复方维A酸凝胶治疗寻常痤疮疗效和安全性评价

Evaluation of efficacy and safety of compound tretinoin gel in treatment of acne vulgaris

目的评价复方维A酸凝胶治疗寻常痤疮的疗效和安全性。方法采用多中心、随机双盲、平行对照临床试验,并与0.025%维A酸乳膏进行对照,每晚外用药物1次,疗程8周,治疗前及治疗后每2周分别对丘疹、脓疱和粉刺计数,进行疗效判断。结果进入临床研究240例,可进行疗效和安全性评价236例。对炎性损害(丘疹和脓疱)试验组在2周时的有效率为18.6%,4周时为41.5%,6周时为64.4%,8周时为82.2%;对照组分别为21.2%、44.9%、69.5%和79.7%,两组比较差异均无统计学意义。对非炎性损害(白头和黑头粉刺)试验组分别为5.3%、19.5%、43.4%和59.3%;对照组分别5.5%、24.6%、50.9%和66.4%,两组比较差异均无统计学意义。用药后局部皮肤反应发生率试验组为64.1%,对照组为32.2%,其中试验组有1例患者发生中重度反应(0.9%),因此而停药,两组比较差异具有统计学意义。结论复方维A酸凝胶治疗寻常痤疮与0.025%维A酸乳膏疗效相似,但局部皮肤不良反应高于后者。

Objective Evaluation of efficacy and safety of compound tretinoin gel in the treatment of acne vulgaris. Methods A randomized,double-blind,parallel study was conducted,tretinoin 0.025% cream as a control,applied once per night for 8 weeks. Efficacy was determined by counting the acne lesions (papules,pustules and comedones) before drug administration and every second week during the treatment period. Results Of 240 recruited patients,236 were appraisable for efficacy and safety. For inflammatory lesion (papules and pustules),the clinical response rates was 18.6% in the trial group and 21.2% in the control group at 2 weeks,41.5% versus 44.9% at 4 weeks respectively,64.4% versus 69.5% at 6 weeks respectively,82.2% versus 79.7% at 8 weeks respectively,and no statistical difference was observed between the two groups. For noninflammatory lesion(comedones),the clinical response rates was 5.3% in the trial group and 5.5% in the control group at 2 weeks,19.5% versus 24.6% at 4 weeks respectively,43.4% versus 50.9% at 6 weeks respectively,59.3% versus 66.4% at 8 weeks respectively,and no statistical difference was observed between the two groups. Transient and mild location skin irritation (erythema,burning,pruritus,scaling and dryness of the skin)occurred,but was well tolerated by the patients,the reaction rate of the trial group(64.1%) was higher significantly than the control group (32.2%,P=0.000). One patient in the trial group experienced moderately severe adverse event (0.9%),stopped using the drugs. Conclusion Compound tretinoin gel was as effective and safety as tretinoin 0.025% cream in acne vulgaris.