Article(id=1236687123215086514, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236687122619495346, articleNumber=null, orderNo=null, doi=null, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=null, receivedDateStr=null, revisedDate=null, revisedDateStr=null, acceptedDate=1656518400000, acceptedDateStr=2022-06-30, onlineDate=1772778786709, onlineDateStr=2026-03-06, pubDate=1682784000000, pubDateStr=2023-04-30, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1772778786709, onlineIssueDateStr=2026-03-06, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1772778786709, creator=13701087609, updateTime=1772778786709, updator=13701087609, issue=Issue{id=1236687122619495346, tenantId=1146029695717560320, journalId=1235980733773295621, year='2023', volume='32', issue='8', pageStart='761', pageEnd='864', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1772778786568, creator=13701087609, updateTime=1772779118928, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1236688516713861515, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236687122619495346, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1236688516713861516, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236687122619495346, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=858, endPage=864, ext={EN=ArticleExt(id=1236687123500299189, articleId=1236687123215086514, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Mining and analysis of cardiac adverse events and death cases of epidermal growth factor receptor inhibitors based on FAERS database, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=
Objective:

To retrospectively analyze the cardiac adverse events and death cases of EGFR inhibitors through data mining of FDA adverse reaction reporting system (FAERS), so as to better understand the safety of EGFR inhibitors.

Methods:

The data in a total of 36 quarters in FAERS database from 2013 to 2021 were mined and analyzed by reporting odds ratio (ROR).

Results:

A total of 30 728 493 adverse events were reported in FAERS database from 2013 to 2021, including 735 693 cardiac adverse events. The effective signals were cetuximab [ROR=1.16, 95%CI (1.07,1.26)], rituximab [ROR=2.94, 95%CI (1.61,5.36)], dactinib [ROR=3.73, 95%CI (2.10,6.62)], and ositinib [ROR=1.55, 95%CI (1.44,1.66)]. McAbs were more likely to cause tachycardia. All heart-related effective signals of TKIs contained pericardial effusion. The significant death signals were panizumab [ROR=1.71, 95%CI (1.54,1.89)], gefitinib [ROR=2.93, 95%CI (2.64,3.25)], erlotinib [ROR=6.72, 95%CI (6.54,6.91)], afatinib [ROR=1.30, 95%CI(1.17,1.45)], dactinib [ROR=14.24, 95%CI (11.27,17.99)], and ositinib [ROR=15.03, 95%CI (14.53,15.54)].

Conclusion:

EGFR receptor inhibitors can cause adverse cardiac events with serious outcomes and increase the risk of death, which are worthy of clinical attention. Due to the limitations of database and detection methods, long-term data are still needed to verify these results to further understand the safety of EGFR inhibitors.

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目的:

通过对美国FDA不良反应报告系统(FAERS)进行数据挖掘,对表皮生长因子受体(EGFR)抑制剂的心脏和死亡不良事件进行了回顾性分析,以更好地了解EGFR受体抑制剂的安全性。

方法:

采用报告比值比法(ROR)对FAERS数据库2013—2021年共计36个季度的数据进行数据挖掘和分析。

结果:

FAERS数据库2013—2021年共报告不良事件30 728 493份,其中心脏不良事件735 693份,有效信号为西妥昔单抗[ROR=1.16,95%CI(1.07,1.26)]、耐昔妥珠单抗[ROR=2.94,95%CI(1.61,5.36)]、达克替尼[ROR=3.73,95%CI(2.10,6.62)]、奥西替尼[ROR=1.55,95%CI(1.44,1.66)]。单抗类更容易引起心动过速,所有的酪胺酸激酶抑制剂(TKIs)心脏相关有效信号中均包含心包积液,死亡信号有意义为帕尼单抗[ROR=1.71,95%CI(1.54,1.89)]、吉非替尼[ROR=2.93,95%CI(2.64,3.25)]、厄洛替尼[ROR=6.72,95%CI(6.54,6.91)]、阿法替尼[ROR=1.30,95%CI(1.17,1.45)]、达克替尼[ROR=14.24,95%CI(11.27,17.99)]、奥西替尼[ROR=15.03,95%CI(14.53,15.54)]。

结论:

EGFR受体抑制剂会引起心脏不良事件且结局较严重,还会增加死亡风险,值得临床关注。由于数据库和检测方法的局限性,仍然需要长期数据来验证这些结果从而进一步了解EGFR受体抑制剂的安全性。

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刘晓健,女,硕士生导师,教授,主要从事肿瘤药理学研究。E-mail:
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邓慧杰,女,硕士研究生,主要从事肿瘤药理学和临床药学研究。E-mail:

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邓慧杰,女,硕士研究生,主要从事肿瘤药理学和临床药学研究。E-mail:

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基于FAERS数据库的表皮生长因子受体抑制剂的心脏和死亡不良事件分析
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邓慧杰 1, 2 , 梁力 2 , 陈燕 2 , 郭宇航 2 , 郭晋敏 2 , 李冰 2 , 刘晓健 1
中国新药杂志 | 药物安全与合理应用 2023,32(8): 858-864
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中国新药杂志 | 药物安全与合理应用 2023, 32(8): 858-864
基于FAERS数据库的表皮生长因子受体抑制剂的心脏和死亡不良事件分析
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邓慧杰1, 2 , 梁力2, 陈燕2, 郭宇航2, 郭晋敏2, 李冰2, 刘晓健1
作者信息
  • 1锦州医科大学基础医学院药理学教研室,锦州 121001
  • 2中国人民解放军联勤保障部队第九六〇医院临床药学科,济南 250000
  • 邓慧杰,女,硕士研究生,主要从事肿瘤药理学和临床药学研究。E-mail:

通讯作者:

刘晓健,女,硕士生导师,教授,主要从事肿瘤药理学研究。E-mail:
Mining and analysis of cardiac adverse events and death cases of epidermal growth factor receptor inhibitors based on FAERS database
Hui-jie DENG1, 2 , Li LIANG2, Yan CHEN2, Yu-hang GUO2, Jin-min GUO2, Bing LI2, Xiao-jian LIU1
Affiliations
  • 1Department of Pharmacology, Basic Medical College of Jinzhou Medical University, Jinzhou 121001, China
  • 2Clinical Pharmacy Department, The 960th Hospital of the Joint Logistics Support Force of the Chinese People's Liberation Army, Jinan 250000, China
出版时间: 2023-04-30
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目的:

通过对美国FDA不良反应报告系统(FAERS)进行数据挖掘,对表皮生长因子受体(EGFR)抑制剂的心脏和死亡不良事件进行了回顾性分析,以更好地了解EGFR受体抑制剂的安全性。

方法:

采用报告比值比法(ROR)对FAERS数据库2013—2021年共计36个季度的数据进行数据挖掘和分析。

结果:

FAERS数据库2013—2021年共报告不良事件30 728 493份,其中心脏不良事件735 693份,有效信号为西妥昔单抗[ROR=1.16,95%CI(1.07,1.26)]、耐昔妥珠单抗[ROR=2.94,95%CI(1.61,5.36)]、达克替尼[ROR=3.73,95%CI(2.10,6.62)]、奥西替尼[ROR=1.55,95%CI(1.44,1.66)]。单抗类更容易引起心动过速,所有的酪胺酸激酶抑制剂(TKIs)心脏相关有效信号中均包含心包积液,死亡信号有意义为帕尼单抗[ROR=1.71,95%CI(1.54,1.89)]、吉非替尼[ROR=2.93,95%CI(2.64,3.25)]、厄洛替尼[ROR=6.72,95%CI(6.54,6.91)]、阿法替尼[ROR=1.30,95%CI(1.17,1.45)]、达克替尼[ROR=14.24,95%CI(11.27,17.99)]、奥西替尼[ROR=15.03,95%CI(14.53,15.54)]。

结论:

EGFR受体抑制剂会引起心脏不良事件且结局较严重,还会增加死亡风险,值得临床关注。由于数据库和检测方法的局限性,仍然需要长期数据来验证这些结果从而进一步了解EGFR受体抑制剂的安全性。

FAERS数据库  /  表皮生长因子受体抑制剂  /  心脏不良事件  /  死亡  /  数据挖掘
Objective:

To retrospectively analyze the cardiac adverse events and death cases of EGFR inhibitors through data mining of FDA adverse reaction reporting system (FAERS), so as to better understand the safety of EGFR inhibitors.

Methods:

The data in a total of 36 quarters in FAERS database from 2013 to 2021 were mined and analyzed by reporting odds ratio (ROR).

Results:

A total of 30 728 493 adverse events were reported in FAERS database from 2013 to 2021, including 735 693 cardiac adverse events. The effective signals were cetuximab [ROR=1.16, 95%CI (1.07,1.26)], rituximab [ROR=2.94, 95%CI (1.61,5.36)], dactinib [ROR=3.73, 95%CI (2.10,6.62)], and ositinib [ROR=1.55, 95%CI (1.44,1.66)]. McAbs were more likely to cause tachycardia. All heart-related effective signals of TKIs contained pericardial effusion. The significant death signals were panizumab [ROR=1.71, 95%CI (1.54,1.89)], gefitinib [ROR=2.93, 95%CI (2.64,3.25)], erlotinib [ROR=6.72, 95%CI (6.54,6.91)], afatinib [ROR=1.30, 95%CI(1.17,1.45)], dactinib [ROR=14.24, 95%CI (11.27,17.99)], and ositinib [ROR=15.03, 95%CI (14.53,15.54)].

Conclusion:

EGFR receptor inhibitors can cause adverse cardiac events with serious outcomes and increase the risk of death, which are worthy of clinical attention. Due to the limitations of database and detection methods, long-term data are still needed to verify these results to further understand the safety of EGFR inhibitors.

FAERS database  /  epidermal growth factor receptor inhibitor  /  cardiac adverse events  /  death  /  data mining
邓慧杰, 梁力, 陈燕, 郭宇航, 郭晋敏, 李冰, 刘晓健. 基于FAERS数据库的表皮生长因子受体抑制剂的心脏和死亡不良事件分析. 中国新药杂志, 2023 , 32 (8) : 858 -864 .
Hui-jie DENG, Li LIANG, Yan CHEN, Yu-hang GUO, Jin-min GUO, Bing LI, Xiao-jian LIU. Mining and analysis of cardiac adverse events and death cases of epidermal growth factor receptor inhibitors based on FAERS database[J]. Chinese Journal of New Drugs, 2023 , 32 (8) : 858 -864 .
2023年第32卷第8期
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  • 首发时间:2026-03-06
  • 出版时间:2023-04-30
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  • 录用日期:2022-06-30
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    1锦州医科大学基础医学院药理学教研室,锦州 121001
    2中国人民解放军联勤保障部队第九六〇医院临床药学科,济南 250000

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刘晓健,女,硕士生导师,教授,主要从事肿瘤药理学研究。E-mail:
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2种不同金属材料的力学参数

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Genus
种数
Number of
species
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species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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