5%咪喹莫特乳膏治疗尖锐湿疣多中心、随机、双盲研究  

Treatment of Condyloma Acuminata with 5% Imiquimod Cream: A Randomized Double-Blind, Placebo-Controlled, Multi-Center Clinical Tria

作　　者：陈昆[1] 郭在培[2] 毕志刚[3] 林宝珠[4] 陈兴平[5] 常宝珠[1] 张谊之[2] 张美华[3] 曾凡钦[4] 江文[5] 顾恒[1] 

机构地区：[1]中国医学科学院,中国协和医科大学皮肤病研究所,南京210042 [2]四川大学华西医院 [3]南京医科大学第一附属医院 [4]中山大学第二附属医院 [5]华中科技大学同济医院

出　　处：《中华皮肤科杂志》2005年第5期268-270,共3页Chinese Journal of Dermatology

摘　　要：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￣8h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。Objective To observe the clinical efficacy and safety of 5% imiquimod cream in topical treatment of anogenital warts. Methods A randomized, double-blind, parallel placebo-controlled clinical study was conducted. Patients with anogenital warts were instructed to apply the test drug topically and then clean the drug with water 6 ~ 8 hours later, three times a week for 8 weeks. Patients whose warts cleared completely were followed up for one month to determine recurrence rates. Results Two hundred and thirty-one patients with anogenital warts were enrolled in this trial. One hundred and sixteen patients were randomly selected to receive 5% imiquimod cream; and the other receive placebo cream. For 2, 4, 6, 8 weeks, the cure rates were 8.41%, 30.84%, 49.53%, 61.68%, respectively in the study group, and 2.68%, 7.14%, 16.07%, 24.11%, respectively in the control group (P < 0.001); the effective rates were 34.58%, 60.75%, 68.22%, 74.77% respectively in the study group, and 10.72%, 18.75%, 28.57%, 32.14% respectively in the control group (P < 0.001). Of the imiquimod-treated patients 10.61% experienced recurrences of warts in a follow-up period of one month. There was no difference of recurrent rates between the two groups. There was no systemic but topical side effects in the study group. The topical side effects mainly included mild to moderate erythema(34.55%). Conclusion 5% imiquimod cream can be used in topical treatment of anogenital warts effectively, safely and conveniently.

关 键 词：5%咪喹莫特 乳膏治疗 双盲研究 外生殖器尖锐湿疣 随机 多中心 临床研究方法 咪喹莫特乳膏 局部不良反应 治疗组 统计学 临床疗效 平行对照 局部外搽 给药部位 安全性 复发率 对照组 组间差 组分 肛周 受试者 用药后 安慰剂 

分 类 号：R752.53[医药卫生—皮肤病学与性病学]