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双盲多中心研究:比较甲氯芬那酸钠、吲哚美辛和安慰剂治疗关节外风湿性疾病的疗效。

Double-blind multicenter study comparing meclofenamate sodium with indomethacin and placebo in the treatment of extra-articular rheumatic disease.

作者信息

Boussina I, Günthner W, Martí Massó R

出版信息

Arzneimittelforschung. 1983;33(4A):649-52.

PMID:6349650
Abstract

161 patients with extra-articular or non-articular disorders as acute shoulder syndrome, periarthritis humero scapularis, syndrome of the angular of the scapula, acute olecranon bursitis, acute epicondylitis and/or epitrochleitis or periarthritis of the hip were treated in this double-blind multicenter study. 53 patients received 300 mg N-(2,6-dichloro-m-tolyl)anthranilic acid, sodium salt (meclofenamate sodium, Meclomen) per day for a maximum of 3 weeks, 54 received 150 mg indomethacin per day and 54 received placebo. Meclofenamate sodium was significantly superior to placebo in the treatment of such symptoms as spontaneous pain, pain on motion, tenderness on pressure associated with acute episodes of extra- or non-articular rheumatism as demonstrated by earlier and superior improvement. Indomethacin showed comparable efficacy. Adverse reactions, mostly gastrointestinal symptoms, were reported by 15 patients receiving meclofenamate sodium (28.3%), 26 patients taking indomethacin (48.2%) and 5 patients in the placebo group (9.3%). The tolerance of meclofenamate sodium was good with the distinct clinical impression that meclofenamate sodium was better tolerated than indomethacin.

摘要

在这项双盲多中心研究中,对161例患有关节外或非关节疾病(如急性肩部综合征、肩周炎、肩胛角综合征、急性鹰嘴滑囊炎、急性上髁炎和/或尺骨上髁炎或髋关节炎)的患者进行了治疗。53例患者每天服用300毫克N-(2,6-二氯间甲苯基)邻氨基苯甲酸钠(甲氯芬那酸钠,甲氯灭酸),最长服用3周;54例患者每天服用150毫克吲哚美辛;54例患者服用安慰剂。甲氯芬那酸钠在治疗关节外或非关节性风湿病急性发作相关的自发痛、运动痛、压痛等症状方面明显优于安慰剂,改善更早且更显著。吲哚美辛显示出相当的疗效。接受甲氯芬那酸钠治疗的15例患者(28.3%)、服用吲哚美辛的26例患者(48.2%)和安慰剂组的5例患者(9.3%)报告了不良反应,主要为胃肠道症状。甲氯芬那酸钠的耐受性良好,明显的临床印象是甲氯芬那酸钠比吲哚美辛耐受性更好。

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