Cammà Calogero, Di Bona Danilo, Schepis Filippo, Heathcote E Jenny, Zeuzem Stefan, Pockros Paul J, Marcellin Patrick, Balart Luis, Alberti Alfredo, Craxì Antonio
IBIM, Consiglio Nazionale delle Ricerche, Palermo, Italy.
Hepatology. 2004 Feb;39(2):333-42. doi: 10.1002/hep.20073.
Multicenter randomized trials have shown that once-weekly pegylated interferon (peginterferon) alfa-2a is more efficacious than conventional interferon alfa-2a (IFN) in patients with chronic hepatitis C. We performed a meta-analysis of 1,013 previously untreated patients (from 3 randomized trials) with pretreatment and post-treatment liver biopsies to assess the differences between peginterferon alfa-2a and IFN in terms of their effects on liver histology. Reported values were standardized mean differences (SMD) between patients receiving peginterferon alfa-2a and those receiving IFN (post-treatment value minus baseline value for each group). We used a random-effects model to quantify the average effect of peginterferon alfa-2a on liver histology. Peginterferon alfa-2a significantly reduced fibrosis compared with IFN (SMD, -0.14; 95% CI: -0.27, -0.01; P =.04). A reduction in fibrosis was observed among sustained virologic responders (SMD, -0.59; 95% CI: -0.89, -0.30; P <.0001) and patients with recurrent disease (SMD, -0.34; 95% CI: -0.54, -0.14; P =.0007), whereas no significant reduction was observed among nonresponders (SMD, -0.13; 95% CI: -0.32, 0.05; P =.15). Logistic regression analysis indicated that patients with sustained virologic responses (SVRs) had an odds ratio (OR) of 1.61 (95% CI: 1.14, 2.29) for reduction in fibrosis compared with patients without SVRs, whereas obese patients (body mass index [BMI] > 30 kg/m(2)) had an OR of 0.56 (95% CI: 0.35, 0.90) compared with normal-weight (BMI < 25 kg/m(2)) and overweight patients (BMI, 25-30 kg/m(2)). In conclusion, in patients with chronic hepatitis C with or without cirrhosis, peginterferon alfa-2a (relative to IFN) significantly reduced fibrosis. The beneficial effects of peginterferon on liver histology are closely related to virologic response.
多中心随机试验表明，对于慢性丙型肝炎患者，每周一次的聚乙二醇化干扰素（peginterferon）α-2a比传统干扰素α-2a（IFN）更有效。我们对1013例先前未经治疗的患者（来自3项随机试验）进行了荟萃分析，这些患者在治疗前和治疗后均接受了肝脏活检，以评估聚乙二醇化干扰素α-2a和IFN在肝脏组织学影响方面的差异。报告的值为接受聚乙二醇化干扰素α-2a的患者与接受IFN的患者之间的标准化平均差异（SMD）（每组治疗后值减去基线值）。我们使用随机效应模型来量化聚乙二醇化干扰素α-2a对肝脏组织学的平均影响。与IFN相比，聚乙二醇化干扰素α-2a显著降低了纤维化程度（SMD，-0.14；95%置信区间：-0.27，-0.01；P = 0.04）。在持续病毒学应答者（SMD，-0.59；95%置信区间：-0.89，-0.30；P < 0.0001）和复发疾病患者（SMD，-0.34；95%置信区间：-0.54，-0.14；P = 0.0007）中观察到纤维化程度降低，而在无应答者中未观察到显著降低（SMD，-0.13；95%置信区间：-0.32，0.05；P = 0.15）。逻辑回归分析表明，与无持续病毒学应答（SVR）的患者相比，有SVR的患者纤维化程度降低的优势比（OR）为1.61（95%置信区间：1.14，2.29），而肥胖患者（体重指数[BMI] > 30 kg/m²）与正常体重（BMI < 25 kg/m²）和超重患者（BMI，25 - 30 kg/m²）相比，OR为0.56（95%置信区间：0.35，0.90）。总之，在有或无肝硬化的慢性丙型肝炎患者中，聚乙二醇化干扰素α-2a（相对于IFN）显著降低了纤维化程度。聚乙二醇化干扰素对肝脏组织学的有益作用与病毒学应答密切相关。
