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依托度酸治疗骨关节炎:一项双盲、安慰剂对照试验。

Etodolac therapy for osteoarthritis: a double-blind, placebo-controlled trial.

作者信息

Williams P I, Hosie J, Scott D L

机构信息

Royal Gwent Hospital, Newport, Wales.

出版信息

Curr Med Res Opin. 1989;11(7):463-70. doi: 10.1185/03007998909115933.

Abstract

The efficacy of etodolac (600 mg/day) and placebo were compared in a 4-week double-blind, parallel-group study involving 104 patients with osteoarthritis of the knee and 106 with osteoarthritis of the hip. Most patients had improvement of their symptoms during the study, but significantly more improvement was seen in the patients taking etodolac. Patients with osteoarthritis of the knee taking etodolac had significantly (p less than 0.05) more improvement than placebo-treated patients in joint swelling, weight-bearing pain, and patient's overall assessment. Patients with osteoarthritis of the hip taking etodolac had significantly (p less than 0.05) greater improvement than placebo-treated patients in hip abduction, weight-bearing pain, joint tenderness, investigator's overall assessment, and patient's overall assessment. The frequency of adverse events was not statistically different in the two treatment groups. However, significantly (p = 0.05) more etodolac-treated patients (n = 9) than placebo-treated patients (n = 2) reported indigestion. The incidence of adverse events was similar in patients aged 65 years and older to that in patients younger than 65 years. Results of laboratory evaluations indicated that etodolac therapy was associated with no more hepatic or renal enzyme abnormalities than was placebo.

摘要

在一项为期4周的双盲平行组研究中,对依托度酸(600毫克/天)和安慰剂的疗效进行了比较,该研究涉及104例膝骨关节炎患者和106例髋骨关节炎患者。大多数患者在研究期间症状有所改善,但服用依托度酸的患者改善更为显著。服用依托度酸的膝骨关节炎患者在关节肿胀、负重疼痛和患者总体评估方面比服用安慰剂的患者有显著(p<0.05)更多的改善。服用依托度酸的髋骨关节炎患者在髋关节外展、负重疼痛、关节压痛、研究者总体评估和患者总体评估方面比服用安慰剂的患者有显著(p<0.05)更大的改善。两个治疗组不良事件的发生率在统计学上没有差异。然而,报告消化不良的依托度酸治疗患者(n = 9)比安慰剂治疗患者(n = 2)显著(p = 0.05)更多。65岁及以上患者不良事件的发生率与65岁以下患者相似。实验室评估结果表明,依托度酸治疗与安慰剂相比,肝或肾酶异常情况并无更多。

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