Crohn's disease (CD) is a chronic gastrointestinal inflammatory disease characterized by
relapse and progression. The incidence and prevalence of IBD are increasing in different
regions around the world, indicating its emergence as a global disease. Though modern medical
therapies including immunomodulators and biologic agents have revolutionized treatment of CD,
the occurrence of steroids-dependence and resistance or intolerance to medical therapy is
quite common. The limitation of present therapeutic management and the high expense of
biologic agents leads to the treatment of CD become "refractoriness". The occurrence rate of
steroids-dependence and resistance or intolerance to thiopurine therapy is quite high during
the course of CD. Approximately 38% of cases required surgery within 10 years. Therefore, the
management of such refractory CD remains a great therapeutic challenge for clinicians.
Thalidomide is an oral agent that has immunomodulatory, antiangiogenic and TNF(tumor necrosis
factor)-a- suppressing effects. The potential role for thalidomide in the treatment of
refractory paediatric and adult CD has been investigated in more and more small open-label
studies and retrospective case series. Recently, a randomized controlled trial showed
thalidomide improved clinical remission at 8 weeks of treatment and longer-term maintenance
of remission in pediatric refractory CD. Gerich et al reported in a retrospective study that
thalidomide improved long-term outcomes among 37 refractory CD adults followed up for a
median of 58 months. However, the dose of thalidomide used in these studies ranged from
50mg/d to 150mg/d, and the occurrence rate of side effects reported variously but all quite
high. The side effects related to the dose of thalidomide were the major concerns of using it
in CD. Moreover, the effect of thalidomide on endoscopic response including mucosal healing
which is a more objective and important outcome in CD was rarely reported. Therefore the aim
of this study is to investigate the efficacy on clinical and endoscopic response and the
adverse effects of using low-dose thalidomide in active adult CD patients.