Laboratory Animal Center, Xi'an Jiaotong University School of Medicine, Shaanxi, China.
Clin Ther. 2010 Aug;32(9):1565-77. doi: 10.1016/j.clinthera.2010.08.009.
The standard treatments for chronic infection with the hepatitis C virus (HCV) are peginterferon α-2a or α-2b plus ribavirin, but it remains unclear if one has a better efficacy and safety profile.
The aim of this study was to perform a meta-analysis of randomized controlled trials (RCTs) comparing peginterferon α-2a and α-2b (in combination with ribavirin) treatments for chronic HCV.
The Cochrane Central Register of Controlled Trials, MEDLINE, Science Citation Index, and EMBASE were searched (1966-April 2010) to identify RCTs that evaluated the sustained virologic response (SVR) to peginterferon α-2a and peginterferon α-2b in patients with chronic HCV. The inclusion criteria were: RCT studies designed to compare the therapeutic effects of peginterferon α-2a (180 μg/wk) and peginterferon α-2b (1.5 μg/kg/wk) for treatment-naive patients with chronic HCV; patients treated for ≥24 weeks if infected with HCV genotypes 2 or 3 and for ≥48 weeks if infected with genotypes 1 or 4, with 24-week follow-ups; and publications written in any language. Reports of duplicated studies were excluded by examining the author list, parent institution, sample size, and results. The primary outcome was the SVR, and the other measures included the liver-related morbidity, all-cause mortality, and adverse events leading to treatment discontinuation.
The literature search yielded 5580 studies, and 7 RCTs comprising 3212 patients matched the inclusion/exclusion criteria. Overall, the SVR rate was significantly higher in patients treated with peginterferon α-2a than in patients treated with peginterferon α-2b (50% vs 46%, respectively; relative risk [RR] = 1.11; 95% CI, 1.02-1.20; P < 0.05) and varying levels of ribavirin treatment. The subgroup analysis found that, in patients with genotypes 1 or 4, the difference between SVR rate in patients treated with peginterferon α-2a and patients treated with peginterferon α-2b was not statistically significant (43% vs 39%; RR = 1.25; 95% CI, 0.99-1.57). A significantly higher SVR rate was achieved in the HCV patients with genotypes 2 or 3 treated with peginterferon α-2a compared with the patients treated with peginterferon α-2b (86% vs 77%; RR = 1.11; 95% CI, 1.02-1.22; P = 0.02). The meta-analysis of adverse events leading to treatment discontinuation revealed no significant differences between the 2 treatments.
The evidence reviewed in this meta-analysis suggests that peginterferon α-2a treatment was associated with a higher SVR rate than peginterferon α-2b treatment in patients with chronic HCV also treated with ribavirin. However, the available evidence on adverse events was insufficient to make recommendations.
慢性丙型肝炎病毒(HCV)感染的标准治疗方法是聚乙二醇干扰素α-2a 或 α-2b 联合利巴韦林,但哪种治疗方法具有更好的疗效和安全性尚不清楚。
本研究旨在对聚乙二醇干扰素α-2a 和 α-2b(联合利巴韦林)治疗慢性 HCV 的随机对照试验(RCT)进行荟萃分析。
检索 Cochrane 对照试验中心注册库、MEDLINE、科学引文索引和 EMBASE(1966 年-2010 年 4 月),以确定评估聚乙二醇干扰素α-2a 和聚乙二醇干扰素α-2b 治疗慢性 HCV 患者持续病毒学应答(SVR)的 RCT。纳入标准为:旨在比较聚乙二醇干扰素α-2a(180μg/wk)和聚乙二醇干扰素α-2b(1.5μg/kg/wk)治疗初治慢性 HCV 患者的疗效的 RCT 研究;治疗 HCV 基因型 2 或 3 的患者至少治疗 24 周,治疗 HCV 基因型 1 或 4 的患者至少治疗 48 周,并进行 24 周随访;以及用任何语言撰写的出版物。通过检查作者名单、母机构、样本量和结果排除重复研究的报告。主要结局为 SVR,其他指标包括肝脏相关发病率、全因死亡率和导致治疗中断的不良事件。
文献检索得到 5580 项研究,7 项 RCT 包括 3212 例符合纳入/排除标准的患者。总体而言,与聚乙二醇干扰素α-2b 治疗相比,聚乙二醇干扰素α-2a 治疗的患者 SVR 率显著更高(分别为 50%和 46%,相对风险[RR] = 1.11;95%CI,1.02-1.20;P < 0.05),且利巴韦林的治疗水平也不同。亚组分析发现,在基因型 1 或 4 的患者中,聚乙二醇干扰素α-2a 治疗患者与聚乙二醇干扰素α-2b 治疗患者的 SVR 率差异无统计学意义(43%和 39%,RR = 1.25;95%CI,0.99-1.57)。基因型 2 或 3 的 HCV 患者中,与聚乙二醇干扰素α-2b 治疗相比,聚乙二醇干扰素α-2a 治疗的 SVR 率显著更高(86%和 77%,RR = 1.11;95%CI,1.02-1.22;P = 0.02)。对导致治疗中断的不良事件的荟萃分析显示,两种治疗方法之间无显著差异。
本荟萃分析的证据表明,与聚乙二醇干扰素α-2b 治疗相比,聚乙二醇干扰素α-2a 治疗联合利巴韦林治疗慢性 HCV 患者的 SVR 率更高。然而,关于不良事件的现有证据不足以提出建议。