小剂量来氟米特治疗类风湿关节炎的长期疗效观察

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。

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

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(P<0.05).In addition,all the secondary end-points in the therapy group also got better improvements than that in the control group(P<0.05).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(P>0.05).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(P<0.05).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.