Schattenkirchner M
Universitats Poliklinik, Munchen, Federal Republic of Germany.
Eur J Rheumatol Inflamm. 1990;10(1):56-65.
The safety of etodolac, a new nonsteroidal anti-inflammatory drug (NSAID), was reviewed by examining data from 3,302 patients enrolled in double-blind and open-label clinical trials and from 8,334 patients taking etodolac in post-marketing surveillance studies. The review determined that gastrointestinal disturbances are the most frequently reported side effects, followed by headache, dizziness, rash, and pruritus. The rate of abdominal pain and dyspepsia is similar to that observed with several other NSAIDs but is lower than that seen with aspirin. Gastrointestinal ulceration occurs in less than 0.3% of patients taking etodolac, and drug-related hepatic, renal, and hematologic dysfunctions are rare. The elderly appear to be no more at risk of experiencing adverse effects than the general population. Overall, the review confirmed the excellent safety profile of etodolac reported previously.
通过审查3302名参与双盲和开放标签临床试验的患者以及8334名在上市后监测研究中服用依托度酸的患者的数据，对新型非甾体抗炎药（NSAID）依托度酸的安全性进行了评估。该评估确定，胃肠道不适是最常报告的副作用，其次是头痛、头晕、皮疹和瘙痒。腹痛和消化不良的发生率与其他几种NSAID相似，但低于阿司匹林。服用依托度酸的患者中胃肠道溃疡发生率低于0.3%，与药物相关的肝、肾和血液系统功能障碍很少见。老年人出现不良反应的风险似乎并不高于普通人群。总体而言，该评估证实了之前报道的依托度酸出色的安全性。
