IL-8单克隆抗体乳膏治疗寻常型银屑病随机双盲对照临床试验

A Randomized, Placebo, Controlled, Double Blind Trial Study on IL-8 Monoclonal Antibody Cream in the Treatment of Psoriasis Vulgaris

目的：研究ＩＬ－８单抗乳膏外用治疗寻常型银屑病的疗效和安全性。方法：采用随机、双盲、安慰剂对照的方法，治疗时间６周。结果：本项临床试验共入选９６例，其中治疗组入选４８例，临床疗效评价病例４５例，安全性评价４６例，４５例中痊愈６例，显效１２例，进步１５例，无效１２例，痊愈率１３．３０，有效率４０％；对照组入选４８例，临床疗效评价病例４４例，安全性评价４６例，４４例中痊愈１例，显效６例，进步１７例，无效２０例，痊愈率２．３％，有效率１５．９％。两组疗效比较经统计学处理，有显著性差异（Ｐ＜０．０１）。治疗组和对照组药物不良反应分别为１０．８％（５／４６例），８．７％（４／４６例），主要是局部刺激，未见全身不良反应。结论：ＩＬ－８单抗乳膏外用治疗寻常型银屑病安全、有效。

OBJECTIVE: The purpose of this study was to evaluate the efficacy and safety of Anti IL-8 monoclonal antibody cream in the treatment of psoriasis vulgaris. METHODS: A randomized, placebo controlled, double blind trial was used to evaluate the efficacy and safety of psoriasis vulgaris. RESULTS: The trial was conducted for the treatment of 96 outpatients.48 patients were enrolled in treatment group, 45 patients were assessable for efficacy and 46 patients assessable for safety while 48 patients were enrolled in controlled group, 44 patients were assessable for efficacy and 46 patients assessable for safety. The results showed that cure 6, excellent 12, improvement 15, failure 12, and cure rate, efficacy rate was 13.3% -40% respectively for treatment group, whereas cure 1, excellent 6, improvement 17, failure 20, and cure rate, efficacy rate was 2.3%, 15.9% respectively for controlled group. The results showed that there was significant statistical difference (P<0.01).The incidence of adverse reaction of treatment and controlled group was 10.8%, 8.7% respectively, and most of them were local irritant reaction, no systemic reaction. CONCLUSION: Anti IL-8 is effective and safe in the treatment of psoriasis vulgaris.