研究疾病:
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特应性皮炎
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研究疾病代码:
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Target disease:
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Atopic dermatitis
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Target disease code:
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研究类型:
Study type:
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干预性研究
Interventional study
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研究设计:
Study design:
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随机平行对照
randomized controlled trial(parallel group design)
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研究所处阶段:
Study phase:
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探索性研究/预试验
Pilot clinical trial
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研究目的:
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本课题拟通过大样本临床观察验证紫草膏治疗特应性皮炎的有效性及安全性。通过观察治疗前后病情改变情况并检测治疗前、后角质层水含量、经表皮水分丢 失量(TEWL)、pH值等皮肤屏障指标,证明紫草膏可以增加皮肤的含水量,减少表皮水分丢失,降低pH值,提高特应性皮炎的临床疗效,降低复发率。因此快速修复皮肤屏障、抗炎,重建皮肤屏障功能可能是紫草膏的主要作用机理。可以作为特应性皮炎外用药治疗的优化方案之一,推广应用。
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Objectives of Study:
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This project intends to verify the effectiveness and safety of Zicao Ointment in the treatment of atopic dermatitis through clinical observation of a large sample. By observing the changes in the condition before and after treatment and detecting skin barrier indexes such as the water content of the stratum corneum before and after the treatment, the amount of transepidermal water loss (TEWL), pH value, etc.. It is proved that Zicao Ointment can increase the water content of the skin and reduce the loss of epidermal water, reduce the pH value, improve the clinical efficacy of atopic dermatitis, and reduce the recurrence rate. Therefore, rapid repair of the skin barrier, anti-inflammatory, and reconstruction of the skin barrier function may be the main mechanism of action of Zicao Ointment. It can be promoted and applied as one of the optimized programs for topical treatment of atopic dermatitis.
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药物成份或治疗方案详述:
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对本科门诊符合入选标准的特应性皮炎患者人群,根据病情及患者的意愿进 行治疗,拟入组 200 例患者进行临床观察,分为西医队列(对照组)和中医队列 (治疗组)。对照组选用糠酸莫米松软膏外用,每天 1 次,2 周为 1 个疗程;治 疗组采用我院院内制剂紫草膏外涂治疗,每日2次,疗程8周。根据痊愈、显效、 有效、无效进行疗效判定。所有患者于初诊、治疗第 1 周、第 2 周、第 4 周、第 8 周复诊。记录皮损面积、皮损严重程度、瘙痒程度及 SCORAD 分值等观察指标, 询问用药依从性及不良反应,对痊愈患者随访 3 个月,未愈患者可采用其他方法治疗。
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Description for medicine or protocol of treatment in detail:
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A group of patients with atopic dermatitis who meet the selection criteria will be treated according to the condition and the patient's wishes. It is planned to enroll 200 patients for clinical observation, and they will be divided into the Western medicine cohort (control group) and the traditional Chinese medicine cohort (treatment group). The control group used mometasone furoate ointment for external use, once a day, for 2 weeks as a course of treatment; the treatment group was treated with our hospital's preparation of Zicao Ointment for external application, twice a day for 8 weeks. The curative effect is judged according to the recovery, marked effect, effective and ineffective. All patients will be revisited at the first visit, the first week, the second week, the fourth week, and the eighth week of treatment. Observation indicators such as the area of the skin lesion, the severity of the skin lesion, the degree of pruritus and the SCORAD score were recorded, and the medication compliance and adverse reactions were asked. The cured patients were followed up for 3 months. The unhealed patients can be treated by other methods.
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纳入标准:
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1.符合特应性皮炎西医诊断标准;
2.年龄 2-12 岁;
3.Scorad 总分评分<=50 分;
4.调查期间病情稳定,有一定表达能力;
5.同意接受此项临 床观察并签订诊疗知情同意书;
6.无严重肝肾疾病、自身免疫性疾病(如系统性红斑狼疮、类风湿病)、HIV 感染者及恶性肿瘤者。
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Inclusion criteria
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1.Meet the diagnostic criteria of Western medicine for atopic dermatitis;
2.Aged 2 to 12 years;
3.Scorad total score <=50 points;
4.Stable condition during the investigation period, with a certain ability to express;
5.Agree to accept this clinical observation and sign an informed consent form for diagnosis and treatment;
6.Patients have no severe liver and kidney diseases, autoimmune diseases (such as systemic lupus erythematosus, rheumatoid disease), HIV infection and malignant tumors.
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排除标准:
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1.治疗前 1 月内有局部糖皮质激素软膏治疗或者系统应用糖 皮质激素史;
2.表面有破溃、渗出严重的特应性皮炎;
3.存在精神障碍的患者;
4.合并有心、脑血管、肝、肾和造血系统等疾病,病情严重者;
5.不同意签署知 情同意书者。
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Exclusion criteria:
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1.A history of topical glucocorticoid ointment treatment or systematic application of glucocorticoid within 1 month before treatment;
2.Severe atopic dermatitis with ulceration and exudation on the surface;
3.Patients with mental disorders;
4.Patients with serious diseases of heart, cerebrovascular, liver, kidney and hematopoietic system;
5.Patients do not agree to sign the letter of consent.
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研究实施时间:
Study execute time:
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从From
2021-08-01
至To
2022-08-31
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征募观察对象时间:
Recruiting time:
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从From
2021-08-01
至To
2022-08-31
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