聚乙二醇干扰素α-2a治疗HBeAg阳性慢性乙型肝炎的Meta分析

Efficacy of Peginterferon α-2a in HBeAg Positive Chronic Hepatitis B:Meta-analysis Study

目的评价聚乙二醇干扰素α-2a与普通干扰素治疗HBeAg阳性慢性乙型肝炎的疗效。方法计算机检索MEDLINE、EBSCO、PubMed、CNKI、万方数据库等,并追查了所有纳入文献的参考文献。检索年限均从建库到2009年5月。纳入聚乙二醇干扰素α-2a与普通干扰素比较治疗HBeAg阳性慢性乙型肝炎的随机对照试验。采用Jadad评分法评价纳入研究的方法学质量,并用Cochrane协作网提供的RevMan5.0软件进行Meta分析,并根据疗程和观察时间的不同进行亚组分析。结果纳入6个随机对照试验(n=688),其中4个研究疗程为48周,2个研究为24周,我们按疗程进行了亚组分析。Meta分析结果显示,聚乙二醇干扰素(180ug/d,48周)HBeAg阴转率、HBV-DNA阴转率、HBeAg血清转换率、ALT复常率均高于普通干扰素组,差异有统计学意义(P<0.05)。聚乙二醇干扰素(180ug/d,24周)仅在HBV-DNA阴转率方面略高于对照组,差异有统计学意义[P=0.04,RR=1.44,95%CI(1.01,2.05)]。但HBeAg阴转率、HBeAg血清转换率及ALT复常率与对照组无统计学差异(P>0.05)。结论48周疗程的聚二乙醇干扰素效果优于普通干扰素,24周疗程的聚二乙醇干扰素在HBV-DNA阴转率方面优于普通干扰素,其他方面与普通干扰素相当。但由于纳入研究的方法学质量均不高,故上述结论在临床使用时应谨慎考虑。

Objective To assess the efficacy between Peginterferon a-2a and common Interferon in HBeAg positive chronic hepatitis B. Methods MEDLINE, EBSCO, PubMed, CNKI, WangFang were searched from the beginning to May 2009, and the references of eligible studies were manually screened. Randomized controlled trials comparing Peginterferon-alpha2a with common interferon in HBeAg positive chronic hepatitis B were eligible for inclusion, ladad score method was adopted to evaluate the methodological quality of included studies. Meta analysis was conducted by RevMan 5.0 software supplied by the Cochrane Collaboration. Subgroup analyses were used in treatment and observation course. Results Six randomized controlled trials were included （n=688）. The treatment duration of 48 weeks and 24 weeks were reported in four and two studies, respectively. We carried out subgroup analysis according to treatment. Meta-analysis showed that Peginterferon-alpha2a （180 ug/d, 48 W） could significantly clear HBeAg, clear HBV- DNA, normalize ALT and HBeAg seroconversion compared with common Interferon （P〈0.05）. Peginterferon-alpha2a （180 ug/d, 24 W） could effectively clear HBV DNA [P=0.04, RR=l.44, 95%CI （1.01, 2.05）], but was not effective in loss of HBeAg, HBeAg seroconversion and ALT normalization （P〉0.05）. Conclusion The efficacy of 48 weeks treatment with Peginterferon -2a is better than common Interferon. The efficacy of 24 weeks treatment with Peginterferon -2a is only better in HBV-DNA negative rate than common Interferon. However, because the methodological quality of included studies is not high, this conclusion should be carefully considered in clinical use.