柳氮磺吡啶、甲氨喋呤及二者合用治疗强直性脊柱炎的临床研究

目的观察单用柳氟磺吡啶（sulfasalazine，SSZ）、甲氨喋呤（methotrexate,MTX）以及二者合用对强直性脊柱炎（ankylosing spondylitis，AS）的临床疗效，以评价3种组合治疗AS的有效性及安全性。方法住院治疗的AS患者150例随机分为3组各50例．分别采用SSZ（SSZ组）、MTX（MTX组）、SSZ联合MTX（联合组）治疗，3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。出院后继续原药物治疗，并随访3年的临床资料，包括临床症状体征、Bath AS活动指数（BASDAI）、Bath AS功能指数（BASFI）、炎性指标等实验室检查及不良反应。结果3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ESR和CRP显著下降．差异有统计学意义（P〈0.05）。腰骶痛、腰背晨僵时间、BASDAI、BASFI，随访各阶段SSZ组和MTX组均较联合组明显改善，差异均有统计学意义（P〈0．05）。而SSZ组和MTX组2组间比较差异均无统计学意义。随访各阶段ESR和CRP3组间差异均无统计学意义。不良反应以胃肠道反应为主。3组间比较无统计学意义，随访所有病例无造血系统障碍发生。结论SSZ与MTX治疗AS的疗效相近，且均优于二者合用，不良反应均较轻，患者可以耐受。单用SSZ或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。

Long-term efficacy of sulfasalazine, methotrexate and sulfasalazine combined with methotrexate in treatment of ankylosing spondylitis: a clinical study

Objective To evaluate the efficacy and safety of sulfasalazine(SSZ),methotrexate(MTX)and SSZ combined with MTX in the treatment of ankylosing spondylitis(AS).Methods One hundred and fifty patients with AS were randomized into three groups,which admitted to our department of rheumatology from 1999 to 2002.Among them 50 patients took SSZ(SSZ group),and 50 patients were treated with MTX(MTX group)matched with 50 SSZ combined with MTX recipients(combined group).One kind of NSAIDs was taken by all the patients as the basic therapy.The treatment remained in three groups after discharged.The follow-up was lasted for three years.The observation included symptoms,signs,Bath AS disease activity index(BASDAI),Bath AS index(BASFI),inflammation markers,laboratory tests and side effects.SPSS11.0 statistics software was used to analyze the data.Results At the 1st,2nd and 3rd year of follow-up,the incidence rates of low back pain were markedly lower than those at admission(P< 0.05),and the time of morning stiffness was obviously shorter than those at admission(P< 0.05),and BASDAI,BASFI,ESR and CRP were significantly lower than those at admission too(P<0.05).During the three-year follow-up,the parameters as low back pain,morning stiffness,BASDAI and BASFI of SSZ group and MTX group were obviously better than those of combined group(P<0.05).However,there was no notable difference between SSZ group and MTX group.AS for ESR and CRP,there were no significant differences among the three groups.Gastrointestinal symptoms were the most common side effects,but there were no notable differences among the three groups.No aplastic anemia was found in the three groups during the three-year follow-up.Conclusion SSZ is as effective as MTX for the treatment of AS,which is better than SSZ combined with MTX.The side effects are mild,and all the patients have good tolerance to the treatment.It is suggested that SSZ or MTX alone is of great superiority compared with the combination of SSZ and MTX.