重组复合干扰素治疗慢性丙型肝炎的临床研究  

Clinical trial of consensus interferon for chronic hepatitis C

作　　者：姚光弼[1] 傅希贤[2] 徐道振[3] 郝连杰[4] 皇甫玉珊[5] 苏纯信 田庚善[2] 

机构地区：[1]上海市静安区中心医院,200040 [2]北京医科大学第一医院 [3]北京地坛医院 [4]同济医科大学附属同济医院 [5]解放军第302医院 [6]北京佑安医院

出　　处：《中华传染病杂志》2000年第2期101-105,共5页Chinese Journal of Infectious Diseases

摘　　要：目的　比较两种剂量的重组复合干扰素 (ConsensusInterferon ,CIFN)和重组干扰素α 2a(IFNα 2a)治疗慢性丙型肝炎患者的疗效和安全性。方法　 187例初治的慢性丙型肝炎 (丙肝 )患者 ,随机分成三组 ,分别接受 :CIFN 15 μg(A组 ) 6 1例、9μg(B组 ) 6 5例和IFNα 2a 3MU(C组 ) 6 1例 ,1周 3次 ,共 2 4周 ,在完成治疗后继续随访 2 4周。本试验以治疗结束时和随访时丙氨酸转氨酶(ALT)复常和丙型肝炎病毒核糖核酸 (HCVRNA)逆转录 聚合酶链反应 (RT PCR)检查阴转考核药物近期和远期疗效 ,同时观察不良反应。结果　 180例完成 2 4周治疗 ,分别为CIFN 15 μg组 5 6例 ,9μg组 6 3例和IFNα 2a组 6 1例。经 2 4周治疗后 ,A、B、C三组的ALT复常率分别为 76 .9%、6 8.3%和 5 7.4% ,HCVRNA的阴转率分别为 89.6 %、73.6 %和 6 0 .4% ,A组和C组比较差异均有显著性 (P<0 .0 5和P <0 .0 1)。在 48周时 ,A、B、C三组的ALT复常率分别为 78.8%、6 3.9%和 5 5 .0 % ,HCVRNA的阴转率分别为 75 .0 %、6 5 .4%和 5 4.7% ,A组和C组比较差异均有显著性 (P <0 .0 1和P<0 .0 5 )。三组患者近期显效率分别为 70 .8%、5 4.7%和 34 .0 % ;远期显效率分别为 6 4.6 %、5 1.9%和43.4%。A组的近期和远期疗效均显著高于C组 (P <0 .0Objective The randomized study was conducted to determine the safety and efficacy of consensus interferon (CIFN) in the treatment of chronic hepatitis C at two doses compared with that of interferon alfa 2a (IFN α 2a). Methods 187 patients were randomized to receive CIFN 15 μg, CIFN 9 μg or 3 MU interferon α 2a. Patients received subcutaneous injections tiw for 24 weeks followed by 24 weeks of observation. Normalization rate of serum alanine aminotransferase (ALT) and seroconversion rate of HCV RNA by (RT PCR) were detected to evaluate the efficacy. The categories and severity of adverse events were registered. Results 180 patients completed full course of treatment, 56 cases of which were treated with CIFN 15 μg,63 cases with CIFN 9 μg and 61 cases with 3MU IFN α 2a, respectively. After 24 weeks treatment, ALT normalization rate for 15 μg CIFN, 9 μg and 3MU IFN α 2a were 76.9%, 68.3% and 57.4%. HCV RNA seroconversion rate were 89.6%, 73.6% and 60.4%. There were significant statistical difference of both ALT normalization rate and HCV RNA seroconversion rate between CIFN 15 μg and IFN α 2a 3MU treated patients ( P <0.05 and P <0.01). After 48 weeks therapy, ALT normalization rate for those three groups were 78.8%, 63.9% and 55.0%, the HCV RNA seroconversion rate were 75.0%, 65.4% and 54.7%. It also showed significant statistical difference between CIFN 15 μg and 3MU IFN α 2a group ( P <0.01 and P <0.05). The short term and long term complete response rate in the patients treated with CIFN 15 μg (70.8% and 64.6%, respectively) were higher than in the patients treated with IFN α 2a 3 MU (34.0% and 43.4%, respectively; P <0.01 and P <0.05). The category, incidence and severity of adverse events were similar in 3 groups. Conclusion CIFN is safe and effective at both 9 μg and 15 μg doses in the treatment of chronic hepatitis C. Futhermore, the results suggest the short term as well as long term efficacy of 15 μg to be more effective than IFN α 2a (3 M

关 键 词：慢性 丙型肝炎 重组复合干扰素 CIFN IFNα-α 

分 类 号：R512.63[医药卫生—内科学]