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Stevens-Johnson Syndrome Associated with Drugs and Vaccines in Children: A Case-Control Study
Authors:Umberto Raucci  Rossella Rossi  Roberto Da Cas  Concita Rafaniello  Nadia Mores  Giulia Bersani  Antonino Reale  Nicola Pirozzi  Francesca Menniti-Ippolito  Giuseppe Traversa  Italian Multicenter Study Group for Vaccine Safety in Drug  Children
Affiliation:1. Paediatric Emergency Department, Bambino Gesù Children’s Hospital, IRCCS, Roma, Italy.; 2. National Centre for Epidemiology, Surveillance and Health Promotion, National Institute of Health, Roma, Italy.; 3. Department of Experimental Medicine, Section of Pharmacology “L. Donatelli”, Second University of Napoli, Napoli, Italy.; 4. Pharmacology and Paediatrics, Università Cattolica S. Cuore, Roma, Italy.; Nottingham University, United Kingdom,
Abstract:

Objective

Stevens-Johnson Syndrome (SJS) is one of the most severe muco-cutaneous diseases and its occurrence is often attributed to drug use. The aim of the present study is to quantify the risk of SJS in association with drug and vaccine use in children.

Methods

A multicenter surveillance of children hospitalized through the emergency departments for acute conditions of interest is currently ongoing in Italy. Cases with a diagnosis of SJS were retrieved from all admissions. Parents were interviewed on child’s use of drugs and vaccines preceding the onset of symptoms that led to the hospitalization. We compared the use of drugs and vaccines in cases with the corresponding use in a control group of children hospitalized for acute neurological conditions.

Results

Twenty-nine children with a diagnosis of SJS and 1,362 with neurological disorders were hospitalized between 1st November 1999 and 31st October 2012. Cases were more frequently exposed to drugs (79% vs 58% in the control group; adjusted OR 2.4; 95% CI 1.0–6.1). Anticonvulsants presented the highest adjusted OR: 26.8 (95% CI 8.4–86.0). Significantly elevated risks were also estimated for antibiotics use (adjusted OR 3.3; 95% CI 1.5–7.2), corticosteroids (adjusted OR 4.2; 95% CI 1.8–9.9) and paracetamol (adjusted OR 3.2; 95% CI 1.5–6.9). No increased risk was estimated for vaccines (adjusted OR: 0.9; 95% CI 0.3–2.8).

Discussion

Our study provides additional evidence on the etiologic role of drugs and vaccines in the occurrence of SJS in children.
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