The Research of Standard Diagnosis and Treatment for Severe Henoch-Schonlein Purpura in Children
Overview
- Phase
- Phase 2
- Intervention
- Dexamethasone
- Conditions
- Henoch-Schoenlein Purpura
- Sponsor
- Nanjing Children's Hospital
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- The Symptoms of Digestive Tract
- Last Updated
- 6 years ago
Overview
Brief Summary
This study is performed to evaluate the efficacy and safety of various measures in the treatment of severe HSP in children.
Detailed Description
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.
Investigators
Aihua Zhang
Hospital vice president
Nanjing Children's Hospital
Eligibility Criteria
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
Arms & Interventions
group 1
Dexamethasone 0.5mg/kg.d i.v.
Intervention: Dexamethasone
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
Intervention: Dexamethasone
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
Intervention: Gamma globulin
group 3
Dexamethasone \& hemoperfusion Dexamethasone 0.5mg/kg.d i.v \& hemoperfusion should be given at least three times in five days
Intervention: Dexamethasone
group 3
Dexamethasone \& hemoperfusion Dexamethasone 0.5mg/kg.d i.v \& hemoperfusion should be given at least three times in five days
Intervention: Hemoperfusion
Outcomes
Primary Outcomes
The Symptoms of Digestive Tract
Time Frame: 2 weeks
The stomachache and other symptoms of digestive tract disappear
The Symptoms of Joint System
Time Frame: 2 weeks
The arthralgia disappears
Secondary Outcomes
- The Skin Rash(2 weeks)
- Renal function(2 weeks)