来氟米特治疗强直性脊柱炎伴周围关节炎

摘要

To evaluate the efficacy and safety of leflunomide ( LFM ) in the treatment of refractory ankylosing spondylitis ( AS ) with peripheral arthritis. Methods A patient-blind, randomized, placebo-controlled clinical trial was employed in this study. 67 cases of active AS with peripheral arthritis patients, who were refractory to the therapy of sulfasalazine( SSZ ) and non-steroidal anti-inflammatory drugs( NSAIDs ), were randomized at baseline to receive either LFM or matching placebo for 24 weeks. The therapeutic effect and adverse reactions were observed. Results After the treatment for 24 weeks, LFM could significantly improve the following indexes of AS with peripheral arthritis: morning stiffness, C-reactive protein, Maastricht ankylosing spondylitis enthesitis score ( MASES ), tenderness peripheral joints, swelling peripheral joints, Bath ankylosing spondylitis patient global score ( BAS-G ), Bath ankylosing spondylitis functional index ( BASFI ), Bath ankylosing spondylitis disease activity index ( BAS-DAI ), patient' s and physician' s global assessment of disease activity, thus the rate of ASAS20 responders was significantly elevated. The indexes included linear definition of the Bath ankylosing spondylitis metrology index( BAS-Mllin ), chest expansion, total pain and night pain in the spine, were not ameliorated. The difference of adverse reactions incidence between the LFM and control group did not reach the statistical significance. Conclusion LFM is effective and safe in the treatment of refractory AS with peripheral arthritis.%目的 探讨来氟米特(LFM)治疗难治性强直性脊柱炎(AS)伴周围关节炎的疗效和安全性.方法 采用患者单盲、随机及安慰剂对照的临床试验研究方法,将67例经柳氮磺胺吡啶(SSZ)和非甾体抗炎药(NSAIDs)治疗无效的活动性AS伴周围关节炎患者随机分为两组,分别接受LFM和安慰剂治疗,疗程24周,观察疗效和不良反应.结果 LFM能显著改善AS伴周围关节炎的晨僵、C反应蛋白(CRP)、Maastricht强直性脊柱炎起止点炎评分(MASES)、压痛周围关节数、肿胀周围关节数、Bath强直性脊柱炎患者整体评分(BAS-G)、Bath强直性脊柱炎功能指数(BASFI)、Bath强直性脊柱炎疾病活动指数(BASDAI)、医师和患者对疾病活动性的整体评价,显著提高ASAS20有效率,但对线形Bath强直性脊柱炎计量指数(BASMIlin)、胸廓扩张度、总背痛及夜间背痛无明显改善.不良反应发生率在LFM组与对照组间差异无显著性.结论 LFM治疗难治性AS伴有的周围关节炎安全、有效.