药物临床试验中研究者对药物不良事件上报的意向性态度分析  

Intentional attitude analysis for adverse drug event reporting of principal investigators in clinical trials

作　　者：曾令烽[1,2] 刘军[2] 潘建科[3] 王璐[4] 王克柱[5] 曾星[2] 王奇[1,2] 

机构地区：[1]广州中医药大学临床药理研究所,广州510405 [2]广东省中医院,广州510120 [3]广州中医药大学第二临床医学院,广州510405 [4]世界中医药学会联合会伦理审查委员会,北京100101 [5]中国医学科学院药用植物研究所,北京100094

出　　处：《中国新药杂志》2015年第10期1150-1154,1159,共6页Chinese Journal of New Drugs

基　　金：国家自然科学基金(81473698);教育部博士点基金项目(20124425110004);广东省财政厅项目([2014]157号);2014年省级优博培育项目(广中医研[2014]55号)

摘　　要：目的:评估临床研究者对发生药物不良事件(Adverse Drug Event,ADE)上报机构伦理委员会的意向性态度与实践,旨在促进ADE及时上报。方法:本研究为一项预试验(pilot study),采用问卷调查的形式,共计37个问卷条目对我院临床主要研究者分别从4个方面进行问卷回馈调查,即"将ADE上报伦委会的意愿与态度"(13条目)、"每次遇到ADE发生并作处理的态度"(4条目)、"影响ADE上报伦委会的因素"(11条目)及"AE发生及其上报的相关知识"(9条目)。数据获取后通过SPSS 18.0进行分析。结果:我院临床专业组中29个主要研究者(问卷调查回馈率95%),当发生ADE时有79.3%反馈将"竭尽全力"(intend to)上报,89.6%"设法"(try to)上报,86.3%"打算"(plan to)上报;研究者觉得上报ADE是"有价值的"(5.5±1.7),"有意义的"(3.3±2.2)、"可以让更多人受益"(5.5±1.7)。部分研究者觉得上报ADE存有消极影响,会"增加医疗事故风险","引发与其他医师的关系紧张/妥协","破坏与患者之间的信任","扰乱正常的工作流程"及"耗费时间";不少研究者对AE上报缺乏相关知识。结论:进行试验的研究者针对所发生的ADE有很强的意识或意愿上报伦理委员会,可基于自身知识不足或经验缺乏,需加强机构内部培训。基于本研究预试验其方法学等限制,在今后仍需在临床中纳入采用大样本、多中心、设计严谨的试验予以进一步验证。Objective： To evaluate the attitude and practice in reporting of adverse drug events （ADEs） a- mong principal investigators （PIs） in clinical trials, for improving ADEs reporting to Ethics Committee （EC）. Methods： This study was a pilot study design involving clinical PIs working in Guangdong Provincial Hospital of Chinese Medicine. The attitude and practice of ADEs＇ reporting among clinical PIs were evaluated by self-adminis-tered questionnaire in four domains i.e. ＂the attitude and intention to report ADEs to EC＂, ＂the attitudes toward reporting ADE each time encountered＂, ＂the factors making it easy or difficult to report ADEs to EC＂ and ＂the knowledge concerning reporting adverse events （AE） to EC＂. Data obtained were entered and analyzed using SPSS version 18.0. Results： A total of 29 clinical PIs responded to the questionnaires and the response rate was 95%. The results indicated that when encountering ADEs, PIs of 79.3% ＂Intend to＂, 89.6% ＂Try to＂, and 86.3% ＂Plan to＂ would report it. Moreover, the PIs considered that reporting ADEs were ＂Valuable＂ （5.5 ± 1.7）, ＂ Meaningful＂ （3.3 ± 2.2） and ＂Beneficial＂ （5.5 ± 1.7）. In addition, most PIs reflected that by reporting ADEs it would contribute to some negative effects such as ＂increase the risk of medical accident＂, ＂cause tension/com- promise with physicians or others＂, ＂result in trust destruction of the patients＂, ＂disturb the normal work flow＂ and ＂waste time＂ It also indicated that many PIs were lack of the related knowledge. Conclusion： There is a strong consciousness or intention for the clinical PIs to report ADEs to the EC; however, due to their own lack of knowledge or experience, it was necessary to conduct and receive training and guidance. The results still need large sample researches with strict design to be further confirmed.

关 键 词：药物不良事件 不良事件上报 预试验 意向性分析 

分 类 号：R969[医药卫生—药理学]