首页|基于FAERS数据库的地夫可特不良反应信号挖掘与分析

基于FAERS数据库的地夫可特不良反应信号挖掘与分析

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目的 挖掘地夫可特的药品不良反应信号,为其临床安全合理使用提供参考.方法 采用报告比值比法和比例报告比值法对FAERS数据库中从2017年第1季度到2023年第2季度共26个季度上报的地夫可特不良反应事件(ADE)报告进行数据挖掘,统计报告病例的性别、年龄等基本信息,对新的ADE信号进行分析.结果 以地夫可特为怀疑药物的ADE报告有3 265例,年龄主要在18岁以下;上报年份主要集中在2019年;主要上报国家为美国.共挖掘得到ADE信号145个,涉及系统器官分类27个,主要集中在各类损伤、中毒及操作并发症、精神病类、全身性疾病及给药部位各种反应等.信号强度排名前3的依次为肌腱断裂、库欣综合征和生长迟缓.同时,还发现了一些新的ADE信号,如脂肪栓塞、韧带扭伤和呕吐等.结论 临床应用地夫可特时,应密切关注患者肌腱断裂、库欣综合征、生长迟缓等说明书中已提及事件的发生,警惕说明书未提及的不良反应,及时采取防治措施,降低临床用药风险.
Mining and analysis of adverse drug reaction signals of deflazacort based on FAERS database
Objective To mine the adverse drug reaction signals of deflazacort to provide reference for its safe and rational clinical use.Methods The ADE reports of deflazacort reported in the FAERS database for a to-tal of 26 quarters from the 1st quarter of 2017 to the 2nd quarter of 2023 were data-mined using the report ratio ratio method and the proportion report ratio method,and the basic information such as gender,age and other basic information of the reported cases were counted and analysed for new ADE signals.Results There were 3 265 ADE reports with deflazacort as the suspected drug,the age was mainly under 18 years old;the year of reporting was mainly concentrated in 2019;and the main reporting country was the United States.A total of 145 ADE sig-nals were obtained from mining,involving 27 system and organ classifications,mainly focusing on various types of injuries,poisoning and operation complications,psychiatric disorders,systemic diseases and various reactions at the site of drug administration.The top 3 signals in terms of intensity were tendon rupture,like Cushing syndrome and growth retardation in that order.Some new ADE signals such as fat embolism,ligament sprain and vomiting were also identified.Conclusion In the clinical application of deflazacort,patients should be closely monitored for the occurrence of events mentioned in the specification,such as tendon rupture,like Cushing syndrome and growth retardation,and be alert to ADEs not mentioned in the specification,so that preventive and curative mea-sures can be taken in a timely manner to reduce the risk of clinical use of the drug.

Drug-related side effects and adverse reactionsDeflazacortFAERS databaseSignal miningReporting odds ratioProportional reporting ratio

尚予淇、郭浩

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包头医学院药学系,内蒙古自治区包头 014000

内蒙古自治区人民医院药学处,内蒙古自治区呼和浩特 010017

药物相关性副作用和不良反应 地夫可特 FAERS数据库 信号挖掘 报告比值比法 比例报告比值法

内蒙古自治区人民医院院内基金项目

2020YN23

2024

中国药物与临床
中国医院协会

中国药物与临床

影响因子:0.846
ISSN:1671-2560
年,卷(期):2024.24(13)
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