中华皮肤科杂志 ›› 2022, Vol. 55 ›› Issue (11): 1021-1025.doi: 10.35541/cjd.20220281

• 药物与临床 • 上一篇    下一篇

[开放获取]   含低聚麦芽糖X的皮肤护理软膏辅助治疗轻中度湿疹患者瘙痒的多中心随机双盲对照研究

李妍1    项璐婧1    李明1    雷明君2    田赞2    袁建国3    周虹3    刘莹3    王洁3    陈晋广4    王渟4    高双双4    张宇5    李邻峰1   

  1. 1首都医科大学附属北京友谊医院皮肤性病科，北京  100050；2河北省中医院皮肤科，石家庄  050013；3湖北省第三人民医院（湖北省中山医院）皮肤科，武汉  430030；4台州市中心医院（台州学院附属医院）皮肤科，台州  318001；5北京坚毅恒泰医疗科技有限公司，北京  100024
  • 收稿日期:2022-04-22 修回日期:2022-09-06 发布日期:2022-11-03
  • 通讯作者: 李邻峰 E-mail:zoonli@sina.com

Efficacy of a skin care ointment containing oligomeric maltose X in the adjuvant treatment of pruritus in patients with mild to moderate eczema: a multicenter, randomized, double-blind controlled clinical study

Li Yan1, Xiang Lujing1, Li Ming1, Lei Mingjun2, Tian Zan2, Yuan Jianguo3, Zhou Hong3, Liu Ying3, Wang Jie3, Chen Jinguang4, Wang Ting4, Gao Shuangshuang4, Zhang Yu5, Li Linfeng1   

  1. 1Department of Dermatology and Venereology, Beijing Friendship Hospital, Capital Medical University, Beijing 100050, China; 2Department of Dermatology, Hebei Traditional Chinese Medical Hospital, Shijiazhuang 050013, China; 3Department of Dermatology, The Third People′s Hospital of Hubei Province （Zhongshan Hospital of Hubei Province）, Wuhan 430030, China; 4Department of Dermatology, Taizhou Central Hospital （Taizhou University Hospital）, Taizhou 318001, Zhejiang, China; 5Beijing Focus C Medical Technology Co, Ltd., Beijing 100024, China
  • Received:2022-04-22 Revised:2022-09-06 Published:2022-11-03
  • Contact: Li Linfeng E-mail:zoonli@sina.com

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摘要： 【摘要】 目的 评价一种含低聚麦芽糖X的皮肤护理软膏辅助治疗湿疹瘙痒的临床疗效和安全性。方法 采用多中心、随机、双盲、模拟剂对照临床研究，2021年3 - 9月于首都医科大学附属北京友谊医院、河北省中医院、湖北省第三人民医院及浙江省台州市中心医院4家医院皮肤科门诊收集轻、中度湿疹患者，采用随机数字表法随机分为两组，观察组外用一种含低聚麦芽糖X的皮肤护理软膏，模拟剂组外用该皮肤护理软膏模拟剂，每天瘙痒发作时即使用，连续使用14 d。分别于辅助治疗前和治疗7、14 d随访，根据湿疹面积及严重程度指数（EASI）、视觉模拟标尺法（VAS）等评价疗效，记录不良事件。主要采用χ2检验和t检验进行疗效和安全性分析。结果 入组患者232例，男90例、女142例，年龄（40.13 ± 13.36）岁；观察组156例，模拟剂组76例。辅助治疗前两组患者EASI评分［（2.07 ± 2.24）分比（2.29 ± 2.28）分］、VAS评分［（6.22 ± 1.78）分比（6.20 ± 1.79）分］差异均无统计学意义（t值分别为-0.70、0.06，P值分别为0.486、0.955）。治疗1 d，两组VAS评分相对各自基线的变化即有统计学意义（P值分别＜0.001、 = 0.003）。治疗14 d，观察组VAS评分均值2.67分，显著低于模拟剂组3.35分（t = -2.28，P = 0.024）。治疗7 d和14 d，与基线相比两组EASI评分均显著下降（均P＜0.001），但两组间差异均无统计学意义（P = 0.853、0.731）。两组均无器械相关不良事件发生。结论 含低聚麦芽糖X的皮肤护理软膏辅助治疗湿疹瘙痒安全、有效，可用于临床。

关键词: 湿疹, 瘙痒症, 麦芽糖, 甘油, 低聚麦芽糖X, 随机对照试验

Abstract: 【Abstract】 Objective To evaluate the clinical efficacy and safety of a skin care ointment containing oligomeric maltose X in the adjuvant treatment of eczema-related pruritus. Methods A multicenter, randomized, double-blind, vehicle-controlled clinical study was conducted. From March to September 2021, outpatients with mild to moderate eczema were collected from departments of dermatology of 4 hospitals, including Beijing Friendship Hospital, Hebei Traditional Chinese Medical Hospital, the Third People′s Hospital of Hubei Province, and Taizhou Central Hospital in Zhejiang Province. The patients were randomly divided into two groups by using a random number table: observation group topically treated with a skin care ointment containing oligomeric maltose X, and vehicle control group topically treated with an ointment vehicle. The ointments were applied during the attacks of itching for 14 consecutive days. Visits were scheduled before, 7, and 14 days after the start of the adjuvant treatment. The efficacy was evaluated according to the eczema area and severity index （EASI） and visual analog scale （VAS）, and adverse events were recorded. The efficacy and safety analyses were conducted by using chi-square test and t test. Results Totally, 232 patients with eczema were enrolled, including 90 males and 142 females, with the age being 40.13 ± 13.36 years; 156 patients were in the observation group, and 76 in the vehicle control group. Before the adjuvant treatment, there were no significant differences in EASI （2.07 ± 2.24 points vs. 2.29 ± 2.28 points） or VAS （6.22 ± 1.78 points vs. 6.20 ± 1.79 points） scores between the observation group and vehicle control group （t = -0.70, 0.06, P = 0.486, 0.955, respectively）. After one-day treatment, the VAS scores significantly decreased compared with the baseline scores in the two groups（P < 0.001, P = 0.003, respectively）. After 14-day treatment, the VAS score was significantly lower in the observation group （2.67 points） than in the vehicle control group （3.35 points; t = -2.28, P = 0.024）. After 7- and 14-day treatment, the EASI scores significantly decreased compared with the baseline scores in both the two groups （all P < 0.001）, but there were no significant differences between the two groups （P = 0.853, 0.731）. No adjuvant treatment-related adverse events were recorded in either of the two groups. Conclusion The skin care ointment containing oligomeric maltose X is safe and effective in the adjuvant treatment of eczema-related pruritus, and can be applied to clinical practice.

Key words: Eczema, Pruritus, Maltose, Glycerol, Oligomeric maltose X, Randomized controlled trial