Ribavirin enhances the efficacy but not the adverse effects of interferon in chronic hepatitis C - Meta-analysis of individual patient data from European centers
Ribavirin enhances the efficacy but not the adverse effects of interferon in chronic hepatitis C - Meta-analysis of individual patient data from European centers
复制标题
DOI：
10.1016/s0168-8278(97)80103-1
复制
发表时间：
1997-05-01
影响因子：
25.7
通讯作者：
Alberti, A
中科院分区：
文献类型：
--
作者：
Schalm, SW;Hansen, BE;Alberti, A
背景/目的：本研究旨在更准确地评估干扰素-利巴韦林联合治疗慢性丙型肝炎的疗效和耐受性。该研究在4个欧洲大学附属肝脏转诊中心进行，共有186名慢性丙型肝炎患者参加了3个随机对照试验和1个开放研究，其中51人接受利巴韦林单药治疗（1000- 1200mg /天）。干扰素单药治疗37例（3 μ 3 x /周），干扰素-利巴韦林联合治疗78例（剂量与单药治疗相同），疗程6个月，对照组20例，治疗后随访6个月。数据分析采用多元逻辑回归方法。结果:疗效的主要结局指标是持续缓解的百分比（治疗后6个月ALT正常化和HCV RNA阴性），干扰素-利巴韦林联合治疗的持续缓解率显著高于干扰素或利巴韦林单药治疗（优势比IFN- riba vs IFN = 9.8, 95% CI 1.9-50），干扰素-利巴韦林联合治疗后持续缓解的估计概率为51%，此前未接受干扰素治疗的患者。52%的患者既往IFN治疗和应答复发，16%的患者既往IFN无应答。未观察到严重不良事件，只有不到10%的患者退出治疗。结论：干扰素-利巴韦林治疗的疗效似乎比干扰素单药治疗在所有主要亚组慢性丙型肝炎患者中提高了两到三倍。鉴于其可接受的毒性特征，干扰素-利巴韦林联合治疗是慢性丙型肝炎新标准治疗的候选药物。
Background/Aims: This study aimed to obtain a more precise estimation of the efficacy and tolerability of interferon-ribavirin combination therapy for chronic hepatitis C.Methods: A meta-analysis was carried out of individual patient data comprising about 90% of the published experience with combination therapy, The study was set in four European university-affiliate liver referral centers, A total of 186 individuals with chronic hepatitis C who had participated in three randomized controlled trials and one open study were selected for the study, Fifty-one had received ribavirin monotherapy (1000-1200 mg/day), 37 interferon monotherapy (3 MU 3 x /week) and 78 interferon-ribavirin combination therapy (dosage as for monotherapy) for 6 months, Twenty patients served as controls, Follow-up after therapy was 6 months. Data analysis was by the multivariate logistical regression method.Results: The primary outcome measure for efficacy was the percentage with a sustained response (ALT normalization and HCV RNA negativity 6 months after therapy), The sustained response rate was significantly higher for interferon-ribavirin combination therapy than for interferon or ribavirin monotherapy (odds ratio IFN-Riba vs IFN = 9.8, 95% CI 1.9-50), The estimated probability of sustained response following interferon-ribavirin combination therapy was 51% for patients without previous IFN therapy, 52% for patients with previous IFN therapy and response-relapse, and 16% for previous IFN non-responders. No serious adverse events were observed and less than 10% withdrew.Conclusions: The efficacy of interferon-ribavirin therapy appears to be enhanced two- to threefold over interferon monotherapy in all major subgroups of chronic hepatitis C patients tested. In view of its acceptable toxicity profile, interferon-ribavirin combination therapy is a candidate for the new standard therapy for chronic hepatitis C.