基于自发呈报系统的碘对比剂不良反应数据挖掘  

Data mining of adverse drug reaction of iodine contrast media based on spontaneous reporting system

作　　者：唐碧雨 吴建茹 魏芬芳 吴文宇 TANG Biyu;WU Jianru;WEI Fenfang;WU Wenyu(Shenzhen Institute of Pharmacovigilance and Risk Management,Guangdong Shenzhen 518024,China)

机构地区：[1]深圳市药物警戒和风险管理研究院,广东深圳518024

出　　处：《中国药房》2022年第17期2129-2132,共4页China Pharmacy

基　　金：广东省药品监督管理局2021年科技创新项目(No.2021ZDB01,No.2021JDB01,No.2021TDB06)。

摘　　要：目的挖掘自发呈报系统中碘对比剂数据的风险信号。方法运用报告比值比法、比例报告比法、英国药品和保健产品管理局综合法和贝叶斯置信度递进神经网络法对5种碘对比剂(碘帕醇、碘海醇、碘普罗胺、碘佛醇、碘克沙醇)不良反应数据进行风险信号挖掘。结果共纳入1164份(2446例次)碘对比剂不良反应,5种碘对比剂共挖掘出14个累及呼吸、免疫等系统/器官的风险信号(上述5种碘对比剂分别有3、2、4、3、2个),以及过敏性休克、皮疹、潮红等32个具体不良反应信号(上述5种碘对比剂分别有11、7、7、3、4个)。结论5种碘对比剂的风险信号验证了该类药品与上述不良反应之间存在一定的关联性,提示临床在使用碘对比剂前需注意患者是否有肿瘤疾病史和联合用药,评估患者肾功能情况,提前给予水化等预防措施;使用时需注意碘对比剂的温度、剂量和推注速率,使用后需及时跟进患者情况以避免迟发不良反应的影响。OBJECTIVE To mine the risk signals of iodine contrast media from spontaneous reporting system.METHODS Reporting odds ratio,proportional reporting ratio,Medicines and Healthcare Products Regulatory Agency and Bayesian confidence propagation neural network were used to mine risk signals of 5 iodine contrast media(iopamidol,iohexol,iopromide,ioversol,iodixanol).RESULTS 1164(2446 case times)adverse drug reaction of iodine contrast media were included,a total of 14 risk signals involving systems/organs such as respiratory system(3,2,4,3,2 for the above 5 iodine contrast media)and immune system and 32 specific adverse drug reaction signals including anaphylactic shock,rash and flushing(11,7,7,3,4 for the above 5 iodine contrast media)were found in 5 iodine contrast media.CONCLUSIONS The risk signals of 5 iodine contrast media verify that there is a certain correlation between these drugs and above adverse drug reactions.It is suggested that before using iodine contrast media in clinic,it is necessary to pay attention to whether the patient has a history of tumor and combined medication,evaluate the patient’s renal function,and give preventive measures such as hydration in advance.When using iodine contrast media,it is necessary to pay attention to the temperature,dose and injection rate.And medical staff need to follow up the patient’s situation in time after using iodine contrast media to avoiding the impact of delayed adverse reactions.

关 键 词：碘对比剂 信号挖掘 自发呈报系统 不良反应 信号检测 

分 类 号：R981.1[医药卫生—药品]