中华皮肤科杂志 ›› 2025, Vol. 58 ›› Issue (5): 425-430.doi: 10.35541/cjd.20240453

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多中心随机对照临床试验观察2%克立硼罗软膏与1%吡美莫司乳膏治疗儿童轻中度特应性皮炎的疗效和安全性

肖星1    王珊2    杨欢3    舒虹4    郭艳萍5    陈谨萍6    路遥7    李钦峰8    梁源2    赵牧童2    罗晓燕3    缪丽敏4    徐锐5    李雪梅6    赖沙7    李建红1    罗珍1    喻泸1    邢璐4    王美潭5    黎晓丽6    徐海涛7    李萍1    王华3    马琳2    

  1. 1深圳市儿童医院皮肤科，深圳  518038；2首都医科大学附属北京儿童医院皮肤科，北京  100045；3重庆医科大学附属儿童医院皮肤科，重庆  400014；4昆明市儿童医院皮肤科，昆明  650000；5哈尔滨市儿童医院皮肤科，哈尔滨  150010；6广州市妇女儿童医疗中心皮肤科，广州  510623；7成都市妇女儿童中心医院皮肤科，成都  610073；8天津市儿童医院皮肤科，天津  300074
    肖星、王珊、杨欢对本文有同等贡献

  • 收稿日期:2024-08-22 修回日期:2025-01-05 发布日期:2025-04-30
  • 通讯作者: 李萍；王华；马琳 E-mail:liping20081110@126.com; huawang@hospital.cqmu.edu.cn; bch_maleen@aliyun.com

Comparison of efficacy and safety of crisaborole ointment 2% versus pimecrolimus cream 1% in the treatment of mild to moderate atopic dermatitis in children: a multicenter, randomized, controlled clinical trial

Xiao Xing1, Wang Shan2, Yang Huan3, Shu Hong4, Guo Yanping5, Chen Jinping6, Lu Yao7, Li Qinfeng8, Liang Yuan2, Zhao Mutong2, Luo Xiaoyan3, Miao Limin4, Xu Rui5, Li Xuemei6, Lai Sha7, Li Jianhong1, Luo Zhen1, Yu Lu1, Xing Lu4, Wang Meitan5, Li Xiaoli6, Xu Haitao7, Li Ping1, Wang Hua3, Ma Lin2   

  1. 1Department of Dermatology, Shenzhen Children′s Hospital, Shenzhen 518038, China; 2Department of Dermatology, Beijing Children′s Hospital, Capital Medical University, Beijing 100045, China; 3Department of Dermatology, Children′s Hospital of Chongqing Medical University, Chongqing 400014, China; 4Department of Dermatology, Kunming Children′s Hospital, Kunming 650000, China; 5Department of Dermatology, Harbin Children′s Hospital, Harbin 150010, China; 6Department of Dermatology, Guangzhou Women and Children′s Medical Center, Guangzhou 510623, China; 7Department of Dermatology, Chengdu Women′s and Children′s Central Hospital, Chengdu 610073, China; 8Department of Dermatology, Tianjin Children′s Hospital, Tianjin 300074, China
    Xiao Xing, Wang Shan and Yang Huan contributed equally to this article
  • Received:2024-08-22 Revised:2025-01-05 Published:2025-04-30
  • Contact: Li Ping; Wang Hua; Ma Lin E-mail:liping20081110@126.com; huawang@hospital.cqmu.edu.cn; bch_maleen@aliyun.com

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摘要： 【摘要】 目的 比较2%克立硼罗软膏与1%吡美莫司乳膏治疗 ≥ 2岁儿童轻中度特应性皮炎的疗效和安全性。方法 采用多中心随机、开放、对照临床试验方法，纳入全国8家医院皮肤科门诊2022年3月至2023年2月期间2 ~ 17岁轻中度特应性皮炎患儿120例，按1∶1比例随机分配至克立硼罗软膏组和吡美莫司乳膏组，分别外用2%克立硼罗软膏与1%吡美莫司乳膏，每日2次，疗程4周，在基线/第1天、第8、15、29天时各访视1次。主要疗效指标为第29天时达到研究者静态整体评估（ISGA）成功的患者百分比，次要疗效指标包括第29天时湿疹面积及严重程度指数（EASI）总评分较基线的变化、达到ISGA改善的患者百分比、峰值瘙痒严重程度数字评定量表评分较基线的变化、皮肤病生活质量指数（DLQI）/婴儿皮肤病生活质量指数（IDLQI）/儿童皮肤病生活质量指数（CDLQI）、皮肤病家庭影响调查表（DFI）评分随时间的变化等。安全性评估指标为不良反应发生率。计数资料组间比较采用χ2检验。因本文计量资料不符合正态分布，组间比较采用秩和检验。结果 共106例轻中度特应性皮炎患儿纳入符合方案分析集，克立硼罗组52例（男女各26例），吡美莫司组54例（男女各27例）。两组受试者的年龄、病程、ISGA和EASI评分在基线时差异均无统计学意义（P > 0.05）。治疗第29天时，克立硼罗组22例（42.31%）、吡美莫司组25例（46.30%）达到ISGA成功，两组差异无统计学意义（χ2 = 0.17，P = 0.68）；克立硼罗组35例（67.31%）、吡美莫司组45例（83.33%）达到ISGA改善，两组差异亦无统计学意义（χ2 = 3.68，P = 0.06）；EASI评分、瘙痒评分、DLQI/IDLQI/CDLQI、DFI评分两组间差异均无统计学意义（均P > 0.05）。两组药膏外用后的不良反应主要是轻至中度疼痛、瘙痒或瘙痒加重等局部反应，无明显系统不良反应。克立硼罗组药物相关不良反应发生率为46.15%（24例），吡美莫司组为37.04%（20例），两组间差异无统计学意义（χ2 = 0.91，P = 0.34）。结论 2%克立硼罗软膏治疗 ≥ 2岁儿童轻中度特应性皮炎的疗效与1%吡美莫司乳膏效果相当，能够早期、快速改善患儿及家庭生活质量，安全性和耐受性良好。

关键词: 皮炎, 特应性, 随机对照试验, 儿童, 克立硼罗, 吡美莫司

Abstract: 【Abstract】 Objective To compare the efficacy and safety of crisaborole ointment 2% versus pimecrolimus cream 1% in the treatment of mild to moderate atopic dermatitis in children aged 2 years or older. Methods A multicenter, randomized, open-label, controlled clinical trial was conducted. A total of 120 pediatric patients aged 2 - 17 years with mild to moderate atopic dermatitis were enrolled from departments of dermatology of 8 hospitals in China between March 2022 and February 2023. The participants were randomly assigned in a 1∶1 ratio to the crisaborole group and the pimecrolimus group, and received the treatment with crisaborole ointment 2% and pimecrolimus cream 1% respectively, twice a day for 4 weeks. Visits were scheduled at baseline/on day 1, as well as on days 8, 15, and 29. The primary efficacy outcome was the percentage of patients achieving the Investigator's Static Global Assessment （ISGA） success （defined as clear ［0］ or almost clear ［1］ on the ISGA scale, combined with ≥ 2‐grade improvement from baseline） on day 29. The secondary efficacy outcomes included changes in the Eczema Area and Severity Index （EASI） total scores from baseline to day 29, percentages of patients achieving ISGA improvement （defined as clear ［0］ or almost clear ［1］ on the ISGA scale）, as well as changes in the Peak Pruritus Numerical Rating Scale （NRS） scores, Dermatology Life Quality Index （DLQI）/Infants' Dermatology Life Quality Index （IDLQI）/Children's Dermatology Life Quality Index （CDLQI） scores, and in the Dermatitis Family Impact （DFI） scores. Drug safety was evaluated according to the incidence of adverse events. Categorical data were compared using the chi-square test. Since measurement data did not follow a normal distribution, the rank sum test was used for comparisons of measurement data between groups. Results A total of 106 children with mild to moderate atopic dermatitis were included in the per-protocol analysis set, with 52 in the crisaborole group （26 males and 26 females） and 54 in the pimecrolimus group （27 males and 27 females）. There were no significant differences in age, disease duration, ISGA and EASI scores at baseline between the two groups （all P > 0.05）. On day 29, 22 patients （42.31%） in the crisaborole group and 25 （46.30%） in the pimecrolimus group achieved ISGA success, with no significant difference between the two groups （χ2 = 0.17, P = 0.68）; 35 patients （67.31%） in the crisaborole group and 45 （83.33%） in the pimecrolimus group achieved ISGA improvement, also with no significant difference between the two groups （χ2 = 3.68, P = 0.06）; additionally, there were no significant differences in the EASI, pruritus NRS, DLQI/IDLQI/CDLQI, or DFI scores between the two groups （all P > 0.05）. Adverse reactions to the two topical agents were mainly local reactions such as mild to moderate pain, itching, or worsening of itching, and no obvious systemic adverse reactions occurred. The incidence of drug-related adverse reactions was 46.15% （24 cases） in the crisaborole group and 37.04% （20 cases） in the pimecrolimus group, with no significant difference between the two groups （χ2 = 0.91, P = 0.34）. Conclusion The efficacy of crisaborole ointment 2% was comparable to that of pimecrolimus cream 1% in the treatment of mild to moderate atopic dermatitis in children aged ≥ 2 years, and it yielded early and rapid improvement in the quality of life of patients and their families, with good safety and tolerability profiles.

Key words: Dermatitis, atopic, Randomized controlled trial, Child, Crisaborole, Pimecrolimus

引用本文

肖星 王珊 杨欢 舒虹 郭艳萍 陈谨萍 路遥 李钦峰 梁源 赵牧童 罗晓燕 缪丽敏 徐锐 李雪梅 赖沙 李建红 罗珍 喻泸 邢璐 王美潭 黎晓丽 徐海涛 李萍 王华 马琳. 多中心随机对照临床试验观察2%克立硼罗软膏与1%吡美莫司乳膏治疗儿童轻中度特应性皮炎的疗效和安全性[J]. 中华皮肤科杂志, 2025,58(5):425-430. doi:10.35541/cjd.20240453

Xiao Xing, Wang Shan, Yang Huan, Shu Hong, Guo Yanping, Chen Jinping, Lu Yao, Li Qinfeng, Liang Yuan, Zhao Mutong, Luo Xiaoyan, Miao Limin, Xu Rui, Li Xuemei, Lai Sha, Li Jianhong, Luo Zhen, Yu Lu, Xing Lu, Wang Meitan, Li Xiaoli, Xu Haitao, Li Ping, Wang Hua, Ma Lin. Comparison of efficacy and safety of crisaborole ointment 2% versus pimecrolimus cream 1% in the treatment of mild to moderate atopic dermatitis in children: a multicenter, randomized, controlled clinical trial[J]. Chinese Journal of Dermatology, 2025, 58(5): 425-430.doi:10.35541/cjd.20240453