The efficacy and safety of thalidomide in the treatment of refractory Crohn’s disease in adults:a double-center,double-blind,randomized–controlled trial  

作　　者：Xiang Peng Zi-Wen Lin Min Zhang Jia-Yin Yao Jun-Zhang Zhao Pin-Jin Hu Qian Cao Min Zhi 

机构地区：[1]Department of Gastroenterology,The Sixth Affiliated Hospital,Sun Yat-sen University,Guangzhou,Guangdong,P.R.China [2]Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Diseases,The Sixth Affiliated Hospital,Sun Yat-sen University,Guangzhou,Guangdong,P.R.China [3]Department of Gastroenterology,Sir Run Run Shaw Hospital Affiliated to Zhejiang University,Hangzhou,Zhejiang,P.R.China

出　　处：《Gastroenterology Report》2022年第1期519-525,共7页胃肠病学报道（英文）

基　　金：supported by Academician Jie-shou Li Intestinal Barrier Special Research Fund[grant number LJS-201908C].

摘　　要：Background Thalidomide is applied in therapy for refractory Crohn’s disease(CD)in adults,but systematic and rigorous clinical evidence is scant.The aim was to provide theoretical references for the efficacy of thalidomide in the therapy for refractory CD in adults.Methods A double-center,double-blind,placebo-controlled,randomized clinical trial of refractory CD in adults in two inflammatory bowel disease centers in China.In the double-blind trial,patients were randomly assigned to 100mg of thalidomide or placebo daily for 8 weeks.The primary outcome was considered as the clinical remission rate calculated based on the Crohn’s disease activity index at the eighth week following thalidomide or placebo treatment.In open label,nonresponse to placebo was additionally treated with 8 weeks of thalidomide;all responders were continuously treated with thalidomide until the 48th week.Results Twenty-five patients were randomly assigned to each group.At the eighth week,the clinical remission rate in the thalidomide group was significantly higher than that in the placebo group(68.0%[17/25]vs 16.0%[4/25];relative risk,4.2;95%confidence interval,1.8–10.9,P<0.001).After a 48-week follow-up,the continuous treatment rate of thalidomide was 46.3%(19/41).Adverse events during the whole process were reported in 58.5%of patients,mainly involving drowsiness,rash,and peripheral neuropathy that were mild and tolerable.Conclusion Thalidomide can be used in the induction and maintenance therapy of refractory CD in adults.And it could be one of the treatment options for refractory CD.

关 键 词：Crohn’s disease THALIDOMIDE REFRACTORY clinical remission 

分 类 号：R574.62[医药卫生—消化系统]