口服屈螺酮炔雌醇片治疗女性中度寻常痤疮的多中心、随机、安慰剂对照临床研究

An oral contraceptive containing ethinyl estradiol and drospirenone for the treatment of women with moderate acne vulgaris： a randomized, multicenter, placebo-controlled clinical trial

目的 评估口服避孕制剂屈螺酮炔雌醇片（YAZ）治疗女性中度寻常痤疮的疗效和安全性.方法 采用多中心、随机、双盲、安慰剂对照研究.入选患者按照随机数字表分为YAZ组和安慰剂组,分别口服YAZ和安慰剂.两组患者在月经的第1天服药,每日1片,连续服用24 d,后服用4d无活性药片,28 d为1个周期,共治疗6个周期.分别于治疗第1、3、6周期及治疗结束后8～15d,对丘疹、脓疱、结节、开放性粉刺和闭合性粉刺进行计数,评估疗效和安全性.结果 7个中心179例女性中度寻常痤疮患者入组,173例入选全分析集,146例完成治疗研究,143例入选符合方案集.治疗6个周期后,全分析集YAZ组和安慰剂组皮损总数平均减少66.8％和37.7％;符合方案集YAZ组和安慰剂组皮损总数平均减少72.6％和55.6％.YAZ组和安慰剂组在第6周期的炎性皮损数与基线期相比分别减少75.5％和60.9％,非炎性皮损数分别减少69.3％和50.2％.在YAZ组中,研究者评定：改善患者比例93.7％（74/79）,安慰剂组78.1％（57/73）.本研究中未出现严重的不良事件.治疗期间YAZ组不良反应发生率为25.3％（22/87）,安慰剂组为4.7％（4/86）.结论 YAZ治疗女性中度寻常痤疮有效且安全.临床试验注册ClinicalTrials.gov Identifier：NCT00818519.

Objective To evaluate the efficacy and safety of an oral contraceptive containing ethinyl estradiol and drospirenone （YAZ） in the treatment of women with moderate ache vulgaris.Methods A multicenter,randomized,double-blind,placebo-controlled clinical trial was conducted.Totally,179 female patients with moderate acne vulgaris were enrolled into this study from 7 research institutions in China,and randomly divided into YAZ group and placebo group by a random number table to be treated by oral YAZ and placebo respectively.In one cycle of treatment,patients administrated YAZ or placebo （one tablet once daily） from the 1st to 24th day of the menstrual cycle followed by a 4-day treatment with inactive tablets.All the patients received six cycles of treatment without a treatmentfree interval.Efficacy and safety were evaluated according to the number of papules,pustules,nodules,open and closed comedones after 1,3 and 6 cycels of treatment and within 8-15 days after the end of treatment.Results Finally,173 patients were eligible for the full analysis set （FAS）,146 completed the study,and 143 were eligible for the per protocol set （PPS）.After 6 cycles of treatment,the total number of lesions was meanly reduced by 66.8% and 37.3% in the YAZ group and placebo group respectively in the FAS,72.6% and 55.6% respectively in the PPS.The number of inflammatory and noninflammatory lesions decreased by 75.5% and 69.3% in the YAZ group respectively after 6 cycles of treatment when compared to baseline,and by 60.9% and 50.2% in the placebo group respectively.The proportion of subjects rated as ＆quot;improved＆quot; by investigators was 93.7% （74/79） in the YAZ group and 78.1% （57/73） in the placebo group.There were no serious adverse events in this study.The incidence rate of adverse reactions was 25.3% （22/87） in the YAZ group,and 4.7% （4/86） in the placebo group.Conclusion Six cycles of treatment with oral YAZ are effective and safe for female patients with moderate acne vulgaris.Trial registration nunber ClinicalTrials.gov Ref.No：NCT00818519.