镇心安神法治疗特应性皮炎多中心随机对照研究

Efficacy of the Suppress-the-Heart-and-Calm-the-Mind Method in the Treatment of Atopic Dermatitis:A Multi-Center Randomized Controlled Trial

目的探讨镇心安神法治疗特应性皮炎(AD)的临床疗效。方法选取作者所在5家医院收治的AD患者210例,随机分为试验组和对照组,各105例。试验组患者按辨证分型予中药镇心安神法治疗;对照组患者予氯雷他定片口服及丁酸氢化可的松乳膏外用。两组均持续治疗8周。结果试验组脱落9例,对照组脱落8例、剔除1例。试验组总有效率为88.54%,与对照组的83.33%无显著差异(P>0.05);两组患者病变范围、皮疹严重程度、瘙痒指数与影响睡眠程度、特应性皮炎指数(SCORAD)评分、生活质量评分均无显著差异(P>0.05);试验组复发率为22.22%,显著低于对照组的54.17%(P<0.05);两组均未出现与药物相关的严重不良反应(P>0.05)。结论镇心安神法治疗AD,具有较好的近期和远期疗效,且能降低复发率。

Objective To investigate the clinical efficacy of the suppress-the-heart-and-calm-the-mind method in the treatment of atopic dermatitis(AD).Methods A total of 210 patients with AD admitted to the five hospitals where the authors worked were selected and randomly divided into the experimental group and the control group,105 cases in each group.The patients in the experimental group were treated with the suppress-the-heart-and-calm-the-mind method with traditional Chinese medicine according to syndrome differentiation,while the patients in the control group were given Loratadine Tablets orally and Hydrocortisone Butyrate Cream externally.Both groups were continuously treated for eight weeks.Results There were nine drop-off cases in the experimental group,eight drop-off cases and one eliminated case in the control group.The total effective rate of the experimental group was 88.54%,which had no significant difference from 83.33%of the control group(P>0.05).There was no significant difference in lesion range,rash severity,pruritus index,sleep affected degree,Scoring Atopic Dermatitis(SCORAD)score,and quality of life score between the two groups(P>0.05).The recurrence rate of the experimental group was 22.22%,which was significantly lower than 54.17%of the control group(P<0.05).No serious adverse drug-related reactions occurred in the two groups.Conclusion Suppress-the-heart-and-calm-the-mind method in the treatment of AD has a good short-term and long-term efficacy,and it can reduce the recurrence rate.