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)  

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

作　　者：马丽娜[1] 陈新月[1] 陈杰[1] 沈成利[1] 汪俊韬[1] 

机构地区：[1]首都医科大学附属北京佑安医院,北京100054

出　　处：《中华实验和临床病毒学杂志》2006年第2期42-45,共4页Chinese Journal of Experimental and Clinical Virology

摘　　要：目的观察聚乙二醇干扰素(PEGIFN)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PEGIFNα-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(5MIU/隔天)联合RBV900mg/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PEGIFNα-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IFNα-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)。PEGIFNα-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PEGIFNα-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PEGIFNα-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PEGIFNα-2a,且具有较好的安全性和耐受性。Objective 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 μg or 135 μg/week） and RBV 900 mg/d, 43 patients were treated with IFNα-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 difference 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-IFNα-2a group was significantly higher than that in IFNα-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-IFNα-2a group was higher than IFNα-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 IFNα-2a group and IFNα-2a group, but the rate of weight decline and the degree of leukocyte decrease were more significant in PEG IFNα-2a group than in IFNα-2a group （ P = 0.001 ）. Conclusion The efficacy of PEG IFNα-2a in the treatment of chronic hepatitis C is superior to that of conventional IFNα-2a, PEG-IFNα-2a had good tolerance and safety profiles.

关 键 词：肝炎 丙型 干扰素Α-2A 临床试验 

分 类 号：R512.63[医药卫生—内科学] R979.5[医药卫生—临床医学]