| Registry | NCT06456086 |
|---|---|
| Status | Unknown |
| Study type | Observational |
| Enrollment | 27 (Actual) |
| Sponsor | First Affiliated Hospital of Kunming Medical University (Other) |
| Conditions | Adverse Drug Reactions |
| Interventions | stimulation with EB virus (Biological) |
| Dates | start 2020-12-01, primary completion 2024-03-31, completion 2024-10-31 (estimated), first posted 2024-06-13, last updated 2024-06-13 |
| Locations | 1 site in China |
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This study aims to investigate the effect of EBV reactivation or EBV reactivation added with dexamethasone(DXM) in patients with adverse drug reactions(CDR) , through evaluating the levels on monocyte, macrophage M2/M1 and cytokines. To investigate whether expression of EBV receptors EphA2 could specifically influence on EBV activation in CDRs. We performed a prospective longitudinal study on the frequencies of Monocyte, Macrophage, M2/M1 and cytokines included IL-4,IL-13,TNF-α,IFN-γ,IFN-β, CXCL9 and CXCL10 after onset of MPE ,SJS/TEN and control groups. PBMCs collected from peripheral blood were cocultured with EBV or EBV with DXM. We next examined whether EBV or EBV with DXM could have a strong impact on the MOs, Mac, M2/M1 and cytokines and which cytokines could be crucial for the interaction between M2/M1 and EBV, by in vitro cocultures. Finally, EphA2 were detected to evaluate reactivation of EBV.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Stevens-Johnson syndrome/toxic epidermal necrolysis | Biological: stimulation with EB virus | ||
| healthy control group | Biological: stimulation with EB virus | ||
| Maculopapular Eruption | Biological: stimulation with EB virus |
Sex: All, ages: 18 Years to any, accepts healthy volunteers
Inclusion Criteria: 1. Age and Gender: The study includes male and female patients aged 18 years and older. 2. a.Erythema Multiforme (MPE) Patients: Diagnosed based on clinical presentation and medical examination findings.b.Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis (SJS/TEN) Patients: Diagnosed according to the criteria set by the International Dermatology Society for SJS or TEN.c.Control Group: Healthy volunteers, without any history of chronic disease or acute infection, and not currently on any medications. Exclusion Criteria: 1. Other Chronic Diseases: Patients with active heart, liver, kidney disease, or other systemic conditions. 2. Acute Infection: Patients who have had a viral or bacterial infection within the month prior to enrollment. 3. Immune Status: Patients who are immunocompromised or are receiving immunosuppressive therapy. 4. Allergy History: Patients with a known allergy to any drugs or agents used in the study. 5. Pregnancy or Lactation: Women who are currently pregnant or breastfeeding.
| Facility | City | Country | Status |
|---|---|---|---|
| Tang Junting | Kunming, Yunnan | China |