盐酸舍曲林和草酸艾司西酞普兰用于抑郁症治疗的安全性比较:基于FAERS数据库不良事件分析  

Comparison of safety of sertraline hydrochloride and escitalopram oxalate in the treatment of depression:an analysis of adverse events from FAERS database

作　　者：何佳蔚 包尔皓 陈晓娅 姚静 He Jiawei;Bao Erhao;Chen Xiaoya;Yao Jing(School of Mental Health,North Sichuan Medical College,Nanchong 637000,China;Clinical Medical College,North Sichuan Medical College,Nanchong 637000,China;Sichuan Mental Health Center,Mianyang Third People′s Hospital,Mianyang 621000,China)

机构地区：[1]川北医学院精神卫生学院,四川南充637000 [2]川北医学院临床医学院,四川南充637000 [3]四川省精神卫生中心·绵阳市第三人民医院,四川绵阳621000

出　　处：《实用药物与临床》2024年第3期174-178,共5页Practical Pharmacy and Clinical Remedies

摘　　要：目的通过对美国FDA不良事件报告系统(FAERS)数据库的数据挖掘,探讨盐酸舍曲林和草酸艾司西酞普兰的安全性差异。方法采用报告比值比(ROR)法和比例报告比值比(PRR)法,对FAERS数据库中2011年第1季度至2023年第2季度报告的盐酸舍曲林和草酸艾司西酞普兰的不良事件进行数据挖掘。结果女性发生不良事件的比例高于男性(男女比例约为1∶2)。盐酸舍曲林和草酸艾司西酞普兰均在18~64岁年龄组中的报告频率更高。累及系统器官分布方面,盐酸舍曲林组和草酸艾司西酞普兰组相似,但在生殖系统及乳腺疾病毒性方面存在差异,盐酸舍曲林的生殖器感觉减退信号更多,草酸艾司西酞普兰则更影响溢乳。在检测到的前10个报告信号中,药物相互作用、药物无效、恶心、头晕、头痛、焦虑的信号在盐酸舍曲林和草酸艾司西酞普兰中均有生成,盐酸舍曲林组中发生自杀意念、药物相互作用、震颤、焦虑等不良事件的可能性更大,草酸艾司西酞普兰组中更可能发生产品替换问题、妊娠期胎儿暴露、药物相互作用,提示二者的高频不良事件之间存在差异。结论盐酸舍曲林和草酸艾司西酞普兰具有相同的部分高频不良事件、相似的全身器官分布和相似的总体安全性,但在精神病类和各类检查方面存在差异,草酸艾司西酞普兰出现心电图QT间期延长不良信号强,用药后应定期复查心电图,减少晕厥、心脏骤停或死亡的风险。盐酸舍曲林出现自杀想法的信号强度高,应重视患者在治疗期间持续出现自杀想法。Objective To explore the differences in the safety between sertraline hydrochloride and escitalopram oxalate through data mining of the FDA Adverse Event Reporting System(FAERS)database.Methods The Reporting Odds Ratio(ROR)and Proportional Reporting Ratio(PRR)methods were used to mine the adverse events of sertraline hydrochloride and escitalopram oxalate reported in the FAERS database from the first quarter of 2011 to the second quarter of 2023.Results The proportion of adverse events in females was higher than that in males(male-to-female ratio:1∶2);both sertraline and escitalopram had higher reporting frequencies in the 18~64 age group.Regarding the distribution of adverse events across system organ classes,sertraline and escitalopram were similar.However,differences were observed in reproductive and breast disorders,with sertraline associated with more reports of reproductive sensory loss and escitalopram more likely to impact lactation.Among the top 10 detected signal events,both drugs had signals of drug interactions,drug ineffectiveness,nausea,dizziness,headaches,and anxiety.However,sertraline had a higher likelihood of adverse events related to suicidal ideation,drug interactions,tremors,and anxiety;while escitalopram had a higher likelihood of reports on product substitution issues,fetal exposure during pregnancy,and drug interactions.There were differences between the two drugs in terms of high-frequency adverse events.Conclusion Sertraline and escitalopram share some high-frequency adverse events,similar overall organ distribution,and comparable safety profiles.However,there are differences in psychiatric and various examination aspects.Escitalopram exhibits a stronger adverse signal of QT interval prolongation on electrocardiograms,indicating the need for periodic ECG monitoring to reduce the risk of syncope,cardiac arrest,or death.Sertraline shows higher signal intensity for suicidal ideation,emphasizing the importance of continuous monitoring of suicidal thoughts in patients during treatment.

关 键 词：盐酸舍曲林 草酸艾司西酞普兰 不良事件 数据挖掘 

分 类 号：R749.4[医药卫生—神经病学与精神病学] R969[医药卫生—临床医学]