基于openFDA对2种一线抗抑郁药物的不良反应分析

目的：探究胰腺抗抑郁症药物草酸艾司西酞普兰（Serotonin reuptake inhibitor-SSRI，五羟色胺再摄取抑制剂）及盐酸度洛西汀（Serotonin-norepinephrine reuptake inhibitor-SNRI，五羟色胺-去甲肾上腺素再摄取抑制剂）不良反应，经美国食品药品管理局公共数据开放项目openFDA （U.S.Food and Drug Administration Public Data Open Project，openFDA）数据库检索2种药物不良反应，对比分析两药不良反应的相关情况，为临床合理用药提供参考依据。方法：在openFDA数据库中，存在药物不良反应端点的交互式图表板块，对2004年1月-2019年12月期间2种药物不良反应报告进行检索，使用应用程序编程接口（Application Programming Interface，API），提取相关数据及图表进行分析。结果：草酸艾司西酞普兰及盐酸度洛西汀的不良反应（ADR）报告数分别为6 826份和5 701份，ADR上报者职业分布比例相似，不良反应集中发生于美国，女性患者显著多于男性患者，用药适应证分别主要为抑郁、焦虑及抑郁、疼痛，2种药物的ADR类型均为严重程度。结论：基于openFDA大数据库能对两药的ADR相关信息进行全面、多维度的挖掘分析，在临床治疗用药时应当开展药学监护，密切关注2种药物使用适应证，及时处理不良反应，促进临床合理用药。

Analysis of adverse drug reactions of two first-line antidepressants based on openFDA

OBJECTIVE To study the adverse effects of pancreatic antidepressants escitalopril oxalate (Serotonin reuptake inhibitor) and duloxil hydrochloride (Serotonin Norepinephrine Reuptake inhibitor SNRI).The adverse reactions of the two drugs were searched in the database of openFDA (U.S.Food and Drug Administration Public Data Open Project),and the relevant situations of adverse reactions of the two drugs were compared and analyzed,so as to provide reference basis for rational clinical medication.METHODS In the openFDA database,the interactive chart board with adverse drug reaction endpoints was used to retrieve the two adverse drug reaction reports from January 2004 to December 2019,and relevant data and charts were extracted for analysis using the Application Programming Interface (API).RESULTS The number of adverse reaction (ADR) reports of escitalopram oxalate and duloxetine hydrochloride was 6 826 and 5 701,respectively.The occupational distribution ratio of ADR reporters was similar.The adverse reactions occurred in the United States,significantly more in female patients than in male patients.The main indications were depression,anxiety,depression and pain.The ADR types of the two drugs were severity.CONCLUSION Based on openFDA database,the ADR related information of the two drugs can be comprehensively and multidimensionally mined and analyzed.Pharmaceutical care should be carried out in clinical treatment of medication,close attention should be paid to the indications for the use of the two drugs,adverse reactions should be handled in time,and clinical rational drug use should be promoted.