Caroit M, Forette B, Hubault A, Pasquier P
Scand J Rheumatol Suppl. 1976;1976(0):123-7.
In this trial, the patients suffering from osteoarthritis of the hip received either ketoporfen or a placebo successively for 2 treatment periods, A and B, of 14 days each. The daily dosage of ketoprofen was 150 mg in 3 doses of 50 mg. In each case treated, the parameters necessary for the diagnosis and those necessary to assess progress under treatment are reported. At the end of the trial, results have been rated according to the preference of the patient for treatment period A or B. The results were analysed by the sequential method. The therapeutic results reported were obtained from various criteria stated in the protocol (subjective evaluation by the patient, pain when resting, duration of morning stiffness, distance of pain-free walking, amplitude of movements, etc.). Nine cases were sufficient to produce a significant statistical result in favour of ketoprofen. In eight observations a preference in favour of ketoprofen was apparent. In one case only, there was no preference for either one or the other of the two treatment periods (failure of ketoprofen and of the placebo). Ketoprofen was excellently tolerated.
在该试验中,患有髋骨关节炎的患者在两个为期14天的治疗阶段A和B中,先后接受酮洛芬或安慰剂治疗。酮洛芬的日剂量为150毫克,分3次服用,每次50毫克。对每个治疗病例,均报告了诊断所需参数以及评估治疗进展所需参数。试验结束时,根据患者对治疗阶段A或B的偏好对结果进行了评定。结果采用序贯法进行分析。报告的治疗结果来自方案中规定的各种标准(患者主观评估、静息时疼痛、晨僵持续时间、无痛行走距离、活动幅度等)。9例病例足以产生有利于酮洛芬的显著统计学结果。在8次观察中,明显表现出对酮洛芬的偏好。仅在1例病例中,对两个治疗阶段中的任何一个均无偏好(酮洛芬和安慰剂均无效)。酮洛芬耐受性良好。