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基于FAERS数据库的托伐普坦不良事件信号挖掘与分析
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| 篇名： | 基于FAERS数据库的托伐普坦不良事件信号挖掘与分析 |
| TITLE： | Signal mining and analysis of adverse drug events for tolvaptan based on FAERS database |
| 摘要： | 目的 基于美国FDA不良事件报告系统（FAERS）数据库挖掘托伐普坦的药品不良事件（ADE）信号，为临床安全用药提供参考。方法收集FAERS数据库2004年第一季度至2020年第三季度的托伐普坦ADE数据，利用比例失衡法中的报告比值比（ROR）法和比例报告比值（PRR）法进行数据挖掘。结果共获得目标药物托伐普坦ADE报告4744例，涉及1279个ADE，上报的国家以美国、日本等为主。共挖掘出托伐普坦ADE信号199个，涉及21个系统器官分类（SOC），主要集中在各类检查（n＝56）、肝胆系统疾病（n＝17）、肾脏及泌尿系统疾病（n＝14）等，其中未在我国现有药品说明书中提及的信号有80个，包括肾小球滤过率降低、位置性眩晕、肾囊肿破裂、肾囊肿感染、肺恶性肿瘤等。结论使用托伐普坦治疗前应做好患者的用药评估，特别应重视有心力衰竭、肝功能不全、肾功能不全等基础疾病的患者；治疗期间应密切监测患者肝功能、肾功能指标，如发生ADE或疾病进展，应及时采取干预措施，避免因ADE导致的相关损伤和疾病恶化。 |
| ABSTRACT： | OBJECTIVE To mine the signals of adverse dr ug events （ADE）for tolvaptan based on FAERS database ，and to provide reference for safe use of drugs in clinic. METHODS The data of tolvaptan-induced ADE were collected from FAERS database during the first quarter of 2004 to the third quarter of 2020；the reporting odds ratio （ROR）method and the proportional reporting ratio （PRR）method of disproportional method were used for data mining. RESULTS A total of 4 744 ADE reports of the target drug tolvaptan were extracted ，involving 1 279 ADEs. The reporting countries were mainly the United States and Japan ，etc. A total of 199 ADE signals were obtained ，involving 21 system organ classes （SOCs），which mainly focused on various examinations（n＝56），hepatobiliary disorders （n＝17），renal and urinary disorders （n＝14），etc. Among them ，80 signals were not mentioned in existing instructions for tolvaptan in China ，such as decreased glomerular filtration rate ，positional vertigo ， rupture of renal cyst ，renal cyst infection ，pulmonary malignant tumor. CONCLUSIONS Before using tolvaptan ，drug evaluation should be performed well ，especially the patients with basic diseases such as heart failure ，liver insufficiency and renal insufficiency. During treatment ，the indexes of liver function and renal function should be closely monitored ；timely intervention measures should be taken to avoid related injury and disease deterioration caused by ADE when ADE or disease progression occurs. |
| 期刊： | 2022年第33卷第03期 |
| 作者： | 陈亚昆，周鹏翔，孙瑞芳，赵荣生 |
| AUTHORS： | CHEN Yakun，ZHOU Pengxiang，SUN Ruifang，ZHAO Rongsheng |
| 关键字： | 托伐普坦；药品不良事件；FAERS数据库；比例失衡法；信号挖掘 |
| KEYWORDS： | tolvaptan；adverse drug event ；FAERS database ；disproportional method ；signal mining |
| 阅读数： | 465 次 |
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