健康志愿者临床试验前后的焦虑与抑郁水平

目的：评估健康志愿者临床试验前后的焦虑与抑郁水平，探讨产生焦虑与抑郁情绪的影响因素及积极应对方式。方法：对35例健康志愿者进行焦虑自评量表（SAS）、抑郁自评量表（SDS）和艾森克个性问卷（EPQ）测定。结果：（1）健康志愿者参加临床试验前SAS标准分为35.40±9.64，与常模组33.80±5.80相比有升高趋势，但无显著差异，P>0.05；与试验后30.94±6.15比较，P<0.05,有显著差异。（2）试验前后SDS标准分别为35.17±6.93、34.91±6.74; P>0.05,无显著差异；均低于常模组。（3）健康志愿者人格特征与焦虑和抑郁情绪之间具有相关性：艾森克个性问卷(EPQ)量表中的N、P得分与SAS、SDS均有显著性相关，r=0.338/0.608和0.335/0.455(P<0.05)；而E分与SAS、SDS得分相关不明显。人格特质是影响焦虑水平的重要因素。结论：健康志愿者在接受临床试验前后会产生焦虑情绪，个性特征与精神状态密切相关。

Level of anxiety and depression on volunteers in clinic trial

AIM: To assess the mental health level of anxiety and depression and related factors in healthy volunteers in clinic trial. METHODS: Self-rating anxiety scale (SAS), self -rating depressive scale (SDS) and Eysenck personality question (EPQ) were applied to thirty-five patients. RESULTS: Among the 35 patients, the SAS standard mean value was 35.40±9.64, which was higher than that of nation-norm (P>0.05), and significantly higher than that of volunteers after trials （P<0.05). The SDS standard mean value was 35.17±6.93 before trials and 34.91±6.93 after trials, which was lower than that of nation-norm. As compared with nation-norm, EPQ scores of intro- and extro-version were significantly lower, and neuroticism and psycho were all significantly higher (P<0.05, P<0.01). It showed that the standard mean values of SAS and SDS before trials were positively related to EPQ P and N score. CONCLUSION: Mental problems existed in healthy volunteers on clinic trials and the occurrence of mental problems are related to their personality characteristic and sociological factors.