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Treatment of Condyloma Acuminata with 5% Imiquimod Cream: A Randomized Double-Blind, Placebo-Controlled, Multi-Center Clinical Trial
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- Author:
- No author available
- Journal Title:
- CHINESE JOURNAL OF DERMATOLOGY
- Issue:
- 5
- DOI:
- 10.3760/j.issn:0412-4030.2005.05.004
- Key Word:
- 尖锐湿疣;咪喹莫特;随机对照试验
Abstract： 目的观察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次局部外搽研究药物,用药后6～8 h用清水清洗,疗程8周.疣体完全消退者继续随访1个月以观察复发率.结果共有231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116例,安慰剂对照组115例.治疗后2、4、6、8周的痊愈率在治疗组分别为8.41%、30.84%、49.53%及61.68%,对照组分别为2.68%、7.14%、16.07%及24.11%,两组间差异有统计学意义(P＜0.001);疗后2、4、6、8周的有效率在治疗组分别为34.58%、60.75%、68.22%及74.77%,对照组分别为10.72%、18.75%、28.57%及32.14%,两组间差异有统计学意义(P＜0.001).治疗组痊愈患者随访1个月后的复发率为10.61%,与对照组相比差异无统计学意义.治疗组无系统不良反应,仅有给药部位的局部不良反应,以轻度和中度红斑为多见,发生率为34.55%.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.
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