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口服镇痛药的交叉和平行研究。

Crossover and parallel study of oral analgesics.

作者信息

Wang R I, Waite E

出版信息

J Clin Pharmacol. 1981 Apr;21(4):162-8. doi: 10.1002/j.1552-4604.1981.tb05695.x.

Abstract

Ten years ago, analgesics were studied using crossover designs. In recent years, analgesics have been studied only in parallel designs primarily because biostatisticians do not like crossover studies. The advantages of crossover studies are numerous: (1) patients serve as their own control; (2) there is less variability of responses among patients; and (3) a smaller number of patients is needed to provide statistically significant data. As long as crossover of treatment medications does not occur within 4 to 6 hours, the problem of carryover effect of the previous medication is insignificant or negligible. Two studies will be presented. One is a crossover study of Percodan with and without naloxone to placebo. The other is a parallel study comparing the effects of propoxyphene with naloxone to those of propoxyphene alone. The results of these studies reaffirm the value of the crossover method of evaluating analgesics.

摘要

十年前,人们使用交叉设计来研究镇痛药。近年来,镇痛药仅在平行设计中进行研究,主要是因为生物统计学家不喜欢交叉研究。交叉研究的优点很多:(1)患者自身作为对照;(2)患者之间的反应变异性较小;(3)需要较少数量的患者来提供具有统计学意义的数据。只要治疗药物的交叉不在4至6小时内发生,先前药物的残留效应问题就微不足道或可以忽略不计。将展示两项研究。一项是含与不含纳洛酮的 Percodan 与安慰剂的交叉研究。另一项是平行研究,比较丙氧芬与纳洛酮的效果与单独使用丙氧芬的效果。这些研究结果再次证实了评估镇痛药的交叉方法的价值。

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