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酮洛芬与安慰剂治疗髋关节骨关节炎的双盲试验

Double-blind trial of ketoprofen compared with placebo in osteoarthrosis of the hip.

作者信息

Hubault A, Caroit M, Forette B, Pasquier P

出版信息

Rheumatol Rehabil. 1976;Suppl:52-5. doi: 10.1093/rheumatology/15.5.52.

Abstract

In this study, patients suffering from osteoarthrosis of the hip received two successive periods of treatment, A and B, each of two weeks, with either ketoprofen or a placebo. The daily dosage of ketoprofen was 150 mg in three divided doses of 50 mg. In each case the findings necessary for diagnosis and for assessment of progress during the treatment were recorded. At the end of the trial, the patient's preference for one or other of the two periods of treatment was used as the criterion. The results were analysed by the sequential method. The therapeutic effects assessed by the various criteria included in the protocol (patient's subjective assessment, pain at rest, duration of morning stiffness, distance walked without pain, range of movements, etc.) were also recorded. Nine cases were sufficient to provide a statistically significant result in favour of ketoprofen. In eight cases the preference was definitely in favour of ketoprofen. In a single case there was no preference for one or other of the two periods of treatment (failure of both ketoprofen and placebo). Tolerance to ketoprofen was excellent.

摘要

在本研究中,患有髋骨关节炎的患者接受了两个连续的治疗阶段,A阶段和B阶段,每个阶段为期两周,治疗药物为酮洛芬或安慰剂。酮洛芬的日剂量为150毫克,分三次服用,每次50毫克。在每种情况下,均记录了诊断和评估治疗期间病情进展所需的各项结果。试验结束时,以患者对两个治疗阶段中某一个阶段的偏好作为评判标准。结果采用序贯法进行分析。还记录了根据方案中各项标准评估的治疗效果(患者主观评估、静息痛、晨僵持续时间、无痛行走距离、活动范围等)。九例病例足以得出支持酮洛芬的具有统计学意义的结果。八例病例中,患者明确偏好酮洛芬。仅一例病例对两个治疗阶段均无偏好(酮洛芬和安慰剂均无效)。对酮洛芬的耐受性良好。

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