The Research of Standard Diagnosis and Treatment for Severe Henoch-Schonlein Purpura in Children
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The Symptoms of Digestive Tract
研究概览
简要总结
This study is performed to evaluate the efficacy and safety of various measures in the treatment of severe HSP in children.
详细描述
Henoch-Schonlein purpura (HSP) is a systemic vasculitis affecting small vessels with immunoglobulin A (IgA)-dominant immune deposits. The clinical manifestations of severe HSP vary from massive hemorrhage and necrosis of the skin to severe gastrointestinal symptoms. The course of the disease would encounter delay and relapse. To some extent, the traditional therapy alleviate the clinical symptoms, but fail to timely clear up the immune depositions, causing the damage to the kidney.
In the study, the patients will be given dexamethasone 0.5mg/kg/d, then be randomised to receive either gamma globulin i.v. or hemoperfusion if the disease can't be controlled with steroid treatment for more than two days.
The investigators will explore the biological markers and compare the efficacy and safety of both measures in the treatment of serve HSP in children. The purpose of the study is to optimize the treatment of severe HSP for children with different ages.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 2 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Severe HSP: could not be controlled with dexamethasone 0.5mg/kg/d or the total dose above 20mg/d for more than two days
排除标准
- •The children with congenital diseases
研究组 & 干预措施
group 1
Dexamethasone 0.5mg/kg.d i.v.
干预措施: Dexamethasone (Drug)
group 2
Dexamethasone & gamma globulin Dexamethasone 0.5mg/kg.d i.v. & gamma globulin i.v. qd*3d, and the total dose is 2g/kg
干预措施: Dexamethasone (Drug)
group 2
Dexamethasone & gamma globulin Dexamethasone 0.5mg/kg.d i.v. & gamma globulin i.v. qd*3d, and the total dose is 2g/kg
干预措施: Gamma globulin (Drug)
group 3
Dexamethasone & hemoperfusion Dexamethasone 0.5mg/kg.d i.v & hemoperfusion should be given at least three times in five days
干预措施: Dexamethasone (Drug)
group 3
Dexamethasone & hemoperfusion Dexamethasone 0.5mg/kg.d i.v & hemoperfusion should be given at least three times in five days
干预措施: Hemoperfusion (Procedure)
结局指标
主要结局
The Symptoms of Digestive Tract
时间窗: 2 weeks
The stomachache and other symptoms of digestive tract disappear
The Symptoms of Joint System
时间窗: 2 weeks
The arthralgia disappears
次要结局
- The Skin Rash(2 weeks)
- Renal function(2 weeks)
研究者
Aihua Zhang
Hospital vice president
Nanjing Children's Hospital