中国临床药理学杂志

新药Ⅰ期临床研究中健康志愿者心理状态的调查分析

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余姝彦 ^1a^,^1b^,^1c , 王晶晶 ^1a^,^1b^,^1c , 刘薇 ^1a^,^1b^,^1c , 朱旭 ^1a^,^1b^,^1c , 毛肖萌 ^1a^,^1b^,^1c , 郁继诚 ^1a^,^1b^,^1c , 吴菊芳 ^1a^,^1b^,^1c , 陈渊成 ^1a^,^1b^,^1c , 杨海静 ^1a^,^1b^,^1c , 李南洋 ^1a^,^1b^,^1c , 武晓捷 ^1a^,^1b^,^1c , 曹国英 ^1a^,^1b^,^1c , 张菁 ^1a^,^1b^,^1c , 曹艳佩 ^1b

中国临床药理学杂志 | 读者园地 2025,41(9): 1310-1314

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中国临床药理学杂志 |读者园地 2025 , 41 (9) : 1310 -1314

新药Ⅰ期临床研究中健康志愿者心理状态的调查分析

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余姝彦^1a^,^1b^,^1c, 王晶晶^1a^,^1b^,^1c, 刘薇^1a^,^1b^,^1c, 朱旭^1a^,^1b^,^1c, 毛肖萌^1a^,^1b^,^1c, 郁继诚^1a^,^1b^,^1c, 吴菊芳^1a^,^1b^,^1c, 陈渊成^1a^,^1b^,^1c, 杨海静^1a^,^1b^,^1c, 李南洋^1a^,^1b^,^1c, 武晓捷^1a^,^1b^,^1c, 曹国英^1a^,^1b^,^1c, 张菁^1a^,^1b^,^1c, 曹艳佩^1b

作者信息

^1a.复旦大学附属华山医院，临床药理研究中心，上海 200040

^1b.复旦大学附属华山医院，国家老年疾病临床医学研究中心，上海 200040

^1c.复旦大学附属华山医院，研究型病房，上海 200040

通讯作者:

曹艳佩，主任护师，硕士生导师 Tel: （021）52888067 E-mail: yanpeicao@fudan.edu.cn

作者简介:

余姝彦（1993-），女，主管护师，主要从事药物临床研究

Investigation and analysis of psychological status survey for healthy participants in phase I clinical research

Shu-yan YU^1a^,^1b^,^1c, Jing-jing WANG^1a^,^1b^,^1c, Wei LIU^1a^,^1b^,^1c, Xu ZHU^1a^,^1b^,^1c, Xiao-meng MAO^1a^,^1b^,^1c, Ji-cheng YU^1a^,^1b^,^1c, Ju-fang WU^1a^,^1b^,^1c, Yuan-cheng CHEN^1a^,^1b^,^1c, Hai-jing YANG^1a^,^1b^,^1c, Nan-yang LI^1a^,^1b^,^1c, Xiao-jie WU^1a^,^1b^,^1c, Guo-ying CAO^1a^,^1b^,^1c, Jing ZHANG^1a^,^1b^,^1c, Yan-pei CAO^1b

Affiliations

^1a.Clinical Pharmacology Research Center, Huashan Hospital, Fudan University, Shanghai 200040, China

^1b.National Clinical Medical Research Center for Geriatric Diseases, Huashan Hospital, Fudan University, Shanghai 200040, China

^1c.Research Ward, Huashan Hospital, Fudan University, Shanghai 200040, China

出版时间: 2025-05-17 doi: 10.13699/j.cnki.1001-6821.2025.09.019

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摘要

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目的

在新药Ⅰ期临床试验中评价基于心理问卷进行阶段评估护理模式对健康志愿者心理状态的影响。

方法

本研究按随机、单盲、对照的临床研究方法设计。将健康志愿者随机分为试验组和对照组。根据健康志愿者焦虑和抑郁状态的影响程度，试验组给予阶段评估护理模式，对照组给予常规护理措施。于给药前、给药日、给药后（试验中期）、出院日以及出组日，2组健康志愿者均进行抑郁自评量表（SDS）及焦虑自评量表（SAS）问卷评估，并观察其成效。

结果

共159例健康志愿者纳入研究，试验组和对照组分别为83例和76例。试验组和对照组SDS评分在给药前分别为（54.93±4.62）和（54.87±4.89）分，在给药日分别为（52.17±6.55）和（53.95±7.03）分，在试验中期分别为（49.94±7.35）和（51.69±9.16）分，在出院日分别为（52.13±6.70）和（53.85±6.76）分，在出组日分别为（51.33±7.99）和（52.60±7.39）分，试验组在给药日至出组日的SDS评分与给药前比较，对照组在试验中期的SDS评分与给药前比较，在统计学上差异均有统计学意义（均P<0.01）。试验组和对照组SAS评分在给药前分别为（36.08±6.45）和（37.04±6.87）分，在给药日分别为（36.18±7.79）和（37.43±8.53）分，在试验中期分别为（35.04±7.09）和（36.86±9.55）分，在出院日分别为（35.82±7.75）和（37.68±8.78）分，在出组日分别为（39.29±9.17）和（36.47±7.91）分，在统计学上差异均无统计学意义（均P>0.05）。

结论

用心理问卷及阶段护理评估表对健康志愿者进行评估、开展护理干预在一定程度上能够减轻志愿者抑郁和焦虑程度。

关键词

新药临床试验 / 心理状态 / 护理评估流程 / 全程护理干预 / 抑郁自评量表 / 焦虑自评量表

Abstract

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Objective

To evaluate the impact of stage assessment nursing mode on the psychological state of healthy participants in Phase I clinical trials of new drugs based on psychological questionnaire.

Methods

This was a randomized, single blind, controlled clinical research. Healthy participants were randomly divided into treatment and control group. According to the impact of anxiety and depression on healthy participants, the treatment group was given a stage evaluation nursing model, while the control group received routine nursing measures. Both groups were evaluated using the self rating depression scale (SDS) and self rating anxiety scale (SAS) questionnaires before administration, on the day of administration, after administration (mid-term of the trial), on the day of discharge, and on the day of withdrawal, and their effectiveness was observed.

Results

A total of 159 healthy participants were included in the study, with 83 cases in the treatment group and 76 cases in the control group. SDS scores of treatment group and control group were (54.93±4.62) and (54.87±4.89) points before administration, (52.17±6.55) and (53.95±7.03) points on the administration day, (49.94±7.35) and (51.69±9.16) points at the mid-term of the trial, (52.13±6.70) and (53.85±6.76) points on the discharge day, (51.33±7.99) and (52.60±7.39) points on the day of withdrawal, respectively. Compared with before administration, there was statistically significant difference in treatment group during administration day and the day of withdrawal, as well as in the mid-term of trial in the control group (all P<0.01). SAS scores for treatment group and control group were (36.08±6.45) and (37.04±6.87) points before administration, (36.18±7.79) and (37.43±8.53) points on administration day, (35.04±7.09) and (36.86±9.55) points at the mid-term of the trial, (35.82±7.75) and (37.68±8.78) points on discharge day, (39.29±9.17) and (36.47±7.91) points on the day of withdrawal, respectively. No statistical significance of SAS scores was observed (all P>0.05).

Conclusion

Use of psychological questionnaires and stage nursing assessment forms for evaluation and nursing intervention can alleviate the levels of depression and anxiety in healthy participants.

Key words

clinical trials of new drugs / mental state / nursing evaluation process / whole nursing intervention / self-rating depression scale / self-rating anxiety scale

引用本文

余姝彦, 王晶晶, 刘薇, 朱旭, 毛肖萌, 郁继诚, 吴菊芳, 陈渊成, 杨海静, 李南洋, 武晓捷, 曹国英, 张菁, 曹艳佩. 新药Ⅰ期临床研究中健康志愿者心理状态的调查分析. 中国临床药理学杂志, 2025 , 41 (9) : 1310 -1314 . DOI: 10.13699/j.cnki.1001-6821.2025.09.019

Shu-yan YU, Jing-jing WANG, Wei LIU, Xu ZHU, Xiao-meng MAO, Ji-cheng YU, Ju-fang WU, Yuan-cheng CHEN, Hai-jing YANG, Nan-yang LI, Xiao-jie WU, Guo-ying CAO, Jing ZHANG, Yan-pei CAO. Investigation and analysis of psychological status survey for healthy participants in phase I clinical research[J]. Chinese Journal of Clinical Pharmacology, 2025 , 41 (9) : 1310 -1314 . DOI: 10.13699/j.cnki.1001-6821.2025.09.019

基金

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上海市“科技创新行动计划”基金资助项目(22S11904702)
复旦大学-护理科研基金资助项目(FNF202162)

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2025年第41卷第9期

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文章信息

doi: 10.13699/j.cnki.1001-6821.2025.09.019

接收时间：2024-12-11
首发时间：2026-08-04
出版时间：2025-05-17

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收稿日期：2024-12-11

基金

上海市“科技创新行动计划”基金资助项目(22S11904702)

复旦大学-护理科研基金资助项目(FNF202162)

作者信息

^1a.复旦大学附属华山医院，临床药理研究中心，上海 200040

^1b.复旦大学附属华山医院，国家老年疾病临床医学研究中心，上海 200040

^1c.复旦大学附属华山医院，研究型病房，上海 200040

通讯作者:

曹艳佩，主任护师，硕士生导师 Tel: （021）52888067 E-mail: yanpeicao@fudan.edu.cn

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https://castjournals.cast.org.cn/joweb/zglcylxzz/CN/10.13699/j.cnki.1001-6821.2025.09.019

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2种不同金属材料的力学参数

科 Family	属数 Number of genus	种数 Number of species	占总种数比例 Percentage of total species (%)	属 Genus	种数 Number of species	占总种数比例 Percentage of total species (%)
鹅膏菌科Amanitaceae	2	11	5.26	鹅膏菌属 Amanita	10	4.78
小菇科 Mycenaceae	2	12	5.74	丝盖伞属 Inocybe	5	2.39
多孔菌科 Polyporaceae	8	14	6.70	蜡蘑属 Laccaria	5	2.39
红菇科 Russulaceae	3	23	11.00	小皮伞属 Marasmius	6	2.87
				小菇属 Mycena	11	5.26
				光柄菇属 Pluteus	5	2.39
				红菇属 Russula	17	8.13
				栓菌属 Trametes	5	2.39

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