Clinical Study on Strategy for Refractory Henoch-Schönlein Purpura
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 3
- 主要终点
- sustained abdominal pain relief
研究概览
简要总结
IgA vasculitis is relatively common in children,especially in Asian countries. Abdominal manifestation could be severe, including bleeding, pancreatitis,appendicitis and intestinal intussusception. Delayed diagnosis could be fatal and cause severe complications.Nowadays no guidelines for those with severe abdominal manifestations in China.However, the most used treatment is steroid. For those severe forms are methylprednisolone pulse, IVIG, immunosuppressants and blood purification. Given the fact that different strategies lead to different endings which varies in cost, adverse effect and clinical outcomes in different medical centers, it is necessary to give birth to a useful and feasible strategy. This clinical trial is a muti-center, randomized,controlled prospective study.Patients with gastrointestinal disease will be recruited in three children's medical centres in Shanghai and will be randomized to two groups: MP group and IVIG group. Cost effect and clinical outcomes will be evaluated. Blood purification will be evaluated as a remedy when MP and IVIG fail to cure.
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
- None
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
- •both genders
- •age between 2-16 years old
- •IgA vasculitis with gastrointestinal involvement
- •course of disease less than 2 months
- •refractory to ordinary dosage of prednisolone (less than 2mg/kg/d）
排除标准
- •patients with severe sepsis
- •patients with central nervous system infection,
- •patients with severe pneumonia
- •patients with chronic infection (such as EBV, CMV, Tuberculosis)
- •patients complicated by CKD who need renal replacement therapy
- •patients suffering from severe central nervous system complications as intracranial hemorrhage or neuropathy
研究组 & 干预措施
Methylprednisolone group
In this group patients will be given Methylprednisolone pulse(15-30mg/kg/d) and continued with oral prednisolone (2mg/kg/d)
干预措施: Methylprednisolone (Drug)
Methylprednisolone group
In this group patients will be given Methylprednisolone pulse(15-30mg/kg/d) and continued with oral prednisolone (2mg/kg/d)
干预措施: other basic supportive treatment (Drug)
IVIG group
In this group patients will be given IVIG (2g/kg) and at the same time oral prednisolone (2mg/kg/d)
干预措施: IVIG (Drug)
IVIG group
In this group patients will be given IVIG (2g/kg) and at the same time oral prednisolone (2mg/kg/d)
干预措施: other basic supportive treatment (Drug)
结局指标
主要结局
sustained abdominal pain relief
时间窗: 3 days after treatment
no abdominal pain complaint and no abdominal tenderness
次要结局
- hypertension(7 days after treatment)
- The number of days in hospital(at the time of discharge)
- sustained abdominal pain relief(7 days after treatment)
- the number of days of taking fasting(At the time of discharge)
- steroid-related diabetes(3 days after treatment)
- cost of treatment(4 weeks after treatment)
- other treatment rather than assigned intervention(4 weeks after treatment)
- Drug-related side effects(3 days after treatment)
- tolarable food type(2 weeks after treatment)
- infection(4 weeks after treatment)
- ocular hypertension(7 days after treatment)