来氟米特治疗活动性强直性脊柱炎的疗效与安全性研究

目的评价来氟米特治疗活动性强直性脊柱炎的疗效及安全性。方法选择2003—2005年中国医科大学附属第一医院风湿免疫科符合活动性强直性脊柱炎诊断标准的门诊及住院患者62例,将其随机分成来氟米特组(26例)和甲氨蝶呤组(36例)。来氟米特组按体重>50kg和<50kg,在治疗开始的3d分别给予负荷剂量50mg/d和40mg/d,在此之后的维持量分别是每周50mg和40mg。甲氨蝶呤组第1周口服5mg,第2周口服10mg,第3周及第3周以后每周口服15mg。2组均每日3次口服柳氮磺胺吡啶0·75g。分别于治疗前、治疗后3个月、6个月、12个月及18个月,做Bath强直性脊柱炎活动性指数(BASDAI)及Bath强直性脊柱炎测量指数(BASMI)评分。同时测定血常规、血沉(ESR)、肝功能、肾功能及尿沉渣。在治疗前、治疗后6个月、10个月、18个月做骶髂关节CT及其他受累关节的X线平片检查。结果来氟米特组共22例随访至18个月,甲氨蝶呤组有29例随访至18个月。从6个月开始来氟米特组BASDAI比甲氨蝶呤组明显好转(P<0·01)。2组BASMI及ESR比较差异均无显著性意义(P>0·05),骶髂关节CT及X线平片对比差异亦无显著性意义,且各自与治疗前对比无加重。来氟米特组不良反应发生率为18·18%(4/22),甲氨蝶呤组为31·03%(9/29)。2组均无肾脏异常及肺间质病。结论本研究提示来氟米特治疗活动性强直性脊柱炎疗效与甲氨蝶呤相似,不良反应较甲氨蝶呤少。

Treatment of active ankylosing spondylitis with leflunomide and methotrexate : a prospective controlled clinical trial

Objective To assess the efficacy and safety of leflunomide in active ankylosing spondylitis.Methods Totally 62 cases of active ankylosing spondylitis were included,and divided randomly into leflunomide group(n=26)and methotrexate group(n=36).The patients in leflunomide group received an oral leflunomide loading dose of 50 mg or 40 mg once daily for the first 3 days followed by a maintenance dose of 50 mg or 40 mg once weekly,according to whether the bodyweight was more than 50 kg or less than 50 kg,respectively.The patients in methotrexate group were prescribed oral methotrexate 5 mg once in the first week,10 mg once in the second week,15 mg once in the third week and thereafter weekly.Sulfasalazine was prescribed 0.75 three times daily in both groups.The Bath Ankylosing Spondylitis Disease Activity Index(BASDAI)and The Bath Ankylosing Spondylitis Metrology Index(BASIM)scoring instruments were used to assess the responsiveness to leflunomide and methotrexate at entry,three months,six months,twelve months and eighteen months after treatment,respectively.Laboratory data including peripheral blood counts(WBC,HGB,RBC),erythrocyte sedimentation rates(ESR),liver enzymes,serum creatinine,urinary sediments were detected at the same time.Sacroiliac joints CT scan and other involved joints x-ray radiograph examinations were taken at entry,six months,twelve months and eighteen months after treatment,respectively.Results Twenty-two cases in leflunomide group and 29 cases in methotrexate group were followed up to eighteen months.BASDAI in leflunomide group was significantly lower(P<0.01)compared with MTX group from six months.As to BASMI and ESR,there were no differences between the two groups at three months,six months,twelve months and eighteen months.No deterioration with sacroiliac joints on CT scan and the involved joints on x-ray radiographs in the two groups was found.The incidence rate of adverse events were higher in MTX group than LEF group.Conclusion Leflunomide shows the same efficacy as methotrexate in active ankylosing spondylitis,while the adverse effects are mild compared with methotrexate.