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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
【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。
【Abstract】 A total of 32 patients with chronic viral hepatitis were treated using recombi-nant human alpha 1- interferon(rHIFNaα1).Of these 10 chronic hepatitis C(CHC)were inject-ed intramuscularlv 1 million international unit(MIU)of rHIFNα1 once a day for ninty days;17 chronic hepatitis C and 12 chronic hepatitis B(CHB)patients,3 MIU rHIFNα1 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 rHIFNα1,64.7%in those recived 3MIU rHIFNα1 respectively. The differance between the proportions of seroconversion of HCVRNA was not statistically significant( P>0.05).Side effects of rHIFNα1 were moderate.Some more work is needed for observeing further responses.
【Key words】 recombinant human alpha-1-interferon; hepatitis B; hepatitis C; therapy.;
- 【文献出处】 河南医学研究 ,HENAN MEDICAL RESEARCH , 编辑部邮箱 ,1995年01期
- 【分类号】R512.6
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