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[酮洛芬新型口服盖仑制剂的开放性临床试验]

[Open clinical trial of a new oral galenic form of ketoprofen].

作者信息

Huck F, Lecocq J, Meyer R, Kuntz J L, Asch L

出版信息

Sem Hop. 1983 Dec 12;59(46):3240-2.

PMID:6318350
Abstract

Thirty-two patients with rheumatoid arthritis and several other rheumatic diseases were entered into a randomized study to investigate the correlation between the pharmacokinetics and clinical effectiveness of Bi-Profenid 150 mg. Each patient was given, in a variable order, one 150 mg Bi-Profenid tablet twice daily for 2 days, and two 50 mg Profenid capsules each morning and noon with one 100 mg suppository each evening for 2 days. Dosage convenience, effectiveness on pain during the second part of the night and resolution of morning stiffness were considered better with Bi-Profenid by 23 patients and with conventional forms by four, while five reported no preference. In 15 patients treated for one month, only 5 reported mild side-effects which did not require withdrawal from the study. The patients' preference appears to be a result of the bioavailability of Bi-Profenid.

摘要

32名类风湿性关节炎患者和其他几种风湿性疾病患者参与了一项随机研究,以调查150毫克双氯芬酸的药代动力学与临床疗效之间的相关性。每位患者按可变顺序接受治疗,即每天两次服用一片150毫克双氯芬酸片剂,共2天;以及每天早晚各服用两片50毫克氯芬那酸胶囊,同时每晚使用一枚100毫克栓剂,共2天。23名患者认为双氯芬酸在剂量便利性、夜间后半段对疼痛的疗效以及晨僵缓解方面优于传统剂型,4名患者认为传统剂型更好,5名患者表示无偏好。在接受一个月治疗的15名患者中,只有5名报告有轻微副作用,无需退出研究。患者的偏好似乎是双氯芬酸生物利用度的结果。

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