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参与I期临床试验的健康志愿者中的感觉寻求倾向。

Sensation seeking amongst healthy volunteers participating in phase I clinical trials.

作者信息

Farré M, Lamas X, Camí J

机构信息

Department of Pharmacology and Toxicology, Universitat Autònoma de Barcelona, Spain.

出版信息

Br J Clin Pharmacol. 1995 Apr;39(4):405-9. doi: 10.1111/j.1365-2125.1995.tb04469.x.

Abstract
  1. Phase I clinical trials are usually carried out in healthy volunteers. In addition to economic gain, factors that may influence willingness to participate include scientific interest, curiosity and choice for risky activities. 2. We assessed the relationship between personality variables and volunteering for clinical pharmacology research. Two personality questionnaires, the Sensation Seeking Scale (SSS, form V) and the Eysenck Personality Questionnaire (EPQ), were administered to 48 male healthy university students who volunteered to participate in a phase I clinical trial and to 43 male university students who were not willing to participate in phase I clinical trials. General norm data were also used for the comparison of results. 3. When healthy volunteers were compared with unwilling subjects, significant differences were found in thrill-and-adventure seeking (7.9 vs 6.7, P = 0.0034), experience seeking (6.4 vs 5.2, P = 0.0012), disinhibition (6.2 vs 4.3, P < 0.0001), boredom susceptibility (3.9 vs 2.8, P = 0.0073), total sensation seeking trait (24.3 vs 19.0, P < 0.0001), extraversion (15.1 vs 13.3, P = 0.0490), and psychoticism (4.4 vs 3.5, P = 0.0086). When healthy volunteers were compared with general norm data similar statistically significant differences were found in all these scales, except for boredom susceptibility and psychoticism. 4. The personality profile of healthy volunteers was characterized by a higher sensation seeking trait and extraversion as compared with individuals who were not willing to participate in phase I clinical trials and general norm data.
摘要
  1. Ⅰ期临床试验通常在健康志愿者中进行。除了经济收益外,可能影响参与意愿的因素还包括科学兴趣、好奇心以及对冒险活动的偏好。2. 我们评估了人格变量与参与临床药理学研究志愿行为之间的关系。对48名志愿参与Ⅰ期临床试验的健康男性大学生和43名不愿意参与Ⅰ期临床试验的男性大学生进行了两份人格问卷测试,即感觉寻求量表(SSS,V型)和艾森克人格问卷(EPQ)。还使用一般常模数据来比较结果。3. 将健康志愿者与不愿意参与的受试者进行比较时,发现他们在刺激与冒险寻求(7.9对6.7,P = 0.0034)、经验寻求(6.4对5.2,P = 0.0012)、去抑制(6.2对4.3,P < 0.0001)、无聊易感性(3.9对2.8,P = 0.0073)、总感觉寻求特质(24.3对19.0,P < 0.0001)、外向性(15.1对13.3,P = 0.0490)和精神质(4.4对3.5,P = 0.0086)方面存在显著差异。将健康志愿者与一般常模数据进行比较时,除了无聊易感性和精神质外,在所有这些量表中也发现了类似的统计学显著差异。4. 与不愿意参与Ⅰ期临床试验的个体和一般常模数据相比,健康志愿者的人格特征表现为更高的感觉寻求特质和外向性。

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