聚乙二醇干扰素治疗慢性丙型肝炎临床疗效、影响因素及安全性分析(附89例临床分析)

目的 观察聚乙二醇干扰素（PEG IFN）α-2a治疗慢性丙型肝炎的效果、疗效影响因素及安全性.方法 观察了89例慢性丙肝患者,对46例慢性丙肝患者予PEG IFNα-2a（180μg或135μg/周）联合利巴韦林（RBV）900mg/d抗病毒治疗,对照组为43例慢性丙肝患者予IFNα-2a（5 MIU/隔天）联合RBV 900mg/d抗病毒治疗.疗程48周,随访24周.两组治疗前HCV-RNA、基因型等临床资料具有可比性,以病毒学应答和生化学应答作为疗效的主要评价指标.同时观察药物不良反应.结果 PEG IFNα-2a组持续应答率（SVR）显著高于IFNα-2a组（分别是56.5%和19.5%,P＜0.0001）.PEGIFNα-2a组治疗基因1型、高病毒载量慢性丙型肝炎的SVR明显高于IFNd-2a组（P＜0.001）,但非基因1型、低病毒载量的SVR两组之间差异无统计学意义（P值分别为0.664、0.116）.PEG IFNα-2a与IFNα-2a有相似的不良反应,但除白细胞减少的程度及体重减轻发生率PEG IFNα-2a组高于IFNα-2a组外（P值为0.001）,余不良反应间差异无统计学意义.结论 PEG IFNα-2a对慢性丙型肝炎患者的疗效优于干扰素IFNα-2a,尤其对基因1型、高病毒载量的患者更应选择PEG IFNα-2a,且具有较好的安全性和耐受性.

Efficacy, influencing factors and safety of PEG-INF alpha-2a (PEG-INF-2a) in the treatment of chronic hepatitis C:analysis of 89 patients

BACKGROUND: To investigate the efficacy, influencing factors and safety of PEG-INF alpha-2a (PEG-INF-2a) in the treatment of hepatitis C. METHODS: Totally 89 patients with hepatitis C were included in this study and 46 patients were treated with PEG-INF-2a (180 microg or 135 microg/week) and RBV 900 mg/d, 43 patients were treated with IFNalpha-2a (5 MIU/qod) and RBV 900 mg/d. The time of treatment was 48 weeks, and all the patients were visited 24 weeks after treatment. There were no significant differences between the two groups in pretreatment HCV-RNA, HCV genotype and other clinical data. The main parameters to evaluate the efficacy were virological and biochemical responses. The side effects were intensively observed. RESULTS: Sustained virological response (SVR) rate in PEG-IFNalpha-2a group was significantly higher than that in IFNalpha-2a group (56.5% and 19.5% respectively, P<0.001). As the patients were divided according to HCV genotype 1 and high virus load, the SVR rate of PEG-INF alpha-2a group was higher than IFNalpha-2a group (P<0.001). However, there was no significant difference between two groups in the patients with non-genotype 1 and low viral load (P=0.664, 0.116). Similar side-effects were observed in PEG-IFNalpha-2a group and IFNalpha-2a group, but the rate of weight decline and the degree of leukocyte decrease were more significant in PEG-INF alpha-2a group than in IFNalpha-2a group (P=0.001). CONCLUSION: The efficacy of PEG-INF alpha-2a in the treatment of chronic hepatitis C is superior to that of conventional IFNalpha-2a, PEG-INF alpha-2a had good tolerance and safety profiles.