Cochrane L A, Nicholson A N, Stone B M
Pharmacol Biochem Behav. 1983 Feb;18(2):307-10. doi: 10.1016/0091-3057(83)90384-2.
Effect of diazepam on sleep in man was investigated in a series of placebo controlled studies and the data on various measures from two groups (young adults and middle age) were retrospectively analysed. Variability of the measures between the two groups with placebo was not different, but the variability of their response to the drug was different, and that of the middle aged group was high. In the young adults there were drug effects, but in the middle aged group no drug effects could be established. The studies suggest that variability of data must be taken into consideration when it is used to indicate the most appropriate dose range. If the variability of response is low the data may indicate the likely effect of the drug on each individual. On the other hand if the variability is high then data obtained from analysis of the group may have limited relevance, and suggest doses which are too high for the majority of the individuals within that group.
在一系列安慰剂对照研究中,调查了地西泮对人类睡眠的影响,并对两组(年轻人和中年人)各种测量数据进行了回顾性分析。两组使用安慰剂时测量值的变异性没有差异,但他们对药物反应的变异性不同,中年组的变异性较高。在年轻人中有药物效应,但在中年组中无法确定药物效应。这些研究表明,在使用数据来指示最合适的剂量范围时,必须考虑数据的变异性。如果反应变异性较低,数据可能表明药物对每个个体的可能影响。另一方面,如果变异性较高,那么从组分析中获得的数据相关性可能有限,并可能提示对该组中大多数个体来说过高的剂量。