重组人α-2a干扰素(酵母)局部注射治疗尖锐湿疣多中心随机双盲对照临床试验

Efficacy of Interferon α-2a(yeast) in the Treatment of Condyloma Acuminatu

目的：研究重组α－２ａ干扰素（酵母）局部注射治疗尖锐湿疣的疗效及安全性。方法：以α－２ａ干扰素（大肠杆菌）作对照，进行了随机、双盲、多中心、对照平行试验。试验组用２％利多卡因１ｍｌ溶解α－２ａ干扰素 １００万 Ｕ，于患者皮损基底部皮内注射，每次１００万Ｕ，每周３次，连续３周，共９次；对照组用同类药α－２ａ干扰素，使用方法与试验组相同。其中试验组入组１１２例，失访１例，可评价病例１１１例，对照组入组１１１例，失访２例，因不符合标准淘汰２例，可评价病例１０７例。结果：试验组１１１例，其中痊愈３８例，显效３３例，进步 ２９例，无效 １１例，痊愈率 ３４．２３％，总有效率 ６３．９６％；对照组 １０７例，其中痊愈２５例，显效３２例，进步３２例，无效１８例，痊愈率２３．３６％，总有效率５３．２７％。两组疗效比较，统计学处理无显著性差异。两组药物不良反应发生率经统计学处理，Ｐ＞０．０５，无显著性差异。结论：提示α－２ａ干扰素（酵母）治疗尖锐湿疣疗效与对照药α－２ａ干扰素（大肠杆菌）相似。

OBJECTIVE: In order to study efficacy and safety of interferon α-2a (yeast) in the treatment of condyloma acuminata. METHODS: A randomized, controlled, multicenter clinical trial was conducted for the treatment 218 outpatients with condyloma acuminata. Interferonα-2a(Escherichia coli) as control group. The dosage of both drugs was 100 × 106 U every other day by local injection. The duration of treatment was three weeks in both groups,total 900×106U. In the randomized controlled study, 112 patients were enrolled in interferon α-2a(yeast) groups, 112 patients were assessed for safety and efficacy while 111 patients were enrolled in control group, 107 patients were assessed for safety and efficacy in controlled group. RESULTS:The results showed that the overall efficacy rates were 63.96% for treatment group and 53.27% for controlled group. The results showed that there was no statistical difference between two groups. The incidence of adverse reaction was 14.4% and 14.0% respectively .The results showed there was no statistical difference between two groups. CONCLUSION: Efficacy and safety of interferon α-2a(yeast) in the treatment of condyloma acuminata were the same with interferon α-2a (Escherichia colt)in the treatment of condyloma acuminata.