药品不良反应信号检测中遮蔽效应的识别及消除方法

项目名称： 药品不良反应信号检测中遮蔽效应的识别及消除方法

项目编号： No.81202285

项目类型： 青年科学基金项目

立项/批准年度： 2013

项目学科： 预防医学、地方病学、职业病学、放射医学

项目作者： 叶小飞

作者单位： 中国人民解放军第二军医大学

项目金额： 23万元

中文摘要： 药品不良反应监测是保障用药安全的重要手段，监测的实施通过药品不良反应信号的检测来完成。课题组前期进行了一系列药品不良反应信号检测方法的研究，在实际应用过程中发现，目前常用的信号检测结果受遮蔽效应影响较大，存在着检出过多假阴性结果的问题。为克服遮蔽效应的影响，减少偏倚，提高信号检出的准确性，本研究拟在前期工作的基础上，以上海市药品不良反应自发呈报系统为依托，建立遮蔽效应识别及消除方法。通过药品与不良反应间发生概率之比，基于压缩估计分析，识别遮蔽效应组合。将含遮蔽效应组合的报告从数据库剔除后对数据分层，重新检测信号。通过随机抽样，从数据库中剔除相同数量的报告后检测信号以考察结果的稳定性。最后将所构建的方法嵌入已建立的药品不良反应信号检测系统之中，推广应用，进而解决遮蔽效应对信号检测结果的影响，切实提高药品不良反应信号检测的效能。

中文关键词： 药品不良反应；信号检测；遮蔽效应；信息成分；压缩估计

英文摘要： Adverse drug reaction (ADR) surveillance is a key factor to ensure the safety use of drugs. The surveillance is usually achieved by the process of ADR signal detection. We have conducted several studies about the methods for ADR signal detection.In the actual application, we observed that the detection results were influenced greatly by the masking effect and there was high false negative rate of the detection results by routine methods.In order to get over the impact of masking effect,minimize the bias and improve the accuracy of the results, we will develop methods for identification and elimination of masking effect based on Shanghai ADR spontaneous reporting system. Firstly, we will compare the probability between drug and ADR, and then identify the masking effect combinations with the shrinkage estimation. Secondly, we will detect the signal again after excluding the reports containing the masking effect combinations in the stratified dataset. Thirdly, we will test the stability of this method by anzlyzing the data by excluding the reports randomly with the same number of those containing masking effect combinations.In the end, this model will be embedded in our ADR signal detection system and applied in the daily surveillance. The method is expected to solve the impact of masking effect and improve the po

英文关键词： adverse drug reaction；signal detection；masking effect；information component；shrinkage estimation