Cochrane Hepato-Biliary Group, Copenhagen Trial Unit, Center for Clinical Intervention Research, Department 3344, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
Hepatology. 2010 Apr;51(4):1176-84. doi: 10.1002/hep.23504.
A combination of weekly pegylated interferon (peginterferon) alpha and daily ribavirin represents the standard of care for the treatment of chronic hepatitis C according to current guidelines. It is not established which of the two licensed products (peginterferon alpha-2a or peginterferon alfa-2b) is most effective. We performed a systematic review of head-to-head randomized trials to assess the benefits and harms of the two treatments. We searched the Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, and LILACS through July 2009. Using standardized forms, two reviewers independently extracted data from each eligible trial report. We statistically combined data using a random effects meta-analysis according to the intention-to-treat principle. We identified 12 randomized clinical trials, including 5,008 patients, that compared peginterferon alpha-2a plus ribavirin versus peginterferon alfa-2b plus ribavirin. Overall, peginterferon alpha-2a significantly increased the number of patients who achieved a sustained virological response (SVR) versus peginterferon alfa-2b (47% versus 41%; risk ratio 1.11, 95% confidence interval 1.04-1.19; P = 0.004 [eight trials]). Subgroup analyses of risk of bias, viral genotype, and treatment history yielded similar results. The meta-analysis of adverse events leading to treatment discontinuation included 11 trials and revealed no significant differences between the two peginterferons.
Current evidence suggests that peginterferon alpha-2a is associated with higher SVR than peginterferon alfa-2b. However, the paucity of evidence on adverse events curbs the decision to definitively recommend one peginterferon over the other, because any potential benefit must outweigh the risk of harm.
根据当前指南，每周聚乙二醇干扰素（peginterferon）α与每日利巴韦林联合使用是慢性丙型肝炎治疗的标准方法。目前还没有确定两种已获许可的产品（peginterferon alpha-2a 或 peginterferon alfa-2b）中哪一种最有效。我们进行了一项头对头随机试验的系统综述，以评估这两种治疗方法的益处和危害。我们检索了 Cochrane 对照试验中心注册库、MEDLINE、EMBASE 和 LILACS，检索时间截至 2009 年 7 月。两位评审员使用标准化表格，分别从每个合格的试验报告中提取数据。我们根据意向治疗原则使用随机效应荟萃分析对数据进行了统计学合并。我们共确定了 12 项随机临床试验，包括 5008 名患者，这些试验比较了 peginterferon alpha-2a 联合利巴韦林与 peginterferon alfa-2b 联合利巴韦林。总体而言，与 peginterferon alfa-2b 相比，peginterferon alpha-2a 显著增加了实现持续病毒学应答（SVR）的患者数量（47%对 41%；风险比 1.11，95%置信区间 1.04-1.19；P = 0.004[八项试验]）。亚组分析显示，在偏倚风险、病毒基因型和治疗史方面，也得到了相似的结果。对导致治疗中断的不良事件的荟萃分析包括 11 项试验，并未发现两种聚乙二醇干扰素之间存在显著差异。
目前的证据表明，peginterferon alpha-2a 与 peginterferon alfa-2b 相比，SVR 更高。然而，由于缺乏关于不良事件的证据，限制了确定推荐使用其中一种聚乙二醇干扰素而不是另一种的决定，因为任何潜在的益处必须超过危害的风险。
