| Methods |
Study Type: interventional study
Study Design: randomised parallel controlled trial |
| Participants |
Inclusion Criteria
Males and females between 18 and 65 years of age Diagnosed with severe drug eruption (SJS/TEN) (see "China Clinical Dermatology" on page 751) When the female patients of childbearing age were enrolled in the trial, their urine pregnancy test must be negative, all patients must agree to take contraceptive measures Provide written informed consent and willing and able to comply with all aspects of the protocol
Exclusion Criteria
Any systemic corticosteroids therapeutic dosage > 0.5 mg/kg/d within 1 week prior to randomisation Suffering from severe neuropsychiatric diseases and endocrine diseases Associated with other cutaneous manifestations that may affect the efficacy judgements by: viral infections, fungal infections, bacterial infections, syphilis, or tuberculosis Patients who are allergic to any ingredient of the drug to be studied Combined viral infectious liver disease, or severe heart disease, or severe hypertension, or associated with life‐threatening gastrointestinal bleeding patients Pregnant or lactating females Any other situations not suitable for this study as determined by the investigators
Age minimum: 18
Age maximum: 65
Gender: both |
| Interventions |
Glucocorticoid group: IVIG 400 mg/kg/d, for 5 days after the withdrawal
Glucocorticoid plus immunoglobulin group: IVIG 400 mg/kg/d for 5 days, then IVIG 400 mg/kg/d, for 5 days after the withdrawal |
| Outcomes |
Primary Outcome(s)
Secondary Outcome(s)
|
| Notes |
We contacted the authors three times via e‐mail (twice in English on 20 May 2020 and 23 February 2021 and once in Chinese on 5 March 2021), but received no response. |
