阿德福韦酯联合胸腺肽α_1与单用阿德福韦酯比较治疗慢性乙肝的系统评价

Adefovir Versus Adefovir-Thymosin Alpha-1 Combination Therapy for Chronic Hepatitis B:A Systematic Review

目的系统评价阿德福韦酯联合胸腺肽α1(ADF+Tα1)与单用阿德福韦酯比较治疗慢性乙型肝炎的疗效。方法电子检索Cochrane图书馆、MEDLINE、PubMed、中国生物医学文献数据库、CNKI、万方、VIP数据库,均从建库检索至2010年2月,并追踪已获文献的参考文献,纳入ADF+Tα1与单用ADF比较的随机对照试验(RCT)。由2名研究者按照Cochrane Handbook 5.0.2手册独立纳入试验、评价质量及提取数据,采用RevMan5.0软件进行Meta分析。结果最终纳入11个RCT,共895例患者,其方法学质量均为C级。Meta分析结果显示:主要结局指标(HBeAg血清转换)在治疗6个月、12个月时,试验组均优于对照组,其差异有统计学意义[RR(95%CI)分别为1.77(1.38,2.27)和1.74(1.44,2.10)];次要结局指标(HBV-DNA转阴、HBeAg转阴、ALT复常、HBV-DNA变异,完全应答、HBsAg阴转)在治疗6个月、12个月后,试验组也均优于对照组,且差异有统计学意义。结论本系统评价结果表明,ADF+Tα1治疗慢性乙型肝炎疗效优于单用ADF,且在治疗6个月时便可观察到明显差异,但受纳入文献质量限制,以上结论尚需高质量的临床试验进一步证实。

Objective To compare adefovir monotherapy with adefovir-thymosin alpha-1 combination therapy for chronic hepatitis B.Methods We searched The Cochrane Library,MEDLINE,PubMed,the Chinese Biomedical Database（CBM）,CNKI,Wanfang,and VIP databases up to February 2010 to identify randomized controlled trials（RCTs）comparing adefovir plus thymosin alpha-1 versus adefovir alone for chronic hepatitis B.We also scanned references of all included studies and pertinent reviews.The methodological quality assessment and data extraction were conducted by two reviewers independently according to the Cochrane Reviewer＇s Handbook 5.0.2.Meta-analyses were performed using RevMan 5.0 software.Results Eleven trials involving 895 patients were included.The results of meta-analyses shoued：the HBeAg seroconversion rate of the combination therapy group was higher than that of the monotherapy group,both at the sixth month and the twelfth month（RR=1.77,95%CI 1.38 to 2.27;RR=1.74,95%CI 1.44 to 2.10）;and there were also significant differences between the two groups for secondary outcomes including HBV-DNA negative,ALT normalization,etc.Conclusion Adefovir-thymosin alpha-1 combination therapy might be more effective than adefovir monotherapy for chronic hepatitis B.Significant differences are even observed at the sixth month.However,the results should be interpreted with caution because of the low quality of the included studies.High-quality,large-scale RCTs are needed to further prove the results.