重组人干扰素α-2a(酵母)治疗带状疱疹临床试验

A randomized controlled multicenter clinical trial on the efficacy and safety of recombinant interferon α-2a(yeast) injection in treatment of herpes zoster

目的 :观察重组干扰素α 2a(酵母 )治疗带状疱疹的疗效及安全性。方法 :采用随机、双盲、多中心、对照的方法 ,治疗组用基因工程干扰素α 2a(酵母 ) ,对照组用干扰素α 2a(大肠杆菌 )。本研究共入组 2 10例 ,实际完成 2 0 6例 ,其中试验组 10 2例 ,对照组 10 4例。结果 :试验组无新起水疱日数、水疱消退日数、急性期疼痛消退日数、后遗神经痛消退日数与对照组比较 ,无统计学差异 ,完全结痂日数比较有统计学意义。试验组、对照组不良反应发生率分别为 13.73%及 2 1.15 % ,经统计学处理P =0 .193 ,无显著性差异。结论 :注射用基因工程干扰素α 2a(酵母 )治疗带状疱疹的疗效及安全性与干扰素α 2a(大肠杆菌 )

Objective:To study the efficacy and safety of recombinant interferon α 2a(yeast) injection in treatment of herpes zoster.Methods:In the randomized,controlled and multicenter study,recombinant interferon α 2a (yeast) was used in the active group and interferon α 2a( E.Coli ) in the controlled group.In 210 patients recruited,206 completed the trial.Among them 102 were in the active group and 104 in the controlled group.Results:Results obtained showed that there were no statistical significant differences among groups in duration of new blister appearance and blister disappearence;duration of starting crustation,acute pain resolving, and postherpetic neuralgiare resolving.There was statistical significant difference among groups in duration of complete crustation.For incidence of side effects (13.73% for active and 21.15% for controlled group),there were no statistical significant difference between groups.Conclusion:Recombinant interferon α 2a (yeast) injection is an effective and safe agent for treatment of herpes zoster. [