来氟米特与柳氮磺吡啶治疗强直性脊柱炎疗效观察

Clinical Study on Effectiveness of Leflunomide Compared with Sulfasalazine in Treatment of Ankylosing Spondylitis

目的观察来氟米特与柳氮磺吡啶治疗强直性脊柱炎的疗效和安全性。方法60例强直性脊柱炎(AS)患者随机分为两组,每组30例,分别服用来氟米特和柳氮磺吡啶,并治疗1年,分别在治疗前和治疗后3、6、12个月记录患者症状、体征、AS活动指数(BASDAI)、AS功能指数(BASFI)等及药物不良反应。结果两组患者在治疗后与治疗前比较,腰背痛、晨僵时间均改善,疼痛关节数、BASDAI、BASFI、红细胞沉降(ESR)、C-反应蛋白(CRP)均下降,差异均有统计学意义(均P<0.05);比较两组间总有效率,差异无统计学意义(P>0.05)。来氟米特组的胃肠道症状发生率明显低于柳氮磺吡啶组,差异有统计学意义(P<0.05)。结论来氟米特治疗强直性脊柱炎的疗效与柳氮磺吡啶相当,但副作用少。

Objective To evaluate the effectiveness and safety of leflunomide compared with sulfasalazine in treatment of ankylosing spondylitis. Methods Sixty cases of ankylosing spondylitis were randomized into two groups：in 30 patients leflunomide was taken and in 30 patients were treated with sulfasalazine.The treatment lasted one year after discharge.The observation items included symptoms and sign,the bath ankylosing spondylitis disease activity index（BASDAI）, the bath ankylosing spondytis function index （BASFI） and side effects have been used to assess the respon- siveness of lefunomide and sulfasalazine therapy at study entry,three months,six months and twelve months after treatment. Results In the third ,sixth and twelfth months of follow-up,the lumbosacral portion pain,the time of lumbodorsal morning stiffness,the count of joint pain,BASDAI,BASFI,ery-throcyte sedimentation rate （ESR）,C-reaction protein （CRP） were all significantly lower than those on admission （P〈0.05）,No notable difference was found in the total effectiveness rates between the groups（P〉0.05）.The incidence rates of gastrointestinal symptoms of leflunomide was less than those of sulfasalazine. Conclusion The effectiveness of leflunomide was the same as those of sulfasalazine in treatment of ankylosing spondylitis.The adverse events of leflunomide are less than those of sulfasalazine.