg转阴率及ALT复常率的效果明显优于单独应用拉米夫定 ,其RR和 95 %CI分别为 16 6 1( 2 2 9,12 0 71) ,6 6 6 ( 1 2 3,35 88)和6 2 6 ( 2 2 9,17 12 )。氧化苦参碱 +胸腺肽对HBVDNA、HBeAg转阴率明显优于单独应用拉米夫定 ,其RR和 95 %CI分别为 2 96 ( 1 2 6 ,6 93) ,2 5 1( 1 0 5 ,5 98)。试验组单独使用阿德福韦与拉米夫定比较 ,两者在HBVDNA及HBeAg转阴率方面差异无统计学意义 [RR 11 0 0 ,95 %CI( 0 6 5 ,186 0 2 ) ;RR 7 0 0 ,95 %CI( 0 39,12 6 92 ) ];干扰素 +拉米夫定对HBVDNA转阴率、HBeAg转阴率。
Objective To evaluate the efficacy and safety of antiviral drugs for hepatitis B with YMDD motif variant.Methods We electronically searched MEDLINE (1989 April, 2004), EMBASE (1989 April, 2004), CBMdisc (expand) (1989 April, 2004), and handsearched unpublished Chinese conference proceedings. Randomized and quasi-randomized trials in patients with chronic hepatitis B with YMDD motif variant correlative to lamivudine were collected. Two reviewers extracted the data and assessed the quality of literature independently. The data were then analyzed by RevMan 4.2 software.Results Five studies involving 6 trials and 284 patients were included. According to the results of meta-analysis, antiviral therapy with adefovir plus lamivudine showed significantly better effects on the clearance of serum HBV DNA and HBeAg and normalization of ALT than that of lamivudine alone (RR 16.61, 95%CI 2.29 to 120.71; RR 6.66, 95%CI 1.23 to 35.88 and RR 6.26, 95%CI 2.29 to 17.12 respectively); also, oxymatrine plus thymothin showed obviously better effects on the clearance of serum HBV DNA and HBeAg (RR 2.96, 95%CI 1.26 to 6.93 and RR 2.51, 95%CI 1.05 to 5.98 respectively).But adefovir alone showed no better effects on clearance of serum HBV DNA and HBeAg than that of lamivudine alone (RR 11.00, 95%CI 0.65 to 186.02 and RR 7.00, 95%CI 0.39 to 126.92 respectively); interferon plus lamivudine showed no better effects on the clearance of serum HBV DNA, HBeAg and the normalization of ALT (RR 3.50, 95%CI 0.90 to 13.58; RR 4.90, 95%CI 0.70 to 35.10 and RR 2.80, 95%CI 0.91 to 8.12 respectively). Chinese herbs plus lamivudine showed no better effects on the clearance of serum HBV DNA (RR 1.16, 95%CI 0.89 to 1.51). There were no significant side effects in the groups, except flu like symptom in the interferon group, slight kidney impairment in the adefovir group, and aggravation of rare cases in lamivudine group.”HZConclusions Antiviral therapy with adefovir plus lamivudine, or oxymatrine plus thymothin, shows better effects than with lamivudine alone in terms of antiviral therapy and clinical outcome improvement. However, the evidence is too weak to draw a definite conclusion in this systematic review. Larger sample size and rigorously designed randomized, double blind, placebo control trials are required for future study.
出处
《中国循证医学杂志》
CSCD
2004年第11期783-788,816,共7页
Chinese Journal of Evidence-based Medicine
