The Clinical Study of Mycophenolate Mofetil in Pediatric Refractory Gastrointestinal Henoch-Schonlein Purpura
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Incidence of Abdominal pain, hematemesis and bloody stools
研究概览
简要总结
Henoch Schönlein purpura (HSP) is the most common type of vasculitis in children, with an incidence of ~10/100,000, whereas >90% of the patients develop symptoms at <10 years of age. Although HSP is generally a self-limiting disease, it may also lead to severe complications, such as intestinal intussusception, infarction and perforation, as well as end-stage renal disease. The management of HSP includes symptomatic treatment and immunosuppressive therapy in certain patients. Previous retrospective studies have reported that most patients with gastrointestinal (GI) symptoms may benefit from early usage of glucocorticoid, whereas there are still a part of HSP patients with GI did not achieved remission after administering of steroid. Therefore, the aim of the present study was to investigate the clinical features of refractory GI HSP and the clinical outcome of mycophenolate mofetil in these patients.
详细描述
the aim of the present study was to investigate the clinical features of refractory GI HSP and the clinical outcome of mycophenolate mofetil in these 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
- 3 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages range from 3 to 18 years old;
- •Patients who meet the diagnostic criteria for HSP and involve the digestive tract: acute diffuse abdominal colic, including intussusception and gastrointestinal bleeding, appears during the course of the disease or is found on physical examination;
- •Refractory gastrointestinal type HSP: treated with Intravenous corticosteroid 2 mg/kg/d for 3 days without effecacy or relapsed during the attenuation of corticosteroid
- •Parents or guardians agree to treatment and sign a written informed consent form.
排除标准
- •Patients who are allergic to MMF;
- •Patients with severe diseases: such as systemic malignancies, heart failure, liver and renal 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 MMF clinical trials;
- •Other situations the researcher thought inappropriate to participate in the study.
研究组 & 干预措施
mycophenolate mofetil in refractory gastrointestinal Henoch-Schönlein purpura
patients who were resistant to steroid were treated with MMF
干预措施: MMF (Drug)
结局指标
主要结局
Incidence of Abdominal pain, hematemesis and bloody stools
时间窗: 6 months
assessed by checklist
次要结局
- count of red blood cells in Stool(6 months)
研究者
Weiping Tan
Professor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University