甲氨蝶呤与柳氮磺吡啶治疗强直性脊柱炎的临床对比研究

目的：对甲氨蝶呤（methotrexate，MTX）和柳氯磺吡啶（sulfasalazine，SSZ）治疗强直性脊柱炎（ankylosing spondylitis，AS）的临床疗效进行长期对比观察，以评价两种药物治疗AS的有效性及安全性。方法：住院治疗的AS患者120例随机分为两组各60例，分别采用SSZ（SSZ组）、MTX（MTX组）治疗，两组患者年龄、性别、病程及病情相匹配，均选择一种非甾体类抗炎药作为基础疗法。随访3年的临床资料．包括症状体征、BathAS活动指数（BASDAI）、Bath AS功能指数（BASFI）、血沉和C反应蛋白等化验检查及不良反应。结果：两组患者随访第1、2、3年与入院时比较，腰骶痛明显减轻（P〈0．05）。晨僵时间显著缩短（P〈0．05），BASDAI和BASFI明显降低（P〈0．05），炎性指标血沉和C反应蛋白显著下降（P〈0．05）；而随访各阶段两组间差异均无统计学意义．不良反应以胃肠道反应和白细胞减少为主，胃肠道反应MTX组（5％）明显低于SSZ组（12％）（P〈0．05），白细胞减少两组间差异无统计学意义；随访所有病例无造血系统障碍发生。结论：MTX和SSZ治疗AS疗效相近。MTX不良反应较少，患者易耐受。采用MTX治疗AS有更多的优越性，其更长期的疗效及安全性有待进一步观察。

Methotrexate versus sulfasalazine in the treatment of ankylosing spondylitis

Objective To evaluate the efficacy and safety of both methotrexate (MTX) and sulfasalazine (SSZ) in the treatment of ankylosing spondylitis (AS) by chronically observing the clinical effects of the two agents. Methods 120 patients with AS were randomized to receive MTX (MTX group,n=60) or SSZ (SSZ group,n=60) under the basic treatment with one kind of NSAIDs,and were followed for three years. The data including symptoms and signs,Bath AS disease activity index (BASDAI),Bath AS functional index (BASFI),ESR,and CRP,along with the adverse events,were documented. Results As compared with those documented at the time of admission,lumbosacralgia was evidently relieved (P < 0.05),the duration of morning stiffness was markedly shortened (P < 0.05),BASDAI and BASFI were obviously declined (P < 0.05),and the inflammatory markers ESR and CRP were significantly decreased (P < 0.05) in the two treatment groups on the first,second,and third year of follow-up. However,there were no notable differences between these groups. The major adverse events included gastrointestinal responses and leucopenia. Fewer gastrointestinal responses occurred in MTX group than in SSZ group (5% vs 12%,P < 0.05) while leucopenia did not differ notably between the two groups. No impaired hematopoiesis was found during three-year of follow-up. Conclusion MTX is as effective as SSZ in the treatment of AS. However,it has fewer side effects and is more tolerable,and its more chronic efficacy and safety needs to be further observed.