受试者对参与临床试验项目妊娠相关知识的认知调查分析  

作　　者：顾海鹰 叶丽冰[2] 陈莹蓉 唐志雁[2] 范胜楠 沈敏敏 

机构地区：[1]浙江中医药大学第五临床医学院,310053 [2]浙江省湖州市中心医院,313000

出　　处：《浙江临床医学》2025年第1期103-105,共3页Zhejiang Clinical Medical Journal

摘　　要：目的 调查受试者对参与临床试验项目妊娠相关知识的认知情况。方法 采用方便抽样法,对临床试验中受试者进行匿名问卷调查,了解受试者的基本情况及其对妊娠相关知识的认知情况。结果 共发放调查问卷328份,回收有效问卷328份,有效回收率100%。在调查的受试者中,健康受试者231例(70.43%)、患者97例(29.57%)。对试验用药品妊娠风险完全清楚113例(34.45%),清楚165例(50.30%),一般34例(10.37%),不清楚16例(4.88%)。调研受试者同意在研究规定时间内不生育孩子且自愿采取有效避孕措施327例(99.70%),受试者或其伴侣怀孕愿意告知医师325例(99.09%)。有效避孕措施男性避孕套加杀精子剂知晓率较高,占比89.02%,宫颈帽或子宫帽加杀精子剂和外科绝育知晓率相对较低,分别占比49.70%和31.71%。女性受试者对临床试验妊娠要求平均知晓率为99.69%,男性受试者对临床试验妊娠要求平均知晓率为99.39%。结论 受试者对临床试验妊娠要求的认知率较高,但对试验用药品妊娠风险的完全了解率不高、对几种有效避孕措施的知晓率较低。Objective To investigate the knowledge of the subjects on pregnancy-related knowledge of participating in clinical trial programs.Methods An anonymous questionnaire survey was conducted on the subjects in the clinical trial program using convenience sampling method to understand the basic situation of the subjects and their knowledge of pregnancy-related knowledge.Results A total of 328 questionnaires were distributed and 328 valid questionnaires were recovered,with a valid recovery rate of 100%.Among the subjects surveyed,231(70.43%)were healthy subjects and 97(29.57%)were patients.The risk of pregnancy with the test drug was fully understood by 113(34.45%),well understood by 165(50.30%),generally understood by 34(10.37%),and unknown by 16(4.88%).327(99.70%)agreed not to have a child and to voluntarily use effective contraception during the time specified in the study,and that the subject or her partner became pregnant.325(99.09%)were willing to inform the study physician.Among the effective contraceptive measures known to the subjects,the knowledge of male condom plus spermicide was relatively high(89.02%),while the knowledge of cervical or uterine cap plus spermicide and surgical sterilization were relatively low(49.70%and 31.71%,respectively).The mean knowledge of clinical trial pregnancy requirements was 99.69%for female subjects and 99.39%for male subjects.Conclusion Subjects have a high rate of awareness of pregnancy requirements for clinical trials,but a low rate of complete knowledge of pregnancy risks of the medicines used in the trials and a low rate of knowledge of certain types of effective contraception.

关 键 词：临床试验 妊娠 认知 调查 

分 类 号：R71[医药卫生—妇产科学]