Clinical Study on Strategy for Refractory Henoch-Schönlein Purpura

Обзор

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.

Вмешательства

• Препарат Methylprednisolone
  1.methylprednisolone pulse (15-30mg/kg/d) for 3 days with continued oral prednisolone(2mg/kg/d) 2.if the patients still complain abdominal pain and feel abdominal tenderness on the third day after intervention , patients would be given IVIG(2g/kg/d)as a change
• Препарат IVIG
  1\. IVIG 2g/kg and oral prednisolone 2mg/kg/d 2.if the patients still complain abdominal pain and feel abdominal tenderness on the third day after intervention , patients would be given methylprednisolone pulse (15-30mg/kg/d) for 3 days
• Препарат other basic supportive treatment
  1. Omeprazole 0.8mg/kg.d.The maximum dose is less than 40mg per day 2. Low molecular weight heparin calcium 50IU/kg.d

Первичные конечные точки

• sustained abdominal pain relief [Срок оценки: 3 days after treatment]

Вторичные конечные точки (11)

• sustained abdominal pain relief [Срок оценки: 7 days after treatment]
• other treatment rather than assigned intervention [Срок оценки: 4 weeks after treatment]
• tolarable food type [Срок оценки: 2 weeks after treatment]
• the number of days of taking fasting [Срок оценки: At the time of discharge]
• Drug-related side effects [Срок оценки: 3 days after treatment]
• hypertension [Срок оценки: 7 days after treatment]
• infection [Срок оценки: 4 weeks after treatment]
• ocular hypertension [Срок оценки: 7 days after treatment]
• steroid-related diabetes [Срок оценки: 3 days after treatment]
• cost of treatment [Срок оценки: 4 weeks after treatment]
• The number of days in hospital [Срок оценки: at the time of discharge]

Критерии участия

Критерии включения

• 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）

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 3 центра

• Children's Hospital of Fudan University — Шанхай
• Children's Hospital of Shanghai — Шанхай
• Shanghai Children's Medical Centre — Шанхай

Идентификаторы

NCT: NCT03647852 · chfuHSP 1.0

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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