1.Clinical consequence of hypophosphatemia during antiviral therapy for chronic hepatitis B
Mee Yeon PARK ; Hojin JEON ; Kyungho PARK ; Junseok JEON ; Minsu PARK ; Sang Ah CHI ; Kyunga KIM ; Dong Hyun SINN ; Jung Eun LEE ; Geum-Youn GWAK ; Wooseong HUH ; Yoon-Goo KIM ; Hye Ryoun JANG
Kidney Research and Clinical Practice 2025;44(1):123-131
Antiviral therapy is an essential treatment for chronic hepatitis B (CHB) infection. Although hypophosphatemia is an important adverse effect of antiviral agents, its clinical significance remains unclear. We investigated the incidence and clinical consequences of hypophosphatemia in a large cohort of CHB patients. Methods: This retrospective cohort study included CHB patients who started antiviral therapy between 2005 and 2015 and continued it for at least 1 year. Patients with decompensated liver cirrhosis, diabetes mellitus, hypertension, concomitant diuretic administration, and end-stage renal disease were excluded. The primary outcome was a change in renal function. Secondary outcomes included the incidence of infection and changes in serum potassium, uric acid, and total carbon dioxide (tCO2). Results: Among the 4,335 patients, hypophosphatemia developed in 75 (1.7%). During the median 2-year follow-up period, patients with hypophosphatemia showed a lower estimated glomerular filtration rate than those in the control group. The incidence of infection and changes in serum potassium, uric acid, and tCO2 were similar between groups. Conclusion: Hypophosphatemia was associated with a renal function decline in patients with CHB receiving antiviral therapy.
2.Evaluating the Efficacy and Safety of Hemofence (Thorombin Cross-Linked Sodium Hyaluronate Gel Matrix) in Hemostasis for Intractable Exudative Bleeding in Spinal Surgery: A Multicenter, Randomized, Phase III Clinical Trial
Sungjae AN ; Woo-Keun KWON ; Il CHOI ; Jang-Bo LEE ; Joohyun KIM ; Junseok W. HUR
Neurospine 2024;21(3):1004-1013
Objective:
To demonstrate the noninferiority of the novel hemostatic agent, Hemofence (BMI Korea Co., Ltd., thrombin cross-linked sodium hyaluronate gel matrix) compared to the established agent, Floseal Hemostatic Matrix (Baxter, thrombin-gelatin matrix) in achieving hemostasis for spinal surgeries, with secondary objectives to assess additional efficacy and safety.
Methods:
This clinical trial was a multicenter, randomized, subject-blinded, active-controlled, parallel-group, phase 3 study. Investigational drugs were administered to the first and second bleeding sites of each participant (or only to the first site if a second site was absent), evaluating hemostasis success rate within 10 minutes and the time to achieve hemostasis. Subsequent visits were conducted for safety assessments. For noninferiority test, a 97.5% one-sided confidence interval (CI) was used; the test group was deemed noninferior if the lower limit exceeded -10%.
Results:
This trial showed a 97.10% success rate in the test group and 96.05% in the control group for primary efficacy. The 95% CI (-4.90% to 7.44%) confirmed the test drug’s noninferiority. Time to hemostasis showed no significant difference between groups. All adverse events, adverse drug reactions, and serious adverse events were statistically similar between groups (p=1.000, p=0.243, and p=0.966, respectively).
Conclusion
A novel hemostatic agent, Hemofence, demonstrated an efficacy and safety profile comparable to that of Floseal.
3.Evaluating the Efficacy and Safety of Hemofence (Thorombin Cross-Linked Sodium Hyaluronate Gel Matrix) in Hemostasis for Intractable Exudative Bleeding in Spinal Surgery: A Multicenter, Randomized, Phase III Clinical Trial
Sungjae AN ; Woo-Keun KWON ; Il CHOI ; Jang-Bo LEE ; Joohyun KIM ; Junseok W. HUR
Neurospine 2024;21(3):1004-1013
Objective:
To demonstrate the noninferiority of the novel hemostatic agent, Hemofence (BMI Korea Co., Ltd., thrombin cross-linked sodium hyaluronate gel matrix) compared to the established agent, Floseal Hemostatic Matrix (Baxter, thrombin-gelatin matrix) in achieving hemostasis for spinal surgeries, with secondary objectives to assess additional efficacy and safety.
Methods:
This clinical trial was a multicenter, randomized, subject-blinded, active-controlled, parallel-group, phase 3 study. Investigational drugs were administered to the first and second bleeding sites of each participant (or only to the first site if a second site was absent), evaluating hemostasis success rate within 10 minutes and the time to achieve hemostasis. Subsequent visits were conducted for safety assessments. For noninferiority test, a 97.5% one-sided confidence interval (CI) was used; the test group was deemed noninferior if the lower limit exceeded -10%.
Results:
This trial showed a 97.10% success rate in the test group and 96.05% in the control group for primary efficacy. The 95% CI (-4.90% to 7.44%) confirmed the test drug’s noninferiority. Time to hemostasis showed no significant difference between groups. All adverse events, adverse drug reactions, and serious adverse events were statistically similar between groups (p=1.000, p=0.243, and p=0.966, respectively).
Conclusion
A novel hemostatic agent, Hemofence, demonstrated an efficacy and safety profile comparable to that of Floseal.
4.Clinical Implication of Maumgyeol Basic Biotypes–Electroencephalography- and Photoplethysmogram-Based Bwave State Inventory
Yunsu KIM ; Junseok HWANG ; Jaehyung LEE ; Seongwon JANG ; Yumi IM ; Sunkyung YOON ; Seung-Hwan LEE
Psychiatry Investigation 2024;21(5):528-538
Objective:
The development of individual subtypes based on biomarkers offers a cost-effective and timely avenue to comprehending individual differences pertaining to mental health, independent from individuals’ subjective insights. Incorporating 2-channel electroencephalography (EEG) and photoplethysmogram (PPG), we sought to establish a subtype classification system with clinical relevance.
Methods:
One hundred healthy participants and 99 patients with psychiatric disorders were recruited. Classification thresholds were determined using the EEG and PPG data from 2,278 individuals without mental disorders, serving to classify subtypes in our sample of 199 participants. Multivariate analysis of variance was applied to examine psychological distinctions among these subtypes. K-means clustering was employed to verify the classification system.
Results:
The distribution of subtypes differed between healthy participants and those with psychiatric disorders. Cognitive abilities were contingent upon brain subtypes, while mind subtypes exhibited significant differences in symptom severity, overall health, and cognitive stress. K-means clustering revealed that the results of our theory-based classification and data-driven classification are comparable. The synergistic assessment of both brain and mind subtypes was also explored.
Conclusion
Our subtype classification system offers a concise means to access individuals’ mental health. The utilization of EEG and PPG signals for subtype classification offers potential for the future of digital mental healthcare.
5.Evaluating the Efficacy and Safety of Hemofence (Thorombin Cross-Linked Sodium Hyaluronate Gel Matrix) in Hemostasis for Intractable Exudative Bleeding in Spinal Surgery: A Multicenter, Randomized, Phase III Clinical Trial
Sungjae AN ; Woo-Keun KWON ; Il CHOI ; Jang-Bo LEE ; Joohyun KIM ; Junseok W. HUR
Neurospine 2024;21(3):1004-1013
Objective:
To demonstrate the noninferiority of the novel hemostatic agent, Hemofence (BMI Korea Co., Ltd., thrombin cross-linked sodium hyaluronate gel matrix) compared to the established agent, Floseal Hemostatic Matrix (Baxter, thrombin-gelatin matrix) in achieving hemostasis for spinal surgeries, with secondary objectives to assess additional efficacy and safety.
Methods:
This clinical trial was a multicenter, randomized, subject-blinded, active-controlled, parallel-group, phase 3 study. Investigational drugs were administered to the first and second bleeding sites of each participant (or only to the first site if a second site was absent), evaluating hemostasis success rate within 10 minutes and the time to achieve hemostasis. Subsequent visits were conducted for safety assessments. For noninferiority test, a 97.5% one-sided confidence interval (CI) was used; the test group was deemed noninferior if the lower limit exceeded -10%.
Results:
This trial showed a 97.10% success rate in the test group and 96.05% in the control group for primary efficacy. The 95% CI (-4.90% to 7.44%) confirmed the test drug’s noninferiority. Time to hemostasis showed no significant difference between groups. All adverse events, adverse drug reactions, and serious adverse events were statistically similar between groups (p=1.000, p=0.243, and p=0.966, respectively).
Conclusion
A novel hemostatic agent, Hemofence, demonstrated an efficacy and safety profile comparable to that of Floseal.
6.Evaluating the Efficacy and Safety of Hemofence (Thorombin Cross-Linked Sodium Hyaluronate Gel Matrix) in Hemostasis for Intractable Exudative Bleeding in Spinal Surgery: A Multicenter, Randomized, Phase III Clinical Trial
Sungjae AN ; Woo-Keun KWON ; Il CHOI ; Jang-Bo LEE ; Joohyun KIM ; Junseok W. HUR
Neurospine 2024;21(3):1004-1013
Objective:
To demonstrate the noninferiority of the novel hemostatic agent, Hemofence (BMI Korea Co., Ltd., thrombin cross-linked sodium hyaluronate gel matrix) compared to the established agent, Floseal Hemostatic Matrix (Baxter, thrombin-gelatin matrix) in achieving hemostasis for spinal surgeries, with secondary objectives to assess additional efficacy and safety.
Methods:
This clinical trial was a multicenter, randomized, subject-blinded, active-controlled, parallel-group, phase 3 study. Investigational drugs were administered to the first and second bleeding sites of each participant (or only to the first site if a second site was absent), evaluating hemostasis success rate within 10 minutes and the time to achieve hemostasis. Subsequent visits were conducted for safety assessments. For noninferiority test, a 97.5% one-sided confidence interval (CI) was used; the test group was deemed noninferior if the lower limit exceeded -10%.
Results:
This trial showed a 97.10% success rate in the test group and 96.05% in the control group for primary efficacy. The 95% CI (-4.90% to 7.44%) confirmed the test drug’s noninferiority. Time to hemostasis showed no significant difference between groups. All adverse events, adverse drug reactions, and serious adverse events were statistically similar between groups (p=1.000, p=0.243, and p=0.966, respectively).
Conclusion
A novel hemostatic agent, Hemofence, demonstrated an efficacy and safety profile comparable to that of Floseal.
8.Validation of prediction model for successful discontinuation of continuous renal replacement therapy: a multicenter cohort study
Junseok JEON ; Eun Jeong KO ; Hyejeong PARK ; Song In BAEG ; Hyung Duk KIM ; Ji-Won MIN ; Eun Sil KOH ; Kyungho LEE ; Danbee KANG ; Juhee CHO ; Jung Eun LEE ; Wooseong HUH ; Byung Ha CHUNG ; Hye Ryoun JANG
Kidney Research and Clinical Practice 2024;43(4):528-537
Continuous renal replacement therapy (CRRT) has become the standard modality of renal replacement therapy (RRT) in critically ill patients. However, consensus is lacking regarding the criteria for discontinuing CRRT. Here we validated the usefulness of the prediction model for successful discontinuation of CRRT in a multicenter retrospective cohort. Methods: One temporal cohort and four external cohorts included 1,517 patients with acute kidney injury who underwent CRRT for >2 days from 2018 to 2020. The model was composed of four variables: urine output, blood urea nitrogen, serum potassium, and mean arterial pressure. Successful discontinuation of CRRT was defined as the absence of an RRT requirement for 7 days thereafter. Results: The area under the receiver operating characteristic curve (AUROC) was 0.74 (95% confidence interval, 0.71–0.76). The probabilities of successful discontinuation were approximately 17%, 35%, and 70% in the low-score, intermediate-score, and highscore groups, respectively. The model performance was good in four cohorts (AUROC, 0.73–0.75) but poor in one cohort (AUROC, 0.56). In one cohort with poor performance, attending physicians primarily controlled CRRT prescription and discontinuation, while in the other four cohorts, nephrologists determined all important steps in CRRT operation, including screening for CRRT discontinuation. Conclusion: The overall performance of our prediction model using four simple variables for successful discontinuation of CRRT was good, except for one cohort where nephrologists did not actively engage in CRRT operation. These results suggest the need for active engagement of nephrologists and protocolized management for CRRT discontinuation.
9.Evaluating the Efficacy and Safety of Hemofence (Thorombin Cross-Linked Sodium Hyaluronate Gel Matrix) in Hemostasis for Intractable Exudative Bleeding in Spinal Surgery: A Multicenter, Randomized, Phase III Clinical Trial
Sungjae AN ; Woo-Keun KWON ; Il CHOI ; Jang-Bo LEE ; Joohyun KIM ; Junseok W. HUR
Neurospine 2024;21(3):1004-1013
Objective:
To demonstrate the noninferiority of the novel hemostatic agent, Hemofence (BMI Korea Co., Ltd., thrombin cross-linked sodium hyaluronate gel matrix) compared to the established agent, Floseal Hemostatic Matrix (Baxter, thrombin-gelatin matrix) in achieving hemostasis for spinal surgeries, with secondary objectives to assess additional efficacy and safety.
Methods:
This clinical trial was a multicenter, randomized, subject-blinded, active-controlled, parallel-group, phase 3 study. Investigational drugs were administered to the first and second bleeding sites of each participant (or only to the first site if a second site was absent), evaluating hemostasis success rate within 10 minutes and the time to achieve hemostasis. Subsequent visits were conducted for safety assessments. For noninferiority test, a 97.5% one-sided confidence interval (CI) was used; the test group was deemed noninferior if the lower limit exceeded -10%.
Results:
This trial showed a 97.10% success rate in the test group and 96.05% in the control group for primary efficacy. The 95% CI (-4.90% to 7.44%) confirmed the test drug’s noninferiority. Time to hemostasis showed no significant difference between groups. All adverse events, adverse drug reactions, and serious adverse events were statistically similar between groups (p=1.000, p=0.243, and p=0.966, respectively).
Conclusion
A novel hemostatic agent, Hemofence, demonstrated an efficacy and safety profile comparable to that of Floseal.
10.A Familial Case Presented with Various Clinical Manifestations Caused by OPA1 Mutation
Jun Ho LEE ; Jaeho KANG ; Yeoung deok SEO ; Jeong Ik EUN ; Hyunyoung HWANG ; Sungyeong RYU ; Junseok JANG ; Jinse PARK
Journal of the Korean Neurological Association 2023;41(1):60-63
Ataxia is presented by various etiologies, including acquired, genetic and degenerative disorders. Although hereditary ataxia is suspected when typical symptom of ataxia with concurrent is identified, it is sometimes difficult to diagnose hereditary ataxia without genetic test. Clinically, next generation sequencing technology has been developed and widely used for diagnosis of hereditary disease. Hereby, we experienced cases of genetically confirmed OPA1 mutation, which are presented with various clinical manifestations including ataxic gait and decreased visual acuity.

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