小剂量来氟米特治疗类风湿关节炎的长期疗效观察

Efficiency of Low-Dose Leflunomide in Treating Active Rheumatoid Arthritis:An Eighteen-Month Trial

目的观察小剂量来氟米特治疗类风湿关节炎(RA)的长期临床疗效。方法将28例RA患者随机分为治疗组(13例)和对照组(12例)。治疗组采用小剂量来氟米特治疗(略去负荷剂量,10 mg/d维持),对照组使用柳氮磺胺吡啶治疗,1.5～2.0 g/d。观察期18个月,观察指标:主要疗效指标为肿胀关节数、压痛关节数、患者及医师对疾病状况总体评价;次要疗效指标为疼痛视觉模拟评分(VAS)、晨僵时间、健康评价问卷(HAQ)、C反应蛋白(CRP)水平;同时记录美国风湿病学会疗效评价指标(ACR20、ACR50)。结果治疗18个月后,治疗组患者主要疗效指标——肿胀关节数、医师及患者总体评价改善方面均优于对照组(P<0.05);且次要疗效指标——VAS、晨僵时间、HAQ评分改善方面亦优于对照组,差异有统计学意义(P<0.05)。达到ACR20标准的病例,治疗组占76.9%,对照组为75.0%,两组间差异无统计学意义(P>0.05);达到ACR50标准的病例,治疗组和对照组分别为61.5%和41.7%,两组间差异有统计学意义(P<0.05)。治疗过程中,治疗组胃肠道反应轻微,有2例出现血压升高,2例出现肝酶升高,2例退出;对照组有1例退出。结论长期小剂量来氟米特治疗活动性RA,与柳氮磺胺吡啶相比疗效确切,患者耐受性好。

Objective To determine the long term clinical efficiency of low-dose leflunomide in treating rheumatoid arthritis.Methods Twenty-eight patients with active rheumatoid arthritis were randomly divided into therapy group（thirteen）,which was administered low dose leflunomide（omitting loading dose,maintenance dose 10 mg/day） and control group（twelve）,which was administered sulphasalazine（1.5~2.0 g/d）.The treatment lasted for eighteen months.The indexes observed：the primary end-points including the numbers of tender and swollen joints and general assessments of physicians and patients,secondary end-points including VAS,morning stiffness,HAQ,CRP level and the efficiency evaluation indexes judged by the Institute of Rheumatology of the United States（ACR20 and ACR50）.Results After eighteen months′ treatment,all the primary end-points in the therapy group got better improvements than that in the control group（P0.05）.In addition,all the secondary end-points in the therapy group also got better improvements than that in the control group（P0.05）.76.9% of the cases in the therapy group and 75.0% in the control group reached the standard of ACR20,and the difference was not significant（P0.05）.61.5% of the cases in the therapy group and 41.7% of the cases in the control group reached the standard of ACR50,and the difference was significant（P0.05）.In the process of treatment,the patients in the therapy had slight gastrointestinal discomfort,two cases′ blood pressure began to rise,two cases′ liver enzymes began to rise and two cases dropped out;there was only one cases in the control group dropped out.Conclusion Comparing with sulphasalazine,long term of low-dose leflunomide in treating active RA can bring about sure curative effect and the patients can have good endurance of medicine.