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(P0.05).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(P0.05).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.