Poynard T, Massard J, Rudler M, Varaud A, Lebray P, Moussalli J, Munteanu M, Ngo Y, Thabut D, Benhamou Y, Ratziu V
Service d'hépatologie, UPMC Liver Center, hôpital La Pitié Salpêtrière, AP-HP, 47-83, boulevard de l'Hôpital, 75651 Paris cedex 13, France.
Gastroenterol Clin Biol. 2009 Oct-Nov;33(10-11):916-22. doi: 10.1016/j.gcb.2009.06.006. Epub 2009 Jul 28.
The impact of interferon treatment in patients with hepatitis B virus (HBV) infection on fibrosis progression in comparison with its natural history has yet to be assessed in any large-scale randomized studies. The present report is a review of the evidence-based data published so far.
Studies were included if they had at least two repeated estimates of liver fibrosis per patient treated with interferon-alpha (whether pegylated or not). Meta-analysis was performed using a random-effects model.
Altogether, 13 studies were included in the review, involving a total of 707 HBV patients treated with interferon-alpha-2a or -2b for 12-83 months. Only one study included pegylated interferon as monotherapy. A total of 787 untreated patients were also followed. Only one study used a non-invasive biomarker. There was a significant reduction in the fibrosis progression rate, with a risk reduction of 0.49 (95% CI: -0.64--0.34; chi(2)=119; degrees of freedom [DF]=6; P<0.0001), and significant heterogeneity (Cochran Q=81; P<0.0001). This significant impact was similar for both randomized (reduction of risk: -0.45; 95% CI: -0.64--0.26; P<0.0001) and not-randomized (controlled) studies (reduction of risk: -0.53; 95% CI: -0.79--0.28; P<0.0001).
According to these findings, the benefit of interferon treatment on fibrosis progression is clinically significant in patients with advanced fibrosis by the reduction of fibrosis progression to cirrhosis. Pegylated interferon now needs to be compared, in terms of benefit-risk factors, with the new generation of HBV treatments (such as entecavir and tenofovir), using non-invasive biomarkers.
与自然病程相比，干扰素治疗对乙型肝炎病毒（HBV）感染患者纤维化进展的影响尚未在任何大规模随机研究中得到评估。本报告是对迄今已发表的循证数据的综述。
纳入的研究需对接受α-干扰素（无论是否聚乙二醇化）治疗的每位患者至少进行两次肝纤维化重复评估。采用随机效应模型进行荟萃分析。
该综述共纳入13项研究，涉及707例接受α-干扰素-2a或-2b治疗12 - 83个月的HBV患者。仅一项研究将聚乙二醇化干扰素作为单一疗法。还对787例未治疗患者进行了随访。仅一项研究使用了非侵入性生物标志物。纤维化进展率显著降低，风险降低0.49（95%可信区间：-0.64至-0.34；χ² = 119；自由度[DF] = 6；P < 0.0001），且存在显著异质性（Cochran Q = 81；P < 0.0001）。这种显著影响在随机研究（风险降低：-0.45；95%可信区间：-0.64至-0.26；P < 0.0001）和非随机（对照）研究（风险降低：-0.53；95%可信区间：-0.79至-0.28；P < 0.0001）中均相似。
根据这些发现，干扰素治疗对纤维化进展的益处在于通过减少纤维化进展为肝硬化，对晚期纤维化患者具有临床意义。现在需要使用非侵入性生物标志物，在获益风险因素方面，将聚乙二醇化干扰素与新一代HBV治疗药物（如恩替卡韦和替诺福韦）进行比较。
