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美泊利单抗相关不良事件信号的挖掘与分析
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| 篇名： | 美泊利单抗相关不良事件信号的挖掘与分析 |
| TITLE： | Mining and analysis of adverse drug event signals related to mepolizumab |
| 摘要： | 目的 为临床合理使用美泊利单抗提供参考。方法采用报告比值比法和贝叶斯可信区间递进神经网络法，对2016年第1季度至2022年第3季度美国FDA不良事件报告系统中有关美泊利单抗的药品不良事件（ADE）报告进行信号挖掘与分析。结果共提取到以美泊利单抗为首要怀疑药物的ADE报告57501份，涉及16358例患者，其中男性所占比例（23.51%）低于女性（50.48%）；报告国家以美国（51.91%）和加拿大（29.94%）为主；消费者（71.18%）是主要上报人群。挖掘出172个ADE阳性信号，主要涉及呼吸系统、胸及纵隔疾病（41.63%），感染及侵染类疾病（14.16%）等13个系统器官分类。共有60个高风险信号，其中15个为美泊利单抗药品说明书明确提及或相关的药品不良反应，45个（如哮喘危象、痰变色、脓痰、一般性疾病引起的睡眠障碍等）为新的高风险信号；各有11个高风险信号有性别差异或年龄差异。结论临床应用美泊利单抗时，除药品说明书中提及的不良反应外，还应重点关注痰液性质的改变、痛性呼吸、睡眠障碍等。 |
| ABSTRACT： | OBJECTIVE To provide reference for rational clinical use of mepolizumab. METHODS The reporting odds ratio method and Bayesian confidence propagation neural network method were used to conduct signal mining and analysis of adverse drug event （ADE） reports related to mepolizumab in the United States Food and Drug Administration Adverse Event Reporting System from the first quarter of 2016 to the third quarter of 2022. RESULTS A total of 57 501 ADE reports were extracted with mepolizumab as the primary suspect drug， involving 16 358 patients. Among these reports， the proportion of males （23.51%） was lower than females （50.48%）. The reporting countries were primarily the United States （51.91%） and Canada （29.94%）. Consumers （71.18%） constituted the main reporting population. A total of 172 ADE-positive signals were identified， mainly involving 13 system organ classes such as the respiratory， thoracic and mediastinal disorders （41.63%）， as well as infectious and parasitic diseases （14.16%）. There were 60 high-risk signals， including 15 that were explicitly mentioned or related to adverse reactions in the drug instructions of mepolizumab and 45 signals （such as asthmatic crisis， sputum discoloured， purulent sputum， sleep disorder due to a general medical condition） were newly identified high-risk signals. Among them， 11 high-risk signals exhibited gender or age differences. CONCLUSIONS When clinically using mepolizumab， in addition to the adverse reactions mentioned in the drug instruction， special attention should also be given to changes in the nature of sputum， painful respiration， and sleep disorders. |
| 期刊： | 2023年第34卷第11期 |
| 作者： | 陈耀鑫；伍绍星；李浩轩；许银姬 |
| AUTHORS： | CHEN Yaoxin，WU Shaoxing，LI Haoxuan，XU Yinji |
| 关键字： | 美泊利单抗；药品不良事件；信号挖掘；合理用药；药品不良反应 |
| KEYWORDS： | mepolizumab； adverse drug events； signal mining； rational drug use； adverse drug reaction |
| 阅读数： | 152 次 |
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