青鹏软膏治疗儿童局限性湿疹的多中心随机对照研究  

Qingpeng ointment for the treatment of localized eczema in Chinese children： a multicenter, randomized controlled study

作　　者：李妍[1] 徐薇[1] 杨宝琦[2] 田洪青[2] 段逸群[3] 王向东[3] 路雪艳[4] 叶珍珍[4] 鞠梅[5] 顾恒[5] 赵建平 陈星 王誉涵 刘玲玲[7] 李邻峰[1] 

机构地区：[1]首都医科大学附属北京友谊医院皮肤性病科,北京100050 [2]山东省皮肤病医院皮肤科 [3]武汉市第一医院皮肤科 [4]北京大学第三医院皮肤科 [5]中国医学科学院北京协和医学院皮肤病医院理疗科 [6]武警浙江总队嘉兴医院皮肤科 [7]北京大学第一医院皮肤科

出　　处：《中华皮肤科杂志》2017年第6期412-416,共5页Chinese Journal of Dermatology

基　　金：中国中西医结合学会-皮肤病研究基金

摘　　要：目的评价青鹏软膏治疗儿童局限性湿疹的有效性和安全性。方法采用多中心、随机开放、0．03％他克莫司软膏对照的临床研究，受试患儿每日2次外用青鹏软膏或0．03％他克莫司软膏，疗程2周，于治疗前、治疗1、2周随访，进行疗效和安全性评价。结果共426例患儿纳入疗效分析。治疗1、2周，青鹏组和他克莫司组有效率比较，差异均无统计学意义（1周：78．92％比81．77％，r=0．545，P=0．460；2N：98．65％比97．54％，x^2=0．721，P=0．396）；但治疗1、2周时，青鹏组瘙痒评分均显著低于他克莫司组（1周：F=14．001，P=0．000；2周：F=11．252，P=0．001）。治疗1周时，青鹏组药物相关性不良反应发生率明显低于他克莫司组（P〈0．05）。主要表现为轻度瘙痒、灼热感等局部刺激反应。结论青鹏软膏治疗儿童局限性湿疹安全、有效，耐受性较好。Objective To evaluate the efficacy and safety of Qingpeng ointment for the treatment of localized eczema in children. Methods A multicenter, randomized, open-labeled, tacrolimus 0.03% ointment-controlled clinical trial was conducted. A total of 442 children with localized eczema were enrolled into this study, and divided into 2 groups to topically apply Qingpeng ointment （Qingpeng group） and tacrolimus 0.03% ointment （tacrolimus group） respectively twice a day for 2 weeks. The children were followed up before the treatment and 1, 2 weeks after the treatment, and the efficacy and safety were evaluated at the same time. Results Clinical data from 426 children were included in the efficacy analysis. At 1, 2 weeks after the treatment, there were no significant differences in the response rate between the Qingpeng group and tacrolimus group （1 week after the treatment： 78.92% vs. 81.77%, x^2 = 0.545, P = 0.460; 2 weeks after the treatment： 98.65% vs. 97.54%, x^2 = 0.721, P = 0.396）. However, the pruritus scores at 1, 2 weeks after the treatment were both significantly lower in the Qingpeng group than in the tacrolimus group （ 1 week： F = 14.001, P = 0.000; 2 weeks： F = 11.252, P = 0.001）. At 1 week after the treatment, the incidence rate of adverse reactions was significantly lower in the Qingpeng group than in the tacrolimus group （P 〈 0.05）. Mild itching, burning sensation and other local irritant sensations were the most common adverse reactions. Conclusion Qingpeng ointment is safe and effective for the treatment of localized eczema in children with good tolerability.

关 键 词：湿疹 儿童 随机对照试验 多中心研究 青鹏软膏 

分 类 号：R29[医药卫生—民族医学]