摘要
目的对药物引起的唾液腺结石进行不相称测定分析,为药物相关性唾液腺结石的预防提供参考。方法采用报告比值比(ROR)法和综合标准(MHRA)法对美国食品药品监督管理局不良事件报告系统(FAERS)中2012年4季度至2023年2季度的个例安全性报告数据中唾液腺结石有关不良反应信号进行检测。结果共检索到唾液腺结石相关报告211例,涉及主要怀疑或次要怀疑药物135个。经ROR法和MHRA法检测后,共有14种药物出现不相称测定信号(SDR),分别为钙剂、马昔腾坦、美托洛尔、左甲状腺素、阿达木单抗、戈利木单抗、托珠单抗、唑来膦酸、地诺单抗、托吡酯、奥氮平、喹硫平、羟丁酸钠和美克洛嗪(按ATC编码排序)。结论检测到唾液腺结石相关SDR的药物14个。临床医务人员在应用上述药物时,应认识到唾液腺结石发生的潜在风险,积极监测并采取相应预防措施。
Objective To conduct a disproportionality analysis of drug-induced salivary gland calculus by using the individual case safety reports in the FDA Adverse Event Reporting System(FAERS)in order to provide a reference for prevention of this disease.Methods Data on individual case safety reports collected between the fourth quarter of 2012 and the second quarter of 2023 in the FAERS was retrieved.The reporting odds ratio(ROR)method and Medicines and Healthcare Products Regulatory Agency(MHRA)method were used for detection of signals of adverse drug reactions related to salivary gland calculus.Results A total of 211 reports related to salivary gland calculus were retrieved,involving 135 primary suspected or secondary suspected drugs.Using the ROR method and MHRA method,signals of disproportionate reporting(SDR)were detected in 14 drugs,which were calcium,macitentan,metoprolol,levothyroxine,adalimumab,golimumab,tocilizumab,zoledronic acid,denosumab,topiramate,olanzapine,quetiapine,sodium oxybate and meclizine(sorted by the ATC code).Conclusion There are 14 types of drugs with SDR related to salivary gland calculus detected in this study.Clinicians should be aware of the potential risks of salivary gland calculus when prescribing drugs mentioned above.Active monitoring and appropriate precautions are required.
作者
曹凯
钱佩佩
高鑫
杨付田
赵亮
徐炳欣
张现军
CAO Kai;QIAN Peipei;GAO Xin;YANG Futian;ZHAO Liang;XU Bingxin;ZHANG Xianjun(Pharmacy Department,Xuchang Central Hospital Affiliated to Henan University of Science and Technology,Xuchang Henan 461000,China;Stomatology Department,Xuchang Central Hospital Affiliated to Henan University of Science and Technology,Xuchang Henan 461000,China;Clinical Research Center,Xuchang Central Hospital Affiliated to Henan University of Science and Technology,Xuchang Henan 461000,China;Henan Provincial Health Commission Key Laboratory of Precision Medicine,Xuchang Henan 461000,China)
出处
《中国药物警戒》
2025年第7期799-804,共6页
Chinese Journal of Pharmacovigilance
基金
许昌市重点研发与推广专项(20230213065)。
