Division of Rheumatology, Buddhist Tzu-Chi General Hospital, Hualien, Taiwan, R.O.C.
J Chin Med Assoc. 2009 Nov;72(11):581-7. doi: 10.1016/S1726-4901(09)70433-2.
To study the clinical effectiveness and adverse reactions of etanercept in patients with active rheumatoid arthritis (RA), in whom combination therapies with disease-modifying antirheumatic drugs (DMARDs) had failed.
One hundred and thirty-three patients with active RA who had been treated without satisfactory effect with DMARDs were entitled, by the Taiwan Bureau of National Health Insurance, to undergo etanercept injection (25 mg subcutaneously, twice weekly) along with oral methotrexate (15 mg weekly) in Taipei Veterans General Hospital. The disease activity score in 28 swollen and 28 tender joints (DAS28), erythrocyte sedimentation rate (ESR), serum C-reactive protein (CRP), rheumatoid factors (RFs), tender joint count (TJC), and swollen joint count (SJC) were recorded at the beginning, 3, 6, 9, and 12 months after treatment. Any adverse event, relevant or irrelevant to the therapy, was recorded throughout the whole course of treatment.
Ninety-four patients completed the 1-year therapeutic program. There were significant improvements in all parameters (DAS28, ESR, CRP, TJC and SJC), which approached satisfactory values at the end of the first 3 months and which were sustained thereafter in most patients. Patients also tolerated the treatment protocol well, with adverse events occurring sporadically. Significant clinical response occurred as early as 3 months after the start and might last beyond 1 year in some patients. Adverse effects such as injection site reaction or infections rarely occurred.
Combination therapy with etanercept and DMARDs seemed to be effective at improving the aching symptoms associated with rheumatoid activity and was well tolerated in this cohort study. It was generally safe, though a small number of non-fatal infections were observed.
研究依那西普（etanercept）在治疗对疾病修饰抗风湿药物（DMARDs）联合治疗反应不佳的活动期类风湿关节炎（RA）患者中的临床疗效和不良反应。
133 例对 DMARDs 治疗反应不佳的活动期 RA 患者，根据台湾全民健康保险局的规定，在台北荣民总医院接受依那西普（25mg 皮下注射，每周两次）联合口服甲氨蝶呤（15mg 每周一次）治疗。在治疗前、治疗后 3、6、9 和 12 个月分别记录 28 个压痛关节和 28 个肿胀关节的疾病活动评分（DAS28）、红细胞沉降率（ESR）、血清 C 反应蛋白（CRP）、类风湿因子（RFs）、压痛关节数（TJC）和肿胀关节数（SJC）。记录整个治疗过程中任何与治疗相关或不相关的不良事件。
94 例患者完成了 1 年的治疗方案。所有参数（DAS28、ESR、CRP、TJC 和 SJC）均有显著改善，在治疗开始后前 3 个月内接近满意值，并且在大多数患者中持续存在。患者也能很好地耐受治疗方案，不良事件偶有发生。在开始治疗后 3 个月内就出现了显著的临床反应，并且在一些患者中可能持续超过 1 年。不良反应如注射部位反应或感染很少发生。
依那西普联合 DMARDs 治疗似乎能有效改善与类风湿活动相关的疼痛症状，并且在本队列研究中耐受良好。虽然观察到少数非致命性感染，但总体上是安全的。
