Baqiyatallah Research Center for Gastroenterology and Liver Disease, Baqiyatallah University of Medical Sciences, Ground floor of Baqiyatallah Hospital, Mollasadra Ave., Vanak Sq., P.O. Box 14155-3651, Tehran, Iran.
Eur J Clin Pharmacol. 2010 Nov;66(11):1071-9. doi: 10.1007/s00228-010-0881-7. Epub 2010 Sep 21.
About one-half of patients with hepatitis C genotype 1 and one-third with genotype 2/3 have treatment failure with peginterferon alpha and ribavirin. Consensus interferon (CIFN) is an option for retreatment of these patients.
To summarize comparative safety and efficacy of different regimens of CIFN for the treatment of patients with chronic hepatitis C infection.
Medline, Scopus, ISI, and Cochran Central Register of Clinical Trials were used.
Randomized clinical trials (RCTs) were eligible for inclusion in the study.
HIV and HBV seronegative patients with positive HCV-RNA during the 6 months before the start of the study were eligible for inclusion.
Different regimens of CIFN were studied.
Studies were appraised based on methods of random sequence generation, allocation concealment, and blinding. The random effects model of DerSimonian and Laird was employed to run the meta-analysis. The end-point was sustained virological response (SVR).
Data of 10 RCTs including 1,600 subjects were extracted. High daily induction dose regimen of CIFN did not yield a higher rate of SVR than low daily induction dose treatment regimen, RR = 0.83 (95% CI 0.58-1.17). A dose of 9 μg thrice weekly (tiw) was associated with a significantly higher rate of SVR compared with 3 μg [RR = 3.14 (95% CI 1.68-5.58)][Symbol: see text]. Withdrawal rate was similar [RR = 1.28 (95% CI 0.65-2.50)] but dose modification was higher in 9 μg [RR = 3.22 (95% CI 1.08-9.60)]. A dose of 18/15 μg tiw was not more effective than 9 μg over a similar treatment duration [RR = 1.02 (95% CI 0. 87-1.19)].
Limitations include inadequate reporting of methodological information and side effects, lack of publication bias assessment due to the small number of studies in each analysis.
High dose daily induction therapy with CIFN is not superior to low dose therapy in terms of SVR. It seems that 9 μg tiw is the optimal treatment dose of CIFN for treatment of HCV infection. Optimal duration and safety profile of CIFN therapy have yet been elucidated.
大约一半的丙型肝炎基因型 1 患者和三分之一的基因型 2/3 患者在接受聚乙二醇干扰素α和利巴韦林治疗后会出现治疗失败。普通干扰素（CIFN）是这些患者再治疗的一种选择。
总结 CIFN 不同方案治疗慢性丙型肝炎感染患者的安全性和疗效。
使用 Medline、Scopus、ISI 和 Cochrane 临床试验中心注册库。
随机临床试验（RCT）符合入选标准。
在研究开始前 6 个月内 HCV-RNA 阳性的 HIV 和 HBV 血清阴性患者符合入选条件。
研究了 CIFN 的不同方案。
根据随机序列生成、分配隐匿和盲法的方法对研究进行评估。采用 DerSimonian 和 Laird 的随机效应模型进行荟萃分析。终点是持续病毒学应答（SVR）。
共提取了 10 项 RCTs 的数据，包括 1600 名受试者。CIFN 的高日诱导剂量方案并未比低日诱导剂量治疗方案产生更高的 SVR 率，RR=0.83（95%CI 0.58-1.17）。每周 3 次给予 9 μg 的剂量与 3 μg 相比，SVR 率显著更高，RR=3.14（95%CI 1.68-5.58）[符号：见正文]。停药率相似[RR=1.28（95%CI 0.65-2.50）]，但 9 μg 剂量调整更高，RR=3.22（95%CI 1.08-9.60）。18/15 μg 每周 3 次的剂量与 9 μg 相比，在相似的治疗时间内并不更有效，RR=1.02（95%CI 0.87-1.19）。
研究存在局限性，包括方法信息和副作用报告不充分，由于每个分析中的研究数量较少，无法评估发表偏倚。
CIFN 的高剂量每日诱导治疗在 SVR 方面并不优于低剂量治疗。似乎 9 μg 每周 3 次是 CIFN 治疗 HCV 感染的最佳治疗剂量。CIFN 治疗的最佳持续时间和安全性仍有待阐明。
