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目的系统评价聚乙二醇干扰素(PEG-IFNα)初始联合阿德福韦酯(ADV)或拉米夫定(LAM)治疗HBe Ag(+)慢性乙型肝炎的疗效。方法计算机检索The Cochrane Library(2014年第11期)、Pub Med、CBM、CNKI、VIP和Wan Fang Data数据库,搜集PEG-IFNα初始联合ADV或LAM治疗HBe Ag(+)慢性乙型肝炎的相关随机对照试验(RCT),检索时限均从建库至2014年12月。由2位评价员独立筛选文献、提取资料和评价纳入研究的偏倚风险后,采用Rev Man 5.2软件进行Meta分析。结果共纳入11个研究,PEG-IFNα初始联合ADV或LAM组793例,PEG-IFNα单药治疗组728例,ADV或LAM单药治疗组510例。Meta分析结果显示:PEGIFNα联合ADV治疗HBe Ag(+)慢性乙型肝炎患者48周,HBs Ag转换率均明显高于单用PEG-IFNα[8.6%vs.0%,OR=7.73,95%CI(1.53,39.05),P=0.01]或单用ADV[8.5%vs.0%,OR=7.75,95%CI(1.07,56.23),P=0.04],HBs Ag转阴率仅明显高于单用ADV[10.5%vs.1.2%,OR=5.56,95%CI(2.14,14.47),P=0.000 4];PEG-IFNα初始联合LAM治疗HBe Ag(+)慢性乙型肝炎患者52周,HBs Ag转换率明显高于单用PEG-IFNα[11.6%vs.5.6%,OR=2.21,95%CI(1.04,4.72),P=0.04];治疗48~52周后随访26周,联合治疗组HBs Ag转阴率或转换率均未显示出明显优于单用PEG-IFNα治疗组(P均>0.05)。结论 PEG-IFNα初始联合ADV或LAM治疗HBe Ag(+)慢性乙型肝炎48~52周获得的总体HBs Ag清除率或转换率仍然很低,但较单药治疗可获得更高的HBs Ag血清学转阴率或转换率,受纳入研究的质量和数量所限,本研究结论尚需开展更多高质量研究予以验证。
Objective To systematically evaluate the efficacy of peginterferon (PEG-IFNα) combined with adefovir dipivoxil (ADV) or lamivudine (LAM) in the treatment of chronic hepatitis B with HBe Ag (+). METHODS: The Cochrane Library (Issue 11 of 2014), Pub Med, CBM, CNKI, VIP and Wan Fang Data were searched by computer. The correlation between PEG-IFNα and ADV or LAM in the treatment of HBeAg (+) chronic hepatitis B Control trial (RCT), retrieval time from the database to December 2014. After two reviewers independently screened the literature, extracted data, and assessed the risk of being included in the study, Meta-analysis was performed using Rev Man 5.2 software. Results A total of 11 studies were included in this study. 793 patients were initially treated with PEG-IFNα combined with ADV or LAM, 728 patients treated with PEG-IFNα alone, and 510 patients treated with ADV or LAM alone. Meta-analysis showed that the conversion rate of HBsAg was significantly higher in patients with HBeAg (+) chronic hepatitis B treated with PEGIFNα and ADV compared with those treated with PEG-IFNα alone [8.6% vs.0%, OR = 7.73, 95% CI (1.53, 39.05), P = 0.01] or with ADV [8.5% vs.0%, OR = 7.75,95% CI (1.07,56.23), P = 0.04] The HBsAg (+) chronic hepatitis B patients were treated with ADV [10.5% vs 1.2%, OR = 5.56, 95% CI 2.14,14.47, P = 0.0004] Ag conversion rate was significantly higher than the single use of PEG-IFNα [11.6% vs.5.6%, OR = 2.21,95% CI (1.04,4.72), P = 0.04]; treatment 48 to 52 weeks followed up 26 weeks, combined treatment group Neither the rates of HBsAg negative conversion nor the conversion rates of HBsAg were significantly better than those of PEG-IFNα alone group (all P> 0.05). Conclusions The overall clearance or conversion of HBsAg from 48 to 52 weeks after PEG-IFNα was initially treated with ADV or LAM in HBeAg (+) chronic hepatitis B remains low, but higher HBsAg serum is obtained than monotherapy Negative rates or conversion rates are limited by the quality and quantity of studies included. The conclusion of this study is still to be verified by more high-quality studies.