研究疾病:
|
特应性皮炎
|
研究疾病代码:
|
|
Target disease:
|
Atopic dermatitis
|
Target disease code:
|
研究类型:
Study type:
|
干预性研究
Interventional study
|
研究设计:
Study design:
|
随机平行对照
randomized controlled trial(parallel group design)
|
研究所处阶段:
Study phase:
|
探索性研究/预试验
Pilot clinical trial
|
研究目的:
|
本研究通过评价滋肾健脾清热饮改善AD患者临床症状、维持时间和减少激素用量情况,从整体角度评价滋肾健脾清热饮的临床疗效和安全性,为基层医疗机构提供有效治疗方药,为优化中医药治疗诊疗方案提供有效支撑。本研究通过评价滋肾健脾清热饮改善AD患者临床症状、维持时间和减少激素用量情况,从整体角度评价滋肾健脾清热饮的临床疗效和安全性,为基层医疗机构提供有效治疗方药,为优化中医药治疗诊疗方案提供有效支撑。
|
Objectives of Study:
|
This study evaluated the clinical efficacy and safety of Zishen Jianpi Qingre Yin in improving the clinical symptoms, maintaining time and reducing the dosage of hormones in AD patients from an overall perspective, so as to provide effective prescriptions for primary medical institutions and provide effective support for optimizing the diagnosis and treatment plan of traditional Chinese medicine. This study evaluated the clinical efficacy and safety of Zishen Jianpi Qingre Yin in improving the clinical symptoms, maintaining time and reducing the dosage of hormones in AD patients from an overall perspective, so as to provide effective prescriptions for primary medical institutions and provide effective support for optimizing the diagnosis and treatment plan of traditional Chinese medicine.
|
药物成份或治疗方案详述:
|
研究分治疗期和维持期,治疗期:IGA评分>1分;维持期:IGA评分≤1分,进入维持治疗。试验分试验组、对照组,两组均给予外用标准治疗药物,试验组在此基础上再给予口服试验药物。治疗期试验组:内服滋肾健脾清热饮每日2次+艾洛松乳膏外用每日1次。内服药物:滋肾健脾清热饮(生地黄、山萸肉、山药、丹皮、生石膏、钩藤等药物组成),剂量按照年龄段(2-6岁:7-12岁:13-16岁=1:2:3)分层比例组成;每付药浓缩煎煮200ml,分为2次口服,早晚各服用一次,饭后半小时温服。外用药物:给予艾洛松乳膏(国药准字H19991418)外用,患处皮肤外涂薄层均匀覆盖,每日1次。药物外用避开面部和身体皱褶部位,面部和身体褶皱部位使用润肤剂基础保湿。可根据皮损情况逐渐减少使用次数和数量。对照组:艾洛松乳膏外用每日1次。维持期艾洛松乳膏外用改为周末治疗(周六、周日每日1次),口服药物同前。
|
Description for medicine or protocol of treatment in detail:
|
The study was divided into treatment period and maintenance period. The treatment period: IGA score > 1; Maintenance period: IGA score ≤1 points, into maintenance treatment. The experiment was divided into experimental group and control group. Both groups were given topical standard treatment drugs, and the experimental group was given oral test drugs on this basis. During the treatment period, the experimental group was treated with Zishen Jianpi Qingre decoction twice a day and topical Elioxone cream once a day. Oral drugs: Zishen Jianpi Qingre decoction (raw Rehmannia, cornus officinalis, yam, Danpi, gypsum, Uncaria uncaria, etc.), dosage according to age (2-6 years old: 7-12 years old: 13-16 years old = 1:2:3) stratified proportion composition; Each medicine was concentrated and decocted 200ml, divided into two oral doses, one in the morning and one in the evening, and warm half an hour after meals. For topical treatment, Aloxone cream (H19991418) was applied to the affected skin once a day. Topical use of the drug avoids facial and body creases, and emollient based moisturization is used for facial and body creases. The frequency and amount of use can be gradually reduced according to the condition of skin lesions. The control group was treated with elioxone cream once a day. During the maintenance period, the topical elioxone cream was changed to weekend treatment (once a day on Saturday and Sunday), and the oral medication was the same as before.
|
纳入标准:
|
(1)符合西医特应性皮炎轻、中度临床诊断标准,IGA评分>1分;(2)符合脾虚肺热证的辨证标准;(3)年龄在2岁至16岁,性别不限; (4)研究前4周内未系统使用糖皮质激素、免疫抑制剂、生物制剂或紫外线;(5)研究前3天内未口服抗组胺药; (6)研究前2周内未外用糖皮质激素或钙调磷酸酶抑制剂等药物;(7)受试者的合法监护人能够充分理解试验目的,在整个研究期间按医生指导使用药物治疗,自愿参加并签署知情同意书。
|
Inclusion criteria
|
(1) Meet the clinical diagnostic criteria of mild to moderate atopic dermatitis with IGA score > 1; (2) in accordance with the syndrome differentiation standard of spleen deficiency and lung heat syndrome; (3) age between 2 and 16 years old, both sexes; (4) no systemic use of glucocorticoids, immunosuppressants, biological agents or ultraviolet rays within 4 weeks before the study; (5) no oral antihistamines within 3 days before the study; (6) no use of topical corticosteroids or calcineurin inhibitors within 2 weeks before the study; (7) The legal guardians of the subjects could fully understand the purpose of the trial, use drugs according to the instructions of doctors during the whole study period, voluntarily participate in and sign the informed consent.
|
排除标准:
|
(1)在需要治疗区域有除AD以外其他皮肤病;(2)有严重的全身性疾病(如心血管系统、呼吸系统、消化系统、神经系统、内分泌系统、泌尿生殖系统疾病等)及免疫缺陷病的患儿;(3)合并较为严重的皮肤感染或全身感染的患者; (4)对研究药物任一成分有过敏史的患者;(5)不能接受中药汤药治疗的患者;(6)目前正在参加其他临床研究或3个月内参加过其他临床研究,研究者判断患儿依从性差,无法按照要求完成研究。
|
Exclusion criteria:
|
(1) skin diseases other than AD in the area requiring treatment; (2) children with severe systemic diseases (such as cardiovascular system, respiratory system, digestive system, nervous system, endocrine system, urogenital system, etc.) and immunodeficiency diseases; (3) patients with serious skin infection or systemic infection; (4) patients with a history of allergy to any component of the study drug; (5) patients who could not accept TCM decoction treatment; (6) The child was currently participating in other clinical studies or had participated in other clinical studies within 3 months, and the investigator judged that the child had poor compliance and could not complete the study as required.
|
研究实施时间:
Study execute time:
|
从From
2024-01-01
至To
2025-12-31
|
征募观察对象时间:
Recruiting time:
|
从From
2024-01-01
至To
2025-12-01
|