Background: There is a dearth of research on the factors linked with adverse events (AEs) associated with nirmatrelvir/ritonavir (NMVr) and molnupiravir (MOL), particularly in the elderly. Therefore, this study aimed to investigate self-reported AEs and identify factors associated with the occurrence of AEs following NMVr or MOL treatment among survey participants aged 60 years or older in South Korea.
Methods: This nationwide survey was conducted through in-person interviews using structured questionnaires, from July 24 to August 31, 2023.
Objectives: This study investigated caregivers' job image, abilities, and educational needs, which are rapidly increasing owing to an aging society.
Design: A self-administered written survey was conducted at 12 general hospitals in Korea from February 1, 2022 to March 15, 2023.
Sample: A total of 451 caregivers participated in the survey as subjects of analysis, and 560 nurses participated as external observers.
Objective: This study aimed to analyze the effect of Smart Cancer Care program on the quality of life and ease of chemotherapy continuation in cancer patients and the effect of additional tele-management on frequency of use and satisfaction with the Smart Cancer Care program.
Methods: 'Smart Cancer Care' is a mobile program that allows cancer patients undergoing chemotherapy to report symptoms of adverse events and receive remote management. In this study, patients were randomly assigned to three groups: Group A, who received only classical face-to-face management; Group B, who used the Smart Cancer Care program as addition; and Group C, who used the Smart Cancer Care program and received telephone management.
Background: Although several studies deal with breakthrough reactions (BTRs) in patients with contrast media (CM) hypersensitivity reactions, the phenomenon is still unclear. Therefore, this study aimed to analyse in depth patients with BTR in two countries.
Methods: We retrospectively analysed the electronic medical records of in- and outpatients (random sample enrolment) from two academic hospitals of tertiary care (Seoul/South Korea, with a special monitoring system exclusively for CM hypersensitivity, and Bern/Switzerland, manually operated) with respect to basic epidemiological data, number of BTRs per patient, and severity grades of severity in follow-up analyses.
Purpose: A "Smart Cancer Care" platform that integrates patient-reported outcomes (PROs) with management has been established in Korea. This study focused on improving health behaviors and connecting patients to welfare services by introducing and assessing the feasibility of "Smart Cancer Care 2.0," an enhanced version designed for monitoring complications post-cancer treatment.
View Article and Find Full Text PDFBackground: Remdesivir is a US Food and Drug Administration-approved drug for coronavirus disease 2019 (COVID-19). Clinical trials were conducted under strictly controlled situations for a selected population, and their reported adverse events may not fully represent conditions in real-world patients. We aimed to estimate the incidence of adverse drug events (ADEs) associated with remdesivir in hospitalized patients with COVID-19, including vulnerable subpopulations, such as those with impaired renal or hepatic function and pregnant women.
View Article and Find Full Text PDFAim: The use of prophylactic antibiotics prior to colorectal surgery reduces surgical site infections. Cefazolin and metronidazole are used as a standard regimen. Ampicillin/sulbactam may be an alternative, but current data are limited.
View Article and Find Full Text PDFPurpose: This study aimed to advance the MetaLAB algorithm and verify its performance with multicenter data to effectively detect major adverse drug reactions (ADRs), including drug-induced liver injury.
Methods: Based on MetaLAB, we created an optimal scenario for detecting ADRs by considering demographic and clinical records. MetaLAB-HOI was developed to identify ADR signals using common model-based multicenter electronic health record (EHR) data from the clinical health outcomes of interest (HOI) template and design for drug-exposed and nonexposed groups.
Pharmacoepidemiol Drug Saf
December 2023
Introduction: With the availability of retrospective pharmacovigilance data, the common data model (CDM) has been identified as an efficient approach towards anonymized multicenter analysis; however, the establishment of a suitable model for individual medical systems and applications supporting their analysis is a challenge.
Objective: The aim of this study was to construct a specialized Korean CDM (K-CDM) for pharmacovigilance systems based on a clinical scenario to detect adverse drug reactions (ADRs).
Methods: De-identified patient records (n = 5,402,129) from 13 institutions were converted to the K-CDM.
Due to the urgency of controlling the coronavirus disease 2019 pandemic, coronavirus disease 2019 messenger ribonucleic acid (mRNA) vaccines have been expeditiously approved and introduced in several countries without sufficient evaluation for adverse events. We analyzed adverse events among Korean healthcare workers who received all 3 doses of the BNT162b2 mRNA vaccine. This survey was conducted among hospital workers of Inha University Hospital who had received the BNT162b2 mRNA vaccine for their first, second, third rounds, and using a diary card.
View Article and Find Full Text PDFBackground: Although beta-lactams are 1 of the major causative agents of severe cutaneous adverse reactions (SCAR), their epidemiology and clinical aspects have been poorly studied. This study aimed to investigate the characteristics of SCAR caused by beta-lactams in the Korean SCAR registry.
Methods: We retrospectively analyzed beta-lactam-induced SCAR cases collected from 28 tertiary university hospitals in Korea between 2010 and 2015.
To investigate the associations of weekend catch-up sleep (WCS) and high-sensitivity C-reactive protein (hs-CRP) levels according to bedtime inconsistency in the Korean population. In this cross-sectional study using the Korea National Health and Nutrition Examination Survey (2016-2018) with 17,665 participants, four groups were defined: no-WCS (WCS within ± 1 h of weekday sleep time), moderate WCS (1 ≤ , < 3 h), severe WCS (≥ 3 h), and inverse WCS (≤ - 1 h). An inconsistent bedtime was defined as a > 2 h difference between weekend and weekday bedtimes.
View Article and Find Full Text PDFBackground: HLA-B*58:01 is a well-known risk factor for allopurinol-induced severe cutaneous adverse reactions (SCARs). However, only a minority of HLA-B*58:01 carriers suffer SCARs after taking allopurinol. The aim of this study was to investigate subsidiary genetic markers that could identify those at further increased risk of developing allopurinol-induced drug reaction with eosinophilia and systemic symptoms (DRESS) in subjects with HLA-B*58:01.
View Article and Find Full Text PDFBackground: Eosinophils are major effector cells of allergic disease and excellent markers of eosinophilic inflammation. Accurate and reliable biomarkers are helpful in the diagnosis, treatment, and control of allergic disease.
Objective: This study aimed to investigate an alternate marker of eosinophilic inflammation, eosinophil-derived neurotoxin (EDN), in a number of allergic diseases.
Inhaled Corticosteroids (ICSs) and oral Leukotriene Receptor Antagonists (LTRAs) are commonly prescribed asthma preventers, however, concerns have been raised as to whether montelukast (LTRA) is associated with an increase in occurrences of neuropsychiatric side effects in children. Our study was conducted to observe prescribing patterns of asthma preventers among paediatric patients specifically focusing on ICSs and LTRAs between Australia and South Korea to see intercountry differences in the use of these medicines. The Health Insurance Review and Assessment Paediatric Patients Sample dataset for South Korea and data provided by Services Australia were used in the study.
View Article and Find Full Text PDFObjective: To evaluate the epidemiology of adverse drug reactions (ADRs) in the Korean population and to identify their characteristics and factors affecting their severity.
Materials And Methods: The analysis was based on the ADRs reported to the Seoul National University Hospital between 2009 and 2018. Statistical assessment (SPSS Statistics 25) included frequency analysis and the χ-test.
Background: An optimal strategy for choosing safe alternative low osmolar contrast media (LOCM) has not yet been established in patients with a history of LOCM-induced anaphylaxis.
Objectives: To validate the practical pathway in patients with anaphylaxis to LOCMs and to compare 2 different doses of challenge testing with skin test-negative LOCM.
Methods: A retrospective cohort study was performed in patients with LOCM-induced anaphylaxis.
Background: Drug desensitization is helpful for patients who have experienced significant hypersensitivity reactions (HSRs) to antineoplastic agents. One-bag desensitization protocols, attracting attention in recent years, need to be validated on their safety and efficacy in a large number.
Methods: One-bag desensitization procedures conducted from 2018 to 2020 were analyzed; their outcomes and the risk factors for breakthrough reactions (BTRs) were assessed in desensitization procedures to major drug types (platins, taxanes, and monoclonal antibodies).
Background With the widespread use of gadolinium-based contrast agents (GBCAs), the incidence of allergic-like hypersensitivity reactions (HSRs) to GBCAs is increasing. Research on the incidence and risk factors for HSRs to GBCAs is needed for their safe use. Purpose To determine the incidence of acute and delayed reactions to GBCAs and to discuss the risk factors and strategies for the prevention of HSRs to GBCAs.
View Article and Find Full Text PDFBackground: The most important aspect of a retrospective cohort study is the operational definition (OP) of the disease. We developed a detailed OP for the detection of sodium-glucose cotransporter-2 inhibitors (SGLT2i) related to diabetic ketoacidosis (DKA). The OP was systemically verified and analyzed.
View Article and Find Full Text PDFBackground: Several type B adverse drug reactions (ADRs), especially severe cutaneous adverse reactions (SCARs), are associated with particular human leukocyte antigen (HLA) genotypes. However, pre-stored HLA information obtained from other clinical workups has not been used to prevent ADRs. We aimed to simulate the preemptive use of pre-stored HLA information in electronic medical records to evaluate whether this information can prevent ADRs.
View Article and Find Full Text PDFPurpose: To evaluate the incidence and risk factors of late adverse reactions (ARs) to non-ionic low-osmolar contrast media (LOCM).
Methods: The occurrence of late AR was monitored on day 1 and from day 7 to day 28 in all patients who received enhanced computed tomography using LOCM during a 5-week study period in a single tertiary hospital. Patients who experienced late AR were followed up for three years.
Allopurinol is the first-line agent for patients with gout, including those with moderate-to-severe chronic kidney disease. However, increased thyroid-stimulating hormone (TSH) levels are observed in patients with long-term allopurinol treatment. This large-scale, nested case-control, retrospective observational study analysed the association between allopurinol use and increased TSH levels.
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