·3586·http://www.chinagp.net E-mail:zgqkyx@chinagp.net.cn
·临床用药研究·曲坦类药物上市后致血管不良反应信号挖掘评价研究
周虎1，杨俊卿2，于跃3，吕亚兰1，赵文龙1*
【摘要】 背景 药品不良反应（ADR）的发生给人类健康带来极大的危害，增加患者的住院时间、经济负担以及死亡率，甚至会造成重大的公共卫生事件，严重威胁人类的生命健康。目的 监测和分析曲坦类药物在上市后的ADR信号，为临床合理用药提供参考。方法 采用比值比（ROR）法对美国食品药品监督管理局不良反应事件呈报系统（AERS）2004-01-01至2017-06-30的曲坦类药物进行ADR信号挖掘，并对结果进行分析评价。结果 在纳入的5 531 574份ADR报告中，以7种曲坦类药物为首要怀疑药物的ADR报告为21 905份，经ROR法检测，共得到502个ADR信号，其中涉及血管严重不良反应信号35个，主要涉及心脏器官、血液和淋巴系统，具有临床参考意义的高危险信号主要包括冠状动脉痉挛〔ROR=21.17，95%CI（17.00，26.35）〕、脑血管收缩〔ROR=35.32，95%CI（25.27，49.37）〕、变异性心绞痛〔ROR=33.00，95%CI（22.96，47.43）〕、血管痉挛〔ROR=25.29，95%CI（17.38，36.81）〕、动脉夹层〔ROR=22.34，95%CI（12.67，39.38）〕、冠状动脉夹层〔ROR=15.47，95%CI（8.64，27.70）〕、雷诺综合征〔ROR=4.31，95%CI（2.96，6.35）〕等不良血管安全信号。结论 基于真实世界的ADR信号研究有助于药物上市后安全再评价研究，为临床合理用药提供参考依据。
【关键词】 曲坦类药物；药物毒性；信号检测；血管事件；药品不良反应；比值比【中图分类号】 R 595 【文献标识码】 A DOI：10.12114/j.issn.1007-9572.2024.00.008
周虎，杨俊卿，于跃，等．曲坦类药物上市后致血管不良反应信号挖掘评价研究［J］．中国全科医学，2024，22（29）：3586-3590．［www.chinagp.net］
ZHOU H，YANG J Q，YU Y，et al．Signal and evaluation of adverse vascular reactions associated with triptans［J］．Chinese General Practice，2024，22（29）：3586-3590．
Signal and Evaluation of Adverse Vascular Reactions Associated with Triptans ZHOU Hu1，YANG Junqing2，YU Yue3，LYU Yalan1，ZHAO Wenlong1*
1.School of Medical Informatics，Chongqing Medical University，Chongqing 400016，China2.School of Pharmacy，Chongqing Medical University，Chongqing 400016，China
3.Division of Biomedical Statistics and Informatics，Mayo Clinic，Rochester MN 55901，U.S.A
*
Corresponding author：ZHAO Wenlong，Professor；E-mail：cqzhaowl@163.com
【Abstract】 Background Adverse drug reaction （ADR） is one of the major problems in the field of medicine, which
may increase the length of stay, economic burden, and risk of death for hospitalized patients.It may even cause major public health incidents, which seriously threaten life and health.Objective To detect and analyze the ADR signals of triptans after marketing and provide references for clinical rational drug use.Methods Reporting odd ratio （ROR） was used to investigate adverse reaction signals of triptans in the Adverse Event Reporting System （AERS） of the Food and Drug Administration of the United States from January 2004 to June 2017, and the results were analyzed and evaluated.Results Totally 5 531 574 reports were found for all drugs, among which 21 905 reports were mainly induced by seven triptan drugs.A total of 502 ADR signals, of which 35 were serious adverse reaction signals, were mainly related to heart, blood and lymphatic system.The high risk signals with clinical reference mainly included coronarospasm 〔ROR=21.17，95%CI（17.00，26.35）〕, cerebral vasoconstriction 〔ROR=35.32，95%CI（25.27，49.37）〕, variant angina 〔ROR=33.00，95%CI（22.96，47.43）〕, vasospasm 〔ROR=25.29，95%CI（17.38，36.81）〕, artery dissection 〔ROR=22.34，95%CI（12.67，39.38）〕, coronary dissection 〔ROR=15.47，95%CI（8.64，27.70）〕, Raynaud's syndrome 〔ROR=4.31，95%CI（2.96，6.35）〕 and others.Conclusion Studies on ADR signals in the real world are helpful to evaluate the post-marketing safety of drugs and provide references for drug use in clinical medication.
【Key words】 Triptans；Drug toxicity；Signal detection；Vascular events；Adverse drug reaction；Odds ratio
基金项目：重庆市社会事业与民生保障科技创新专项（cstc2015shmszx10004）—基于临床大数据的医疗行为分析系统研究与开发
1.400016重庆市，重庆医科大学医学信息学院 2.400016重庆市，重庆医科大学药学院 3.55901美国明尼苏达州，美国梅奥医院生物医学统计学与信息系
*
通信作者：赵文龙，教授；E-mail：cqzhaowl@163.com
曲坦类药物上市后致血管不良反应信号挖掘评价研究
