国产人α＿1型基因工程干扰素治疗慢性肝炎Ⅲ期临床试验  

A PHASE Ⅲ CLINICAL TRIAL:THE EFFICACY OF DOMESTIC RECOMBINANT HUMAN ALPHA-1-INTERFERON IN TREATMENT OF CHRONIC VIRAL HEPATITIS

作　　者：赵敏[1] 熊诗松[1] 刘欣[1] 单英[1] 周灵杰[1] 巴秋菊[1] 

机构地区：[1]河南省医学科学研究所

出　　处：《河南医学研究》1995年第1期24-26,共3页Henan Medical Research

摘　　要：３９例慢性肝炎患者，其中乙型肝炎１２例，丙型肝炎２７例，接受人α＿１型基因工程干扰素治疗（ｒＨＩＦＮα＿１）。１０例丙型肝炎病人ｒＨＩＦＮα＿１每日肌注１×１０￣６Ｕ，连用９０天，１７例丙型肝炎病人和乙型肝炎ｒＨＩＦＮα＿１每日肌注３×１０￣６Ｕ，连用９０天。治疗后乙型肝炎组ＨＢｅＡｇ和ＨＢＶＤＮＡ的阴转率均为４１．６７％；丙型肝炎用１×１０￣６Ｕ／ｄ和３×１０￣６Ｕ／ｄ组ＨＣＶＲＮＡ阴转率分别为５０％和６４．７％，两个剂量组阴转率比较差异无显著性（Ｐ＞０．０５），治疗期间不良反应发生率较低，远期疗效尚待观察。A total of 32 patients with chronic viral hepatitis were treated using recombi-nant human alpha 1- interferon(rHIFNaα_1).Of these 10 chronic hepatitis C(CHC)were inject-ed intramuscularlv 1 million international unit(MIU)of rHIFNα_1 once a day for ninty days;17 chronic hepatitis C and 12 chronic hepatitis B(CHB)patients,3 MIU rHIFNα_1 once a dayfor ninty days. At the end of the therapeutic couse there were 41. 67%of patients with CHBwho had a seroconversion of HBeAg and HBV DNA. HCV RNA in sera detected by PCR dis-appeared in 50%in patients with CHC recived 1 MIU rHIFNα_1,64.7%in those recived 3MIU rHIFNα_1 respectively. The differance between the proportions of seroconversion of HCVRNA was not statistically significant( P>0.05).Side effects of rHIFNα_1 were moderate.Some more work is needed for observeing further responses.

关 键 词：A1型 基因工程 干扰素 乙型肝炎 丙型肝炎 

分 类 号：R512.605[医药卫生—内科学] R978.7[医药卫生—临床医学]