1.Multi-center, prospective, non-interventional, observational study on the efficacy and safety of Mirabek® in adult patients with overactive bladder
Jee Soo PARK ; Won Sik JANG ; Jongchan KIM ; Moon-Hwa PARK ; Won Sik HAM
Investigative and Clinical Urology 2025;66(1):27-35
Purpose:
Mirabegron, the first-in-class beta-3 agonist, is the mainstay medication for overactive bladder (OAB). The aim of this study was to investigate the efficacy and safety of generic drugs of mirabegron (Mirabek® ) in adults diagnosed with OAB through a multicenter, prospective, non-interventional observational study.
Materials and Methods:
Adult patients with OAB prescribed Mirabek® SR Tab. 50 mg for the first time were recruited from hospitals between September 2021 and September 2022. Participants underwent baseline registration followed by two follow-ups at 4-and 8-week intervals. Data on demographics, medical history, OAB symptoms, vital signs, medication administration, and adverse events were collected.
Results:
Among 1,714 patients, Mirabek® SR Tab. 50 mg effectively improved OAB symptoms over an 8-week treatment period, with significant differences in symptom improvement between baseline and both 4- and 8-week time points as well as between 4 weeks and 8 weeks. The incidence rate of adverse events was 0.70%; most cases were mild with no severe reactions.
Conclusions
This study demonstrated that Mirabek® , a generic drug of betmiga, is an effective and safe treatment option for adults with OAB. Furthermore, the introduction of generic drug reduced the costs of prescription drugs and expanded the opportunity for many patients to access mirabegron.
2.Clinical Practice Guideline for Blood-based Circulating Tumor DNA Assays
Jee-Soo LEE ; Eun Hye CHO ; Boram KIM ; Jinyoung HONG ; Young-gon KIM ; Yoonjung KIM ; Ja-Hyun JANG ; Seung-Tae LEE ; Sun-Young KONG ; Woochang LEE ; Saeam SHIN ; Eun Young SONG ;
Annals of Laboratory Medicine 2024;44(3):195-209
Circulating tumor DNA (ctDNA) has emerged as a promising tool for various clinical applications, including early diagnosis, therapeutic target identification, treatment response monitoring, prognosis evaluation, and minimal residual disease detection. Consequently, ctDNA assays have been incorporated into clinical practice. In this review, we offer an indepth exploration of the clinical implementation of ctDNA assays. Notably, we examined existing evidence related to pre-analytical procedures, analytical components in current technologies, and result interpretation and reporting processes. The primary objective of this guidelines is to provide recommendations for the clinical utilization of ctDNA assays.
3.Incidence and Pattern of Recurrence after Surgical Resection in Organ-Confined Renal Cell Carcinoma
Jongchan KIM ; Won Sik HAM ; Jee Soo PARK ; Won Sik JANG
Yonsei Medical Journal 2024;65(11):623-628
Purpose:
To evaluate the incidence and pattern of recurrence after surgery in patients with organ-confined renal cell carcinoma (RCC) to establish an appropriate follow-up plan.
Materials and Methods:
In this retrospective study, we evaluated data from 2960 patients who underwent radical or partial nephrectomy for stage 1 or 2 RCC. We investigated the location of first recurrence and recurrence-free survival (RFS) by plotting Kaplan–Meier curves and analyzed the associated variables using Cox regression analysis.
Results:
During a median follow-up of 59 months, the 10-year RFS rates were 94.5%, 75.0%, and 57.9%, for T1a, T1b, and T2 RCC, respectively. A total of 211 patients experienced recurrence: 67 after 5 years, and 14 after 10 years. The most common sites of the first recurrence were the lungs, bones, and contralateral kidneys. Male sex, older age, higher pathologic T stage, higher nuclear grade, clear-cell RCC, and presence of differentiation were associated with recurrence. Among patients followed up for more than 60 months, higher pathologic T stage and grade, as well as clear cell RCC were predictors of RFS.
Conclusion
Late recurrence after surgery is common in patients with organ-confined RCC, with recurrence occurring even after 10 years. Consequently, long-term follow-up, of perhaps 10 years or more, including imaging studies of the abdomen, lungs, and bone, should be considered for the early detection of recurrence.
4.Incidence and Pattern of Recurrence after Surgical Resection in Organ-Confined Renal Cell Carcinoma
Jongchan KIM ; Won Sik HAM ; Jee Soo PARK ; Won Sik JANG
Yonsei Medical Journal 2024;65(11):623-628
Purpose:
To evaluate the incidence and pattern of recurrence after surgery in patients with organ-confined renal cell carcinoma (RCC) to establish an appropriate follow-up plan.
Materials and Methods:
In this retrospective study, we evaluated data from 2960 patients who underwent radical or partial nephrectomy for stage 1 or 2 RCC. We investigated the location of first recurrence and recurrence-free survival (RFS) by plotting Kaplan–Meier curves and analyzed the associated variables using Cox regression analysis.
Results:
During a median follow-up of 59 months, the 10-year RFS rates were 94.5%, 75.0%, and 57.9%, for T1a, T1b, and T2 RCC, respectively. A total of 211 patients experienced recurrence: 67 after 5 years, and 14 after 10 years. The most common sites of the first recurrence were the lungs, bones, and contralateral kidneys. Male sex, older age, higher pathologic T stage, higher nuclear grade, clear-cell RCC, and presence of differentiation were associated with recurrence. Among patients followed up for more than 60 months, higher pathologic T stage and grade, as well as clear cell RCC were predictors of RFS.
Conclusion
Late recurrence after surgery is common in patients with organ-confined RCC, with recurrence occurring even after 10 years. Consequently, long-term follow-up, of perhaps 10 years or more, including imaging studies of the abdomen, lungs, and bone, should be considered for the early detection of recurrence.
5.Genetic Landscape and Clinical Manifestations of Multiple Endocrine Neoplasia Type 1 in a Korean Cohort: A Multicenter Retrospective Analysis
Boram KIM ; Seung Hun LEE ; Chang Ho AHN ; Han Na JANG ; Sung Im CHO ; Jee-Soo LEE ; Yu-Mi LEE ; Su-Jin KIM ; Tae-Yon SUNG ; Kyu Eun LEE ; Woochang LEE ; Jung-Min KOH ; Moon-Woo SEONG ; Jung Hee KIM
Endocrinology and Metabolism 2024;39(6):956-964
Background:
Multiple endocrine neoplasia type 1 (MEN1) is an autosomal dominant disorder characterized by tumors in multiple endocrine organs, caused by variants in the MEN1 gene. This study analyzed the clinical and genetic features of MEN1 in a Korean cohort, identifying prevalent manifestations and genetic variants, including novel variants.
Methods:
This multicenter retrospective study reviewed the medical records of 117 MEN1 patients treated at three tertiary centers in Korea between January 2012 and September 2022. Patient demographics, tumor manifestations, outcomes, and MEN1 genetic testing results were collected. Variants were classified using American College of Medical Genetics and Genomics (ACMG) and French Oncogenetics Network of Neuroendocrine Tumors propositions (TENGEN) guidelines.
Results:
A total of 117 patients were enrolled, including 55 familial cases, with a mean age at diagnosis of 37.4±15.3 years. Primary hyperparathyroidism was identified as the most common presentation (84.6%). The prevalence of gastroenteropancreatic neuroendocrine tumor and pituitary neuroendocrine tumor (PitNET) was 77.8% (n=91) and 56.4% (n=66), respectively. Genetic testing revealed 61 distinct MEN1 variants in 101 patients, with 18 being novel. Four variants were reclassified according to the TENGEN guidelines. Patients with truncating variants (n=72) exhibited a higher prevalence of PitNETs compared to those with non-truncating variants (n=25) (59.7% vs. 36.0%, P=0.040).
Conclusion
The association between truncating variants and an increased prevalence of PitNETs in MEN1 underscores the importance of genetic characterization in guiding the clinical management of this disease. Our study sheds light on the clinical and genetic characteristics of MEN1 among the Korean population.
6.Incidence and Pattern of Recurrence after Surgical Resection in Organ-Confined Renal Cell Carcinoma
Jongchan KIM ; Won Sik HAM ; Jee Soo PARK ; Won Sik JANG
Yonsei Medical Journal 2024;65(11):623-628
Purpose:
To evaluate the incidence and pattern of recurrence after surgery in patients with organ-confined renal cell carcinoma (RCC) to establish an appropriate follow-up plan.
Materials and Methods:
In this retrospective study, we evaluated data from 2960 patients who underwent radical or partial nephrectomy for stage 1 or 2 RCC. We investigated the location of first recurrence and recurrence-free survival (RFS) by plotting Kaplan–Meier curves and analyzed the associated variables using Cox regression analysis.
Results:
During a median follow-up of 59 months, the 10-year RFS rates were 94.5%, 75.0%, and 57.9%, for T1a, T1b, and T2 RCC, respectively. A total of 211 patients experienced recurrence: 67 after 5 years, and 14 after 10 years. The most common sites of the first recurrence were the lungs, bones, and contralateral kidneys. Male sex, older age, higher pathologic T stage, higher nuclear grade, clear-cell RCC, and presence of differentiation were associated with recurrence. Among patients followed up for more than 60 months, higher pathologic T stage and grade, as well as clear cell RCC were predictors of RFS.
Conclusion
Late recurrence after surgery is common in patients with organ-confined RCC, with recurrence occurring even after 10 years. Consequently, long-term follow-up, of perhaps 10 years or more, including imaging studies of the abdomen, lungs, and bone, should be considered for the early detection of recurrence.
7.Obstructive Sleep Apnea: Pathophysiology and Treatment
Jee-Won JANG ; Hye-Min JU ; Hye-Mi JEON ; Yong-Woo AHN ; Sung-Hee JEONG ; Soo-Min OK
Journal of Oral Medicine and Pain 2024;49(4):71-78
Obstructive sleep apnea (OSA) is a disorder driven by a combination of anatomical and functional factors. A narrow upper airway, fatty deposits around the tongue, and enlarged soft tissues all contribute to airway collapse. Additionally, reduced neuromuscular activity during sleep and increased instability in respiratory control heighten the risk of airway obstruction. OSA is linked to serious health problems, including metabolic disorders, cardiovascular diseases, and excessive daytime sleepiness, underscoring the importance of early diagnosis and treatment. Diagnosis is typically made through polysomnography, and continuous positive airway pressure therapy remains the most effective treatment.For individuals with mild to moderate OSA, oral appliance therapy offers a viable alternative, while emerging treatments such as hypoglossal nerve stimulation and pharmacological interventions provide additional options. By identifying distinct OSA phenotypes, personalized treatment approaches can be developed, and future research should focus on optimizing these strategies to meet the specific needs of individual patients.
8.Differences in Symptoms According to the Concordance Value Between Self-Reported Pain Sites and Standardized Palpation Pain Sites in Temporomandibular Disorder Patients: Pilot Study
Jee-Won JANG ; Seo-Young CHOI ; Yong-Woo AHN ; Sung-Hee JEONG ; Soo-Min OK ; Hye-Mi JEON ; Hye-Min JU
Journal of Oral Medicine and Pain 2024;49(3):49-56
Purpose:
The aims were to investigate potential differences in clinical assessments among acute pain-related temporomandibular disorder (TMD) with different concordance value (CV) between number of self-reported painful site (NSP) and number of painful sites on palpation (NPP), and if it makes sense to treat them differently.
Methods:
A total of 61 patients were divided into three groups according to CV: 10 patients (concordance poor [CP]), 19 patients (concordance moderate [CM]), and 32 patients (concordance high [CH]). Clinical assessments were conducted using a standardized method in diagnostic criteria for temporomandibular disorders (DC/TMD). We compared collected information including sex, diagnosis, numerical rating scale (NRS), NPP, NSP, sleep duration, DC/TMD Axis II questionnaire, and perceived stress scale among three groups.
Results:
Among the clinical assessment, NRS, sleep duration, NPP, NSP, total scores of Oral Behaviors Checklist, Patient Health Questionnaire (PHQ)-15, PHQ-9 showed significant differences among 3 groups. NRS, NPP, NSP, PHQ-15, and PHQ-9 were higher in the CP group than in the CM and CH groups. Sleep duration was positively and NPP, NRS were negatively correlated with CV.
Conclusions
While previous studies suggested differences between chronic and acute TMD in DC/TMD items, our findings propose the CV might be a key factor that could predict the severity and susceptibility of acute-TMD patients. However, Additional studies are required to determine whether their long-term prognosis was similar to that of chronic pain patients and what the response to treatment was among the three groups.
9.Genetic Landscape and Clinical Manifestations of Multiple Endocrine Neoplasia Type 1 in a Korean Cohort: A Multicenter Retrospective Analysis
Boram KIM ; Seung Hun LEE ; Chang Ho AHN ; Han Na JANG ; Sung Im CHO ; Jee-Soo LEE ; Yu-Mi LEE ; Su-Jin KIM ; Tae-Yon SUNG ; Kyu Eun LEE ; Woochang LEE ; Jung-Min KOH ; Moon-Woo SEONG ; Jung Hee KIM
Endocrinology and Metabolism 2024;39(6):956-964
Background:
Multiple endocrine neoplasia type 1 (MEN1) is an autosomal dominant disorder characterized by tumors in multiple endocrine organs, caused by variants in the MEN1 gene. This study analyzed the clinical and genetic features of MEN1 in a Korean cohort, identifying prevalent manifestations and genetic variants, including novel variants.
Methods:
This multicenter retrospective study reviewed the medical records of 117 MEN1 patients treated at three tertiary centers in Korea between January 2012 and September 2022. Patient demographics, tumor manifestations, outcomes, and MEN1 genetic testing results were collected. Variants were classified using American College of Medical Genetics and Genomics (ACMG) and French Oncogenetics Network of Neuroendocrine Tumors propositions (TENGEN) guidelines.
Results:
A total of 117 patients were enrolled, including 55 familial cases, with a mean age at diagnosis of 37.4±15.3 years. Primary hyperparathyroidism was identified as the most common presentation (84.6%). The prevalence of gastroenteropancreatic neuroendocrine tumor and pituitary neuroendocrine tumor (PitNET) was 77.8% (n=91) and 56.4% (n=66), respectively. Genetic testing revealed 61 distinct MEN1 variants in 101 patients, with 18 being novel. Four variants were reclassified according to the TENGEN guidelines. Patients with truncating variants (n=72) exhibited a higher prevalence of PitNETs compared to those with non-truncating variants (n=25) (59.7% vs. 36.0%, P=0.040).
Conclusion
The association between truncating variants and an increased prevalence of PitNETs in MEN1 underscores the importance of genetic characterization in guiding the clinical management of this disease. Our study sheds light on the clinical and genetic characteristics of MEN1 among the Korean population.
10.Genetic Landscape and Clinical Manifestations of Multiple Endocrine Neoplasia Type 1 in a Korean Cohort: A Multicenter Retrospective Analysis
Boram KIM ; Seung Hun LEE ; Chang Ho AHN ; Han Na JANG ; Sung Im CHO ; Jee-Soo LEE ; Yu-Mi LEE ; Su-Jin KIM ; Tae-Yon SUNG ; Kyu Eun LEE ; Woochang LEE ; Jung-Min KOH ; Moon-Woo SEONG ; Jung Hee KIM
Endocrinology and Metabolism 2024;39(6):956-964
Background:
Multiple endocrine neoplasia type 1 (MEN1) is an autosomal dominant disorder characterized by tumors in multiple endocrine organs, caused by variants in the MEN1 gene. This study analyzed the clinical and genetic features of MEN1 in a Korean cohort, identifying prevalent manifestations and genetic variants, including novel variants.
Methods:
This multicenter retrospective study reviewed the medical records of 117 MEN1 patients treated at three tertiary centers in Korea between January 2012 and September 2022. Patient demographics, tumor manifestations, outcomes, and MEN1 genetic testing results were collected. Variants were classified using American College of Medical Genetics and Genomics (ACMG) and French Oncogenetics Network of Neuroendocrine Tumors propositions (TENGEN) guidelines.
Results:
A total of 117 patients were enrolled, including 55 familial cases, with a mean age at diagnosis of 37.4±15.3 years. Primary hyperparathyroidism was identified as the most common presentation (84.6%). The prevalence of gastroenteropancreatic neuroendocrine tumor and pituitary neuroendocrine tumor (PitNET) was 77.8% (n=91) and 56.4% (n=66), respectively. Genetic testing revealed 61 distinct MEN1 variants in 101 patients, with 18 being novel. Four variants were reclassified according to the TENGEN guidelines. Patients with truncating variants (n=72) exhibited a higher prevalence of PitNETs compared to those with non-truncating variants (n=25) (59.7% vs. 36.0%, P=0.040).
Conclusion
The association between truncating variants and an increased prevalence of PitNETs in MEN1 underscores the importance of genetic characterization in guiding the clinical management of this disease. Our study sheds light on the clinical and genetic characteristics of MEN1 among the Korean population.

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