1.Signal Detection of DPP-IV Inhibitors using Spontaneous Adverse Event Reporting System in Korea
Hyejung PYO ; Tae Young KIM ; Su Been CHOI ; Hyeong Jun JO ; Hae Lee KANG ; Jung Sun KIM ; Hye Sun GWAK ; Ji Min HAN
Korean Journal of Clinical Pharmacy 2024;34(2):100-107
Background:
The purpose of this study was to detect signals of adverse events (AEs) of DPP-IV inhibitors using the KIDs-Korea Adverse Event Reporting System (KAERS) database.
Methods:
This study was conducted using AEs reported from January 2009to December 2018 in the KIDs-KAERS database. For signal detection, disproportionality analysis was performed. Signals of DPPIV inhibitor that satisfied the data-mining indices of reporting odds ratio (ROR) were detected.
Results:
Among the total number of 10,364 AEs to all oral hypoglycemic agents, the number of reported AEs related to DPP-IV inhibitors was 1,674. Analysis of re-ported AEs of DPP-IV inhibitors at the SOC levels showed that Respiratory system disorders were the highest at 4.31 (95% CI 3.01-6.17), followed by Skin and appendages disorders at 2.04 (95% CI 1.74-2.38). When analyzing AEs reported at the PT level, phar-yngitis was the highest at 73.90 (95% CI 17.59-310.49), followed by arthralgia at 6.08 (95% CI 2.04-18.11), and coughing at 5.21 (95% CI 2.07-13.15).
Conclusions
Based on the result of the study, deeper consideration is required according to the characteristics of the patients in prescribing DPP-IV inhibitors among oral hypoglycemic agents, and continuous monitoring of the occurrence of related Adverse Drug Reactions during administration is also required.
2.Signal Detection of DPP-IV Inhibitors using Spontaneous Adverse Event Reporting System in Korea
Hyejung PYO ; Tae Young KIM ; Su Been CHOI ; Hyeong Jun JO ; Hae Lee KANG ; Jung Sun KIM ; Hye Sun GWAK ; Ji Min HAN
Korean Journal of Clinical Pharmacy 2024;34(2):100-107
Background:
The purpose of this study was to detect signals of adverse events (AEs) of DPP-IV inhibitors using the KIDs-Korea Adverse Event Reporting System (KAERS) database.
Methods:
This study was conducted using AEs reported from January 2009to December 2018 in the KIDs-KAERS database. For signal detection, disproportionality analysis was performed. Signals of DPPIV inhibitor that satisfied the data-mining indices of reporting odds ratio (ROR) were detected.
Results:
Among the total number of 10,364 AEs to all oral hypoglycemic agents, the number of reported AEs related to DPP-IV inhibitors was 1,674. Analysis of re-ported AEs of DPP-IV inhibitors at the SOC levels showed that Respiratory system disorders were the highest at 4.31 (95% CI 3.01-6.17), followed by Skin and appendages disorders at 2.04 (95% CI 1.74-2.38). When analyzing AEs reported at the PT level, phar-yngitis was the highest at 73.90 (95% CI 17.59-310.49), followed by arthralgia at 6.08 (95% CI 2.04-18.11), and coughing at 5.21 (95% CI 2.07-13.15).
Conclusions
Based on the result of the study, deeper consideration is required according to the characteristics of the patients in prescribing DPP-IV inhibitors among oral hypoglycemic agents, and continuous monitoring of the occurrence of related Adverse Drug Reactions during administration is also required.
3.Signal Detection of DPP-IV Inhibitors using Spontaneous Adverse Event Reporting System in Korea
Hyejung PYO ; Tae Young KIM ; Su Been CHOI ; Hyeong Jun JO ; Hae Lee KANG ; Jung Sun KIM ; Hye Sun GWAK ; Ji Min HAN
Korean Journal of Clinical Pharmacy 2024;34(2):100-107
Background:
The purpose of this study was to detect signals of adverse events (AEs) of DPP-IV inhibitors using the KIDs-Korea Adverse Event Reporting System (KAERS) database.
Methods:
This study was conducted using AEs reported from January 2009to December 2018 in the KIDs-KAERS database. For signal detection, disproportionality analysis was performed. Signals of DPPIV inhibitor that satisfied the data-mining indices of reporting odds ratio (ROR) were detected.
Results:
Among the total number of 10,364 AEs to all oral hypoglycemic agents, the number of reported AEs related to DPP-IV inhibitors was 1,674. Analysis of re-ported AEs of DPP-IV inhibitors at the SOC levels showed that Respiratory system disorders were the highest at 4.31 (95% CI 3.01-6.17), followed by Skin and appendages disorders at 2.04 (95% CI 1.74-2.38). When analyzing AEs reported at the PT level, phar-yngitis was the highest at 73.90 (95% CI 17.59-310.49), followed by arthralgia at 6.08 (95% CI 2.04-18.11), and coughing at 5.21 (95% CI 2.07-13.15).
Conclusions
Based on the result of the study, deeper consideration is required according to the characteristics of the patients in prescribing DPP-IV inhibitors among oral hypoglycemic agents, and continuous monitoring of the occurrence of related Adverse Drug Reactions during administration is also required.
4.Signal Detection of DPP-IV Inhibitors using Spontaneous Adverse Event Reporting System in Korea
Hyejung PYO ; Tae Young KIM ; Su Been CHOI ; Hyeong Jun JO ; Hae Lee KANG ; Jung Sun KIM ; Hye Sun GWAK ; Ji Min HAN
Korean Journal of Clinical Pharmacy 2024;34(2):100-107
Background:
The purpose of this study was to detect signals of adverse events (AEs) of DPP-IV inhibitors using the KIDs-Korea Adverse Event Reporting System (KAERS) database.
Methods:
This study was conducted using AEs reported from January 2009to December 2018 in the KIDs-KAERS database. For signal detection, disproportionality analysis was performed. Signals of DPPIV inhibitor that satisfied the data-mining indices of reporting odds ratio (ROR) were detected.
Results:
Among the total number of 10,364 AEs to all oral hypoglycemic agents, the number of reported AEs related to DPP-IV inhibitors was 1,674. Analysis of re-ported AEs of DPP-IV inhibitors at the SOC levels showed that Respiratory system disorders were the highest at 4.31 (95% CI 3.01-6.17), followed by Skin and appendages disorders at 2.04 (95% CI 1.74-2.38). When analyzing AEs reported at the PT level, phar-yngitis was the highest at 73.90 (95% CI 17.59-310.49), followed by arthralgia at 6.08 (95% CI 2.04-18.11), and coughing at 5.21 (95% CI 2.07-13.15).
Conclusions
Based on the result of the study, deeper consideration is required according to the characteristics of the patients in prescribing DPP-IV inhibitors among oral hypoglycemic agents, and continuous monitoring of the occurrence of related Adverse Drug Reactions during administration is also required.
5.Longitudinal Comparative Analysis of Circulating Tumor DNA and Matched Tumor Tissue DNA in Patients with Metastatic Colorectal Cancer Receiving Palliative First-Line Systemic Anti-Cancer Therapy
Seung-been LEE ; Ji-Won KIM ; Hong-Geun KIM ; Sung-Hyun HWANG ; Kui-Jin KIM ; Ju Hyun LEE ; Jeongmin SEO ; Minsu KANG ; Eun Hee JUNG ; Koung Jin SUH ; Se Hyun KIM ; Jin Won KIM ; Yu Jung KIM ; Jee Hyun KIM ; Nak-Jung KWON ; Keun-Wook LEE
Cancer Research and Treatment 2024;56(4):1171-1182
Purpose:
This study aimed to compare tumor tissue DNA (ttDNA) and circulating tumor DNA (ctDNA) to explore the clinical applicability of ctDNA and to better understand clonal evolution in patients with metastatic colorectal cancer undergoing palliative first-line systemic therapy.
Materials and Methods:
We performed targeted sequencing analysis of 88 cancer-associated genes using germline DNA, ctDNA at baseline (baseline-ctDNA), and ctDNA at progressive disease (PD-ctDNA). The results were compared with ttDNA data.
Results:
Among 208 consecutively enrolled patients, we selected 84 (41 males; median age, 59 years; range, 35 to 90 years) with all four sample types available. A total of 202 driver mutations were found in 34 genes. ttDNA exhibited the highest mutation frequency (n=232), followed by baseline-ctDNA (n=155) and PD-ctDNA (n=117). Sequencing ctDNA alongside ttDNA revealed additional mutations in 40 patients (47.6%). PD-ctDNA detected 13 novel mutations in 10 patients (11.9%) compared to ttDNA and baseline-ctDNA. Notably, seven mutations in five patients (6.0%) were missense or nonsense mutations in APC, TP53, SMAD4, and CDH1 genes. In baseline-ctDNA, higher maximal variant allele frequency (VAF) values (p=0.010) and higher VAF values of APC (p=0.012), TP53 (p=0.012), and KRAS (p=0.005) mutations were significantly associated with worse overall survival.
Conclusion
While ttDNA remains more sensitive than ctDNA, our ctDNA platform demonstrated validity and potential value when ttDNA was unavailable. Post-treatment analysis of PD-ctDNA unveiled new pathogenic mutations, signifying cancer’s clonal evolution. Additionally, baseline-ctDNA’s VAF values were prognostic after treatment.
6.Immune Cells Are DifferentiallyAffected by SARS-CoV-2 Viral Loads in K18-hACE2 Mice
Jung Ah KIM ; Sung-Hee KIM ; Jeong Jin KIM ; Hyuna NOH ; Su-bin LEE ; Haengdueng JEONG ; Jiseon KIM ; Donghun JEON ; Jung Seon SEO ; Dain ON ; Suhyeon YOON ; Sang Gyu LEE ; Youn Woo LEE ; Hui Jeong JANG ; In Ho PARK ; Jooyeon OH ; Sang-Hyuk SEOK ; Yu Jin LEE ; Seung-Min HONG ; Se-Hee AN ; Joon-Yong BAE ; Jung-ah CHOI ; Seo Yeon KIM ; Young Been KIM ; Ji-Yeon HWANG ; Hyo-Jung LEE ; Hong Bin KIM ; Dae Gwin JEONG ; Daesub SONG ; Manki SONG ; Man-Seong PARK ; Kang-Seuk CHOI ; Jun Won PARK ; Jun-Won YUN ; Jeon-Soo SHIN ; Ho-Young LEE ; Ho-Keun KWON ; Jun-Young SEO ; Ki Taek NAM ; Heon Yung GEE ; Je Kyung SEONG
Immune Network 2024;24(2):e7-
Viral load and the duration of viral shedding of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are important determinants of the transmission of coronavirus disease 2019.In this study, we examined the effects of viral doses on the lung and spleen of K18-hACE2 transgenic mice by temporal histological and transcriptional analyses. Approximately, 1×105 plaque-forming units (PFU) of SARS-CoV-2 induced strong host responses in the lungs from 2 days post inoculation (dpi) which did not recover until the mice died, whereas responses to the virus were obvious at 5 days, recovering to the basal state by 14 dpi at 1×102 PFU. Further, flow cytometry showed that number of CD8+ T cells continuously increased in 1×102 PFU-virusinfected lungs from 2 dpi, but not in 1×105 PFU-virus-infected lungs. In spleens, responses to the virus were prominent from 2 dpi, and number of B cells was significantly decreased at 1×105PFU; however, 1×102 PFU of virus induced very weak responses from 2 dpi which recovered by 10 dpi. Although the defense responses returned to normal and the mice survived, lung histology showed evidence of fibrosis, suggesting sequelae of SARS-CoV-2 infection. Our findings indicate that specific effectors of the immune response in the lung and spleen were either increased or depleted in response to doses of SARS-CoV-2. This study demonstrated that the response of local and systemic immune effectors to a viral infection varies with viral dose, which either exacerbates the severity of the infection or accelerates its elimination.
7.Daily Self-Monitoring and Feedback of Circadian Rhythm Measures in Major Depression and Bipolar Disorder Using Wearable Devices and Smartphones–The Circadian Rhythm for Mood (CRM®) Trial Protocol: A Randomized Sham Controlled Double-Blind Trial
Ji Won YEOM ; Yeaseul YOON ; Ju Yeon SEO ; Chul-Hyun CHO ; Taek LEE ; Jung-Been LEE ; Sehyun JEON ; Leen KIM ; Heon-Jeong LEE
Psychiatry Investigation 2024;21(8):918-924
The circadian rhythm for mood (CRM) is a digital therapeutic, which aims to prevent mood episode and improve clinical course in patients with major mood disorders. Developed on the circadian rhythm hypothesis of mood disorder, CRM predicts the impending risk of mood episode with its built-in algorithm, utilizing wearable devices data and daily self-reports, and provides personalized feedback. In a pilot study of the CRM, the users experienced less frequent and shorter duration of mood episodes than the non-users. To investigate the efficacy of the upgraded CRM, a double-blind, randomized, sham-controlled, parallel-group trial is designed. Patients aged between 19 and 70, diagnosed with bipolar I disorder, bipolar II disorder, or major depressive disorder, in a euthymic state for more than two months, can participate. During this 12-month trial, participants are assessed for episode recurrence every three months, and the efficacy of the CRM as a potential digital therapeutic is evaluated. Trial registration: ClinicalTrials.gov Identifier: NCT05400785.
8.Aerobic Capacity and Obesity Ratio of Korea Firefighters by Job Duties:Implications for Fitness Management
Ji-Been KIM ; Min-Geon JE ; Chae-Been KIM ; Jung-Jun PARK ; Hyun-Joo KANG ; Wook SONG ; Chung-Gun LEE ; Yeon-Soon AHN ; Han-Joon LEE ; Dong-Il SEO
The Korean Journal of Sports Medicine 2024;42(1):23-30
Purpose:
Firefighting duties range from field roles such as suppression, rescue, and emergency medical services (EMS) to various administrative tasks. Despite these differences, they face uniform fitness standards in Korea. This study seeks to define distinct fitness needs for each duty and provide data for customized standards.
Methods:
One hundred seventy-six Korean male firefighters participated, categorized into suppression (n=76), rescue (n=22), administrative (n=27), and EMS (n=51) roles. All underwent maximal oxygen consumption (VO2 max) tests for aerobic capacity, with body composition measured using bioelectrical impedance and height recorded with a stadiometer.
Results:
The VO2 max (mL/kg/min) among Korean male firefighters varied across different job duties: suppression (39.96±5.84), rescue (44.84±4.85), administration (40.27±7.01), and EMS (40.51±6.75). Rescue had the highest VO2 max, which was significantly higher (p=0.013). The body mass index (BMI, kg/m2 ) values were as follows: suppression (25.07±2.55), rescue (24.95±1.71), EMS (24.33±3.21), and administration (25.10±2.48). There was no statistically significant difference in BMI values (p=0.464).
Conclusion
This study evaluated the VO2 max and BMI of South Korean male firefighters according to their job duties. It found that 54.5% did not meet the recommended VO2 max standard of 42 mL/kg/min for their activities, and 77.5% had a BMI indicating overweight or higher. However, it is important to note that not every firefighting duty requires high fitness levels. The key is ensuring firefighters possess the fitness necessary for their specific roles to maintain safety and efficiency. The study aims to provide data for creating fitness management guidelines tailored to the diverse duties of firefighters.
9.Effect of Different Types of Foam Rollers on Self-Myofascial Release of the Quadriceps Femoris
Heun Jae RYU ; Ji Hun KIM ; Han Na KWON ; Ri Been KIM ; Ji Hwan BYUN ; Yuean Hei LEE ; Jeong Pyo SEO
Journal of Korean Physical Therapy 2023;35(4):89-94
Purpose:
This study investigates the impact of self-myofascial release using a foam roller on the quadriceps femoris for pelvic stability.We further compare the effects of a GRID surface Foam Roller (GFR), a Non-Vibration Foam Roller (NVFR), and a Vibration Foam Roller (VFR).
Methods:
Thirty healthy adults (15 males, 15 females) participated in this study and were randomly assigned to one of three conditions:GFR, NVFR, or VFR. Participants walked at self-selected speeds with an arm sling before and after foam roller stretching. The analyzed gait parameters included pelvic tilt, pelvic obliquity, and pelvic rotation.
Results:
In the NVFR and VFR groups, there was a Significant differences were obtained in the pelvic tilt between pre-test and post-test values (p< 0.05) in the NVFR and VFR groups, but no significant difference was observed in the GFR group (p> 0.05). Comparing the amount of change between the three groups exhibited a significant decrease in pelvic tilt in the NVFR and VFR groups compared to the GFR group (p< 0.017). No significant differences were found in pelvic obliquity and pelvic rotation (p> 0.05) in all groups.
Conclusion
While walking, the use of a VFR for self-myofascial release results in pelvic alteration by reducing the anterior pelvic tilt. We propose that a foam roller can be utilized to enhance pelvic stability during gait.
10.Laboratory information management system for COVID-19 non-clinical efficacy trial data
Suhyeon YOON ; Hyuna NOH ; Heejin JIN ; Sungyoung LEE ; Soyul HAN ; Sung-Hee KIM ; Jiseon KIM ; Jung Seon SEO ; Jeong Jin KIM ; In Ho PARK ; Jooyeon OH ; Joon-Yong BAE ; Gee Eun LEE ; Sun-Je WOO ; Sun-Min SEO ; Na-Won KIM ; Youn Woo LEE ; Hui Jeong JANG ; Seung-Min HONG ; Se-Hee AN ; Kwang-Soo LYOO ; Minjoo YEOM ; Hanbyeul LEE ; Bud JUNG ; Sun-Woo YOON ; Jung-Ah KANG ; Sang-Hyuk SEOK ; Yu Jin LEE ; Seo Yeon KIM ; Young Been KIM ; Ji-Yeon HWANG ; Dain ON ; Soo-Yeon LIM ; Sol Pin KIM ; Ji Yun JANG ; Ho LEE ; Kyoungmi KIM ; Hyo-Jung LEE ; Hong Bin KIM ; Jun Won PARK ; Dae Gwin JEONG ; Daesub SONG ; Kang-Seuk CHOI ; Ho-Young LEE ; Yang-Kyu CHOI ; Jung-ah CHOI ; Manki SONG ; Man-Seong PARK ; Jun-Young SEO ; Ki Taek NAM ; Jeon-Soo SHIN ; Sungho WON ; Jun-Won YUN ; Je Kyung SEONG
Laboratory Animal Research 2022;38(2):119-127
Background:
As the number of large-scale studies involving multiple organizations producing data has steadily increased, an integrated system for a common interoperable format is needed. In response to the coronavirus disease 2019 (COVID-19) pandemic, a number of global efforts are underway to develop vaccines and therapeutics. We are therefore observing an explosion in the proliferation of COVID-19 data, and interoperability is highly requested in multiple institutions participating simultaneously in COVID-19 pandemic research.
Results:
In this study, a laboratory information management system (LIMS) approach has been adopted to systemically manage various COVID-19 non-clinical trial data, including mortality, clinical signs, body weight, body temperature, organ weights, viral titer (viral replication and viral RNA), and multiorgan histopathology, from multiple institutions based on a web interface. The main aim of the implemented system is to integrate, standardize, and organize data collected from laboratories in multiple institutes for COVID-19 non-clinical efficacy testings. Six animal biosafety level 3 institutions proved the feasibility of our system. Substantial benefits were shown by maximizing collaborative high-quality non-clinical research.
Conclusions
This LIMS platform can be used for future outbreaks, leading to accelerated medical product development through the systematic management of extensive data from non-clinical animal studies.

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