Leflunomide for Refractory Skin Henoch-Schonlein Purpura in Children
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Rash frequency
研究概览
简要总结
This study conducted a prospective, multicenter, one-arm clinical trial on the combination of leflunomide and steroid therapy for refractory skin Henoch-Schonlein Purpura in children on the basis of ethical principles. A one-year follow-up was conducted to evaluate the changes in the main indicators (frequency of rash recurrence) and secondary indicators (proportion of kidney damage, proportion of joint involvement, T lymphocyte subpopulations, and inflammatory factors) before and after treatment, Exploring the safety and effectiveness of leflunomide in the treatment of refractory skin type HSP in children, it is expected that leflunomide combined with conventional treatment can improve the remission rate of HSP children's skin purpura and reduce HSP recurrence. The research results are expected to bring new treatment methods and strategies for this group of patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ranges from 1 to 18 years old;
- •Patients meet the HSP diagnostic criteria;
- •Refractory skin type HSP: Rashes are dense and large in area, often treated with antibiotics, antihistamines, calcium supplements, and glucocorticoids (2 mg/kg/d) for 5 days. The rash does not subside or fresh rash still appears, and frequently repeated more than 3 times during hospitalization.
- •Parents or guardians agree to treatment and sign a written informed consent form.
排除标准
- •Individuals who are allergic to leflunomide;
- •Concomitant severe underlying diseases (such as systemic malignancy, heart failure, liver and kidney failure, immune deficiency, severe infectious diseases, organ transplant surgery, or other current indications for emergency surgery);
- •Patients with other digestive system diseases;
- •Those who have previously used flumiphene in clinical trials;
- •Excluding purpura caused by drugs, infectious factors, and other autoimmune diseases.
- •Other situations where the researcher deems it inappropriate to participate in the study.
研究组 & 干预措施
Administration of Leflunomide in refractory skin Henoch-Schonlein purpura
Rashes are dense and large in area, often treated with antibiotics, antihistamines, calcium supplements, and glucocorticoids (2 mg/kg/d) for 5 days. The rash does not subside or new rash still appears, and it frequently repeats more than 3 times during hospitalization.
干预措施: Leflunomide (Drug)
结局指标
主要结局
Rash frequency
时间窗: 12 months
Rash frequency in a months
次要结局
未报告次要终点
研究者
Weiping Tan
Professor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University