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( Raeseok Lee ),( Sung-yeon Cho ),( Dong-gun Lee ),( Hyojin Ahn ),( Hyeah Choi ),( Su-mi Choi ),( Jae-ki Choi ),( Jung-hyun Choi ),( Shin Young Kim ),( Youn Jeong Kim ),( Hyo-jin Lee ) 대한내과학회 2022 The Korean Journal of Internal Medicine Vol.37 No.4
Background/Aims: The risk factors and clinical impacts of coronavirus disease 2019 (COVID-19)-associated pulmonary aspergillosis (CAPA) remain controversial, and no data have been reported in Korea. This study aimed to investigate the epidemiology and importance of CAPA diagnostic efforts and to identify the predictors of CAPA and the impacts on clinical outcomes. Methods: Between January 2020 and May 2021, data of severely to critically ill COVID-19 patients were extracted from seven hospitals of the Catholic Medical Center through a clinical data warehouse. Corticosteroid use was subcategorized into total cumulative dose, early 7-day dose, mean daily dose, and duration of use. Results: A total of 2,427 patients were screened, and 218 patients were included. CAPA was diagnosed in 4.6% (10/218) of all hospitalized and 11.2% (10/89) of intensive care unit patients. Total cumulative dose (over 1,000 mg as methylprednisolone) and daily high-dose corticosteroid use (over 60 mg/day) were independent predictors but not early 7-day high-dose corticosteroid use (over 420 mg/week) (odds ratio [OR], 1.731; 95% confidence interval [CI], 0.350 to 8.571) nor prolonged use (OR, 2.794; 95% CI, 0.635 to 13.928). In-hospital overall mortality was 11.9% (26 of 218). CAPA itself did not affect the outcome; rather, daily high-dose steroid use significantly increased the 30-day mortality (hazard ratio, 5.645; 95% CI, 1.225 to 26.091). Conclusions: CAPA was not uncommon, especially in critically ill patients. Daily high-dose corticosteroid use was the predictor of CAPA and associated with high mortality rates. High-dose corticosteroids use after early inflammatory phase should be avoided, and active surveillance methods for CAPA are essential for those high-risk patients.
서정원 ( Jeong-won Seo ),이재옥 ( Jaeok Lee ),채규한 ( Gyuhan Chae ),도원임 ( Won-im Do ),이상훈 ( Sang-hun Lee ),정래석 ( Raeseok Jung ),신원 ( Won Shin ) 한국보건정보통계학회(구 한국보건통계학회) 2017 보건정보통계학회지 Vol.42 No.3
The aim of this study is to provide a method to apply the electronic data standard for electronic transmission of individual case safety reports (ICSRs) in Korea. In Korea, it is necessary to implement the ICH E2B guideline and the ICH MedDRA guideline within 5 years after approval to join ICH members in November 2016. With the spread of the internet network and the IT infrastructure worldwide, Data standardization has been developed not only by major countries such as the US, Europe, and Japan, but also by around the world. In addition, it is necessary to strengthen voluntary or mandatory reporting from consumers, pharmaceutical companies, and healthcare professionals by following the standardized electronic information exchange system for international sharing. This can be an opportunity to overcome limitations on the quality and quantity of information available at the time of authorization. Based on the data system applying the electronic standards, it is possible to search and prevent Korean inherent side effects by using the collected and analyzed information. The exchange of information of standardized data will enable regulatory authorities to communicate with data from different structure as well as many other countries with a single common document. We first reviewed the necessity of development of data standard for drug safety reporting. The ICH E2B guideline adopted as an international standard has been analyzed and the need for introduction into Korea has been examined. In major ICH regions like US, EU and Japan, regional implementation guides for E2B (R3) guideline were prepared and implemented in accordance with the guide. The guides and the status of these countries were compared and analyzed. Regional implementation guide for introducing ICH E2B, an international standard, in Korea was made which was reflecting domestic regulations such as pharmaceutical safety management regulations.