5%咪喹莫特乳膏治疗尖锐湿疣的多中心随机双盲平行对照研究

Treatment of Condyloma Acuminatum with 5% Imiquimod Cream:A Multi-centre,Randomized,Double-blind,Parallel-controlled Clinical Trial

目的了解5%咪喹莫特乳膏治疗肛周和外生殖器尖锐湿疣的临床疗效和安全性。方法采用随机、双盲、平行对照临床研究方法,共入选尖锐湿疣患者237例,随机分为治疗组119例,给予5%咪喹莫特乳膏适量;对照组118例,给予2.5%氟尿嘧啶乳膏适量;均为每周3次外搽,疗程8周;疣体完全消退者继续随访8周以观察复发率。结果治疗组和对照组的痊愈率分别为66.4%,66.1%(P>0.05);有效率分别为85.7%,85.6%(P>0.05)。治疗组痊愈后复发6例,复发率5.0%;对照组痊愈后复发27例,复发率22.9%(P<0.05)。治疗组发生不良反应29例,发生率24.4%,对照组发生不良反应44例,发生率37.3%(P<0.05)。治疗组不良反应主要为给药部位的红斑和糜烂,无系统不良反应。结论5%咪喹莫特乳膏治疗尖锐湿疣疗效好,安全性好,使用方便。

Objective To survey the clinical therapeutic effectiveness and safeness of 5% imiquimod cream in the topical treatment of condyloma acuminatum at the perianal region and external genitalia. Methods A randomized, double blind, multi-centre, parallel-controlled clinical study was carried out. Two hundred thirty seven patients with anogenital eondyloma acuminatum enrolled into the trial were randomly divided into 2 groups ： the treatment group （ n = 119） and control group （n = 118）. Patients of the treatment group and control group were given each 5% imiquimod cream qs and 2.5% 5-fluorouracil cream qs, respectively, administered by topical smearing 3 times a week. The course of treatment in both groups lasted 8 weeks. Patients whose warts had been cleared up completely were followed up for 8 weeks for checking on recurrence rates. Results The cure rates were 66.4% in patients of the treatment group and 66.1% in those of the control group （ P 〉 0.05） ; the effective rates in patients of the treatment group and control group were 86.7% and 85.6%, respectively （ P 〉 0. 05）. 6 patients in the treatment group and 27 patients in the control group experienced recurrences of warts after complete recovery, the recurrence rates being 5.0% and 22.4% , respectively （ P 〈 0.05 ）. Adverse reactions were encountered in 29 patients （24.4% ） of the treatment group and 44 patients （37.3%） of the control group （ P 〈 0.05）. The major adverse reactions in patients of the treatment group included erythema and erosion in the topical areas where the drug was smeared, There were no systemic adverse reactions in patients of both groups. Conclusion 5% imiquimod cream was shown to be effective, safe and handy in the topical treatment of anogenital condyloma acuminatun,.