Brown J H, Hull J, Biundo J J
J Clin Pharmacol. 1975 May-Jun;15(5-6):455-63. doi: 10.1002/j.1552-4604.1975.tb02369.x.
The safety and effectiveness of tolmetin was assessed in ten patients with active rheumatoid arthritis for 12 months. All patients met the requirements of the American Rheumatism Association's diagnostic criteria for definite rheumatoid arthritis. None of the patients had received gold, antimalarials, or glucocorticoids. All had been stabilized, more or less, with aspirin. Monthly measurements were made of grip strength, duration of morning stiffness, time to the onset of fatigue, Westergren sedimentation rates, the number of swollen joints, number of hot joints, the time to walk 50 feet, and the circumference of proximal interphalangeal (PIP) joints (measured in millimeters with a plastic-loop arthrocircameter). The initial dosage of tolmetin in all patients was 600 mg a day, given orally in three divided doses. Upon completion of the study, the average daily oral dosage was 1400 mg tolmetin. No other antiinflammatory drugs were allowed. The results indicate that tolmetin affords symptomatic relief of rheumatoid arthritis; its use results in global improvement in 80 per cent of the patients, and a net improvement in one or more of the parameters used to assess disease activity in 100 per cent of the patients; it seems to be sufficiently safe to administer to patients over a long period of time; there was no evidence of severe toxicity of any kind; gastrointestinal side effects were uncommon, and epigastric distress, in particular, was not observed.
在10名活动性类风湿性关节炎患者中对托美丁的安全性和有效性进行了为期12个月的评估。所有患者均符合美国风湿病协会明确类风湿性关节炎的诊断标准要求。所有患者均未接受过金制剂、抗疟药或糖皮质激素治疗。所有人或多或少都已用阿司匹林使病情稳定下来。每月测量握力、晨僵持续时间、疲劳发作时间、魏氏血沉率、肿胀关节数、发热关节数、步行50英尺所需时间以及近端指间关节（PIP）的周长（用塑料环关节测量仪以毫米为单位测量）。所有患者托美丁的初始剂量为每日600mg，分三次口服给药。研究结束时，托美丁的平均每日口服剂量为1400mg。不允许使用其他抗炎药。结果表明，托美丁能缓解类风湿性关节炎的症状；其使用使80%的患者整体病情得到改善，100%的患者在用于评估疾病活动的一个或多个参数上有净改善；长期给患者服用似乎足够安全；没有任何严重毒性的证据；胃肠道副作用不常见，尤其未观察到上腹部不适。
