| 孙璇,张科,李正翔.5种阿片受体激动剂不良反应信号的数据挖掘与分析[J].安徽医药,2023,27(2):420-424. |
| 5种阿片受体激动剂不良反应信号的数据挖掘与分析 |
| Data mining and analysis of adverse reaction signals of five opioid receptor agonists |
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| DOI：10.3969/j.issn.1009-6469.2023.02.048 |
| 中文关键词: 阿片受体激动剂 吗啡 可待因 哌替啶 芬太尼 美沙酮 数据挖掘 FAERS数据库 不良反应 报告比值比 |
| 英文关键词: Opioid receptor agonist Morphine Codeine Pethidine Fentanyl Methadone Data mining FAERS data-base Adverse event Reporting odds ratio |
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| 中文摘要: |
| 目的基于美国食品药品管理局不良事件报告系统( FAERS)对 5种阿片受体激动剂(吗啡、可待因、哌替啶、芬太尼、美沙酮)相关不良反应进行挖掘分析，为阿片受体激动剂的临床安全用药提供参考依据。方法利用美国食品药品管理局公共数据开放项目(OpenFDA)平台，收集 2004年第 1季度至 2021年第 4季度 FAERS数据库中 5种阿片受体激动剂的不良反应报告数据，采用报告比值比( reporting odds ratio，ROR)法对 5种阿片受体激动剂的药品不良反应( ADR)进行信号挖掘，分析 ADR报告中的安全警告信号。结果最终得到吗啡 165 572份，可待因 79 574份，哌替啶 9 838份，芬太尼 145 819份，美沙酮 43 433份 ADR报告。这些 ADR报告中女性 207 657份多于男性 156 810份，主要集中于 18~60岁年龄段病人，且美国地区的上报数最多为 282 820份，严重 ADR报告中以住院或住院时间延长的上报数最多为 129 454份。在上报数前 20位的 ADR中，药物依赖、过量、新生儿戒断综合征、怀孕期间胎儿暴露相关 ADR在 5种药物的说明书中均有提及，各类神经系统疾病及精神病类相关 ADR在说明书较为常见。经 ROR法检测发现，常见有精神障碍相关 ADR，吗啡和可待因信号强度最为显著，药物依赖性吗啡信号最强，除芬太尼外其余学习障碍和发育迟缓高危信号均较强，自杀身亡美沙酮信号最强。结论通过对吗啡、可待因、哌替啶、芬太尼和美沙酮等阿片受体激动剂的严重和其他重要 ADR信号的挖掘与分析，可更深入了解此类药物的 ADR特征和潜在风险，促进临床安全用药。 |
| 英文摘要: |
| Objective To mine and analyze the adverse reactions related to five opioid receptor agonists (morphine, codeine, pethi-dine, fentanyl and methadone) based on the FDA adverse event reporting system(FAERS), so as to provide reference basis for the clini-cal safety of opioid receptor agonists.Methods Using FDA open platform, the adverse reaction report data of five opioid receptor ago-nists in FAERS database from the first quarter of 2004 to the fourth quarter of 2021 were collected. The ADR signals of five opioid re-ceptor agonists were mined by reporting odds ratio (ROR) method, and the safety warning signals in ADR reports were analyzed.Re. sults A total of 165 572 morphine, 79 574 codeine, 9 838 pethidine, 145 819 fentanyl and 43 433 methadone ADR reports were ob-tained. Among these ADR reports, 207 657 were female more than 156 810 were male, mainly concentrated in patients aged from 18 to60 years old, and the maximum number of ADR reports in the United States was 282 820, and the maximum number of serious ADR re-ports involving hospitalization or prolonged hospitalization was 129 454.Among the top 20 ADRs reported, ADRs related to drug depen-dence, overdose, neonatal withdrawal syndrome and fetal exposure during pregnancy were mentioned in the instructions of five drugs,and ADRs related to various nervous system diseases and psychosis were common in the instructions. The ROR method showed thatthere were common ADRs related to mental disorders, the signal intensity of morphine and codeine was the most significant, the signalintensity of drug-dependent morphine was the strongest, except fentanyl, the high-risk signals of learning disabilities and growth retar-dation were strong, and the signal intensity of methadone for suicide was the strongest.Conclusion By mining and analyzing the se-vere and other important ADR signals of opioid receptor agonists such as morphine, codeine, pethidine, fentanyl and methadone, wecan further understand the ADR characteristics and potential risks of these drugs and promote clinical safe drug use. |
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