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НЕЖЕЛАТЕЛЬНЫЕ ЯВЛЕНИЯ ЛЕКАРСТВЕННЫХ СРЕДСТВ СРЕДИ ГОСПИТАЛИЗИРОВАННЫХ ПАЦИЕНТОВ С COVID-19. ОПЫТ ИСПОЛЬЗОВАНИЯ ИНСТРУМЕНТА GLOBAL TRIGGER TOOL. / Алексеева, Нина Петровна; Мишинова (Ковалева) , Софья Андреевна; Колбин, Алексей Сергеевич; Вербицкая, Елена Владимировна; Гомон, Юлия Михайловна.

в: КАЧЕСТВЕННАЯ КЛИНИЧЕСКАЯ ПРАКТИКА, № 1, 19.04.2024, стр. 30-44.

Результаты исследований: Научные публикации в периодических изданияхстатьяРецензирование

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Author

Алексеева, Нина Петровна ; Мишинова (Ковалева) , Софья Андреевна ; Колбин, Алексей Сергеевич ; Вербицкая, Елена Владимировна ; Гомон, Юлия Михайловна. / НЕЖЕЛАТЕЛЬНЫЕ ЯВЛЕНИЯ ЛЕКАРСТВЕННЫХ СРЕДСТВ СРЕДИ ГОСПИТАЛИЗИРОВАННЫХ ПАЦИЕНТОВ С COVID-19. ОПЫТ ИСПОЛЬЗОВАНИЯ ИНСТРУМЕНТА GLOBAL TRIGGER TOOL. в: КАЧЕСТВЕННАЯ КЛИНИЧЕСКАЯ ПРАКТИКА. 2024 ; № 1. стр. 30-44.

BibTeX

@article{2ab587a85b30429b8a1b22cc264a569a,
title = "НЕЖЕЛАТЕЛЬНЫЕ ЯВЛЕНИЯ ЛЕКАРСТВЕННЫХ СРЕДСТВ СРЕДИ ГОСПИТАЛИЗИРОВАННЫХ ПАЦИЕНТОВ С COVID-19. ОПЫТ ИСПОЛЬЗОВАНИЯ ИНСТРУМЕНТА GLOBAL TRIGGER TOOL",
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{\textquoteright}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.",
author = "Алексеева, {Нина Петровна} and {Мишинова (Ковалева)}, {Софья Андреевна} and Колбин, {Алексей Сергеевич} and Вербицкая, {Елена Владимировна} and Гомон, {Юлия Михайловна}",
year = "2024",
month = apr,
day = "19",
doi = "https://doi.org/10.37489/2588-0519-2024-1-30-44",
language = "русский",
pages = "30--44",
journal = "КАЧЕСТВЕННАЯ КЛИНИЧЕСКАЯ ПРАКТИКА",
issn = "2588-0519",
publisher = "Издательство ОКИ",
number = "1",

}

RIS

TY - JOUR

T1 - НЕЖЕЛАТЕЛЬНЫЕ ЯВЛЕНИЯ ЛЕКАРСТВЕННЫХ СРЕДСТВ СРЕДИ ГОСПИТАЛИЗИРОВАННЫХ ПАЦИЕНТОВ С COVID-19. ОПЫТ ИСПОЛЬЗОВАНИЯ ИНСТРУМЕНТА GLOBAL TRIGGER TOOL

AU - Алексеева, Нина Петровна

AU - Мишинова (Ковалева) , Софья Андреевна

AU - Колбин, Алексей Сергеевич

AU - Вербицкая, Елена Владимировна

AU - Гомон, Юлия Михайловна

PY - 2024/4/19

Y1 - 2024/4/19

N2 - 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.

AB - 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.

UR - https://www.mendeley.com/catalogue/8a72e579-6b5b-3dd5-9f04-81ac6f51f5a4/

U2 - https://doi.org/10.37489/2588-0519-2024-1-30-44

DO - https://doi.org/10.37489/2588-0519-2024-1-30-44

M3 - статья

SP - 30

EP - 44

JO - КАЧЕСТВЕННАЯ КЛИНИЧЕСКАЯ ПРАКТИКА

JF - КАЧЕСТВЕННАЯ КЛИНИЧЕСКАЯ ПРАКТИКА

SN - 2588-0519

IS - 1

ER -

ID: 127564667