The Therapeutic Value and Mechanism of Recombinant Human Interleukin-2 in Children With Henoch-schönlein Purpura
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- The change of immunological responses
研究概览
简要总结
The study aims to explore the therapeutic value and mechanism of Interleukin-2 on children with Henoch-schönlein purpura.
详细描述
The investigators designed a single center, open-label, prospective study that routinely administered low-dose IL-2 therapy to monitor the improvement of clinical and laboratory parameters to explore its efficacy and to observe changes in immune cell subsets and cytokines.For all patients,rhIL-2(500,000 unit per square meter) infusions seven days;recurrent patients were applied again for 7 days;patients who were diagnosed HSPN were treated on a routine basis for 7 consecutive days, and then once every two week for 3months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age <18 years old
- •meet the EULAR/PRINTO/PRES for the diagnosis of HSP
- •HIV negative;Negative for HBV and HCV.
排除标准
- •heart failure (cardiac function ≥ grade III NYHA)
- •liver insufficiency (upper limit of normal range of transaminase > 2 times)
- •renal insufficiency (creatinine clearance ≤30ml/min)
- •acute or severe infections such as bacteremia and sepsis
- •malignant tumor
- •high-dose steroid pulse therapy or intravenous injection of glucocorticoids in the last 1 month
- •mental disorders or any other chronic illness or substance abuse may interfere with the ability to comply with agreements or provide information
- •Intestinal ischemia or perforated gastrointestinal bleeding requires surgery
- •Inability to comply with IL-2 treatment regimen.
研究组 & 干预措施
Recombinant Human Interleukin-2
patients were treated with IL-2.
干预措施: IL-2 (Drug)
结局指标
主要结局
The change of immunological responses
时间窗: day 0,day 7
Enumeration of the number of subjects with a change in the absolute number of immune cells and serum cytokines in the peripheral blood
次要结局
- The value of serum immunoglobulins and complements(day 0,day 7,3 month,6 month)
- Incidence of adverse drug reactions(up to 6 month)