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首页> 外文期刊>International journal of clinical pharmacology and therapeutics >Psycho- and immunopharmacological factors relevant to selection of volunteers in clinical studies.
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Psycho- and immunopharmacological factors relevant to selection of volunteers in clinical studies.

机译：与临床研究中志愿者选择有关的心理和免疫药理学因素。

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There are many well-known factors and variables which play a role in the evaluation of pharmacokinetic and pharmacodynamic results gained from healthy volunteers. The genetic constitution is influenced by age, sex, circadian and seasonal variations, dietary factors, immunological function, alcohol intake, smoking, etc. Vesell repeatedly pointed out these facts some time ago [Vesell 1982, Vesell and Passananti 1977]. Since Janke [1964], we have suspected that personality traits can also influence the drug response. The following overview is dedicated to this field designated as differential psychopharmacology which, from the point of view ofthe author, has been given too little attention by pharmacologists and clinical pharmacologists. It has been demonstrated that the effect of psychotropic drugs, including placebo, can be differentially influenced by personality traits, e.g. introversion/extroversion, high level neuroticism/low level neuroticism and success motivation/failure motivation. For example, relatively high doses of diazepam (0.3 mg/kg), when compared to placebo, only impaired the psychophysical performance of extroverted volunteers whereas introverted volunteers remained unaffected. Pharmacokinetic parameters, e.g. absorption, biotransformation, can also be affected by the level of neuroticism or by anxiety, as demonstrated for diazepam, caffeine, paracetamol and theophylline. The absorption kinetics of diazepam and caffeine clearly differ between volunteers with high neuroticism scores and those with low neuroticism scores. Emotionally unstable volunteers absorbed the substances more quickly and more completely than emotionally stable volunteers. There were surprising differences in various immunological indices between dominant and submissive subjects. In dominant volunteers the immune system was more activated than in submissive volunteers. In the future, it will become increasingly necessary to obtain results for such target groups and to avoid generalized data, which may conceal the actual events. Differential clinical psycho-neuro-immunopharmacology may be an approach which is helpful in the development of "volunteer models" for clinical research in Phase I.
机译：有许多众所周知的因素和变量在评估从健康志愿者获得的药代动力学和药效学结果中起作用。遗传构成受年龄，性别，昼夜节律和季节变化，饮食因素，免疫功能，饮酒，吸烟等因素的影响。Vesell前段时间反复指出了这些事实[Vesell 1982; Vesell和Passananti 1977]。自从扬克（1964）起，我们一直怀疑人格特质也会影响药物反应。以下概述专门针对这一被称为差异心理药理学的领域，从作者的角度来看，药理学家和临床药理学家对此给予的关注很少。已经证明，包括安慰剂在内的精神药物的作用会受到人格特质的不同影响，例如人格特质。内向/外向，高级神经质/低级神经质和成功动机/失败动机。例如，与安慰剂相比，相对较高的地西epa剂量（0.3 mg / kg）只会损害外向型志愿者的心理生理机能，而内向型志愿者则不受影响。药代动力学参数，例如吸收，生物转化也会受到神经质或焦虑的影响，如地西demonstrated，咖啡因，扑热息痛和茶碱的研究表明。神经质评分较高的志愿者和神经质评分较低的志愿者之间，地西epa和咖啡因的吸收动力学明显不同。情绪不稳定的志愿者比情绪稳定的志愿者更快，更彻底地吸收了这些物质。在显性和顺从性受试者之间，各种免疫学指标存在令人惊讶的差异。在显性志愿者中，免疫系统比顺从性志愿者中的免疫系统更活跃。将来，越来越需要获得此类目标群体的结果，并避免使用可能掩盖实际事件的通用数据。差异性临床神经心理免疫药理学可能是一种有助于开发用于第一阶段临床研究的“志愿者模型”的方法。

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