Phillips G, Selfridge D I, Hayes G, Rose C M
Curr Med Res Opin. 1987;10(7):486-93. doi: 10.1185/03007998709112408.
An open, parallel-group study was carried out to compare the efficacy and tolerance of a sustained-release capsule formulation of tiaprofenic acid at a dosage of 600 mg once daily with standard 300 mg tiaprofenic acid tablets given twice daily. Four hundred and eighty-five general practice patients with rheumatic disease requiring long-term non-steroidal anti-inflammatory drug therapy were included in the analysis. Patients were randomly allocated to receive, in a ratio of 3:1, either 2 X 300 mg sustained-release capsules at night or standard 300 mg tablets twice daily for a treatment period of 3 months. Pain, impairment of function and duration of morning stiffness were assessed at Week 0 (after a 3-day washout period) and at the end of Weeks 4, 8 and 12. Side-effects and compliance were also recorded at the end of Weeks 4, 8 and 12. Eighty-one (16.7%) patients withdrew from the study, with no significant difference in the withdrawal rates for the two treatment groups. Both treatment groups showed significant improvements clinically during tiaprofenic acid treatment; there were no significant differences between the two groups at Weeks 4, 8 or 12, nor were there any significant differences between the two treatment groups in the number of patients reporting side-effects at any of the assessments. In total, 36% of patients reported side-effects during the trial. The results indicate that both formulations are effective, well-tolerated treatments for rheumatic disease in general practice.
开展了一项开放性平行组研究，以比较噻洛芬酸缓释胶囊制剂（每日一次，剂量为600毫克）与标准的噻洛芬酸片（每日两次，每次300毫克）的疗效和耐受性。485名需要长期非甾体抗炎药治疗的风湿性疾病全科患者纳入分析。患者按3:1的比例随机分配，夜间服用2粒300毫克缓释胶囊或每日两次服用标准300毫克片剂，治疗期为3个月。在第0周（3天洗脱期后）以及第4、8和12周结束时评估疼痛、功能障碍和晨僵持续时间。在第4、8和12周结束时也记录副作用和依从性。81名（16.7%）患者退出研究，两个治疗组的退出率无显著差异。两个治疗组在噻洛芬酸治疗期间临床均有显著改善；在第4、8或12周时两组之间无显著差异，在任何一次评估中报告有副作用的患者数量在两个治疗组之间也无显著差异。在试验期间，总计36%的患者报告有副作用。结果表明，对于全科医疗中的风湿性疾病，这两种制剂都是有效的、耐受性良好的治疗方法。
