抗肿瘤药物临床试验患者的睡眠现状及影响因素分析  

Analysis of sleep status and impact factor of patients in clinical trials of antineoplastic drugs

作　　者：李陵君 张伟英[2] 王文静[3] 阳秀月 胡玉婷 王静 严欣露 Li Lingjun;Zhang Weiying;Wang Wenjin;Yang Xiuyue;Hu Yuting;Wang Jing;Yan Xinlu(Oncology Department of Eastern Hospital Affiliated to Tongji University,Shanghai 200123,China;Nursing Department of Eastern Hospital Affiliated to Tongji University,Shanghai 200123,China;Gynaecology and Obstetrics Department of Eastern Hospital Affiliated to Tongji University,Shanghai 200123,China)

机构地区：[1]同济大学附属东方医院肿瘤科,上海200123 [2]同济大学附属东方医院护理部,上海200123 [3]同济大学附属东方医院妇产科,上海200123

出　　处：《中国实用护理杂志》2024年第29期2279-2284,共6页Chinese Journal of Practical Nursing

基　　金：上海市卫健委上海市健康科普专项(JKKPZX-2022-A09)。

摘　　要：目的探究抗肿瘤药物临床试验患者的睡眠现状及影响因素分析,为改善抗肿瘤药物临床试验患者的睡眠状况提供依据。方法2023年4—5月,采用方便抽样法选择同济大学附属东方医院新药Ⅰ期临床试验病区107例肿瘤患者为研究对象。应用一般资料调查表、匹兹堡睡眠质量指数量表(PSQI)、患者自评疼痛的数字评定量表(NRS)、广泛性焦虑障碍量表(GAD-7)和患者抑郁自评工具(PHQ-9)进行横断面调查并评估其睡眠状况。采用多因素逻辑回归方法分析影响患者睡眠的相关因素。结果有效回收问卷103份,患者年龄20~75岁,其中男61例,女42例;47.57%(49/103)的抗肿瘤药物临床试验患者出现睡眠异常。患者的PSQI总分为(7.66±3.93)分,高于国内常模(3.88±2.52)分,差异具有统计学意义(t=9.76,P<0.01)。Logistic回归分析显示,给药周期(OR=0.432,95%CI 0.191~0.978,P<0.05)与疼痛(OR=3.004,95%CI 1.135~7.948,P<0.05)为睡眠异常的影响因素。结论抗肿瘤药物临床试验患者的睡眠质量异常发生率较高,睡眠质量较差。影响抗肿瘤药物临床试验患者的睡眠质量的因素主要与给药周期和疼痛有关,应针对这些特点制订改善抗肿瘤药物临床试验患者睡眠质量的个体化方案,以提高其生命质量,积极面对临床研究用药。Objective To explore the sleep status and impact factor analysis of patients in clinical trials of antineoplastic drugs,and provide a basis for improving the sleep status and impact analysis of patients in clinical trials of antineoplastic drugs.Methods From April to May 2023,107 oncology patients in the Phase I Clinical Trial Ward of the Affiliated East Hospital of Tongji University were selected as the research objects by convenient sampling method.The general information questionnaire,Pittsburgh Sleep Quality Index Scale(PSQI),Numeric rating scale(NRS),Generalized Anxiety Disorder Scale(GAD-7)and Depression Self-Ration Tool Scale(PHQ-9).Multivariate Logistic regression analysis methods were used to carry out a cross-sectional investigation and the relevant factors affecting patients′sleep.Results Totally 103 questionnaires were effectively collected.The 103 patients′age ranged from 20 to 75 years old,including 61 males and 42 females.47.57%(49/103)patients in clinical trials of antineoplastic drugs had abnormal sleep.The average score of patients(PSQI)(7.66±3.93)was higher than the average score of the domestic norm(3.88±2.52),and there was significant statistical difference(t=9.76,P<0.01).Logistic regression analysis showed that pain(OR=3.004,95%CI 1.135-7.948,P<0.05)and trial cycle(OR=0.432,95%CI 0.191-0.978,P<0.05)were significant risk factors for abnormal sleep quality.Conclusions The incidence of abnormal sleep quality in patients of clinical trials of antineoplastic drugs is high,but the sleep quality is poor.The factors that affect the sleep quality of patients in clinical trials of antineoplastic drugs are mainly related to the patient′s trial cycle and cancer pain.According to these characteristics,individualized programs should be developed to improve the sleep quality of patients with advanced cancer,so as to improve the quality of life of patients with advanced cancer.

关 键 词：肿瘤 药物临床试验 睡眠 匹兹堡睡眠质量指数 焦虑 抑郁 

分 类 号：R473.73[医药卫生—护理学]