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 -