摘要
目的探讨参与临床药物试验受试者心理健康状况调查及对策。方法选取2016年3月至2016年12月感染性疾病中心、干部病房内一科与肾病科参与临床药物试验受试者100例,参与临床药物试验完成时参照心理测试量表[贝克抑郁量表(Beck depression inventory,BDI)与症状自评量表(symptom checklist 90,SCL-90)]评定心理健康状况。结果 100例参与临床药物试验受试者BDI、SCL-90评分分别为(14. 60±3. 75)分、9. 07±2. 18)分,其中年龄<65岁、受教育程度(大学及其以上)、地理因素(本地)、既往试验经历(有)、治疗环境(住院)、疾病因素(轻微)、用药途径(注射、吸入)、药物不良反应(无)的受试者BDI、SCL-90评分明显降低,差异有统计学意义(P <0. 05);100例参与临床药物试验受试者配合依从率为95. 00%(95/100),脱落率5. 00%(5/100),其中依从组BDI评分与SCL-90评分明显低于脱落组,差异有统计学意义(P <0. 05); Pearson相关性分析显示,BDI评分、SCL-90评分与依从率呈负相关(r=-0. 625,P=0. 009)。结论参与临床药物试验受试者心理健康状况可能与年龄、受教育程度、地理因素等具有紧密的关系,且积极的心理健康干预可明显改善遵医行为与试验质量。
Objective To investigate the psychological health condition and countermeasure of subjects participating in clinical drug trial.Methods One hundred subjects who participated in clinical drug trial in our hospital from March 2016 to December 2016 were enrolled in the study.The psychological health conditions of these subjects at the end of clinical trial were evaluated according to[Beck depression inventory(BDI)and Symptom Checklist-90(SCL-90)].Results The BDI,SCL-90 scores in 100 subjects were 14.60±3.75 points,9.07±2.18 points,respectively,in which the BDI,SCL-90 scores in the subjects aged<65 years,with educational background of university and above,geography factor(local citizen),with trail experience,treatment environment(hospitalization),disease factors(minor),medication way(injection,inhalation),without drug side effects were significantly decreased(P<0.05).The compliance rate was 95.00%(95/100),the loss rate was 5.00%(5/100),moreover the BDI,SCL-90 scores in compliance group were significantly lower than those in loss group(P<0.05).The Pearson correlation analysis showed that BDI,SCL-90 scores were negatively correlated with compliance rate(r=-0.625,P<0.01).Conclusion The psychological health condition of subjects participating in clinical drug trial may be closely correlated with the factors including age,education degree,geography factors,moreover,the positive psychological health intervention can obviously improve the compliance behavior and trail quality.
作者
闫桂霞
王红
祖二梅
靳喜琴
YAN Guixia;WANG Hong;ZU Ermei;LE Xiqin(Department of Infectious Diseases,The First Hospital of Xinjiang Medical University,Xinjiang,Urumqi 830054,China)
出处
《河北医药》
CAS
2018年第21期3326-3329,共4页
Hebei Medical Journal
基金
新疆医科大学人文社会科学基金项目(编号:2016XYFG51)
关键词
临床药物试验
受试者
心理健康状况
调查
对策
clinical drug trial
subjects
psychological health condition
investigation
countermeasures
作者简介
通讯作者:靳喜琴,830054 乌鲁木齐市,新疆医科大学第一附属医院干部病房内一科;E-mail:yanguixiatg@163.com。
