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目的评价5%咪喹莫特乳膏治疗尖锐湿疣的疗效和安全性,并与2.5%5-氟脲嘧啶乳膏进行对照。方法对尖锐湿疣患者进行多中心、随机双盲、平行对照的临床试验研究。5%咪喹莫特乳膏试验组和2.5%5-氟脲嘧啶乳膏对照组均每周外用药物3次,共治疗8周。结果本研究共244例患者完成全部观察,其中,咪喹莫特组125例,5-氟脲嘧啶组119例。咪喹莫特组治疗后2、4、6、8周的痊愈率分别为52.00%、74.40%、81.60%、92.80%、有效率分别为79.20%、93.60%、97.60%、97.60%.5-氟脲嘧啶组治疗后2、4、6、8周的痊愈率分别为52.10%、70.59%,78.15%、89.92%、有效率分别为84.03%、94.12%、94.96%、97.48%。两组差异均无统计学意义(P>0.05)。不良事件主要为局部不良反应,如局部红斑、疼痛、糜烂,瘙痒等,未见系统性不良反应。结论5%咪喹莫特乳膏治疗尖锐湿疣疗效确切,使用方法简便,耐受性较好。
Objective To evaluate the efficacy and safety of 5% imiquimod cream in the treatment of condyloma acuminatum and to compare with 2.5% 5-fluorouracil cream. Methods A multicenter, randomized, double-blind, parallel-controlled clinical trial of patients with condyloma acuminatum was performed. 5% imiquimod cream test group and 2.5% 5-fluorouracil cream control group were treated with drugs 3 times a week for a total of 8 weeks. Results A total of 244 patients completed all the observations in this study, including 125 in the imiquimod group and 119 in the 5-fluorouracil group. The recovery rates of imiquimod group were 52.00%, 74.40%, 81.60% and 92.80% at 2, 4, 6 and 8 weeks after treatment, respectively, and the effective rates were 79.20%, 93.60%, 97.60% and 97.60% Fluorouracil group 2,4,8,8 weeks after treatment, the cure rates were 52.10%, 70.59%, 78.15%, 89.92%, the effective rates were 84.03%, 94.12%, 94.96%, 97.48%. There was no significant difference between the two groups (P> 0.05). Adverse events mainly local adverse reactions, such as local erythema, pain, erosion, itching, etc., no systemic adverse reactions. Conclusion 5% imiquimod cream for the treatment of condyloma acuminate curative effect is exact, the method of use is simple and well tolerated.