Grisanti A M, Vaz A A, Samara A M
Rheumatology Department, University of Chile, Santiago.
Clin Ther. 1992 Nov-Dec;14(6):791-800.
This study compared the efficacy and safety of etodolac, a new nonsteroidal anti-inflammatory drug of the pyranocarboxylic class, with that of diclofenac in patients with osteoarthritis of the knee. A total of 172 patients entered this double-blind, parallel study and were randomly assigned to receive etodolac 600 mg/day (n = 85) or diclofenac 150 mg/day (n = 87) for 8 weeks. Both treatment groups showed a statistically significant reduction in pain at the second week and significant improvement (P < or = 0.05) from baseline in all efficacy assessments for the remainder of the study. Seventeen (20%) patients in the etodolac group and 21 (24%) patients in the diclofenac group reported at least one adverse event. Seven (8%) patients treated with etodolac and eight (9%) of those receiving diclofenac withdrew prematurely from the trial. One diclofenac-treated patient had a significant increase in alanine aminotransferase at the final evaluation. The results of this study indicate that etodolac was well tolerated and as effective as diclofenac in relieving the signs and symptoms of osteoarthritis.
本研究比较了新型吡喃羧酸类非甾体抗炎药依托度酸与双氯芬酸对膝骨关节炎患者的疗效和安全性。共有172例患者进入这项双盲、平行研究,并被随机分配接受8周的依托度酸600毫克/天(n = 85)或双氯芬酸150毫克/天(n = 87)治疗。两个治疗组在第2周时疼痛均有统计学意义的减轻,且在研究剩余时间的所有疗效评估中与基线相比均有显著改善(P≤0.05)。依托度酸组有17例(20%)患者和双氯芬酸组有21例(24%)患者报告了至少1次不良事件。接受依托度酸治疗的7例(8%)患者和接受双氯芬酸治疗的8例(9%)患者提前退出试验。1例接受双氯芬酸治疗的患者在最终评估时丙氨酸转氨酶显著升高。本研究结果表明,依托度酸耐受性良好,在缓解骨关节炎体征和症状方面与双氯芬酸同样有效。