作者
Marzia Lazzerini, Stefano Martelossi, Giuseppe Magazzù, Salvatore Pellegrino, Maria Cristina Lucanto, Arrigo Barabino, Angela Calvi, Serena Arrigo, Paolo Lionetti, Monica Lorusso, Francesca Mangiantini, Massimo Fontana, Giovanna Zuin, Gabriella Palla, Giuseppe Maggiore, Matteo Bramuzzo, Maria Chiara Pellegrin, Massimo Maschio, Vincenzo Villanacci, Stefania Manenti, Giuliana Decorti, Sara De Iudicibus, Rossella Paparazzo, Marcella Montico, Alessandro Ventura
发表日期
2013/11/27
期刊
Jama
卷号
310
期号
20
页码范围
2164-2173
出版商
American Medical Association
简介
Importance
Pediatric-onset Crohn disease is more aggressive than adult-onset disease, has high rates of resistance to existing drugs, and can lead to permanent impairments. Few trials have evaluated new drugs for refractory Crohn disease in children.
Objective
To determine whether thalidomide is effective in inducing remission in refractory pediatric Crohn disease.
Design, Setting, and Patients
Multicenter, double-blind, placebo-controlled, randomized clinical trial of 56 children with active Crohn disease despite immunosuppressive treatment, conducted August 2008–September 2012 in 6 pediatric tertiary care centers in Italy.
Interventions
Thalidomide, 1.5 to 2.5 mg/kg per day, or placebo once daily for 8 weeks. In an open-label extension, nonresponders to placebo received thalidomide for an additional 8 weeks. All responders continued to receive thalidomide for an additional minimum 52 weeks.
Main Outcomes …
学术搜索中的文章
M Lazzerini, S Martelossi, G Magazzù, S Pellegrino… - Jama, 2013