The Research of Standard Diagnosis and Treatment for Severe HSP in Children
Ключови думи
Резюме
Описание
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.
Дати
| Последна проверка: | 01/31/2020 |
| Първо изпратено: | 08/19/2015 |
| Очаквано записване подадено: | 08/31/2015 |
| Първо публикувано: | 09/03/2015 |
| Изпратена последна актуализация: | 02/24/2020 |
| Последна актуализация публикувана: | 02/25/2020 |
| Действителна начална дата на проучването: | 07/31/2015 |
| Приблизителна дата на първично завършване: | 06/30/2020 |
| Очаквана дата на завършване на проучването: | 06/30/2020 |
Състояние или заболяване
Интервенция / лечение
Drug: Dexamethasone
Drug: group 2
Procedure: group 3
Фаза
Групи за ръце
| Arm | Интервенция / лечение |
|---|---|
| Experimental: group 1 Dexamethasone 0.5mg/kg.d i.v. | |
| Experimental: 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 | Drug: group 2 |
| Experimental: group 3 Dexamethasone & hemoperfusion Dexamethasone 0.5mg/kg.d i.v & hemoperfusion should be given at least three times in five days | Procedure: group 3 |
Критерии за допустимост
| Възрасти, отговарящи на условията за проучване | 2 Years Да се 2 Years |
| Полове, допустими за проучване | All |
| Приема здрави доброволци | Да |
| Критерии | Inclusion Criteria: - Severe HSP: could not be controlled with dexamethasone 0.5mg/kg/d or the total dose above 20mg/d for more than two days Exclusion Criteria: - The children with congenital diseases |
Резултат
Първични изходни мерки
1. The Symptoms of Digestive Tract [2 weeks]
2. The Symptoms of Joint System [2 weeks]
Вторични изходни мерки
1. The Skin Rash [2 weeks]
2. Renal function [2 weeks]
