丙肝病毒1型患者在干扰素单药治疗后复发，使用不同剂量的共识干扰素联合利巴韦林治疗：一项随机对照试验。

Different doses of consensus interferon plus ribavirin in patients with hepatitis C virus genotype 1 relapsed after interferon monotherapy: a randomized controlled trial.

作者信息

Alaimo Giuseppe, Di Marco Vito, Ferraro Donatella, Di Stefano Rosa, Porrovecchio Salvatore, D'Angelo Francesca, Calvaruso Vincenza, Craxì Antonio, Almasio Piero Luigi

机构信息

Cattedra di Gastroenterologia, University of Palermo, Piazza delle Cliniche 2, Palermo 90127, Italy.

出版信息

World J Gastroenterol. 2006 Nov 14;12(42):6861-4. doi: 10.3748/wjg.v12.i42.6861.

DOI:10.3748/wjg.v12.i42.6861

PMID:17106937

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4087443/

Abstract

AIM

To assess the efficacy of different schedules of consensus interferon (CIFN) plus ribavirin in retreating chronic hepatitis C patients who relapsed after recombinant interferon (rIFN) monotherapy.

METHODS

Forty-five patients (34 males and 11 females) with chronic hepatitis due to hepatitis C virus (HCV) genotype 1 who relapsed after a previous course of rIFN monotherapy were randomized to receive 9 mug CIFN three times per week for 52 wk (group A, n = 22) or 18 mug CIFN three times per week for 52 wk (group B, n = 23) in combination with ribavirin 800 to 1200 mg daily for 52 wk (according to body weight). Virological response was evaluated at week 24 (EVR), at the end of treatment (ETR) and at 76 wk (SVR).

RESULTS

By intention-to-treat analysis, subjects in group A had an EVR in 35% of cases, an ETR in 35% and a SVR in 27.3% of cases. Subjects in group B had an EVR in 32% of cases, an ETR in 35% and a SVR in 26.1% of cases. Treatment was stopped because of adverse effects (mostly intolerance) in 15 patients (6 in group A and 9 in group B). IFN dose reduction was needed in 2 patients (1 in group A and 1 in group B). Ribavirin dose was reduced in 2 patients in group A and 1 in group B respectively. Among the 15 subjects who received at least 80% of the intended schedule, the rate of SVR was 80% (6 in group A and 6 in group B).

CONCLUSION

CIFN in combination with ribavirin when given to HCV genotype 1 relapsers after rIFN monotherapy obtains an unsatisfactory rate of sustained viral clearance independently of dosage of the drug. This may be due to its scarce tolerability.

摘要

目的

评估不同给药方案的共识干扰素（CIFN）联合利巴韦林对重组干扰素（rIFN）单药治疗后复发的慢性丙型肝炎患者的疗效。

方法

45例丙型肝炎病毒（HCV）基因1型慢性肝炎患者（男34例，女11例），在接受过一个疗程的rIFN单药治疗后复发，随机分为两组，A组（n = 22）接受9μg CIFN，每周3次，共52周；B组（n = 23）接受18μg CIFN，每周3次，共52周，两组均联合利巴韦林，根据体重每日800至1200mg，共52周。在第24周（早期病毒学应答，EVR）、治疗结束时（治疗结束时应答，ETR）和第76周（持续病毒学应答，SVR）评估病毒学应答。

结果

意向性分析显示，A组患者的EVR为35%，ETR为35%，SVR为27.3%。B组患者的EVR为32%，ETR为35%，SVR为26.1%。15例患者（A组6例，B组9例）因不良反应（主要是不耐受）停止治疗。2例患者（A组1例，B组1例）需要降低IFN剂量。A组和B组分别有2例和1例患者需要降低利巴韦林剂量。在15例接受至少80%预定疗程的患者中，SVR率为80%（A组6例，B组6例）。