沙利度胺治疗难治性克罗恩病的初步疗效观察

Preliminary efficacy of thalidomide in refractory Crohn＇s disease treatment

目的观察沙利度胺对难治性CD的疗效及安全性。方法纳人经糖皮质激素及硫唑嘌呤治疗无效或糖皮质激素依赖的中重度活动期CD患者21例，予沙利度胺100mg／d睡前顿服，随访1年。对其临床疗效、内镜下表现及安全性进行评估。结果21例难治性CD患者中，6例因不良反应停药，2例因无效停药，3例仍继续用药但未完成1年随访，10例完成1年随访。f艋床症状缓解、显效及无效分别占23．8％（5／21）、19．0％（4／21）及57．1％（12／21）。内镜下黏膜愈合、好转及无改善分别占9．5％（2／21）、14．3％（3／21）及76．2％（16／21）。不良反应发生率为71．4％（15／21），包括皮疹、便秘、嗜睡、手足麻木、白细胞减少和肌肉酸痛。出现不良反应的平均时间为3．4周。结论沙利度胺对难治性CD具有一定疗效，可用于不愿使用生物制剂或手术的患者，但应注意其不良反应。

Objective To observe the efficacy and safety of thalidomide in refractory Crohn＇s disease （CD）. Methods A total of 21 moderate or severe active CD patients were enrolled, who had no response to glucocorticoid and azathioprine treatment or steroid-dependent. The patients were administrated with thalidomide 100 mg/d before sleep and followed up for one year. The clinical efficacy, endoscopic findings and safety were evaluated. Results Among 21 refractory CD patients, six patients stopped medication due to adverse effect and two because of ineffectiveness, three patients continued medication not completed one year follow-up, 10 patients completed one year follow-up. The clinical remission, effective and ineffective rates were 23.8 % （ 5/21 ）, 19.0 % （4/21 ） and 57.1 % （ 12/ 21 ） respectively. Under endoscope, the mucosal healing, improvement and no improvement rates were 9.5%/00（2/21）, 14.3%（3/21） and 76.2% （16/21） respectively. The adverse effect rate was 71.4% （15/21） including rash, conspitation, sommolence, numbness of hands and feet, leucopenia and muscular soreness. The mean time of the adverse effects onset was 3.4 weeks. Conclusions Thalidomide is effective in refractory CD treatment and could be used in patients unwilling to use biological medication or receive surgery. But the adverse effects should be noted.