Nan Zhao, Huimin Wang, Huilin Xu, Xixian Tang, Dedong Cao
{"title":"基于食品药品监督管理局不良事件报告系统数据库的抗肿瘤药物与自杀相关不良事件的关系分析。","authors":"Nan Zhao, Huimin Wang, Huilin Xu, Xixian Tang, Dedong Cao","doi":"10.1177/20503121241308686","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>The potential association between new antineoplastic drugs and an increased risk of suicide-related adverse drug reactions remains unclear. This study aims to utilize the FAERS public database to analyze suicide-related adverse drug reactions associated with common antitumor drugs and to investigate potential risk signals for such adverse drug reactions.</p><p><strong>Methods: </strong>This study was a retrospective analysis utilizing the FAERS database. The FAERS database was examined for reports of suicide-related adverse events associated with antitumor drugs, spanning from 2004 to 2023. To identify and verify adverse event signals, we employed reporting odds ratios, proportional reporting ratios, and Bayesian methods (Bayesian Confidence Propagation Neural Network). Additionally, logistic regression analysis was performed to assess outcomes in tumor patients.</p><p><strong>Results: </strong>A total of 223,781 suicide-related adverse event reports were screened, of which 3790 involved common antitumor drugs. The top five drugs reported were tretinoin (<i>n</i> = 1220), methotrexate (<i>n</i> = 664), celecoxib (<i>n</i> = 505), rituximab (<i>n</i> = 107), and imatinib (<i>n</i> = 105). Risk signal analysis indicated that, with the exception of tretinoin (ROR = 6.317), the reporting odds ratio values for the other drugs were below 2. Among cancer patients, the most frequently reported adverse events included suicidal ideation (<i>n</i> = 233), completed suicide (<i>n</i> = 131), and suicide attempts (<i>n</i> = 97). Regression analysis revealed that risk factors for patient death included indication (OR = 0.967, <i>p</i> < 0.01), gender (OR = 0.57, <i>p</i> < 0.01), and type of adverse event (OR = 4.644, <i>p</i> < 0.01).</p><p><strong>Conclusion: </strong>The findings suggest that antineoplastic drugs may not statistically increase the risk of suicide-related adverse events. However, specific tumor types and suicide-related adverse events may contribute to increased mortality in cancer patients. Further research is warranted to elucidate the risk of suicide-related adverse events in oncology patients.</p>","PeriodicalId":21398,"journal":{"name":"SAGE Open Medicine","volume":"12 ","pages":"20503121241308686"},"PeriodicalIF":2.3000,"publicationDate":"2024-12-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11653442/pdf/","citationCount":"0","resultStr":"{\"title\":\"Analysis of the relationship between antineoplastic drugs and suicide-related adverse events based on the food and drug administration adverse event reporting system database.\",\"authors\":\"Nan Zhao, Huimin Wang, Huilin Xu, Xixian Tang, Dedong Cao\",\"doi\":\"10.1177/20503121241308686\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>The potential association between new antineoplastic drugs and an increased risk of suicide-related adverse drug reactions remains unclear. This study aims to utilize the FAERS public database to analyze suicide-related adverse drug reactions associated with common antitumor drugs and to investigate potential risk signals for such adverse drug reactions.</p><p><strong>Methods: </strong>This study was a retrospective analysis utilizing the FAERS database. The FAERS database was examined for reports of suicide-related adverse events associated with antitumor drugs, spanning from 2004 to 2023. To identify and verify adverse event signals, we employed reporting odds ratios, proportional reporting ratios, and Bayesian methods (Bayesian Confidence Propagation Neural Network). Additionally, logistic regression analysis was performed to assess outcomes in tumor patients.</p><p><strong>Results: </strong>A total of 223,781 suicide-related adverse event reports were screened, of which 3790 involved common antitumor drugs. The top five drugs reported were tretinoin (<i>n</i> = 1220), methotrexate (<i>n</i> = 664), celecoxib (<i>n</i> = 505), rituximab (<i>n</i> = 107), and imatinib (<i>n</i> = 105). Risk signal analysis indicated that, with the exception of tretinoin (ROR = 6.317), the reporting odds ratio values for the other drugs were below 2. Among cancer patients, the most frequently reported adverse events included suicidal ideation (<i>n</i> = 233), completed suicide (<i>n</i> = 131), and suicide attempts (<i>n</i> = 97). Regression analysis revealed that risk factors for patient death included indication (OR = 0.967, <i>p</i> < 0.01), gender (OR = 0.57, <i>p</i> < 0.01), and type of adverse event (OR = 4.644, <i>p</i> < 0.01).</p><p><strong>Conclusion: </strong>The findings suggest that antineoplastic drugs may not statistically increase the risk of suicide-related adverse events. However, specific tumor types and suicide-related adverse events may contribute to increased mortality in cancer patients. Further research is warranted to elucidate the risk of suicide-related adverse events in oncology patients.</p>\",\"PeriodicalId\":21398,\"journal\":{\"name\":\"SAGE Open Medicine\",\"volume\":\"12 \",\"pages\":\"20503121241308686\"},\"PeriodicalIF\":2.3000,\"publicationDate\":\"2024-12-17\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11653442/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"SAGE Open Medicine\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1177/20503121241308686\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/1/1 0:00:00\",\"PubModel\":\"eCollection\",\"JCR\":\"Q2\",\"JCRName\":\"MEDICINE, GENERAL & INTERNAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"SAGE Open Medicine","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1177/20503121241308686","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/1/1 0:00:00","PubModel":"eCollection","JCR":"Q2","JCRName":"MEDICINE, GENERAL & INTERNAL","Score":null,"Total":0}
引用次数: 0
摘要
背景:新的抗肿瘤药物与自杀相关药物不良反应风险增加之间的潜在关联尚不清楚。本研究旨在利用FAERS公共数据库分析常见抗肿瘤药物与自杀相关的药物不良反应,并探讨此类药物不良反应的潜在风险信号。方法:本研究采用FAERS数据库进行回顾性分析。FAERS数据库检查了2004年至2023年期间与抗肿瘤药物相关的自杀相关不良事件的报告。为了识别和验证不良事件信号,我们采用报告优势比、比例报告比和贝叶斯方法(贝叶斯置信传播神经网络)。此外,对肿瘤患者的预后进行了logistic回归分析。结果:共筛选出223,781例自杀相关不良事件报告,其中3790例涉及常用抗肿瘤药物。报告的前5名药物分别是维甲酸(1220)、甲氨蝶呤(664)、塞来昔布(505)、利妥昔单抗(107)和伊马替尼(105)。风险信号分析显示,除维甲酸(ROR = 6.317)外,其他药物的报告优势比值均小于2。在癌症患者中,最常见的不良事件包括自杀意念(n = 233)、自杀未遂(n = 131)和自杀未遂(n = 97)。回归分析显示,患者死亡的危险因素包括适应症(OR = 0.967, p p p)。结论:抗肿瘤药物可能不会增加自杀相关不良事件的发生风险。然而,特定的肿瘤类型和自杀相关的不良事件可能导致癌症患者死亡率的增加。需要进一步的研究来阐明肿瘤患者自杀相关不良事件的风险。
Analysis of the relationship between antineoplastic drugs and suicide-related adverse events based on the food and drug administration adverse event reporting system database.
Background: The potential association between new antineoplastic drugs and an increased risk of suicide-related adverse drug reactions remains unclear. This study aims to utilize the FAERS public database to analyze suicide-related adverse drug reactions associated with common antitumor drugs and to investigate potential risk signals for such adverse drug reactions.
Methods: This study was a retrospective analysis utilizing the FAERS database. The FAERS database was examined for reports of suicide-related adverse events associated with antitumor drugs, spanning from 2004 to 2023. To identify and verify adverse event signals, we employed reporting odds ratios, proportional reporting ratios, and Bayesian methods (Bayesian Confidence Propagation Neural Network). Additionally, logistic regression analysis was performed to assess outcomes in tumor patients.
Results: A total of 223,781 suicide-related adverse event reports were screened, of which 3790 involved common antitumor drugs. The top five drugs reported were tretinoin (n = 1220), methotrexate (n = 664), celecoxib (n = 505), rituximab (n = 107), and imatinib (n = 105). Risk signal analysis indicated that, with the exception of tretinoin (ROR = 6.317), the reporting odds ratio values for the other drugs were below 2. Among cancer patients, the most frequently reported adverse events included suicidal ideation (n = 233), completed suicide (n = 131), and suicide attempts (n = 97). Regression analysis revealed that risk factors for patient death included indication (OR = 0.967, p < 0.01), gender (OR = 0.57, p < 0.01), and type of adverse event (OR = 4.644, p < 0.01).
Conclusion: The findings suggest that antineoplastic drugs may not statistically increase the risk of suicide-related adverse events. However, specific tumor types and suicide-related adverse events may contribute to increased mortality in cancer patients. Further research is warranted to elucidate the risk of suicide-related adverse events in oncology patients.