ABSTRACT
Most of the medicines used to treat the novel coronavirus infection (COVID-19) are either approved under an accelerated procedure or not approved for the indication. Consequently, their safety requires special attention. The aim of the study was to review methodological approaches to collecting data on the safety of medicines, using COVID-19 treatment regimens involving azithromycin as a case study. Material(s) and Method(s): PubMed (MEDLINE), Scopus, eLIBRARY, and Cyberleninka databases were searched for publications on azithromycin as part of combination therapy for COVID-19 in 2020-2021. Search queries included names of the medicinal product or its pharmacotherapeutic group and words describing adverse drug reactions (ADRs) during treatment. Result(s): the analysis included 7 publications presenting the results of studies covering the use of azithromycin as part of COVID-19 combination therapy in more than 4000 patients. Most commonly, the patients receiving COVID-19 therapy including azithromycin developed cardiovascular ADRs (up to 30% of azithromycin prescription cases). In 3 of the analysed publications, safety information was collected through spontaneous reporting and active identification based on the findings of laboratory and instrumental investigations performed during the clinical studies;in other 3, only spontaneous reports were used;and in the last one, ADR database information was studied. Conclusion(s): currently, information on ADRs associated with the use of medicines is mainly gathered via spontaneous reporting. Direct sourcing of information on personal experiences with a certain product from patients, among other means through social media analysis, opens a promising direction towards the improvement of existing approaches to collecting safety data.Copyright © 2022 Obstetrics, Gynecology and Reproduction. All rights reserved.
ABSTRACT
Introduction. On average, 10% of patients hospitalized due to new coronavirus infection (COVID-19) will be readmitted. To date, the reasons for readmission and the characteristics of these cases are not fully presented. The aim of the study was to analyze readmissions of COVID-19 patients to identify the causes of readmission, clinical features, examination data and treatment outcomes. Materials and methods. The study was performed retrospectively by using electronic records of the medical cases of the St. Petersburg City Hospital of St. George. Inclusion criteria: 1) the presence of two or more hospitalizations during 2020–2021;2) COVID-19 confirmed by polymerase chain reaction within 14 days before or during the first hospitalization, or the detection of changes in the lungs with a high probability associated with COVID-19 during primary computed tomography. One hundred and two people met the specified criteria. Results. In 85% of cases, the cause of re-admission was symptoms of respiratory infection;in 13% – thrombotic events (pulmonary embolism, acute cerebrovascular accident, deep vein thrombosis of the lower extremities);12% – severe pain syndrome of various localizations;11%-infectious and inflammatory processes;9% – antibiotic-associated diarrhea;5% – atrial fibrillation and less often other pathologies. Patients with respiratory symptoms had a high degree of respiratory failure, an increase in the volume of affected lung tissue and an increase in the content of various markers of inflammation in the blood when compared with the data of the initial examination. Nine percent of patients died during hospitalization. Conclusions. The leading cause of repeated inpatient treatment of COVID-19 patients were symptoms of reactivation of the infection with a number of indicators of a greater severity of this "second wave” of the disease. Further studies are required to reduce the risk of repeated inpatient treatment. © 2022, Remedium Group Ltd. All rights reserved.
ABSTRACT
Introduction. On average, 10% of patients hospitalized due to new coronavirus infection (COVID-19) will be readmitted. To date, the reasons for readmission and the characteristics of these cases are not fully presented. The aim of the study was to analyze readmissions of COVID-19 patients to identify the causes of readmission, clinical features, examination data and treatment outcomes. Materials and methods. The study was performed retrospectively by using electronic records of the medical cases of the St. Petersburg City Hospital of St. George. Inclusion criteria: 1) the presence of two or more hospitalizations during 2020–2021;2) COVID-19 confirmed by polymerase chain reaction within 14 days before or during the first hospitalization, or the detection of changes in the lungs with a high probability associated with COVID-19 during primary computed tomography. One hundred and two people met the specified criteria. Results. In 85% of cases, the cause of re-admission was symptoms of respiratory infection;in 13% – thrombotic events (pulmonary embolism, acute cerebrovascular accident, deep vein thrombosis of the lower extremities);12% – severe pain syndrome of various localizations;11%-infectious and inflammatory processes;9% – antibiotic-associated diarrhea;5% – atrial fibrillation and less often other pathologies. Patients with respiratory symptoms had a high degree of respiratory failure, an increase in the volume of affected lung tissue and an increase in the content of various markers of inflammation in the blood when compared with the data of the initial examination. Nine percent of patients died during hospitalization. Conclusions. The leading cause of repeated inpatient treatment of COVID-19 patients were symptoms of reactivation of the infection with a number of indicators of a greater severity of this "second wave” of the disease. Further studies are required to reduce the risk of repeated inpatient treatment. © 2022, Remedium Group Ltd. All rights reserved.
ABSTRACT
Most of the medicines used to treat the novel coronavirus infection (COVID-19) are either approved under an accelerated procedure or not approved for the indication. Consequently, their safety requires special attention. The aim of the study was to review methodological approaches to collecting data on the safety of medicines, using COVID-19 treatment regimens involving azithromycin as a case study. Material(s) and Method(s): PubMed (MEDLINE), Scopus, eLIBRARY, and Cyberleninka databases were searched for publications on azithromycin as part of combination therapy for COVID-19 in 2020-2021. Search queries included names of the medicinal product or its pharmacotherapeutic group and words describing adverse drug reactions (ADRs) during treatment. Result(s): the analysis included 7 publications presenting the results of studies covering the use of azithromycin as part of COVID-19 combination therapy in more than 4000 patients. Most commonly, the patients receiving COVID-19 therapy including azithromycin developed cardiovascular ADRs (up to 30% of azithromycin prescription cases). In 3 of the analysed publications, safety information was collected through spontaneous reporting and active identification based on the findings of laboratory and instrumental investigations performed during the clinical studies;in other 3, only spontaneous reports were used;and in the last one, ADR database information was studied. Conclusion(s): currently, information on ADRs associated with the use of medicines is mainly gathered via spontaneous reporting. Direct sourcing of information on personal experiences with a certain product from patients, among other means through social media analysis, opens a promising direction towards the improvement of existing approaches to collecting safety data. Copyright © 2022 Obstetrics, Gynecology and Reproduction. All rights reserved.