CAJ | 학술논문

目的观察小剂量来氟米特治疗类风湿关节炎的长期临床疗效.方法 28例类风湿关节炎病例随机进入治疗组(15例)及对照组(13例).治疗组采用小剂量来氟米特(略去负荷剂量),日剂量10 mg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,主要疗效指标为肿胀、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、晨僵时间、健康评价问卷(HAQ)、C反应蛋白；同时记录美国风湿病学会疗效评价指标( ACR20、50).结果治疗18个月后:主要疗效指标肿胀关节数改善及疾病总体评价,治疗组均优于对照组[肿胀关节数:(-8.5±6.3)、(-7.9±6.4)个,患者主观评价:(-1.4±0.8)、(-1.2±0.6)分,医师主观评价:(-1.4±1.2)、(-1.3±0.9)分,P均＜0.01]；在次要疗效指标方面,治疗组疼痛评分、晨僵时间及HAQ评分改善优于对照组[疼痛VAS评分:(-32.4±23.7)、(-31.6±24.8)分,晨僵时间:(-97.8±6.2)、(-92.4±5.2)min,HAQ:(-0.62 ±0.08)、(-0.57 ±0.02)分,P均＜0.01].达到ACR20标准的患者,治疗组占76.9％,对照组为75.0％(P＞0.05)；达到ACR50标准的患者分别占61.5％、47.0％ (P ＜0.05).研究过程中治疗组胃肠道反应轻微,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类风湿关节炎,与柳氮磺胺吡啶相比疗效确切,耐受性好.
목적 관찰소제량래불미특치료류풍습관절염적장기림상료효.방법 28례류풍습관절염병례수궤진입치료조(15례)급대조조(13례).치료조채용소제량래불미특(략거부하제량),일제량10 mg유지,대조조사용류담광알필정치료,1.5 ～2.0 g/d.관찰기18개월,주요료효지표위종창、압통관절수、환자급의사대질병상황총체평개；차요료효지표위동통시각모의평분、신강시간、건강평개문권(HAQ)、C반응단백；동시기록미국풍습병학회료효평개지표( ACR20、50).결과 치료18개월후:주요료효지표종창관절수개선급질병총체평개,치료조균우우대조조[종창관절수:(-8.5±6.3)、(-7.9±6.4)개,환자주관평개:(-1.4±0.8)、(-1.2±0.6)분,의사주관평개:(-1.4±1.2)、(-1.3±0.9)분,P균＜0.01]；재차요료효지표방면,치료조동통평분、신강시간급HAQ평분개선우우대조조[동통VAS평분:(-32.4±23.7)、(-31.6±24.8)분,신강시간:(-97.8±6.2)、(-92.4±5.2)min,HAQ:(-0.62 ±0.08)、(-0.57 ±0.02)분,P균＜0.01].체도ACR20표준적환자,치료조점76.9％,대조조위75.0％(P＞0.05)；체도ACR50표준적환자분별점61.5％、47.0％ (P ＜0.05).연구과정중치료조위장도반응경미,2례출현혈압승고,2례출현간매승고,2례퇴출；대조조유1례퇴출.결론 장기소제량래불미특치료활동성류풍습관절염,여류담광알필정상비료효학절,내수성호.
Objective To perspectively evaluate the long-term efficacy of low dose leflunomide in treatment of rheumatoid arthritis.Methods Twenty-eight patients with rheumatoid arthritis were randomly divided into treatment group( n =15 ) and control group ( n =13 ).The patients in treatment group were treated with low dose leflunomide( omitting the loading dose) and with maintenance dose of 10 mg/day.And the patients in control group were treated with sulphasalazine in the dose of 1.5 ～ 2.0 g/d.The observation lasted for 18 months and the observed indicator were as follows:( 1 ) The primary efficacy indicators:counts of swollen and tender joints,overall assessment of disease status made by patients and physicians; ( 2 ) Secondary efficacy indicators:pain visual analogue scale,duration of morning stiffness,health assessment questionnaire (HAQ),Creaction protein,the American College of Rheumatology Outcome Assessment (ACR20,50).Results Eighteen months after treatment,the primary efficacy indicators in the treatment group were superior to the control group ( swollen joint counts:( - 8.5 ± 6.3 ) vs ( - 7.9 ± 6.4) ; overall assessment by patients:( - 1.4 ± 0.8 ) points vs ( - 1.2 ± 0.6) points; overall assessment by physicians:( - 1.4 ± 1.2 ) points vs ( - 1.3 ± 0.9 ) points; P ＜0.01 ).In the secondary efficacy indicators,pain visual analogue scale,duration of morning stiffness and health assessment questionnaire(HAQ) in the treatment group were significantly improved compared with the control group(VAS score:( - 32.4 ± 23.7) points vs ( - 31.6 ± 24.8) points; duration of morning stiffness:( [ - 97.8 ± 6.2 ] min vs [ - 92.4 ± 5.2 ] min; HAQ:[ - 0.62 ± 0.08 ] points vs [ - 0.57 ± 0.02 ] points,P ＜0.01 ),there was no significant difference on the percentage of patients achieving ACR20 standard between the treatment group and the control group (76.9％ vs 75.0％,P ＞ 0.05 ),but there was significant difference on the percentage of patients achieving ACRS0 standard between the treatment group and the control group( 61.5％ vs 47.0％,P ＜ 0.05 ).The gastrointestinaladverse reactions for patients in the treatment group were mild and there were 2 cases of elevated blood pressure,2 cases of elevated liver enzymes and 2 cases out of the trail,in the control group,there was 1 case out of the trial.Conclusion The long-term treatment of active rheumatoid arthritis with low dose leflunomide can achieve exact efficacy and good tolerability compared with the treatment with sulfasalasine.