小剂量来氟米特治疗类风湿关节炎的长期疗效  

Long-term efficacy of low dose leflunomide in the treatment of rheumatoid arthritis

作　　者：王军[1] 祖比亚[1] 林德帅[1] 杨俊生[1] 覃学勇[1] 廖明[1] 

机构地区：[1]南方医科大学附属柳州医院柳州市柳铁中心医院肾内科,545007

出　　处：《中国综合临床》2012年第4期364-367,共4页Clinical Medicine of China

基　　金：广西医药卫生自筹经费计划课题（Z2010135）

摘　　要：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10mg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：（-97．84-6．2）、（-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。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 rag/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 indieators：naJn 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： 1- 8. 5 ± 6. 3 ） vs i - 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 ）,

关 键 词：活动性类风湿关节炎 来氟米特 治疗组 长期疗效 小剂量 疼痛视觉模拟评分 柳氮磺胺吡啶 美国风湿病学会 

分 类 号：R593.22[医药卫生—内科学]