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达罗他胺ADE信号的挖掘与分析
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| 篇名： | 达罗他胺ADE信号的挖掘与分析 |
| TITLE： | Signal mining and analysis of adverse drug event signals of darolutamide |
| 摘要： | 目的 挖掘并分析达罗他胺的药物不良事件（ADE）信号，为其临床安全使用提供参考。方法基于美国FDA不良事件报告系统（FAERS）数据库收集2019年第3季度到2022年第3季度达罗他胺相关的ADE报告，采用报告比值比（ROR）法和比例报告比值（PRR）法进行数据挖掘和分析。结果提取到达罗他胺相关的ADE报告565份，其中以达罗他胺为首要怀疑药物的ADE报告356份，挖掘得到38个ADE信号，涉及15个系统器官分类（SOC），患者年龄主要集中在65岁以上。达罗他胺ADE信号的SOC主要集中在各类检查，全身性疾病及给药部位各种反应，良性、恶性及性质不明的肿瘤（包括囊状和息肉状），肾脏及泌尿系统疾病等。该药说明书中未提及的ADE信号有13个，包括前列腺特异性抗原升高、吞咽困难、认知障碍、勃起功能障碍、横纹肌溶解、男性乳腺发育、血小板计数降低等。结论临床在使用达罗他胺时，除了关注该药说明书中提及的ADE外，还应密切关注前列腺特异性抗原升高、横纹肌溶解、男性乳腺发育、血小板计数降低等潜在ADE，以避免因ADE引起的停药或器官损伤。 |
| ABSTRACT： | OBJECTIVE To explore and analyze the adverse drug event （ADE） signals of darolutamide and provide a reference for its clinical safe use. METHODS ADEs related to darotamide were collected based on the US FDA adverse event reporting system （FAERS） database from the third quarter of 2019 to the third quarter of 2022. Data mining and analysis were conducted by the report odds ratio （ROR） and proportional reporting ratio （PRR） methods. RESULTS A total of 565 ADE reports related to darolutamide were extracted， 356 ADE reports about darolutamide as the primary suspected drug were included， 38 ADE signals with darolutamide as the primary suspected drug were excavated， involving 15 system organ class （SOC）， mainly concentrated in patients over 65 years old. The SOC of darotamide ADE signal mainly focused on various examinations， systemic diseases and various reactions at the administration site， benign/malignant tumors or those with unknown nature （including cystic and polypoid）， kidney and urinary system diseases. A total of 13 ADE signals not mentioned in the instructions included increased prostate-specific antigen， dysphagia， cognitive impairment， erectile dysfunction， rhabdomyolysis， gynecomastia and decreased platelet count， etc. CONCLUSIONS When using darolutamide， in addition to ADE in the drug instruction， we should pay close attention to potential ADE， such as increased prostate-specific antigen， rhabdomyolysis， gynecomastia and decreased platelet count， so as to avoid drug withdrawal or organ damage caused by ADE. |
| 期刊： | 2024年第35卷第03期 |
| 作者： | 乔丽娟；陈金花；康建 |
| AUTHORS： | QIAO Lijuan，CHEN Jinhua，KANG Jian |
| 关键字： | 达罗他胺；美国FDA不良事件报告系统；报告比值比法；比例报告比值法；信号挖掘 |
| KEYWORDS： | darolutamide； FDA adverse event reporting system； report odds ratio； proportional reporting ratio； signal mining |
| 阅读数： | 58 次 |
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