每天使用3.75%咪喹莫特乳膏治疗肛门生殖器疣：两项随机、安慰剂对照研究中女性患者的综合结果。
Imiquimod 3.75% cream applied daily to treat anogenital warts: combined results from women in two randomized, placebo-controlled studies.
作者信息
Baker David A, Ferris Daron G, Martens Mark G, Fife Kenneth H, Tyring Stephen K, Edwards Libby, Nelson Anita, Ault Kevin, Trofatter Kenneth F, Liu Tiepu, Levy Sharon, Wu Jason
机构信息
Division of Infectious Disease, Department of Obstetrics, Gynecology & Reproductive Medicine, Stony Brook Health Science Center, Stony Brook University Medical Center, Stony Brook, NY 11794-8091, USA.
出版信息
Infect Dis Obstet Gynecol. 2011;2011:806105. doi: 10.1155/2011/806105. Epub 2011 Aug 24.
OBJECTIVE
To evaluate if new imiquimod formulations using a shorter treatment duration are safe and efficacious to treat anogenital warts.
METHODS
In two studies 534 women ≥12 years of age (mean 33.4) with 2-30 warts (mean 7.9) and total wart area ≥10 mm(2) (mean 166.3) were randomized (1:2:2) to placebo (106), imiquimod 2.5% (212) or 3.75% (216) creams applied once daily until complete clearance or a maximum of 8 weeks.
RESULTS
For placebo, imiquimod 2.5% and 3.75%, respectively, complete clearance of all warts was achieved in 14.2%, 28.3%, and 36.6% of women (intent-to-treat, P = 0.008 imiquimod 2.5%, and P < 0.001 3.75% versus placebo). Mean changes in wart counts were -10.7%, -50.9%, and -63.5% (per-protocol, P < 0.001 each active versus placebo) and safety-related discontinuation rates 0.9%, 1.4%, and 2.3%.
CONCLUSIONS
Imiquimod 3.75% applied daily for up to 8 weeks was well tolerated and superior to placebo in treating women with external anogenital warts.
目的
评估使用较短治疗疗程的新型咪喹莫特制剂治疗肛门生殖器疣是否安全有效。
方法
在两项研究中，534名年龄≥12岁（平均33.4岁）、有2 - 30个疣体（平均7.9个）且疣体总面积≥10平方毫米（平均166.3平方毫米）的女性被随机分组（1:2:2），分别接受安慰剂（106人）、2.5%咪喹莫特（212人）或3.75%咪喹莫特（216人）乳膏治疗，每日涂抹一次，直至疣体完全清除或最长治疗8周。
结果
安慰剂组、2.5%咪喹莫特组和3.75%咪喹莫特组中，疣体完全清除的女性比例分别为14.2%、28.3%和36.6%（意向性分析，2.5%咪喹莫特组P = 0.008，3.75%咪喹莫特组与安慰剂组相比P < 0.001）。疣体数量的平均变化分别为-10.7%、-50.9%和-63.5%（符合方案分析，各活性药物组与安慰剂组相比P均< 0.001），与安全性相关的停药率分别为0.9%、1.4%和2.3%。
结论
每日应用3.75%咪喹莫特治疗长达8周，耐受性良好，在治疗女性外生殖器疣方面优于安慰剂。
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