摘要
目的 基于美国FDA不良事件报告系统(FAERS)挖掘特立帕肽的药品不良事件(ADE)信号,为临床安全用药提供依据。方法 采用比例失衡法对FAERS自建库至2022年第3季度所有的特立帕肽ADE报告进行信号挖掘,并用《药事管理标准医学词典》(MedDRA)中药物不良反应术语集的首选系统器官分类(SOC)和首选术语(PT)对挖掘到的风险信号进行分类和描述。结果 获得以特立帕肽为首要怀疑药物的ADE报告71 435份。按ROR法和PRR法共得到特立帕肽强信号721个,涉及22个系统器官分类,ADE信号数量按系统器官分类排序前5位分别为“各种肌肉骨骼及结缔组织疾病”“各类损伤、中毒及操作并发症”“各类检查”“良性、恶性及性质不明的肿瘤(包括囊状和息肉状)”和“胃肠系统疾病”有临床参考意义的高风险信号包括软骨肿瘤(ROR=48.666)、牙吸收(ROR=13.124)、钙质沉着(ROR=11.633)等。结论 利用FAERS数据能够全面深入分析特立帕肽上市后的ADE,进而有效降低临床用药风险。
Objective Exploring adverse drug event(ADE) signals of teriparatide based on the US FDA Adverse Event Reporting System(FAERS),in order to provide evidence for safe clinical medication.Methods Using disproportionality analysis,researchers performed signal mining on all adverse drug event(ADE) reports of teriparatide in the FAERS,starting from the establishment of the database until the third quarter of 2022.The identified risk signals were classified and described using the system organ class(SOC) and preferred term(PT) from the Medical Dictionary for Regulatory Activities(MedDRA) preferred terms version 25.1.Results A total of 71 435 ADE reports suspected teriparatide as the primary drug.using Reporting Odds Ratio(ROR) and Proportional Reporting Ratio(PRR) methods,a total of 721 strong signals associated with teriparatide were obtained,involving 22 SOCs.The ADE signals were ranked by SOC,with the top five being various musculoskeletal and connective tissue disorders,various injuries,poisonings,and procedural complications,various examinations,benign and malignant neoplasms of uncertain and unspecified nature(including cystic and polypoid lesions),and gastrointestinal disorders.Among them,clinically meaningful high-risk signals included chondrosarcoma(ROR=48.666),tooth absorption(ROR=13.124),calcium deposition(ROR=11.633),etc.Conclusion Utilizing FAERS database enables comprehensive and in-depth analysis of adverse reactions following the market approval of teriparatide,thereby effectively reducing clinical medication risks.
作者
郑卓婷
刘易陇
严润
赵艳双
罗羽鸶
龙恩武
ZHENG Zhuoting;LIU Yilong;YAN Run;ZHAO Yanshuang;LUO Yuxiong;LONG Enwu(Department of Pharmacy,Leshan People′s Hospital,Sichuan Province,Leshan 614000,China;不详)
出处
《临床合理用药杂志》
2023年第35期1-5,9,共6页
Chinese Journal of Clinical Rational Drug Use
基金
四川省科技计划项目(2021YFS0197)。
关键词
特立帕肽
比例失衡法
不良反应
信号挖掘
Teriparatide
Proportional imbalance method
Adverse reactions
Signal mining
