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目的评价苦参素联合阿德福韦酯治疗慢性乙型肝炎患者(CHB)的安全性和有效性。方法计算机检索Cochrane图书馆(2009年第1期)、PubMed(1975～2009.3)、中国生物医学文献数据库(1978～2009.3)和中文科技期刊全文数据库(1989～2009),同时手工检索其他相关文献,查找苦参素联合阿德福韦酯治疗CHB的随机对照试验(RCT)。按照纳入与排除标准选择文献、评价质量,提取数据,而后采用RevMan5.0.0软件进行Meta分析。结果共纳入10个RCT,合计855例CHB患者,其中试验组436例,对照组419例。Meta分析结果显示,苦参素联合阿德福韦酯组患者治疗12月后的血清ALT复常率、血清HBV-DNA转阴率、血清HBeAg转阴率以及HBeAg/抗HBe血清转换率均优于单用阿德福韦酯组,且差异有统计学意义,其RR及其95%CI分别为1.28(1.17,1.40)、1.27(1.13,1.42)、1.80(1.32,2.44)、2.11(1.47,3.03)。结论苦参素联合阿德福韦酯治疗CHB,能明显提高乙肝患者的HBsAg/抗HBs血清转换率,而达到较好的治疗效果。
Objective To evaluate the safety and efficacy of oxymatrine combined with adefovir dipivoxil in the treatment of patients with chronic hepatitis B (CHB). Methods The Cochrane Library (2009 issue 1), PubMed (1975-2009.3), Chinese Biomedical Literature Database (1978-2009.3) and Chinese Science and Technology Periodicals Full-text Database (1989-2009) were searched by computer. Other relevant documents were searched by hand, To find a randomized controlled trial (RCT) of oxymatrine combined with adefovir dipivoxil in the treatment of CHB. According to inclusion and exclusion criteria, select the literature, evaluate the quality, extract data, and then use RevMan5.0.0 software for meta-analysis. Results A total of 10 RCTs were enrolled. A total of 855 CHB patients were included, of which 436 were in the experimental group and 419 in the control group. Meta-analysis showed that the serum ALT normalization rate, serum HBV-DNA negative rate, serum HBeAg negative rate, and HBeAg / anti-HBe seroconversion rate were significantly higher in patients treated with oxymatrine and adefovir dipivoxil for 12 months There were statistically significant differences in RR and 95% CI of 1.28 (1.17,1.40), 1.27 (1.13, 1.42), 1.80 (1.32, 2.44), 2.11 (1.47 , 3.03). Conclusion Oxymatrine combined with adefovir dipivoxil treatment of CHB, can significantly improve the HBsAg / anti-HBs in patients with hepatitis B seroconversion rate, and achieve better therapeutic effect.