基于数据挖掘法对β受体阻滞剂药物相关急性肾衰竭信号的分析-中国药房

基于数据挖掘法对β受体阻滞剂药物相关急性肾衰竭信号的分析

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篇名：	基于数据挖掘法对β受体阻滞剂药物相关急性肾衰竭信号的分析
TITLE：	Analysis of β-blockers associated with acute renal failure signal based on data mining method
摘要：	目的挖掘并评价β受体阻滞剂药物相关急性肾衰竭（ARF）信号。方法采用报告比值比（ROR）法和贝叶斯置信区间递进神经网络（BCPNN）法，并从标准国际医学用语词典（MedDRA）分析查询（SMQ）术语集、首选术语（PT）级术语2个维度对美国FDA不良事件报告系统（FAERS）中4种β受体阻滞剂（美托洛尔、比索洛尔、阿替洛尔、奈必洛尔）药物相关ARF进行信号检测与分析，当2种方法同时检出阳性信号时，提示检出可疑信号。结果以SMQ术语集“acuterenalfailure”狭义范围检索到4种β受体阻滞剂致ARF报告共14328份，其中男性（6964份）多于女性（6206份），患者年龄主要集中在中老年（≥45岁），严重不良事件占77.23％。基于SMQ术语集的信号检索结果显示，美托洛尔、比索洛尔、阿替洛尔、奈必洛尔使用ROR法检出的ROR值及95％置信区间分别为：2.58（2.51，2.65）、5.30（5.14，5.47）、2.80（2.69，2.91）、3.28（3.04，3.53）；BCPNN法检出的信号成分（IC）及IC下限分别为：1.29（1.25）、2.26（2.22）、1.42（1.36）、1.64（1.53），提示这4种β受体阻滞剂药物相关ARF均检出可疑信号。基于PT级术语的信号检测结果显示，ROR法检出37个阳性信号，BCPNN法检出38个阳性信号，2种方法同时检出36个可疑信号。具体到各药物，美托洛尔均检出12个可疑信号，比索洛尔和阿替洛尔均检出9个可疑信号，奈必洛尔均检出6个可疑信号，且4种药物检出的信号数量和类型都存在一定差异。结论4种β受体阻滞剂均可能存在ARF发生风险。与美托洛尔、阿替洛尔相比，比索洛尔、奈必洛尔与ARF的统计学相关性较强，提示医务人员在临床使用过程中应注意观察该类药物可能的肾脏相关药物不良反应。
ABSTRACT：	OBJECTIVE To excavate and evaluate β-blockers associated with acute renal failure（ARF）signal. METHODS Using the report odds ratio （ROR）method and Bayesian confidence interval progressive neural network （BCPNN）method，signal detection and analysis were performed for 4 kinds of β-blockers（metoprolol，bisoprolol，atenolol，nebivolol）associated with ARF Δ 基金项目：重庆市临床药学重点专科建设项目（No.渝卫办发 in FDA adverse event reporting system （FAERS）from the two 〔2020〕68号）；重庆医科大学未来医学青年创新团队发展支持计划项 dimensions of Standard International Dictionary of Medical 目（No.W0081） Terms （MedDRA） analysis query （SMQ） term set and ＊药师，硕士研究生。研究方向：药物警戒。电话：023-68485161。 preferred term （PT） level terms. When the two methods E-mail：2020121624@stu.cqmu.edu.cn detected positive signals at the same time ，it indicated that # 通信作者：主任药师，硕士生导师。研究方向：临床药学、药物警 suspicious signals were detected. RESULTS Totally 14 328 戒。电话：023-63625666。E-mail：jiayuntaomail@hospital.cqmu.edu.cn ARF reports of 4 kinds of β-blockers were retrieved within the ·1380· China Pharmacy 2022Vol. 33 No. 11 中国药房 2022年第33卷第11期 narrow sense of “acute renal failure ”in SMQ term set ，of which men （6 964）were more than women （6 206）. The age of patients was mainly concentrated in the middle-aged and elderly （≥45 years old ），and serious adverse events accounted for 77.23％. The results of signal retrieval based on SMQ term set showed that ROR values and 95％ confidence intervals of metoprolol ，bisoprolol， atenolol and nebivolol detected by ROR method were 2.58（2.51，2.65），5.30（5.14，5.47），2.80（2.69，2.91）and 3.28（3.04， 3.53）respectively. The signal components （IC）detected by BCPNN method and the lower limit of IC were 1.29（1.25），2.26 （2.22），1.42（1.36）and 1.64（1.53）respectively，suggesting suspicious signals were detected in these four kinds of β-blockers associated ARF. The results of signal detection based on PT level terms showed that 37 positive signals were detected by ROR method，38 positive signals were detected by BCPNN method ，and 36 suspicious signals were detected by the two methods at the same time. For each drug ，12 suspicious signals of metoprolol were detected at the same time ，9 suspicious signals of bisoprolol and atenolol were detected at the same time ，and 6 suspicious signals of nebivolol were detected at the same time ；the number and type of signals were different among the 4 kinds of drug. CONCLUSIONS Four kinds of β-blockers may cause ARF. Compared with metoprolol and atenolol ，bisoprolol and nebivolol have strong statistical correlation with ARF ，suggesting that medical personnel should pay attention to the possible renal related adverse reactions of these drugs in the process of clinical use.
期刊：	2022年第33卷第11期
作者：	王红力，张妮，钟贵遵，陈思琪，季欢欢，龚莉，潘玲云，贾运涛
AUTHORS：	WANG Hongli ，ZHANG Ni，ZHONG Guizun ，CHEN Siqi，JI Huanhuan ，GONG Li，PAN Lingyun ，JIA Yuntao
关键字：	β受体阻滞剂；急性肾衰竭；数据挖掘；信号检测
KEYWORDS：	β-blockers；acute renal failure ；data mining ；signal detection
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