Purpura, Schoenlein-Henoch
Conditions
Keywords
HSP
Brief summary
The study aims to explore the therapeutic value and mechanism of Interleukin-2 on children with Henoch-schönlein purpura.
Detailed description
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.
Interventions
DRUGIL-2
For all patients,rhIL-2 infusions seven days;recurrent patients was 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.
Sponsors
The First Hospital of Jilin University
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
group A:patients were treated with IL-2.group B:patients were not treated with IL-2.
Eligibility
Sex/Gender
ALL
Age
No minimum to 17 Years
Healthy volunteers
Yes
Inclusion criteria
1. age \<18 years old 2. meet the EULAR/PRINTO/PRES for the diagnosis of HSP 3. HIV negative;Negative for HBV and HCV.
Exclusion criteria
1. heart failure (cardiac function ≥ grade III NYHA) 2. liver insufficiency (upper limit of normal range of transaminase \> 2 times) 3. renal insufficiency (creatinine clearance ≤30ml/min) 4. acute or severe infections such as bacteremia and sepsis 5. malignant tumor 6. high-dose steroid pulse therapy or intravenous injection of glucocorticoids in the last 1 month 7. mental disorders or any other chronic illness or substance abuse may interfere with the ability to comply with agreements or provide information 8. Intestinal ischemia or perforated gastrointestinal bleeding requires surgery 9. Inability to comply with IL-2 treatment regimen.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The change of immunological responses | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The value of serum immunoglobulins and complements | day 0,day 7,3 month,6 month | Laboratory measures were detected, including,serum total IgE, serum Ig A,serum IgG,serum IgM,C3 and C4. |
| Incidence of adverse drug reactions | up to 6 month | Adverse events includes injection site reactions, influenza-like symptoms, infection, fever, tumor, cardiovascular event,drug-induced liver and kidney damage. |
Countries
China
Outcome results
None listed