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目的:了解妇产科门诊患者对药物临床试验的知晓度,为开展药物临床试验相关知识培训工作提供依据。方法:自行设计调查问卷,选择某医院妇产科门诊患者及家属进行问卷调查。结果:发放问卷158份,回收有效问卷145份。17.93%调查对象表示没有听说过药物临床试验。48.28%调查对象对药物临床试验及相关知识知晓合格。仅3.37%调查对象对药物临床试验中受试者享有权益知晓,86.50%表示没有听说过药物临床试验中伦理委员会及其职能。性别、文化程度及医疗支出对调查对象知晓合格程度有影响,文化程度对知晓是否合格影响最大(OR:2.312,95%CI:1.061-2.148)。结论:调查对象对药物临床试验基本认知不足,建议针对性加强药物临床试验相关知识宣传,增强公众认识。
Objective: To understand the obstetrics and gynecology clinic patient awareness of drug clinical trials, to provide the basis for the training of knowledge related to drug clinical trials. Methods: To design a questionnaire, select a hospital obstetrics and gynecology clinic patients and their families to conduct a questionnaire survey. Results: 158 questionnaires were distributed and 145 valid questionnaires were collected. 17.93% of respondents said they had never heard of drug clinical trials. 48.28% of the respondents were satisfied with the clinical trials of drugs and related knowledge. Only 3.37% of the respondents were aware of the rights and interests of the subjects in the drug clinical trials, 86.50% said they had not heard about the ethics committee and their functions in the drug clinical trials. The level of education, gender, educational level and medical expenditure have an impact on the level of knowledgeable compliance of the respondents, and the level of education has the greatest impact on the knowledge of compliance (OR: 2.312, 95% CI: 1.061-2.148). Conclusions: The survey subjects have little understanding of drug clinical trials, and it is suggested that the publicity should be strengthened by publicizing the related knowledge of drug clinical trials.