Morley K D, Bernstein R M, Hughes G R, Black C M, Rajapakse C N, Wilson L
Curr Med Res Opin. 1984;9(1):28-34. doi: 10.1185/03007998409109555.
An open study was carried out in 46 patients with osteoarthritis of the hip to compare the efficacy and tolerance of treatment with ketoprofen given either as 100 mg capsules twice daily or as 2 capsules of 100 mg ketoprofen in a controlled-release formulation given once daily. The results of subjective and objective assessments before and during 3-months' treatment in the 48 patients who completed the trial showed both treatments produced improvement in all parameters, except for the time taken for inactivity stiffness to develop, and there was no significant difference between treatments in terms of efficacy. The controlled-release preparation, however, was significantly better tolerated than the ordinary capsule form. Minor haematological and biochemical changes during treatment were noted but these were not of clinical importance. Six patients, 2 receiving the controlled-release and 4 receiving the ordinary formulation of ketoprofen, were withdrawn because of lack of efficacy or unacceptable side-effects.
对46例髋骨关节炎患者进行了一项开放性研究,以比较每日两次服用100毫克胶囊酮洛芬与每日一次服用2粒100毫克控释制剂酮洛芬的治疗效果和耐受性。在完成试验的48例患者中,3个月治疗前和治疗期间的主观和客观评估结果显示,两种治疗方法在所有参数上均有改善,但不包括出现静息僵硬的时间,且两种治疗方法在疗效方面无显著差异。然而,控释制剂的耐受性明显优于普通胶囊剂型。治疗期间注意到有轻微的血液学和生化变化,但这些变化不具有临床重要性。6例患者因疗效不佳或出现不可接受的副作用而退出研究,其中2例接受控释制剂,4例接受普通剂型的酮洛芬。