来氟米特联合甲氨蝶呤治疗类风湿关节炎40例临床观察

The efficacy and safety of combination therapy with methotrexate and leflunomide in patients with active rheumatoid arthritis

目的观察来氟米特联合甲氨蝶呤治疗类风湿关节炎(rheumatoid arthritis,RA)的临床疗效和安全性。方法选取80例活动期RA患者,应用抽签随机法分为两组各40例,两组治疗开始时均服用同一种非甾体抗炎药(洛索洛芬60 mg bid),对照组单用甲氨蝶呤10 mg/周,联合治疗组同时加用来氟米特20 mg/次。观察患者用药前及用药后4、6、12、18、24周的肿胀关节数、疼痛关节数、压痛关节数、晨僵时间、健康评估问卷(health assessment questionnaire,HAQ)、受试者评估的疼痛VAS评分、受试者评估的疾病总体状况VAS评分、研究者评估的疾病总体情况VAS评分、疾病活动分数(DAS28)、类风湿因子(RF)、血沉(ESR)及超敏C反应蛋白(CRP)水平,血常规、肝肾功,同时观察不良反应发生情况,并进行统计分析。结果联合治疗组用药24周后ACR20改善率优于对照组(P<0.05),两组ACR70改善率比较在治疗4、18及24周时差异有统计学意义(P<0.05)。治疗24周时两组DAS28评分及不良反应发生率比较差异无统计学意义(P>0.05)。结论来氟米特联合甲氨蝶呤治疗RA与单用甲氨蝶呤比较能够更好的控制病情,而不良反应并无明显增加。

Objective＊ the efficacy and safety of combination therapy with methotrexate（ MTX）and leflunomide in patients with active rheumatoid arthritis（RA）. Methods 80 patients with active RA were randomly divided into two groups, one group with MTX 10 mg/week, the other group with MTN 10 mg once a week plus leflunomide 20 mg once a day. At baseline and after 4 weeks, 6 weeks, 12 weeks, 18 weeks ,24 weeks of treatment, swollen joint count, tender joint count, duration of morning stiffness, doctor and pa- tient evaluation, disease activity score（ DAS28 ）, erythrocyte sedimentation rate（ ESR）, ultra-sensitivity C-reactive protein（CRP） level were doeumented.χ2 test and the t test were used for statistical analysis. Results After 24 weeks of treatment,ACR20 improvement in the combination therapy group was better than that in the control group（ 78% vs 53%, P 〈 0. 05 ）, and there was no difference in DAS28 score and the incidence of adveme reactions between two groups. Conclusion Compared with MTX monothrapy, the combination thera- py with MTX and leflunomide can better and safely eontrol the disease.