来氟米特与柳氮磺吡啶治疗强直性脊柱炎的临床对比研究

Clinical study on long-term effectiveness of leflunomide compared with sulfasalazine in treatment of ankylosing spondylitis

目的:对来氟米特(leflunomide,LEF)和柳氮磺吡啶(sulfasalazine,SASP)治疗强直性脊柱炎(ankylosing spon- dylitis,AS)的疗效进行为期2年的临床对比观察,以评价两种药物治疗AS的有效性及安全性。方法:将112例住院治疗的AS患者随机分为两组,每组各56例,分别采用LEF(LEF组)或SASP(SASP组)治疗,两组患者的年龄、性别、病程及病情相匹配,均选择一种非甾体类抗炎药(NSAIDs)作为基础疗法。随访2年,记录症状体征、Bath AS活动指数(BASDAI)、Bath AS功能指数(BASFI)、红细胞沉降率和C-反应蛋白浓度等实验室检查及不良反应。结果:两组患者随访第1、2年与入院时比较,腰骶痛明显减轻,腰背晨僵时间显著缩短,BASDAI和BASFI明显降低,炎性指标红细胞沉降率和C-反应蛋白浓度显著下降(均P<0．05);随访第1、2年两组间比较,腰骶痛、腰背晨僵时间、BASDAI、BASFI、红细胞沉降率和C-反应蛋白浓度, LEF组较SASP组改善明显,差异均有统计学意义(P<0．05)。药物不良反应以胃肠道反应、白细胞数减少和皮疹为主,LEF组胃肠道反应明显低于SASP组(5．2％vs11．8％)(P<0．05),白细胞数减少和皮疹两组间差异无统计学意义。结论:LEF治疗AS疗效优于SASP。LEF不良反应少,服用方便,患者易耐受,其更长期的疗效及安全性有待进一步观察。

Objective： To evaluate the long-term effectiveness and safety of leflunomide （LEF） compared with sulfasalazine （SASP） in treatment of ankylosing spondylitis （AS）. Methods： One hundred and twelve in patients with AS were randomized into two groups： 56 patients took LEF （LEF group）, and 56 patients were treated with SASP （SASP group）. One kind of NSAIDs was taken by all the patients as the basic therapy. The treatment in two groups lasted two years after discharge. The obserVation items included symptoms, signs, Bath AS disease activity index （BASDAI）, Bath AS functional index （BASFI）, erythrocyte sedimentation rate （ESR）, C-reaction protein （CRP） and side effects. SPSS 12.0 statistics software was used to analyze the data. Results： In the 1st and 2nd years of follow-up, the incidence rates of lumbosacral portion pain,the time of lumbodorsal morning stiffness,BASDAI,BASFI, ESR and CRP were significantly lower than those on admission （P〈0.05）,and there were notable differences between the two groups, too （P〈0.05）. Gastrointestinal symptoms,leucopenia and rash were the most common side effects. The incidence rates of gastrointestinal symptoms of LEF group were lower than those of SASP group （5.2% vs 11, 8%, P〈0. 05）. As for leucopenia and rash, there were no notable differences between the two groups. Conclasion：LEF is better than SASP in the treatment of AS. The side effects of LEF are less than those of SASP,and the patients have better tolerance to LEF than SASP. It is suggested that LEF is superior to SASP in the treatment of AS.