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依托度酸与吲哚美辛治疗膝骨关节炎的双盲平行对照研究

Double-blind, parallel comparison of etodolac and indomethacin in patients with osteoarthritis of the knee.

作者信息

Karbowski A

机构信息

Klinik und Poliklinik für Allgemeine Abteilung Orthopädie der WWU, Münster, Federal Republic of Germany.

出版信息

Curr Med Res Opin. 1991;12(5):309-17. doi: 10.1185/03007999109112666.

Abstract

The efficacy and tolerability of etodolac and indomethacin were compared in patients with osteoarthritis of the knee. Sixty-four patients entered a double-blind, parallel trial and were randomly assigned to receive 300 mg etodolac twice daily (n = 31) or 50 mg indomethacin 3-times daily (n = 33) for 6 weeks. Both groups showed significant (p less than or equal to 0.05) improvement from baseline in all efficacy assessments at the final evaluation. However, significantly (p less than or equal to 0.05) greater decreases from baseline were seen for etodolac than for indomethacin in patients' global evaluation, pain intensity, night pain, standing pain, walking pain, pain getting up from a chair, tenderness on pressure, and knee flexion. In addition, 67% of the patients in the etodolac group indicated improvement in their condition at the final evaluation, compared with 53% of the patients who received indomethacin. No patients in the etodolac group withdrew because of adverse reactions compared to 4 patients in the indomethacin group. Furthermore, significantly more patients in the indomethacin group (52%) than in the etodolac group (19%) reported drug-related adverse reactions. Thus, the results of this study strongly indicate that etodolac is more effective and produces fewer side-effects than indomethacin in the treatment of patients with osteoarthritis.

摘要

对依托度酸和吲哚美辛治疗膝骨关节炎的疗效和耐受性进行了比较。64例患者进入一项双盲、平行试验,随机分为两组,一组每日两次服用300mg依托度酸(n = 31),另一组每日三次服用50mg吲哚美辛(n = 33),疗程6周。在最终评估时,两组在所有疗效评估方面均较基线有显著(p≤0.05)改善。然而,在患者总体评估、疼痛强度、夜间疼痛、站立疼痛、行走疼痛、从椅子上起身时的疼痛、压痛和膝关节屈曲方面,依托度酸组较基线的下降幅度显著(p≤0.05)大于吲哚美辛组。此外,在最终评估时,依托度酸组67%的患者表示病情有所改善,而接受吲哚美辛治疗的患者这一比例为53%。依托度酸组无患者因不良反应退出,而吲哚美辛组有4例。此外,吲哚美辛组报告与药物相关不良反应的患者(52%)显著多于依托度酸组(19%)。因此,本研究结果强烈表明,在治疗膝骨关节炎患者时,依托度酸比吲哚美辛更有效且副作用更少。

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