咪喹莫特乳膏治疗尖锐湿疣的随机双盲平行对照临床研究  

Imiquimod cream in treatment of condylomata acuminata:randomized,double-blind controlled clinical trial

作　　者：万苗坚[1] 赖维[1] 黄怀球[1] 陆春[1] 苏向阳[1] 吕瑛[1] 朱国兴[1] 

机构地区：[1]中山大学附属第三医院皮肤科,广东广州510630

出　　处：《中国新药与临床杂志》2004年第9期589-591,共3页Chinese Journal of New Drugs and Clinical Remedies

摘　　要：目的 :评价 5 %咪喹莫特乳膏治疗尖锐湿疣的疗效和安全性。方法 :随机双盲、平行对照临床试验 ,A组和B组各 30例。A组每周外用 5 %咪喹莫特乳膏 ,B组每周用 2 .5 %氟尿嘧啶软膏均 3次 ,共 8wk。对皮损消退者再随访 12wk ,观察其复发情况。结果 :治疗后 8wk ,A组和B组有效率分别为 10 0 %和 93% ,痊愈率均为 93%。 2组间疗效比较差异无统计学意义 (P >0 .0 5 )。A组的复发率为 2 1% ,B组为 39% ,2组间差异有显著意义 (P <0 .0 5 )。 2组不良反应均为局部轻度一过性红斑、灼热等 ,发生率均为 37%。结论 :5 %咪喹莫特乳膏治疗尖锐湿疣疗效确切、不良反应轻和复发率低。AIM: To evaluate the efficacy and safety of 5 % imiquimod cream in the treatment of external condylomata acuminata. METHODS: A randomized, double-blind and controlled clinical trial was employed.5 % imiquimod cream and 2.5 % fluorouracil cream was applied to all external warts three times weekly for 8 wk. Patients who experienced total clearance of the disease were evaluated and followed up for recurrence to 12 wk.RESULTS:Thirty patients with condyloma cuminatum were enrolled in the group A and other 30 patients for the group B. After 8 wk treatment, the number and area of the warts were significantly reduced by compariny with the baseline in both groups(P<0.05), and the total efficacy rates was 100 % in the group A and 93 % in the group B. The cure rate was 93 % in each of the two groups. There was no significant difference in efficacy and cure rate between the two groups(P> 0.05). The recurrence rates in the group A and group B were 21 % and 39 % respectively, with statistically significant difference for the two groups (P<0.05). Local slight adverse reaction rate was 37 % in each of the groups including transient erythma and burn feeling. CONCLUSION:5 % imiquimod cream is an effective, safety preparation for treatment of condyloma acuminatum with relative low recurrence rate.

关 键 词：尖锐湿疣 随机对照试验 双盲法 咪喹莫特 

分 类 号：R986[医药卫生—药品] R752.53[医药卫生—药学]