Department of Rheumatology, Mianyang Central Hospital, Mianyang, Sichuan, China.
Department of Clinical Research Center, Dazhou Central Hospital, No. 56 Nanyuemiao Street, Tongchuan District, Dazhou, Sichuan, China.
Sci Rep. 2020 Jul 23;10(1):12339. doi: 10.1038/s41598-020-69309-z.
Leflunomide (LEF) is a conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) for the treatment of rheumatoid arthritis. However, there are few reports on the comparison of efficacy between LEF alone and combined with other csDMARDs. Here, the efficacy and safety of LEF monotherapy (88) and combination (361) therapy groups were evaluated. After 3 months, there were no significant differences in 28-joint disease activity score (DAS28), health assessment questionnaire (HAQ), erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) between the monotherapy and combination groups (all P > 0.05). According to the European League Against Rheumatism (EULAR) response criteria, it was found that the DAS28 response rates were similar in the two groups (P > 0.05). Besides, the two groups presented similar safety profiles. Subgroup analysis found that there was no difference in efficacy among the three combined therapies (LEF + methotrexate (MTX), LEF + hydroxychloroquine (HCQ), and LEF + MTX + HCQ) and LEF monotherapy. Furthermore, when the dose of LEF was less than 40 mg/day, no significant difference in efficacy was observed between low and high doses. Overall, these results indicated that low dose LEF monotherapy was not inferior to the combination therapy.
来氟米特（LEF）是一种传统的合成疾病修饰抗风湿药物（csDMARDs），用于治疗类风湿关节炎。然而，关于 LEF 单独治疗与联合其他 csDMARDs 治疗疗效的比较报告较少。在这里，评估了 LEF 单药（88 例）和联合（361 例）治疗组的疗效和安全性。治疗 3 个月后，两组 28 关节疾病活动评分（DAS28）、健康评估问卷（HAQ）、红细胞沉降率（ESR）和 C 反应蛋白（CRP）均无显著差异（均 P＞0.05）。根据欧洲抗风湿病联盟（EULAR）反应标准，发现两组 DAS28 反应率相似（P＞0.05）。此外，两组具有相似的安全性特征。亚组分析发现，三种联合治疗（LEF+甲氨蝶呤（MTX）、LEF+羟氯喹（HCQ）和 LEF+MTX+HCQ）与 LEF 单药治疗之间疗效无差异。此外，当 LEF 剂量小于 40mg/天时，低剂量和高剂量之间的疗效无显著差异。总体而言，这些结果表明，低剂量 LEF 单药治疗并不劣于联合治疗。
