早期临床试验肿瘤受试者认知功能调查与影响因素分析

Investigation on cognitive function of tumor subjects in early clinical trials and analysis of its influencing factors

目的调查参与早期临床试验的肿瘤受试者认知功能的现状,并进行影响因素分析。方法选取2019年9月至2021年7月该院参与早期临床试验的肿瘤受试者83例,采用自行设计的一般调查问卷收集肿瘤受试者基本信息,采用北京版蒙特利尔认知评估量表调查肿瘤受试者认知功能现状。结果不同文化程度肿瘤受试者认知功能总评分比较,差异有统计学意义(F=7.667,P<0.001),主要表现在视空间与执行功能(F=4.736,P=0.004)、命名(F=2.889,P=0.041)、语言(F=5.049,P=0.003)、抽象(F=6.155,P=0.001)、延迟记忆(F=3.126,P=0.030)、定向(F=3.249,P=0.026)5个维度。不同医疗保险(医保)参保情况肿瘤受试者认知功能总评分比较,差异有统计学意义(F=8.150,P=0.001),主要表现在空间(F=9.568,P<0.001)、注意(F=4.712,P=0.012)、定向(F=3.654,P=0.030)3个维度。不同睡眠状况肿瘤受试者在语言维度上的认知功能评分比较,差异有统计学意义(F=4.012,P=0.010)。结论参与早期临床试验的肿瘤受试者认知功能的主要影响因素为文化程度、睡眠状况、医保参保情况。

Objective To investigate the current status of cognitive function among the tumor subjects participating in early clinical trials,and analyze the influencing factors. Methods From September 2019 to July 2021,a total of 83 tumor subjects who participated in early clinical trial in the hospital were selected.The basic information of the tumor subjects was collected with self-designed general questionnaires.The status of cognitive function of the tumor subjects was investigated with Montreal Cognitive Assessment(Beijing version). Results There was statistically significant difference in total cognitive function score among the tumor subjects with different educational levels( F =7.667, P <0.001),mainly manifested in five dimensions:visual space and executive function( F =4.736, P =0.004),naming( F =2.889, P =0.041),language( F =5.049, P =0.003),abstraction( F =6.155, P =0.001),delayed memory( F =3.126, P =0.030),and orientation( F = 3.249 , P =0.026).There was statistically significant difference in total cognitive function score among the tumor subjects with different medical insurance participation status( F =8.150, P =0.001),mainly manifested in three dimensions:spatial( F =9.568, P <0.001),attention( F =4.712, P =0.012),and directional( F = 3.654 , P =0.030).There was statistically significant difference in cognitive function score in language dimension among the tumor subjects with different sleep status( F =4.012, P =0.010). Conclusion The main influencing factors on cognitive function of the tumor subjects participating in early clinical trials are educational level,sleep status,and medical insurance participation status.