对肿瘤患者临床研究认识的调查与思考

·论著·

对肿瘤患者临床研究认识的调查与思考

魏艳，彭晋，柳麒，周福祥（武汉大学中南医院肿瘤放化疗科，湖北省肿瘤医学临床研究中心，肿瘤生物学行为湖北省重点实验室，武汉 430071）

摘要：目的了解肿瘤患者对临床研究及相关伦理知识的认识程度，为提高患者对临床研究认识采取相应的对策奠定基础。方法对武汉大学中南医院肿瘤放化疗科住院治疗的肿瘤患者随机进行问卷调查，对调查结果统计分析。结果发放调查问卷90份，有效问卷为81份，回收率为95.6%。96.30%（78/81）的患者表示想要知晓自身病情，且在知晓病情的情况下，仍有75.31%的患者认为自己有治愈的希望。目前，仍有70.37%（57/81）的患者对临床研究是否有益持怀疑态度。在调查的所有肿瘤患者中，对临床研究的参与意愿仅为40.7%。82.72%（67/81）的患者对签署知情同意书持没必要、无所谓或不知道态度。多因素分析显示，受教育程度的高低是影响患者对临床试验了解程度的重要因素（P ＜0.05，OR=2.559，95%CI=1.037~6.314），差异具有统计学意义。年龄因素影响患者对知情权的要求程度（P＜0.05，OR=3.450，95%CI=1.684~7.067）。结论目前住院肿瘤患者有强烈的病情知晓需求，对临床研究及相关伦理知识认识欠缺。应在肿瘤患者治疗群体中扩大对临床研究及其伦理内容的宣传与讲解，强调临床研究伦理审查的意义及对受试者的保护作用，提高肿瘤患者参与临床研究的意愿与参与度。

关键词：肿瘤；临床试验；伦理审查；知情同意

Investigation and consideration of cancer patients’ understanding of clinical research

WEI Yan, PENG Jin, LIU Qi, ZHOU Fu-xiang

Department of Radiochemotherapy, Zhongnan Hospital of Wuhan University, Hubei Cancer Clinical Study Center, Hubei Key Laboratory of Tumor Biological Behaviors, Wuhan 430071, China

Abstract: Objective To investigate the level of awareness of cancer patients on clinical research and related ethical knowledge, so as to lay the foundation for improving patients’ understanding of clinical research. Methods A random questionnaire survey was conducted among cancer patients in the department of oncology and radiotherapy in Zhongnan Hospital of Wuhan University, and make a statistical analysis of the results. Results A total of 90 questionnaires were issued, of which 81 were valid questionnaires, with a recovery rate of 95.6%. 96.30% (78/81) of the patients indicated that they wanted to know their condition, and 75.31% of them believed that they had the hope of cure when they were aware of the disease. At present, 70.37% (57/81) of patients were still sceptical about whether the clinical research is beneficial or not. Among all the cancer patients surveyed, the willingness to participate in clinical research was only 40.7%. 82.72% (67/81) of the patients believed that signing the informed consent was unnecessary or indifferent. Multifactor analysis showed that the degree of education was an important factor affecting the patients’ understanding of clinical trials (P<0.05, OR=2.559, 95%CI=1.037~6.314), and the difference was statistically significant. Age factor affected patients’ demand for the right of informed consent (P<0.05, OR=3.450, 95%CI=1.684~7.067). Conclusions At present, hospitalized cancer patients have strong demands o know their conditions, but they lack the knowledge of clinical research and related ethical knowledge. The publicity and explanation of clinical research and its ethical content in the treatment group of cancer patients should be expanded. The significance of the ethical review of clinical research and the protection of the subjects should be emphasized to improve the willingness of the cancer patients to participate in the clinical study.

Key words: Cancer; Clinic trial; Ethical review; Informed consent

DOI：10.16689/11-9349/r.2018.02.014

引言

据中国肿瘤统计数据显示，中国2015年肿瘤新发病例为429.2万例，肿瘤死亡病例高达281.4万例。肿瘤已成为国民健康的巨大威胁，且治疗效果十分有限[1, 2]。临床试验是评估肿瘤新疗法疗效和安全性的一个关键步骤，肿瘤临床试验有助于提高现有诊疗水平，为肿瘤患者提供最佳的诊治方案，为难治疾病寻找新的治疗方法[3-5]。积极参与肿瘤临床试验对于降低肿瘤患者死亡率及提高生活质量至关重要，多项研究提示对于罕见、生存率较低的癌种患者，参加临床研究将会得到更好的生存结局[6]。既往有调查研究显示，在符合临床研究入组条件的患者中，仅有一小部分愿意参加临床试验，对临床研究的接受度较差，患者排斥的原因主