中华皮肤科杂志

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5%咪喹莫特乳膏治疗外生殖器/肛周疣随机对照研究

王爱平1, 顾军2, 郭在培3, 苏晓红4, 周华5, 曾凡钦6, 涂亚庭7, 朱学骏1   

  1. 1. 北京大学第一医院皮肤性病科, 北京100034;
    2. 第二军医大学附属长海医院皮肤性病科;
    3. 四川大学华西医院皮肤性病科;
    4. 中国医学科学院、中国协和医科大学皮肤病研究所;
    5. 深圳市慢性病防治院皮肤病性病研究所;
    6. 中山大学附属第二医院皮肤性病科;
    7. 华中科技大学同济医学院附属协和医院皮肤性病科
  • 收稿日期:2006-04-18 出版日期:2007-05-15 发布日期:2007-05-15
  • 通讯作者: 朱学骏,email:zhuxj@public.bta.net.cn E-mail:zhuxj@public.bta.net.cn

Imiquimod 5% cream for the treatment of external anogenital warts:a randomised controlled study

WANG Ai-ping1, GU Jun2, GUO Zai-pei3, SU Xiao-hong4, ZHOU Hua5, ZENG Fan-qin6, TU Ya-ting7, ZHU Xue-jun1   

  1. Department of Dermatology, Peking University First Hospital, Beijing 100034, China
  • Received:2006-04-18 Online:2007-05-15 Published:2007-05-15

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摘要： 目的 评价5%咪喹莫特乳膏(艾达乐)治疗外生殖器/肛周疣的有效性和安全性。方法 采用随机、双盲、平行对照、七个中心临床研究。患者随机入组,一组患者先接受咪喹莫特治疗16周或至所有基线疣消失,然后给予赋形剂4周。另一组患者先接受赋形剂治疗4周,然后再接受咪喹莫特治疗16周或至所有基线疣消失。每周外用乳膏3次(晚上应用,至少保留8 h),每4周评估一次临床疗效。结果 共144例患者入选。在研究结束时(20周),综合两个治疗组合并显示,基线疣计数减少≥50%的患者为75.0%(意向性治疗分析,ITT)和83.5%(符合方案完成试验集分析,PP),疣完全清除率分别为79.9%(ITT分析)和89.8%(PP分析)。在第4周时,咪喹莫特组基线疣计数减少≥50%的患者为48.6%,赋形剂组为19.4%,P=0.0004;咪喹莫特组疣完全清除率为22.2%,赋形剂组为6.9%,P=0.009。最常见的不良事件发生是用药部位的皮肤反应(38.9%),无严重不良事件发生。结论 咪喹莫特乳膏治疗外生殖器/肛周疣疗效明显优于赋形剂,每周3次,疗程16周,安全有效,使用方便。

关键词: 疣, 生殖器, 咪喹莫特, 随机对照试验

Abstract: Objective To evaluate the efficacy and safety of imiquimod 5% cream(Aldara)in the treatment of external anogenital warts.Methods A seven-centre,randomized,double-blinded,paral-lel-controlled study was conducted.Patients were randomly assigned either to imiquimod group,beginning with imiquimod treatment for 16 weeks followed by 4 weeks of vehicle control,or to vehicle control group, treated initially with vehicle for 4 weeks followed by 16 weeks of imiquimod.Imiquimod was applied at night 3 times a week,with a minimum retention period of 8 hours for every time.All patients were clinically evaluated every 4 weeks.Patients could stop treatment at any time if there was complete resolution of base-line warts during the 20-week treatment period.The primary outcome measure was partial clearance(defined as a reduction of≥50% of baseline wart count)rate.Secondary outcome measure included complete clear-ance(defined as a complete elimination of baseline warts)rate and reduction rate of baseline wart count or size.Results A total of 144 patients were enrolled in this study.At the end of the study,the partial clear-ance rate was 75.0%(108/144)in intension to treat(ITT)population,and 83.5%(106/127)in per protocol(PP)population.The complete clearance rate was 79.9%(115/144)and 89.8%(114/127)in ITT and PP population,respectively.At 4 weeks,significant difference was found between the imiquimod and vehicle groups in the partial clearance rates[48.6%(35/72)vs 19.4%(14/72),P=0.0004]and complete clearance rates[22.2%(16/72)vs 6.9%(5/72),P=0.009].The most common adverse event was application site reactions,which were generally mild to moderate.No severe side effects were observed. Conclusions The efficacy of imiquimod 5% cream is superior to that of vehicle in the treatment of exter-nal anogenital warts,and the 16-week treatment strategy,at a frequency of 3 times a week,is effective,safe, and convenient.

Key words: Warts, Genitalia, Imiquimod, Randomized controlled trials