重组复合干扰素治疗慢性丙型肝炎的临床研究

目的 比较两种剂量的重组复合干扰素（Ｃｏｎｓｅｎｓｕｓ Ｉｎｔｅｒｆｅｒｏｎ，ＣＩＦＮ）和重组干扰素α－２α（ＩＦＮα－２α）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：ＣＩＦＮ１５μｇ（Ａ组）６１例、９μｇ（Ｂ组）６５例和ＩＦＮα－２α３ＭＵ（Ｃ组）６１例，１周３次，共２４周，在完成治疗后继续随访２４周。本试验以治疗结束时和随访时丙氨

Clinical trial of consensus interferon for chronic hepatitis C

Objective 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 in-terferon alfa-2a(IFN α-2a). Methods 187 patients were randomized to receive CIFN 15μg,CIFN 9μg or 3 MU interferon α-2a.Patients received subcutaneous iniections tiw for 24 weeks followed bv 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 15μg,63 cases with CIFN 9/zg and 61 cases with 3MU IFN α-2a,respectively,After 24 weeks treatment,ALT normalization rate for 15μg CIFN,9μg 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 signifi-cant 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 therapv,ALT nor-malization 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 15μg(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,incidenee 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 sug-gest the short-term as well as long-term efficacy of 15μg to be more effective than IFN α-2a(3 MU)with-out increasing toxicity.