克疣毒软膏和安慰剂治疗尖锐湿疣(湿毒聚结证)的随机双盲对照临床试验

目的评价克疣毒软膏对尖锐湿疣(CA)湿毒聚结证型的复发率及脱疣的疗效和安全性。方法采用随机、双盲、平行对照、多中心临床试验。全分析集(FAS)共454例,克疣毒软膏组(试验组)340例,安慰剂组(对照组)114例;符合方案集(PPS)429例,试验组323例,对照组106例。软膏外涂覆盖疣体,3次/d,疗程3周,随访3月。CA复发率、脱疣疗效作为有效性指标,实验室指标、不良事件作为安全性指标。结果FAS分析:试验组和对照组的复发率为17.65%,59.65%,两组脱疣的有效率为20.00%,2.63%。PPS分析:试验组和对照组复发率分别为18.58%,64.15%,两组脱疣的有效率为20.74%,2.83%。试验组复发率、脱疣疗效均优于对照组(P<0.01)。两组不良事件发生率分别为5.65%和6.67%,差异无显著性(P=0.7871)。结论克疣毒软膏治疗CA复发率低,临床用药安全。

Randomized, Double-blind Controlled Clinical Trial of Keyoudu Ointment vs Placebo in Treatment of Condyloma Acuminatum with Syndrome of Damp-toxin Accumulation

Objective To evaluate the efficacy and safety of relapse rate and anti-wart of Keyoudu Ointment in treatment of condyloma acuminatum (CA) with syndrome of damp-toxin accumulation.Methods A randomized,double-blind,parallel controlled,multi-center clinical study was conducted.All 454 cases of Full Analysis Set(FAS) were divided 340 cases into Keyoudu Ointment group(trial group)and 114 cases into placebo group(control group).All 429 cases of Per Protocol Set(PPS) were divided 323 cases and 106 cases into two groups respectively.The wart was coated with ointment 3 times a day for one treatment courses(3 weeks) and follow-up observation(3 months).The effective indexs were relapse rate and anti-wart efficacy of CA,but the safety indexs were laboratory indexs and adverse reactions. Results FAS analysis:The relapse rate of CA(17.65% vs 59.65%)and total markedly effective rate of anti-wart(20.00% vs 2.63%)in trial group were superior to those in control group(P<0.05)respectively.PPS analysis:The relapse rate of CA(18.58% vs 64.15%) and total markedly effective rate of anti-wart(20.74% vs 2.83%) in trial group were superior to those in control group(P<0.05).The incidence of adverse events showed no statistical differences between two groups(5.56% vs 6.58%,P=0.7871).Conclusion Keyoudu Ointment has a lower relapse rate and is security in clinical practice.