研究疾病:
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慢性自发性荨麻疹
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研究疾病代码:
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Target disease:
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Chronic spontaneous urticarial
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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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本项目基于本课题组前期研究基础,以CSU为研究对象,以功能性磁共振成像(fMRI)作为研究手段,观察CSU受试者脑功能改变,以及穴位埋线对受试者静息态脑功能区及其功能区网络连接的干预作用,探讨慢性自发性荨麻疹瘙痒及穴位埋线治疗的中枢机制。并基于中医经典理论“诸痛痒疮,皆属于心”,评价穴位埋线治疗CSU的疗效与安全性。
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Objectives of Study:
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In this project, based on our previous research, the CSU as the research object, by functional magnetic resonance imaging (fMRI) as a means of research, to observe the CSU subjects brain function change, and acupoint burying line of subjects were resting state brain function and its effect on the functional areas the connections of intervention, to explore the diagnosis and treatment of chronic idiopathic urticaria pruritus and acupuncture point bury line of the central mechanism. Based on the classical theory of TRADITIONAL Chinese medicine "all pain and itching sores belong to the heart", the efficacy and safety of acupoint catgut embedding in the treatment of CSU were evaluated.
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药物成份或治疗方案详述:
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Description for medicine or protocol of treatment in detail:
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纳入标准:
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1. 年龄18-60岁之间,性别不限。
2. 符合慢性自发性荨麻疹诊断标准:风团每天发作或间歇发作,每次持续时间不超过24小时,持续时间>6周。
3. 尽管在使用H1抗组胺药, 但在入组前至少连续6周出现风团与瘙痒;每日发作至少1次,以风团及瘙痒为主,不伴发严重的全身症状。
4. 7天荨麻疹活动性评分(UAS)≥16分,每周瘙痒评分≥8分。
5. 右利手。
6. 既往无埋线治疗史。
7. 签署知情同意书,自愿并同意完成本临床研究的各步骤。
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Inclusion criteria
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1. Age between 18 and 60, regardless of gender.
2. Meet the diagnostic criteria of chronic spontaneous urticaria: the onset of wind masses every day or intermittently, each duration of no more than 24 hours, the duration of > 6 weeks.
3. Despite the use of H1 antihistamines, wind masses and pruritus were present for at least 6 weeks prior to enrollment; At least once a day, mainly wind mass and pruritus, without serious systemic symptoms.
4. 7-day urticaria activity score (UAS)≥16 points, weekly pruritus score ≥ 8 points.
5. Right-handed.
6. No history of catgut embedding.
7. Sign informed consent, voluntarily and agree to complete all steps of the clinical study.
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排除标准:
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1.明确诱因的慢性荨麻疹(如物理性荨麻疹);
2.入组前30天因任何指征而接受(每天,或者大于等于连续3个隔天)的系统使用糖皮质激素、羟基氯喹、甲氨蝶呤、环孢素、环磷酰胺,或静脉注射免疫球蛋白;
3.筛选前7天,随机分组前14天,接受过任何H2抗组胺药、白三烯受体拮抗剂、奥马珠单抗等生物制剂治疗;
4.筛选前3天,H1抗组胺药超过许可剂量;
5.合并有严重心脑血管、糖尿病、骨代谢异常等疾病,或肝、肾疾病及造血系统等严重的原发性疾病者;伴有系统性红斑狼疮等严重自身免疫性疾病者;
6.除慢性荨麻疹以外的疾病,具有荨麻疹或血管性水肿症状,如荨麻疹血管炎、多形红斑、皮肤肥大细胞增多(色素性荨麻疹)和遗传性或获得性血管性水肿(如由于C1抑制剂缺乏);
7.与慢性瘙痒相关的可能会影响研究评估和治疗结果的皮肤病(如特应性皮炎、大疱性天疱疮、疱疹性皮炎、老年瘙痒等);
8.埋线材料过敏者;
9.研究期间有生育需求,妊娠,哺乳期妇女;
10.磁共振检查禁忌者;
11.最近3个月内正在参与或参加过其他临床试验;
12.1个月内使用过精神类药物。
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Exclusion criteria:
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1. Clear cause of chronic urticaria (such as physical urticaria);
2. Glucocorticoid, hydroxychloroquine, methotrexate, cyclosporine, cyclophosphamide, or intravenous immunoglobulin for any indication (daily, or more than 3 consecutive other days) received during the first 30 days of enrollment;
3. Received any H2 antihistamine, leukotriene receptor antagonist, omalizumab and other biological agents 7 days before screening and 14 days before randomization;
4. Three days before screening, H1 antihistamines exceeded the permitted dose;
5. Complicated with serious cardiovascular and cerebrovascular diseases, diabetes, abnormal bone metabolism and other diseases, or liver and kidney diseases, hematopoietic system and other serious primary diseases; Patients with systemic lupus erythematosus and other serious autoimmune diseases;
6. Diseases other than chronic urticaria with symptoms of urticaria or angioedema, such as urticaria vasculitis, Erythema multiform, cutaneous mastocytosis (pigmentary urticaria) and hereditary or acquired angioedema (e.g., due to deficiency of C1 inhibitor);
7. Skin diseases related to chronic pruritus (e.g., atopic dermatitis, bullous pemphigus, herpetic dermatitis, pruritus in old age, etc.) that may affect the evaluation and treatment of the study;
8. People allergic to buried wire materials;
9. Women with fertility needs, pregnancy and lactation during the study period;
10. Contraindicated mri patients;
11. Participating in or participating in other clinical trials within the last 3 months;
12. Used psychotropic drugs within the past month.
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研究实施时间:
Study execute time:
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从From
2021-10-31
至To
2024-10-31
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征募观察对象时间:
Recruiting time:
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从From
2022-09-01
至To
2024-09-01
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