| 王军祖比亚杨俊生覃学勇尹琦廖明.小剂量来氟米特治疗类风湿关节炎的临床研究[J].,2011,11(6):1145-1148 |
| 小剂量来氟米特治疗类风湿关节炎的临床研究 |
| Small dose of leflunomide for rheumatoid arthritis |
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| DOI： |
| 中文关键词: 来氟米特 类风湿关节炎 小剂量 临床研究 |
| 英文关键词: Leflunomide rheumatoid arthritis low-dose clinical trial |
| 基金项目:广西卫生厅自筹经费课题(Z2010135) |
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| 中文摘要: |
| 目的：前瞻性观察小剂量来氟米特治疗类风湿关节炎（RA）的临床疗效。方法：32 例类风湿关节炎病例随机进入治疗组及对
照组。治疗方案治疗组采用小剂量来氟米特（略去负荷剂量，每日剂量10mg 维持），对照组使用柳氮磺胺吡啶治疗，1.5-2.0g/ 日。
观察期6 个月，观察指标为主要疗效指标：肿胀、压痛关节数、患者及医师对疾病状况总体评价；次要疗效指标疼痛视觉模拟评
分、晨僵时间、美国风湿病学会疗效评价指标（ACR20、50）、健康评价问卷(HAQ)、C 反应蛋白。结果：治疗6 个月后，主要疗效指标
压痛、肿胀关节数改善及医师总体评价，来氟米特均优于柳氮磺胺吡啶(p<0.05)。在次要疗效指标方面，来氟米特组HAQ 评分及
C 反应蛋白改善优于柳氮磺胺吡啶组(p<0.05)，两组在关节晨僵改善无明显差异。达到ACR20 标准的病例，来氟米特组占56.3％，
柳氮磺胺吡啶组占57.1％(p>0.05)；达到ACR50 标准分别为37.5％、35.7％(p>0.05)。研究中，来氟米特组胃肠道反应轻微，有2 例
出现血压升高。结论：小剂量来氟米特治疗类风湿关节炎治疗活动性类风湿关节炎，与柳氮磺胺吡啶疗效相当，耐受性好。 |
| 英文摘要: |
| Objectives: To prospectively study the efficiency of low-dose leflunomide in active rheumatoid arthritis with
sulphasalazine. Methods: thirty-two subjects with active rheumatoid arthritis were randomized assigned to low dose leflunomide(omitting
loading dose, maintenance dose10mg/day) or sulphasalazine for six months. The primary end-points were tender and swollen joint counts
and global physician and patients assessments. Results: After six months, the mean changes in the low-dose leflunomide and
sulphasalazine, respectively, were -9.7 and -8.3 for tender joint count(p<0.05); -7.6 and -6.7 for swollen joint count(p<0.05); -1.1 and -1.0
for physician global assessment(p<0.05); -1.1 and -1.1 for patients global assessment(p>0.05); the improved HAQ scores and C-reactive
protein in leflunomide group were higher when comared with those of controlled group, while the ACR response in the two groups were
comparable. The adverse events for patients received low-dose leflunomide were slightly except for two drug-related hypertension.
Conclusion: Low-dose leflunomide used in the study were efficacious for active rheumatoid arthritis treatment compared with
sulphasalazine, and it was well tolerated. |
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