5%咪喹莫特乳膏治疗尖锐湿疣的临床研究

Evaluation of Topical 5% Imiquimod Cream on the Treatment of Condylomata Acuminata

目的探讨5%咪喹莫特乳膏治疗尖锐湿疣的有效性和安全性。方法采用多中心、随机、双盲、安慰剂平行对照法对236例尖锐湿疣患者进行了8周的临床研究。结果有116例治疗组患者和120例对照组患者完成临床观察并纳入统计分析。两组治疗后2周、6周及治疗后8周在疗效评价方面有显著差异(P<0.05),不良反应主要是轻至中度的红斑、水肿、糜烂、刺痛及瘙痒。结论5%咪喹莫特乳膏是一种治疗外生殖器疣有效而安全的新药。

Objective To evaluate the efficacy and safety of topical 5% imiquimod cream in the treatment of condylomata acuminate. Methods A double-blind,controlled study in which patients with condylomata acuminate were randomized to 8 weeks of treatment with 5% imiquimod cream or the cream base. Results 116 patients were randomized to topical 5% imiquimod cream and 120 patients to placebo. Significant difference of efficacy between the two groups were observed after weeks of 2,6 and 8 （P 〈 0.05）. The most common adverse effects were slight or moderate erythema, edema, erosion and itching. Conclusion Topical 5% imiquimod cream is effective and safe therapy for extra - genital warts.