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.Analysis of Factors Associated with Daytime Sleepiness in Korean Adolescents
Eun Jeong JANG ; Jung Sun KIM ; Kitai KIM ; Hye Sun GWAK ; Ji Min HAN
Korean Journal of Clinical Pharmacy 2024;34(1):21-29
Background:
Daytime sleepiness, a common phenomenon among adolescents focused on academics, has negative effects on aspects such as growth and overall learning. However, research on various drugs and diseases affecting daytime sleepiness is lacking in the reality. Therefore, this study aims to investigate the factors influencing daytime sleepiness in adolescents with daytime sleepiness.
Methods:
This study was conducted through a survey of 2,432 middle and high school students, aged 14 to 19. The questionnaire consisted of information on socio-demographic characteristics, overall health status, and sleep patterns. The Pediatric Daytime Sleepiness Scale (PDSS), translated into Korean, was used to assess daytime sleepiness. Daytime sleepiness was measured bycalculating the total score for each item of the PDSS, and divided into two groups based on the cutoff value of 19, which was theupper quartile.
Results:
We analyzed a total of 1,770 students including 799 boys and 971 girls. Students with a PDSS score of 19or higher made up 33.3% of boys and 66.7% of girls. In multivariate analyses, females, smoking, poor self-reported health level, sleep after 12 am, not feeling refreshed in the morning, headache, muscle pain, and scoliosis increased the risk of daytime sleepinesssignificantly. The AUROC of PDSS, including significant factors in multivariate analyses, was 0.751 (95% CI 0.725~0.776).
Conclusions
Daytime sleepiness in adolescents affects growth, academic performance, and emotional stability. Therefore, it is important to manage medications, diseases, and other factors that affect daytime sleepiness on a social level.
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.Analysis of Factors Associated with Daytime Sleepiness in Korean Adolescents
Eun Jeong JANG ; Jung Sun KIM ; Kitai KIM ; Hye Sun GWAK ; Ji Min HAN
Korean Journal of Clinical Pharmacy 2024;34(1):21-29
Background:
Daytime sleepiness, a common phenomenon among adolescents focused on academics, has negative effects on aspects such as growth and overall learning. However, research on various drugs and diseases affecting daytime sleepiness is lacking in the reality. Therefore, this study aims to investigate the factors influencing daytime sleepiness in adolescents with daytime sleepiness.
Methods:
This study was conducted through a survey of 2,432 middle and high school students, aged 14 to 19. The questionnaire consisted of information on socio-demographic characteristics, overall health status, and sleep patterns. The Pediatric Daytime Sleepiness Scale (PDSS), translated into Korean, was used to assess daytime sleepiness. Daytime sleepiness was measured bycalculating the total score for each item of the PDSS, and divided into two groups based on the cutoff value of 19, which was theupper quartile.
Results:
We analyzed a total of 1,770 students including 799 boys and 971 girls. Students with a PDSS score of 19or higher made up 33.3% of boys and 66.7% of girls. In multivariate analyses, females, smoking, poor self-reported health level, sleep after 12 am, not feeling refreshed in the morning, headache, muscle pain, and scoliosis increased the risk of daytime sleepinesssignificantly. The AUROC of PDSS, including significant factors in multivariate analyses, was 0.751 (95% CI 0.725~0.776).
Conclusions
Daytime sleepiness in adolescents affects growth, academic performance, and emotional stability. Therefore, it is important to manage medications, diseases, and other factors that affect daytime sleepiness on a social level.
5.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.
6.Analysis of Factors Associated with Daytime Sleepiness in Korean Adolescents
Eun Jeong JANG ; Jung Sun KIM ; Kitai KIM ; Hye Sun GWAK ; Ji Min HAN
Korean Journal of Clinical Pharmacy 2024;34(1):21-29
Background:
Daytime sleepiness, a common phenomenon among adolescents focused on academics, has negative effects on aspects such as growth and overall learning. However, research on various drugs and diseases affecting daytime sleepiness is lacking in the reality. Therefore, this study aims to investigate the factors influencing daytime sleepiness in adolescents with daytime sleepiness.
Methods:
This study was conducted through a survey of 2,432 middle and high school students, aged 14 to 19. The questionnaire consisted of information on socio-demographic characteristics, overall health status, and sleep patterns. The Pediatric Daytime Sleepiness Scale (PDSS), translated into Korean, was used to assess daytime sleepiness. Daytime sleepiness was measured bycalculating the total score for each item of the PDSS, and divided into two groups based on the cutoff value of 19, which was theupper quartile.
Results:
We analyzed a total of 1,770 students including 799 boys and 971 girls. Students with a PDSS score of 19or higher made up 33.3% of boys and 66.7% of girls. In multivariate analyses, females, smoking, poor self-reported health level, sleep after 12 am, not feeling refreshed in the morning, headache, muscle pain, and scoliosis increased the risk of daytime sleepinesssignificantly. The AUROC of PDSS, including significant factors in multivariate analyses, was 0.751 (95% CI 0.725~0.776).
Conclusions
Daytime sleepiness in adolescents affects growth, academic performance, and emotional stability. Therefore, it is important to manage medications, diseases, and other factors that affect daytime sleepiness on a social level.
7.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.
8.Analysis of Factors Associated with Daytime Sleepiness in Korean Adolescents
Eun Jeong JANG ; Jung Sun KIM ; Kitai KIM ; Hye Sun GWAK ; Ji Min HAN
Korean Journal of Clinical Pharmacy 2024;34(1):21-29
Background:
Daytime sleepiness, a common phenomenon among adolescents focused on academics, has negative effects on aspects such as growth and overall learning. However, research on various drugs and diseases affecting daytime sleepiness is lacking in the reality. Therefore, this study aims to investigate the factors influencing daytime sleepiness in adolescents with daytime sleepiness.
Methods:
This study was conducted through a survey of 2,432 middle and high school students, aged 14 to 19. The questionnaire consisted of information on socio-demographic characteristics, overall health status, and sleep patterns. The Pediatric Daytime Sleepiness Scale (PDSS), translated into Korean, was used to assess daytime sleepiness. Daytime sleepiness was measured bycalculating the total score for each item of the PDSS, and divided into two groups based on the cutoff value of 19, which was theupper quartile.
Results:
We analyzed a total of 1,770 students including 799 boys and 971 girls. Students with a PDSS score of 19or higher made up 33.3% of boys and 66.7% of girls. In multivariate analyses, females, smoking, poor self-reported health level, sleep after 12 am, not feeling refreshed in the morning, headache, muscle pain, and scoliosis increased the risk of daytime sleepinesssignificantly. The AUROC of PDSS, including significant factors in multivariate analyses, was 0.751 (95% CI 0.725~0.776).
Conclusions
Daytime sleepiness in adolescents affects growth, academic performance, and emotional stability. Therefore, it is important to manage medications, diseases, and other factors that affect daytime sleepiness on a social level.
10.A Randomized Controlled Trial for Doing vs. Omitting Intraoperative Frozen Section Biopsy for Resection Margin Status in Selected Patients Undergoing Breast-Conserving Surgery (OFF-MAP Trial)
Tae-Kyung YOO ; Young-Joon KANG ; Joon JEONG ; Jeong-Yoon SONG ; Sun Hee KANG ; Hye Yoon LEE ; Eui Tae KIM ; Onvox YI ; Han-Byoel LEE ; Soojeong CHOI ; Hyung Seok PARK ; Geumhee GWAK ; Jae Il KIM ; Min Kyoon KIM ; Jeeyeon LEE ; Hee Joon KANG ; Byung Joo CHAE
Journal of Breast Cancer 2021;24(6):569-577
Purpose:
Intraoperative frozen section biopsy is used to reduce the margin positive rate and re-excision rate and has been reported to have high diagnostic accuracy. A majority of breast surgeons in the Republic of Korea routinely perform frozen section biopsy to assess margins intraoperatively, despite its long turnaround time and high resource requirements. This study aims to determine whether omitting frozen section biopsy for intraoperative margin evaluation in selected patients is non-inferior to performing frozen section biopsy in terms of resection margin positivity rate.
Methods
This study is a phase III, randomized controlled, parallel-group, multicenter non-inferiority clinical trial. Patients meeting the inclusion criteria and providing written informed consent will be randomized to the “frozen section biopsy” or “frozen section biopsy omission” group after lumpectomy. Patients with clinical stage T1–T3 disease who are diagnosed with invasive breast cancer by core-needle biopsy and plan to undergo breast-conserving surgery will be included in this study. If a daughter nodule, non-mass enhancement, or microcalcification is identified on preoperative imaging, these features must be within 1 cm of the main mass for inclusion in the trial. The target sample size is 646 patients per arm. The primary endpoint will be the resection margin positive rate, and the secondary endpoints include the reoperation rate, operating time, residual cancer after reoperation, residual cancer after re-excision according to the frozen section biopsy result, resection volume, patient quality of life, and cost-effectiveness.Discussion: This is the first randomized clinical trial utilizing frozen section biopsy for intraoperative margin evaluation and aims to determine the non-inferiority of omitting frozen section biopsy in selected patients compared to performing frozen section biopsy.We expect that this trial will help surgeons perform the procedure more efficiently while ensuring patient safety.

Result Analysis
Print
Save
E-mail