S. Mishinova, A. Kolbin, E. V. Verbitskaya, N. P. Alekseeva, Y. Gomon
{"title":"COVID-19 住院患者的药物不良事件。使用全球触发工具的经验","authors":"S. Mishinova, A. Kolbin, E. V. Verbitskaya, N. P. Alekseeva, Y. Gomon","doi":"10.37489/2588-0519-2024-1-30-44","DOIUrl":null,"url":null,"abstract":"The Global Trigger Tool is a reliable method for detecting adverse events, demonstrating positive predictive value and significant sensitivity among patients with COVID-19.The objective of this study was to develop and apply an adapted Global Trigger Tool to identify potential adverse events among hospitalized patients with moderate to severe COVID-19.Materials and methods. The study included a literature review, analysis of spontaneous reports n=873 in the national database of the Russian Federation for the COVID-19 indication for the period 2020–2022, and application of the trigger tool in a single-center retrospective study n=329. Statistical processing was performed by the method of disproportionality with the determination of the odds ratio of reporting. The symptom-syndrome method based on parameterization of interaction effects using Zhegalkin polynomials was used to identify significant effects of drug associations; Fisher’s exact test was used to select the most significant associations for occurrence.Results. Among the triggers with a frequency of 10 or higher in terms of mortality rate (≥80%), the leading ones were: pulmonary edema, hypotension, and respiratory failure, which is consistent with the COVID-19 clinical course of the disease. A disproportionately high incidence of respiratory failure was associated with favipiravir use. Leukocytosis associated with tofacitinib use and drug-induced liver damage associated with tocilizumab use.Conclusions. The identified potential adverse events and their associated mortality risks among patients with moderate to severe COVID-19 allow for compliance with current clinical guidelines for the management of patients with COVID-19.","PeriodicalId":326764,"journal":{"name":"Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice","volume":null,"pages":null},"PeriodicalIF":0.0000,"publicationDate":"2024-04-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Adverse drug events among hospitalized COVID-19 patients. Experience with the Global Trigger Tool\",\"authors\":\"S. Mishinova, A. Kolbin, E. V. Verbitskaya, N. P. Alekseeva, Y. Gomon\",\"doi\":\"10.37489/2588-0519-2024-1-30-44\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"The Global Trigger Tool is a reliable method for detecting adverse events, demonstrating positive predictive value and significant sensitivity among patients with COVID-19.The objective of this study was to develop and apply an adapted Global Trigger Tool to identify potential adverse events among hospitalized patients with moderate to severe COVID-19.Materials and methods. The study included a literature review, analysis of spontaneous reports n=873 in the national database of the Russian Federation for the COVID-19 indication for the period 2020–2022, and application of the trigger tool in a single-center retrospective study n=329. Statistical processing was performed by the method of disproportionality with the determination of the odds ratio of reporting. The symptom-syndrome method based on parameterization of interaction effects using Zhegalkin polynomials was used to identify significant effects of drug associations; Fisher’s exact test was used to select the most significant associations for occurrence.Results. Among the triggers with a frequency of 10 or higher in terms of mortality rate (≥80%), the leading ones were: pulmonary edema, hypotension, and respiratory failure, which is consistent with the COVID-19 clinical course of the disease. A disproportionately high incidence of respiratory failure was associated with favipiravir use. Leukocytosis associated with tofacitinib use and drug-induced liver damage associated with tocilizumab use.Conclusions. The identified potential adverse events and their associated mortality risks among patients with moderate to severe COVID-19 allow for compliance with current clinical guidelines for the management of patients with COVID-19.\",\"PeriodicalId\":326764,\"journal\":{\"name\":\"Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2024-04-19\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.37489/2588-0519-2024-1-30-44\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.37489/2588-0519-2024-1-30-44","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
Adverse drug events among hospitalized COVID-19 patients. Experience with the Global Trigger Tool
The Global Trigger Tool is a reliable method for detecting adverse events, demonstrating positive predictive value and significant sensitivity among patients with COVID-19.The objective of this study was to develop and apply an adapted Global Trigger Tool to identify potential adverse events among hospitalized patients with moderate to severe COVID-19.Materials and methods. The study included a literature review, analysis of spontaneous reports n=873 in the national database of the Russian Federation for the COVID-19 indication for the period 2020–2022, and application of the trigger tool in a single-center retrospective study n=329. Statistical processing was performed by the method of disproportionality with the determination of the odds ratio of reporting. The symptom-syndrome method based on parameterization of interaction effects using Zhegalkin polynomials was used to identify significant effects of drug associations; Fisher’s exact test was used to select the most significant associations for occurrence.Results. Among the triggers with a frequency of 10 or higher in terms of mortality rate (≥80%), the leading ones were: pulmonary edema, hypotension, and respiratory failure, which is consistent with the COVID-19 clinical course of the disease. A disproportionately high incidence of respiratory failure was associated with favipiravir use. Leukocytosis associated with tofacitinib use and drug-induced liver damage associated with tocilizumab use.Conclusions. The identified potential adverse events and their associated mortality risks among patients with moderate to severe COVID-19 allow for compliance with current clinical guidelines for the management of patients with COVID-19.