摘要
目的 基于FDA不良事件报告系统(FAERS)数据库挖掘婴幼儿使用普萘洛尔的不良事件信号,为临床安全使用普萘洛尔提供参考。方法 采用英国药品和健康产品管理局(MHRA)的综合标准法(简称MHRA法)和贝叶斯置信传播神经网络(BCPNN)法,对FAERS数据库中2004年第1季度至2022年第2季度婴幼儿使用普萘洛尔的所有不良事件报告进行信号挖掘和分析。结果 纳入以普萘洛尔为首要怀疑药物的不良事件报告共75 290例,以严重不良事件为主(62.33%),报告来源主要为美国(50.18%)。经MHRA法和BCPNN法筛选最终获得普萘洛尔不良事件信号91个,涉及报告总数为1147例,其中说明书未记载的不良事件信号67个。不良事件主要累及系统器官分类为代谢及营养类疾病、精神病类疾病和神经系统疾病;不良事件首选术语以低血糖及其并发症、四肢厥冷、睡眠障碍及睡眠质量差的信号强度大,与普萘洛尔关联性强。结论 婴幼儿使用普萘洛尔治疗时,临床应重点关注低血糖及其并发症、四肢厥冷、睡眠障碍及睡眠质量差的患儿,以减少不良事件的发生。
Objective To conduct mining the adverse event signals of propranolol in infants based on the FDA adverse event reporting system(FAERS) database,and provide references for the safe use of propranolol in clinic.Methods The medicines and healthcare products regulatory agency(MHRA) and the bayesian confidence propagation neural network(BCPNN) methods were used to conduct signal mining and analysis on the adverse event reports of propranolol used by infants from the first quarter of 2004 to the second quarter of 2022 in the FAERS database.Results A total of 75 290 adverse event reports were included in the study,most of which were serious adverse events(62.33%).These reports were mainly from the United States(50.18%).91 adverse event signals were mined by the MHRA method and the BCPNN method,nvolving 1147 cases in total,including 67 adverse event signals were not recorded in the drug instructions.The system organ classes involved by these adverse events were mainly metabolism and nutrition disorders,mental disorders and nervous system disorders.Among all the adverse event preferred terms,hypoglycemia and its complications,peripheral coldness,sleep disorders and poor sleep quality had high signal intensity,and were strongly associated with propranolol.Conclusion When infants were treated with propranolol,medical staffs should focus on the risks such as hypoglycemia and its complications,peripheral coldness,sleep disorders and poor sleep quality to reduce the occurrence of adverse events.
作者
杨荣
张友波
孔健
顾锦华
YANG Rong;ZHANG You-bo;KONG Jian;GU Jin-hua(Department of Pharmacy,Nantong Maternal and Child Health Care HospitalJiangsu Nantong 226007,China;Department of Pediatric Surgery,Nantong Maternal and Child Health Care Hospital,Jiangsu Nantong 226007,China)
出处
《临床药物治疗杂志》
2023年第7期71-75,共5页
Clinical Medication Journal
