慢性病患者参与药物临床试验意愿的影响因素：医学伦理观念调查

doi:10.3969/j.issn.1006-9771.2021.03.018

《中国康复理论与实践》 ›› 2021, Vol. 27 ›› Issue (3): 361-367.doi: 10.3969/j.issn.1006-9771.2021.03.018

慢性病患者参与药物临床试验意愿的影响因素：医学伦理观念调查

李梅欣^1,²,郑欣^1,²,史文丽^1,²,刘志青^1,²,何静杰^1,³()

^1.首都医科大学康复医学院，北京市 100068
^2.中国康复研究中心北京博爱医院，临床营养科，北京市 100068
^3.中国康复研究中心北京博爱医院，神经康复科，北京市 100068

收稿日期:2021-01-21 修回日期:2021-03-10 出版日期:2021-03-25 发布日期:2021-04-02
通讯作者: 何静杰 E-mail:hejingjie@126.com
作者简介:李梅欣(1969-)，女，汉族，河北辛集市人，硕士，副主任医师，主要研究方向：糖尿病及其并发症|何静杰(1963-)，女，汉族，吉林通化市人，硕士，主任医师、教授，主要研究方向：神经康复。

Factors Related with Willingness to Participate in Pharmacological Clinical Trials of Patients with Chronic Diseases: Investigation of Medical Ethics

Mei-xin LI^1,²,Xin ZHENG^1,²,Wen-li SHI^1,²,Zhi-qing LIU^1,²,Jing-jie HE^1,³()

^1.Capital Medical University School of Rehabilitation, Beijing 100068, China
^2.Clinical Nutrition Department, Beijing Bo'ai Hospital, China Rehabilitation Research Center, Beijing 100068, China
^3.Neurological Rehabilitation, Beijing Bo'ai Hospital, China Rehabilitation Research Center, Beijing 100068, China

Received:2021-01-21 Revised:2021-03-10 Published:2021-03-25 Online:2021-04-02
Contact: Jing-jie HE E-mail:hejingjie@126.com

摘要/Abstract

摘要： 目的

调查慢性病患者医学伦理观念及参与药物临床试验意愿，并分析其特点及相关影响因素。

方法

2020年12月，选取北京博爱医院内科门诊的慢性病患者318例，采用自制医学伦理问卷对患者的医学伦理观念和参与药物临床试验的意愿进行访谈式调查。

结果

病程、地域、文化程度对慢性病患者医学知识关注度、患者权益和责任认知度有影响。多因素Logistic回归分析显示，治疗满意度、医生信任度与患者参与药物临床试验的意愿相关(P < 0.05)。患者首先关注药物临床试验的安全性，其次是疗效。

结论

关注和保护慢性病患者的医疗权益，提高医生信任度，加强临床试验相关知识宣传，可增强慢性病患者参与药物临床试验的意愿。

关键词: 药物临床试验, 参与意愿, 医学伦理

Abstract: Objective

To investigate the medical ethics and willingness to participate in pharmacological clinical trials of patients with chronic diseases, and explore the related factors.

Methods

In December, 2020, 318 patients with chronic diseases from the Department of Internal Medicine, Beijing Bo'ai Hospital were investigated with a self-made medical ethics questionnaire for the items of medical ethics and willingness to participate in pharmacological clinical trials.

Results

The attention to medical knowledge, awareness of their rights and responsibilities were various with the courses of disease, educational levels and resident areas. The satisfaction for treatment and trust to the doctors were related with the willingness to participate in pharmacological clinical trials by multivariate Logistic regression (P < 0.05). The patients in trials paid the most attention to the safety of the trail, and then the therapeutic effect.

Conclusion

Promoting and protecting the medical rights, improving the trust to doctors, strengthening the publicity of clinical trial knowledge, may promote the willingness to participate in pharmacological clinical trials of patients with chronic diseases.

Key words: pharmacological clinical trials, willingness, medical ethics

中图分类号:

R969.4

李梅欣,郑欣,史文丽,刘志青,何静杰. 慢性病患者参与药物临床试验意愿的影响因素：医学伦理观念调查[J]. 《中国康复理论与实践》, 2021, 27(3): 361-367.

Mei-xin LI,Xin ZHENG,Wen-li SHI,Zhi-qing LIU,Jing-jie HE. Factors Related with Willingness to Participate in Pharmacological Clinical Trials of Patients with Chronic Diseases: Investigation of Medical Ethics[J]. 《Chinese Journal of Rehabilitation Theory and Practice》, 2021, 27(3): 361-367.

图/表 6

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参考文献 36

1	健康中国行动推进委员会. 健康中国行动(2019—2030年)[EB /OL]. (2019-07-09). .
2	国家卫生计生委疾病预防控制局. 中国居民营养与慢性病状况报告(2015年)[M]. 北京:人民卫生出版社, 2016.
	Bureau of Disease Control and Prevention, NHFPC. Report on Nutrition and Chronic Diseases of Chinese Residents (2015) [M]. Beijing: People's Health Publishing House, 2016.
3	国务院办公厅. 中国防治慢性病中长期规划(2017-2025年)[EB/OL].(2017-01-22). .
4	U.S. National Library of Medicine. Clinical trials [EB/OL]. (2019-10-25). .
5	国家药品监督管理局. 药物临床试验管理规范[A]. 2020-07-01.
6	Li N, Huang H Y, Wu D W, et al. Changes in clinical trials in mainland China over the decade 2009-18: a systematic review [J]. Lancet Oncol, 2019, 20(11): 619-626.
7	孙胜男,赵维纲,董颖越,等. 糖尿病患者自我管理现状及影响因素分析[J]. 中华护理杂志, 2011, 46(3): 229-233.
	Sun S N, Zhao W G, Dong Y Y, et al. Analysis of self-management status and influencing factors of diabetic patients [J]. Chin T Nurs, 2011, 46(3): 229-233.
8	王明霞,刘健,雷良华,等. 三甲医院医务工作者对临床伦理认知的分析[J]. 医学与哲学, 2019, 32(5): 42-46.
	Wang M X, Liu J, Lei L H, et al. Analysis on clinical ethics cognition of medical workers in third-class a hospital [J]. Med Philosoph, 2019, 32(5): 42-46.
9	陈静,杨兰,柯雄,等. 患者社会经济地位对医患沟通行为的影响研究[J]. 医学与哲学, 2018, 39(3A): 607-612.
	Chen J, Yang L, Ke X, et al. Study on the influence of socio-economic status of patients on doctor-patient communication behavior [J]. Med Philosoph, 2018, 39(3A): 607-612.
10	张杭杰,丁林玲,潘雪娇,等. 浙江省医疗卫生人员新型冠状病毒疫苗接种意愿和影响因素调查[J]. 中国疫苗和免疫, 2021. doi: 10.19914/j.CJVI.2021030. doi: 10.19914/j.CJVI.2021030
	Zhang H J, Ding L L, Pan X J, et al. Willingness to receive novel coronavirus vaccine and factors influencing willingness among healthcare workers in Zhejiang province [J]. Chin J Vaccines Immun, 2021. doi: 10.19914/j.CJVI.2021030. doi: 10.19914/j.CJVI.2021030
11	刘春华,刘珏,张展,等. 妇科患者药物临床试验参加意愿调查分析[J]. 护理学, 2017, 6(2): 19-24.
	Liu C H, Liu J, Zhang Z, et al. Investigation of participants' willingness on gynecological clinical trials [J]. Nurs Sci, 2017, 6(2): 19-24.
12	赵俊. 阶层地位、医患信任与试验性医疗参与意愿: 城市居民的医学伦理观念调查[J]. 南京社会科学, 2017(9): 76-82.
	Zhao J. Class status,trust between doctors and patients and willingness to participate into clinical trial: case studies from Nanjing residents' medical ethical views [J]. Nanjing Soc Sci, 2017(9): 76-82.
13	Moorcraft S Y, Marriott C, Peckitt C, et al. Patients' willingness to participate in clinical trials and their views on aspects of cancer research: results of a prospective patient survey [J]. Trials, 2016, 17(1): 17.
14	Gummersbach E, der Schmitten J I, Mortsiefer A, et al. Willingness to participate in mammography screening: a randomized controlled questionnaire study of responses to two patient information leaflets with different factual content [J]. Dtsch ArzteblInt, 2015, 112(5): 61-68.
15	Holla da J, Marfori W, Tognolini A, et al. Successful patient recruitment in CT imaging clinical trials: what factors influence patient participation? [J]. Acad Radial, 2014, 21(1): 52-57.
16	中华人民共和国国家卫生健康委员会科技教育司. 关于印发重大新药创制科技重大专项示范性药物临床评价技术平台建设课题工作要求的通知[A]. 2019-01.
17	卿文浩,王磊,阎柯. 抗肿瘤药物临床试验受试者保护的法律分析[J]. 肿瘤药学, 2020, 10(6): 745-749.
	Qing W H, Wang L, Yan K. Legal analysis on protection of subjects in clinical trials of anti-tumor [J]. Drug Anti-tumor Pharm, 2020, 10(6): 745-749.
18	黄慧瑶,樊琦,房虹,等. 肿瘤患者药物临床试验接受意愿及相关原因分析[J]. 中国肺癌杂志, 2020, 23(1): 41-49.
	Huang H Y, Fan Q, Fang H, et al. Acceptance and related causes of clinical trials among cancer patients in China [J]. Chin J Lung Cancer, 2020, 23(1): 41-49.
19	Woolfall K, Shilling V, Hickey H, et al. Parents agendas in paediatric clinical trial recruitment are different from researchers and often remain unvoiced: a qualitative study [J]. PLoS One, 2013, 8(7): e67352.
20	Waldman A T, Shumski M J, Jerrehian M, et al. Parent and medical professional willingness to enroll children in a hypothetical pediatric optic neuritis treatment trial [J]. Front Neurol, 2011(2): 75-81.
21	Schapira M M, Mackenzie E R, Lam R, et al. Breast cancer survivors willingness to participate in an acupuncture clinical trial: a qualitative study [J]. Support Care Cancer, 2014, 22(5): 1207-1215.
22	Wu E, Wang T, Lin T, et al. A comparative study of patients attitudes toward clinical research in the United States and urban and rural China [J]. Clin Transl Sci, 2015, 8(2): 123-131.
23	孙鑫,谭婧,王雯,等. 建立真实世界数据与研究技术规范,促进中国真实世界证据的生产与使用[J]. 中国循证医学杂志, 2019, 19(7): 755-762.
	Sun X, Tan J, Wang W, et al. Developing technical guidance for real world data and studies to achieve better production and use of real-world evidence in China [J]. Chin J Eviden-based Med, 2019, 19(7): 755-762.
24	夏侠,李媛媛,王坤. 药物临床试验风险评估体系建立的初步探讨[J]. 中国临床药理学杂志, 2016, 32(8): 753-755.
	Xia X, Li Y Y, Wang K, et al. Preliminary study on the establishment of drug clinical trial risk assessment system [J]. Chin J Clin Pharmacol, 2016, 32(8): 753-755.
25	王瑾,汶柯,范贞. 药物临床试验中受试者风险管理及基本权益保护[J]. 中国新药与临床杂志, 2015, 34(10): 748-753.
	Wang J, Wen K, Fan Z. Risk management and protection of subjects' benefits and rights in drug [J]. Chin J New Drugs Clin Remed, 2015, 34(10): 748-753.
26	李丰杉,余勤. 新形势下伦理委员会在受试者/患者权益保护中的作用[J]. 中国临床药理学杂志, 2020, 36(19): 3165-3168.
	Li F S, Yu Q. Role of ethics committee in protecting the rights and interests of subjects / patients in the new situation [J]. Chin J Clin Pharmacol, 2020, 36(19): 3165-3168.
27	Lim Y, Lim J M, Jeong W J, et al. Korean cancer patients' awareness of clinical trials, perceptions on the benefit and willingness to participate [J]. Cancer Res Treat, 2017, 49(4): 1033-1043.
28	曹羽明,曹越,徐影,等. 潜在受试者对药物临床试验认知的调查[J]. 医药导报, 2017, 36(2): 226-230.
	Cao Y M, Cao Y, Yu Y, et al. Prevalence survey of congnition of potential participants for clinical trials [J]. Herald Med, 2017, 36(2): 226-230.
29	张丽燕. 对肿瘤患者药物临床试验参与志愿与相关因素的调査[J]. 药学与临床研究, 2017, 25(2): 168-170.
	Zhang L Y. Investigation on the willingness to participate in clinical trials of cancer patients and related factors [J]. Pharm Clin Res, 2017, 25(2): 168-170.
30	徐岩,张晓方,李海燕,等. 公众对临床研究认知的调查分析及培训方案探讨[J]. 中国新药杂志, 2017, 26(14): 1618-1622.
	Xu Y, Zhang X F, Li H Y, et al. Survey on public knowledge of clinical research and exploration of training programs [J]. Chin J New Drug, 2017, 26(14): 1618-1622.
31	李树婷,郝鹏,毛冬蕾,等. 我国新药临床试验受试者教育工作的现状和推进策略[J]. 中国新药杂志, 2019, 28(20): 2524-2528.
	Li S T, Hao P, Mao D L, et al. The status and promotion strategy of subjects education in clinical trials of new drugs in China [J]. Chin J New Drug, 2019, 28(20): 2524-2528.
32	杨钊,黄蓝,武志昂. 我国药物临床试验发展面临的机遇与挑战及政策建议[J]. 中国新药杂志, 2013, 22(14): 1619-1624.
	Yang Z, Huang L, Wu Z A. The opportunities and challenges of clinical trial development in China [J]. Chin J New Drug, 2013, 22(14): 1619-1624.
33	程雅倩,何文. 我国药物临床试验的进展和监管体系现状[J]. 中国药师, 2019, 22(6): 1132-1137.
	Chen Y Q, He W. Development status of clinical trials and supervising system in China [J]. Chin Pharmacist, 2019, 22(6): 1132-1137.
34	国家药品监督管理局. 药物药物临床试验登记与信息公布平台[EB/OL]. (2019-08-29). .
35	吴世彩. 康复医学的伦理性设定及其实践研究[J]. 中国康复理论与实践, 2021, 27(2): 125-130.
	Wu S C. Research on ethical connotation and its practice of rehabilitation medicine [J]. Chin J Rehabil Theory Pract, 2021, 27(2): 125-130.
36	付艳玲,邱卓英,李沁燚. 应用世界卫生组织«残疾评定量表»分析门诊慢性病患者功能状态[J]. 中国康复理论与实践, 2015, 21(9): 999-1001.
	Fu Y L, Qiu Z Y, Li Q Y. Functioning of outpatients with chronic diseases using World Health Organization Disability Assessment Schedule 2.0 [J]. Chin J Rehabil Theory Pract, 2015, 21(9): 999-1001.

变量		n	赋值
性别	男	129	1
性别	女	189	2
婚姻	已婚	234	1
	未婚	16	2
	离异	33	3
	丧偶	35	4
文化程度	初中及以下	70	1
	高中或专科	146	2
	本科	87	3
	研究生	15	4
宗教信仰	有	0	1
宗教信仰	无	318	2
支付类型	公费	56	1
	医保	209	2
	农村合作医疗	35	3
	自费	18	4
病程	< 5年	88	1
	5~10年	97	2
	> 10年	133	3
地域	城市	270	1
	农村	27	2
	流动人口	21	3

变量(赋值)		< 5年	5~10年	> 10年	χ²值	P值
医学知识关注度	从不关注(= 1)	5	32	29	13.232	0.010
	偶尔关注(= 2)	43	44	39
	非常关注(= 3)	40	21	65
家庭支持	非常支持(= 1)	66	90	117	6.859	0.032
	一般(= 2)	22	7	16
患者权益和责任认知度	完全认知(= 1)	42	18	48	9.237	0.048
	部分知道(= 2)	38	71	65
	不知道(= 3)	8	8	20
治疗效果满意度	满意(= 1)	65	78	105	2.617	0.722
	一般满意(= 2)	20	17	25
	不满意(= 3)	3	2	3
医生信任度	非常不信任(= 1)	0	0	0	2.339	0.311
	有些不信任(= 2)	0	0	0
	说不清楚(= 3)	24	42	42
	比较信任(= 4)	59	51	85
	非常信任(= 5)	5	4	6
自我管理能力	非常好(= 1)	74	83	113	1.945	0.936
	一般(= 2)	13	12	15
	较差(= 3)	1	2	5

变量(赋值)		城市	农村	流动人口	χ²值	P值
治疗效果满意度	满意(= 1)	221	10	17	12.651	0.008
	一般满意(= 2)	42	16	4
	不满意(= 3)	7	1	0
患者权益和责任认知度	完全认知(= 1)	89	4	15	24.523	< 0.001
	部分知道(= 2)	162	10	2
	不知道(= 3)	19	13	4
医生信任度	非常不信任(= 1)	0	0	0	2.650	0.321
	有些不信任(= 2)	0	0	0
	说不清楚(= 3)	91	14	3
	比较信任(= 4)	175	7	13
	非常信任(= 5)	4	6	5

项目	B	SE	Wald	P值	Exp(B)
医生信任度	1.922	0.339	32.082	< 0.001	0.146
治疗效果满意度	-0.399	0.183	4.737	0.030	1.491

慢性病患者参与药物临床试验意愿的影响因素：医学伦理观念调查

Factors Related with Willingness to Participate in Pharmacological Clinical Trials of Patients with Chronic Diseases: Investigation of Medical Ethics

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