龙牡润燥方治疗血虚风燥型特应性皮炎随机对照研究OA
Longmu Runzao Formula for Atopic Dermatitis Patients with Blood Deficiency Induced Wind-Dryness Pattern:A Randomized Controlled Trial
目的 观察龙牡润燥方治疗血虚风燥型特应性皮炎(AD)的临床疗效及安全性.方法 筛选123例2022年12月—2023年12月在中国中医科学院西苑医院皮肤科门诊就诊血虚风燥型AD患者,符合纳入标准60例.按照1∶1比例随机分为治疗组和对照组,每组各30例.两组均接受统一基础治疗,予润肤剂外用,治疗组给予龙牡润燥方口服,对照组给予氯雷他定片口服.两组疗程均为8周,并于12周随访.观察并记录两组患者治疗前后特应性皮炎评分(SCORAD)、皮肤病生活质量指数(DLQI)、瘙痒数字评分(NRS)、中医证候及主、次症评分及不良反应.结果 研究过程中对照组脱落2例.最终纳入分析58例(治疗组30例,对照组为28例).治疗8周后,治疗组总有效率为86.67％(26/30),高于对照组[60.71％(17/28),x2=5.088,P=0.024].两组 SCORAD、DLQI、NRS 及中医证候评分均较治疗前均降低(P＜0.01),且治疗组改善程度优于对照组(P＜0.01,P＜0.05).随访4周,治疗组各项指标仍优于对照组(P＜0.05).两组均未见明显的不良反应.结论 龙牡润燥方可有效改善血虚风燥型AD患者临床症状,缓解瘙痒,提高其生活质量及安全性方面优于氯雷他定片.(国际传统医学临床试验注册平台注册,No.ITMCTR2025001537)
Objective To observe the clinical efficacy and safety of Longmu Runzao Formula in treating atopic dermatitis(AD)patients with blood deficiency induced wind-dryness pattern.Methods Totally 123 AD patients with blood deficiency induced wind-dryness pattern who visited the Dermatology Outpatient Department of Xiyuan Hospital,China Academy of Chinese Medical Sciences between December 2022 and December 2023,and 60 met inclusion criteria were enrolled.They were randomly assigned to the treatment group and control group in 1∶1 ratio,with 30 patients in each group.Both groups received topical emollients.Patients in the treatment group took Longmu Runzao Formula,while those in the control group took Loratadine Tablet.Both groups underwent an 8-week treatment cycle,followed by a 4-week follow-up.The following parameters were observed and recorded:pre-and post-treatment scores for the Standardized Scoring of Atopic Dermatitis(SCORAD),Dermatology Life Quality Index(DLQI),Numerical Rating Scale for Itch(NRS),Chinese medicine syndrome scores,scores for primary and secondary symptoms,and adverse reaction.Results Two patients dropped out of the control group during the study.Fifty-eight patients were ultimately included in the analysis(treatment group:30;control group:28).After 8 weeks of treatment,the overall response rate in the treatment group was 86.67％(26/30),significantly higher than that in the control group[60.71％(17/28),x2=5.088,P=0.024].Both groups showed significant reductions in SCORAD,DLQI,NRS,and TCM syndrome scores,as compared with the baseline(P＜0.01).Besides,the improvement in the treatment group was more significant(P＜0.01,P＜0.05).At 4-week follow-up,the above-mentioned indices were better in the treatment group than in the control group(P＜0.05).No significant adverse reactions were observed in either group.Conclusion Longmu Runzao Formula was effective in improving clinical symptoms,alleviating pruritus,and enhancing quality of life in AD patients with blood deficiency induced wind-dryness pattern.(International Traditional Medicine Clinical Trials Registry,No.ITMCTR2025001537)
崔晗;张天博;迟慧彦;马婉婷;夏慧杰;宋艳丽
中国中医科学院西苑医院皮肤科(北京 100091)中国中医科学院西苑医院皮肤科(北京 100091)中国中医科学院西苑医院皮肤科(北京 100091)中国中医科学院西苑医院皮肤科(北京 100091)中国中医科学院西苑医院皮肤科(北京 100091)中国中医科学院西苑医院皮肤科(北京 100091)
特应性皮炎龙牡润燥方血虚风燥型随机对照试验
atopic dermatitisLongmu Runzao Formulablood deficiency induced wind-dryness patternrandomized controlled trial
《中国中西医结合杂志》 2026 (7)
820-824,5
中国中医科学院科技创新工程(No.CI2021A02310)
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