咪喹莫特乳膏治疗尖锐湿疣随机、双盲、多中心研究

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、平行对照的临床研究方法,受试者每周3次外搽研究药物,疗程8周。疣体完全消退者继续随访1月以观察复发率。结果 共有258例肛周及外生殖器尖锐湿疣患者参加本次研究,其中5%咪喹莫特乳膏治疗组129例,安慰剂对照组129例。治疗后2、4、6、8周的痊愈率在治疗组分别为12.30%、32.79%、50%及60.66%,对照组分别为4.88%、14.63%、19.51%及26.02%,两组间差异有非常显著性(P<0.001);疗后2、4、6、8周的有效率在治疗组分别为36.89%、59.84%、68.03%及70.49%,对照组分别为13.82%、26.83%、32.52%及32.52%,两组间差异有非常显著性(P<0.001)。治疗组74例痊愈患者经随访1月后有4例复发,复发率为5.41%,与对照组相比差异无显著性。治疗组给药部位局部不良反应包括:红斑60.94%、水肿31.26%、糜烂42.96%、溃疡4.68%、灼热20.32%、疼痛36.72%、瘙痒17.18%。无系统不良反应。结论 5%咪喹莫特乳膏治疗肛周和外生殖器尖锐湿疣疗效好,安全性好,使用方便。

Treatment of Condyloma Acuminatum with Imiquimod Cream: A Randomized, Double-blind, Placebo-controlled, Multi-central Clinical Trial

Objective To observe the clinical efficacy and safety of5%imiquimod cream in the top-ical treatment of condyloma acuminatum(CA).Methods A randomized,double-blind,parallel placebo-controlled clinical study was conducted.The test drug was topically used in CA patients,three times a week for8weeks.Patients whose warts cleared completely were followed up for one month to determine recurrence rates.Results Two hundred fifty-eight patients with anogenital warts were enrolled into this trial.One hun-dred twenty-nine patients were randomly selected to receive5%imiquimod cream;129patients were ran-domly chosen to receive placebo cream.Results showed that the cure rates were12.30%,32.79%,50%,60.66%respectively in study group for2,4,6,8weeks and were4.88%,14.63%,19.51%,26.02%respec-tively in control group for2,4,6,8weeks(P<0.001).The response rates were36.89%,59.84%,68.03%,70.49%respectively in study group for2,4,6,8weeks and13.82%,26.83%,32.52%,32.52%respec-tively in control group for2,4,6,8weeks(P<0.001).Of imiquimod-treated patients whose warts cleared completely and who finished one month follow-up period,5.41%(4of74)experienced recurrences of warts.Side effect included erythema(60.94%),edema(31.26%),erosion(42.96%),ulceration(4.68%),burning(20.32%),pain(36.72%),itching(17.18%).There was no systemic side effect in two groups.Conclusion5%Imiquimod cream in the topical treatment of anogenital warts is effective,safe and convenient.