长效干扰素与普通干扰素治疗HBeAg阳性慢性乙型肝炎患者疗效的meta分析

Meta analysis of efficacy of pegylated interferon versus common interferon in the treatment of HBeAg positive chronic hepatitis B

目的评价长效干扰素与普通干扰素治疗HBeAg+慢性乙型肝炎患者的疗效。方法检索Medline、Embase、EBSCO、中国生物医学文献数据库(CBM)、中文科技期刊数据库(VIP)、中国期刊全文数据库(CNKI)、万方数字化期刊全文数据库,纳入长效干扰素(PEG-IFN-ɑ-2a或者PEG-IFN-ɑ-2b)与普通干扰素比较治疗HBeAg+慢性乙型肝炎的随机对照研究,并追查了所有纳入文献的参考文献,检索年限均为建库至2016年7月1日。由2位研究者独立进行文献筛选、资料提取及纳入研究的偏倚风险评价后,采用RevMan 5.2软件进行Meta分析。结果最终纳入13项研究1 263例,其中长效干扰素组616例,普通干扰素组647例。Mate分析结果显示,长效干扰素组在治疗HBeAg阳性慢性乙型肝炎24周和48周时观察ALT复常率、HBV-DNA转阴率、HBeAg转阴率三个指标均优于普通干扰素组(P<0.05),在12周时长效干扰素组HBV-DNA转阴率较普通干扰素组高(Z=2.19,P=0.03),而ALT复常率、HBeAg转阴率方面与普通干扰素组比较差异无统计学意义(P>0.05);在治疗12周和24周时,两组所检测的HBsAg阴转率差异无统计学意义(P>0.05),而疗程延长至48周时,长效干扰素组HBsAg阴转率高于普通干扰素组(Z=2.34,P=0.02);在HBeAg血清转换率方面,疗程12周和48周差异均无统计学意义(P<0.05),而在24周时,长效干扰素组优于普通干扰素组(Z=2.90,P=0.004)。结论在治疗24周、48周时,长效干扰素(PEG-IFN-ɑ-2a或者PEGIFN-ɑ-2b)治疗HBeAg阳性慢性乙型肝炎患者在ALT复常率、HBV-DNA转阴率和HBeAg转阴率三个指标均优于普通干扰素;仅48周疗程时长效干扰素HBsAg阴转率较普通干扰素组高;仅24周疗程时长效干扰素HBeAg血清转换率较高。受纳入研究数量和质量限制,上述结论仍需开展高质量研究加以验证。

Objective To evaluate the efficacy of pegylated interferon（PEG-IFN-ɑ-2a or PEG-IFN-ɑ-2b） and common interferon in the treatment of HBeAg positive chronic hepatitis B. Methods Randomized controlled trials（RCTs） about the efficacy comparison between pegylated interferon（PEG-IFN-ɑ-2a or PEG-IFN-ɑ-2b） and common interferon for the treatment of HBeAg positive chronic hepatitis B before July 1st, 2016 were searched from Medline, Embase, EBSCO, Chinese Biomedical Literature Database（CBM）, VIP, CNKI and Wanfang database. The references of the obtained literatures were also traced. Mate-analysis was performed by using Rev Man 5.2 software after two researchers screened literature independently, extracted data and assessed the risk of bias. Results Thirteen RCTs（n=1 263） were involved, including 616 cases in Pegylated interferon group and 647 cases in common interferon group. The results of meta-analysis showed that at 24 week and 48 week, the ALT normalization, HBV-DNA negative conversion rate and HBeAg negative conversion rate in Pegylated interferon group were significantly higher than those in common interferon group（P0.05）. At 12 week, HBV-DNA negative conversion rate in Pegylated interferon group was higher than that in common interferon group（Z=2.19,P=0.03）, but there were no statistical differences in ALT normalization and HBeAg negative conversion rate between Pegylated interferon group and common interferon group（P0.05）. At 12 week and 24 week, there was no statistical difference in the HBs Ag negative conversion rate between the two groups（P0.05）, but at 48 week, HBs Ag negative conversion rate in Pegylated interferon group was higher than that in common interferon group（Z=2.34, P=0.02）. At 12 week and 48 week, there was no statistical difference in the HBeAg seroconversion rate between Pegylated interferon group and common interferon group（P0.05）, however, that in the Pegylated interferon group was higher than common interferon group at 24 week（Z=2.90, P=0.004）. Conclusion After the treatment for 24 weeks and 48 weeks, Pegylated interferon（PEG-IFN-ɑ-2a or PEG-IFN-ɑ-2b） was superior to common interferon in ALT normalization, HBV-DNA negative conversion rate, HBeAg negative conversion rate. At 48 week, only HBs Ag negative conversion rate in Pegylated interferon group was higher than that in common interferon group, and at24 week, only HBeAg seroconversion rate in Pegylated interferon group was higher than common interferon. Due to the quantity and quality limitations of included studies, more high quality studies are needed to verify the above conclusions.