沙利度胺治疗强直性脊柱炎的长期疗效与安全性

The efficacy and safety of long-term thalidomide in the treatment of ankylosing spondylitis

目的 了解强直性脊柱炎（AS）患者接受沙利度胺1年治疗的疗效与安全性.方法 共有232例难治性AS患者纳入本研究,沙利度胺每晚睡前顿服150 mg.定期对患者的强直性脊柱炎病情活动性指数（BASDAI）、脊柱痛评分和药物相关不良反应进行评价.结果 从治疗的第3个月开始,BASDAI评分下降[（5.8±1.2）分降至（3.7±1.2）分,P〈0.05],脊柱痛评分明显下降[（6.2±1.0）分降至（3.1±1.3）分,P〈0.05],随着治疗时间的延长,这种改善程度进一步增加.148例（63.8%）患者的BASDAI评分和脊柱痛评分均下降50%以上,其中脊柱痛消失的患者人数达到76例（32.8%）.常见不良反应有困倦（31.0%）、便秘（17.2%）、口干（16.4%）、头晕（14.7%）和头皮屑（11.2%）.32例（13.8%）患者因不良反应停用沙利度胺,上述不良反应多于停药后缓解.结论 长期使用沙利度胺对难治性AS安全有效,其疗效随着用药时间的延长有增加趋势.

Objective To investigate the long term efficacy and safety of thalidomide in the treatment of refractory ankylosing spondylitis.Methods A total of 232 patients with refractory ankylosing spondylitis were recruited into open study using thaiidomide at a dose of 150 mg/d, bath ankylosing spondylitis disease activity index （ BASDAI） , spinal pain score and thaiidomide related side effects were observed regularly.Results From the third month, BASDAI and spine pain score decreased significantly when compared with those of the base line （ P 〈 0.05）.Such improvement became more obvious as time went on.A total of 148 patients （63.8% ） got 〉50% improvement in BASDAI and spine pain score, and 76 cases （32.8% ） reported absence of spine pain.The major side effects were drowsiness, constipation, dry mouth, dizziness and dandruff.Thirty two patients （13.8% ） withdrew from the study because of adverse events.Most of the adverse effects disappeared as thaiidomide was stopped.Conclusion Long term thaiidomide is effective and safe for treating resistant ankylosing spondylitis and it has cumulative effect as duration prolongs.