阿德福韦酯联合苦参素治疗慢性乙型肝炎疗效与安全性的系统评价

Adefovir-Matrine Combination Therapy for Chronic Hepatitis B: A Systematic Review

目的系统评价阿德福韦酯(ADF)单用及其与苦参素联用(ADF+M)治疗慢性乙型肝炎的疗效与安全性。方法计算机检索Cochrane图书馆、MEDLINE、PubMed、CBM、CNKI、万方及VIP数据库,检索时间均从建库至2010年7月,并追索已获文献的参考文献,纳入ADF单用与ADF+M比较的随机对照试验(RCT)。由2名研究者按照Cochrane Handbook 5.0.2独立进行质量评价及数据提取,而后采用RavMan 5.0软件进行Meta分析。结果共纳入24个RCT,其中B级1个,C级23个,合计2 092例患者。Meta分析结果显示:治疗6个月和12个月后,试验组(ADF+M)在主要结局指标(HBeAg血清转换)[6个月:RR=2.05,95%CI(1.53,2.74);12个月:RR=2.13,95%C(I1.74,2.60)]和次要结局指标(HBV-DNA阴转、HBeAg阴转、ALT复常、HBV-DNA变异,完全应答、HBsAg阴转)上,均优于对照组(ADF),两组差异均有统计学意义。结论现有证据表明,对于慢性乙型肝炎的治疗,ADF+M优于ADF单用,且在治疗6个月时便可观察到明显差异。但受纳入研究的质量影响,上述结论尚需高质量的临床试验进一步证实。

Objective To evaluate the efficacy of adefovir monotherapy（ADF） versus adefovir-Matrine combination therapy（ADF＋M） for chronic hepatitis B.Methods Such databases as The Cochrane Library,MEDLINE,PubMed,CBM,CNKI,WanFang and VIP Database were searched from the date of their establishment to July 2010,and the references of all included studies were also traced so as to identify randomized controlled trials（RCTs） of ADF versus ADF＋M.Quality assessment and data extraction were conducted in accordance with the Cochrane Handbook 5.0.2 by two reviewers independently.Meta-analyses were conducted by using RevMan 5.0 software.Results A total of 24 RCTs involving 2 092 patients were included.The results of meta-analyses showed that at the end of the treatment for both six months and 12 months,respectively,the ADF＋M group was superior to ADF group with a significant difference in both the HBeAg seroconversion rate as the primary outcome（six months： RR=2.05,95%CI 1.53 to 2.74;12 months： RR=2.13 95%CI 1.74 to 2.60） and the secondary outcome such as HBV-DNA negative conversion,HBeAg negative conversion,ALT normalization,HBV-DNA variation,complete response and HBsAg negative conversion,etc.Conclusion As the current evidence shows,ADF＋M therapy is superior to ADF therapy for chronic hepatitis B.The significant difference can even be observed at the end of the treatment for six months.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.