1.High-Dose Rifampicin for 3 Months after Culture Conversion for Drug-Susceptible Pulmonary Tuberculosis
Nakwon KWAK ; Joong-Yub KIM ; Hyung-Jun KIM ; Byoung-Soo KWON ; Jae Ho LEE ; Jeongha MOK ; Yong-Soo KWON ; Young Ae KANG ; Youngmok PARK ; Ji Yeon LEE ; Doosoo JEON ; Jung-Kyu LEE ; Jeong Seong YANG ; Jake WHANG ; Kyung Jong KIM ; Young Ran KIM ; Minkyoung CHEON ; Jiwon PARK ; Seokyung HAHN ; Jae-Joon YIM
Tuberculosis and Respiratory Diseases 2025;88(1):170-180
Background:
This study aimed to determine whether a shorter high-dose rifampicin regimen is non-inferior to the standard 6-month tuberculosis regimen.
Methods:
This multicenter, randomized, open-label, non-inferiority trial enrolled participants with respiratory specimen positivity by Xpert MTB/RIF assay or Mycobacterium tuberculosis culture without rifampicin-resistance. Participants were randomized at 1:1 to the investigational or control group. The investigational group received high-dose rifampicin (30 mg/kg/day), isoniazid, and pyrazinamide until culture conversion, followed by high-dose rifampicin and isoniazid for 12 weeks. The control group received the standard 6-month regimen. The primary outcome was the rate of unfavorable outcomes at 18 months post-randomization. The non-inferiority margin was set at <6% difference in unfavorable outcomes rates. The study is registered with ClinicalTrials.gov (NCT04485156)
Results:
Between 4 November 2020 and 3 January 2022, 76 participants were enrolled. Of these, 58 were included in the modified intention-to-treat analysis. Unfavorable outcomes occurred in 10 (31.3%) of 32 in the control group and 10 (38.5%) of 26 in the investigational group. The difference was 7.2% (95% confidence interval, ∞ to 31.9%), failing to prove non-inferiority. Serious adverse events and grade 3 or higher adverse events did not differ between the groups.
Conclusion
The shorter high-dose rifampicin regimen failed to demonstrate non-inferiority but had an acceptable safety profile.
2.High-Dose Rifampicin for 3 Months after Culture Conversion for Drug-Susceptible Pulmonary Tuberculosis
Nakwon KWAK ; Joong-Yub KIM ; Hyung-Jun KIM ; Byoung-Soo KWON ; Jae Ho LEE ; Jeongha MOK ; Yong-Soo KWON ; Young Ae KANG ; Youngmok PARK ; Ji Yeon LEE ; Doosoo JEON ; Jung-Kyu LEE ; Jeong Seong YANG ; Jake WHANG ; Kyung Jong KIM ; Young Ran KIM ; Minkyoung CHEON ; Jiwon PARK ; Seokyung HAHN ; Jae-Joon YIM
Tuberculosis and Respiratory Diseases 2025;88(1):170-180
Background:
This study aimed to determine whether a shorter high-dose rifampicin regimen is non-inferior to the standard 6-month tuberculosis regimen.
Methods:
This multicenter, randomized, open-label, non-inferiority trial enrolled participants with respiratory specimen positivity by Xpert MTB/RIF assay or Mycobacterium tuberculosis culture without rifampicin-resistance. Participants were randomized at 1:1 to the investigational or control group. The investigational group received high-dose rifampicin (30 mg/kg/day), isoniazid, and pyrazinamide until culture conversion, followed by high-dose rifampicin and isoniazid for 12 weeks. The control group received the standard 6-month regimen. The primary outcome was the rate of unfavorable outcomes at 18 months post-randomization. The non-inferiority margin was set at <6% difference in unfavorable outcomes rates. The study is registered with ClinicalTrials.gov (NCT04485156)
Results:
Between 4 November 2020 and 3 January 2022, 76 participants were enrolled. Of these, 58 were included in the modified intention-to-treat analysis. Unfavorable outcomes occurred in 10 (31.3%) of 32 in the control group and 10 (38.5%) of 26 in the investigational group. The difference was 7.2% (95% confidence interval, ∞ to 31.9%), failing to prove non-inferiority. Serious adverse events and grade 3 or higher adverse events did not differ between the groups.
Conclusion
The shorter high-dose rifampicin regimen failed to demonstrate non-inferiority but had an acceptable safety profile.
3.High-Dose Rifampicin for 3 Months after Culture Conversion for Drug-Susceptible Pulmonary Tuberculosis
Nakwon KWAK ; Joong-Yub KIM ; Hyung-Jun KIM ; Byoung-Soo KWON ; Jae Ho LEE ; Jeongha MOK ; Yong-Soo KWON ; Young Ae KANG ; Youngmok PARK ; Ji Yeon LEE ; Doosoo JEON ; Jung-Kyu LEE ; Jeong Seong YANG ; Jake WHANG ; Kyung Jong KIM ; Young Ran KIM ; Minkyoung CHEON ; Jiwon PARK ; Seokyung HAHN ; Jae-Joon YIM
Tuberculosis and Respiratory Diseases 2025;88(1):170-180
Background:
This study aimed to determine whether a shorter high-dose rifampicin regimen is non-inferior to the standard 6-month tuberculosis regimen.
Methods:
This multicenter, randomized, open-label, non-inferiority trial enrolled participants with respiratory specimen positivity by Xpert MTB/RIF assay or Mycobacterium tuberculosis culture without rifampicin-resistance. Participants were randomized at 1:1 to the investigational or control group. The investigational group received high-dose rifampicin (30 mg/kg/day), isoniazid, and pyrazinamide until culture conversion, followed by high-dose rifampicin and isoniazid for 12 weeks. The control group received the standard 6-month regimen. The primary outcome was the rate of unfavorable outcomes at 18 months post-randomization. The non-inferiority margin was set at <6% difference in unfavorable outcomes rates. The study is registered with ClinicalTrials.gov (NCT04485156)
Results:
Between 4 November 2020 and 3 January 2022, 76 participants were enrolled. Of these, 58 were included in the modified intention-to-treat analysis. Unfavorable outcomes occurred in 10 (31.3%) of 32 in the control group and 10 (38.5%) of 26 in the investigational group. The difference was 7.2% (95% confidence interval, ∞ to 31.9%), failing to prove non-inferiority. Serious adverse events and grade 3 or higher adverse events did not differ between the groups.
Conclusion
The shorter high-dose rifampicin regimen failed to demonstrate non-inferiority but had an acceptable safety profile.
4.High-Dose Rifampicin for 3 Months after Culture Conversion for Drug-Susceptible Pulmonary Tuberculosis
Nakwon KWAK ; Joong-Yub KIM ; Hyung-Jun KIM ; Byoung-Soo KWON ; Jae Ho LEE ; Jeongha MOK ; Yong-Soo KWON ; Young Ae KANG ; Youngmok PARK ; Ji Yeon LEE ; Doosoo JEON ; Jung-Kyu LEE ; Jeong Seong YANG ; Jake WHANG ; Kyung Jong KIM ; Young Ran KIM ; Minkyoung CHEON ; Jiwon PARK ; Seokyung HAHN ; Jae-Joon YIM
Tuberculosis and Respiratory Diseases 2025;88(1):170-180
Background:
This study aimed to determine whether a shorter high-dose rifampicin regimen is non-inferior to the standard 6-month tuberculosis regimen.
Methods:
This multicenter, randomized, open-label, non-inferiority trial enrolled participants with respiratory specimen positivity by Xpert MTB/RIF assay or Mycobacterium tuberculosis culture without rifampicin-resistance. Participants were randomized at 1:1 to the investigational or control group. The investigational group received high-dose rifampicin (30 mg/kg/day), isoniazid, and pyrazinamide until culture conversion, followed by high-dose rifampicin and isoniazid for 12 weeks. The control group received the standard 6-month regimen. The primary outcome was the rate of unfavorable outcomes at 18 months post-randomization. The non-inferiority margin was set at <6% difference in unfavorable outcomes rates. The study is registered with ClinicalTrials.gov (NCT04485156)
Results:
Between 4 November 2020 and 3 January 2022, 76 participants were enrolled. Of these, 58 were included in the modified intention-to-treat analysis. Unfavorable outcomes occurred in 10 (31.3%) of 32 in the control group and 10 (38.5%) of 26 in the investigational group. The difference was 7.2% (95% confidence interval, ∞ to 31.9%), failing to prove non-inferiority. Serious adverse events and grade 3 or higher adverse events did not differ between the groups.
Conclusion
The shorter high-dose rifampicin regimen failed to demonstrate non-inferiority but had an acceptable safety profile.
5.High-Dose Rifampicin for 3 Months after Culture Conversion for Drug-Susceptible Pulmonary Tuberculosis
Nakwon KWAK ; Joong-Yub KIM ; Hyung-Jun KIM ; Byoung-Soo KWON ; Jae Ho LEE ; Jeongha MOK ; Yong-Soo KWON ; Young Ae KANG ; Youngmok PARK ; Ji Yeon LEE ; Doosoo JEON ; Jung-Kyu LEE ; Jeong Seong YANG ; Jake WHANG ; Kyung Jong KIM ; Young Ran KIM ; Minkyoung CHEON ; Jiwon PARK ; Seokyung HAHN ; Jae-Joon YIM
Tuberculosis and Respiratory Diseases 2025;88(1):170-180
Background:
This study aimed to determine whether a shorter high-dose rifampicin regimen is non-inferior to the standard 6-month tuberculosis regimen.
Methods:
This multicenter, randomized, open-label, non-inferiority trial enrolled participants with respiratory specimen positivity by Xpert MTB/RIF assay or Mycobacterium tuberculosis culture without rifampicin-resistance. Participants were randomized at 1:1 to the investigational or control group. The investigational group received high-dose rifampicin (30 mg/kg/day), isoniazid, and pyrazinamide until culture conversion, followed by high-dose rifampicin and isoniazid for 12 weeks. The control group received the standard 6-month regimen. The primary outcome was the rate of unfavorable outcomes at 18 months post-randomization. The non-inferiority margin was set at <6% difference in unfavorable outcomes rates. The study is registered with ClinicalTrials.gov (NCT04485156)
Results:
Between 4 November 2020 and 3 January 2022, 76 participants were enrolled. Of these, 58 were included in the modified intention-to-treat analysis. Unfavorable outcomes occurred in 10 (31.3%) of 32 in the control group and 10 (38.5%) of 26 in the investigational group. The difference was 7.2% (95% confidence interval, ∞ to 31.9%), failing to prove non-inferiority. Serious adverse events and grade 3 or higher adverse events did not differ between the groups.
Conclusion
The shorter high-dose rifampicin regimen failed to demonstrate non-inferiority but had an acceptable safety profile.
6.Evaluation of the Efficacy and Safety of DW1903 in Patients with Gastritis: A Randomized, Double-Blind, Noninferiority, Multicenter, Phase 3 study
Jie-Hyun KIM ; Hwoon-Yong JUNG ; In Kyung YOO ; Seon-Young PARK ; Jae Gyu KIM ; Jae Kyu SUNG ; Jin Seok JANG ; Gab Jin CHEON ; Kyoung Oh KIM ; Tae Oh KIM ; Soo Teik LEE ; Kwang Bum CHO ; Hoon Jai CHUN ; Jong-Jae PARK ; Moo In PARK ; Jae-Young JANG ; Seong Woo JEON ; Jin Woong CHO ; Dae Hwan KANG ; Gwang Ha KIM ; Jae J. KIM ; Sang Gyun KIM ; Nayoung KIM ; Yong Chan LEE ; Su Jin HONG ; Hyun-Soo KIM ; Sora LEE ; Sang Woo LEE
Gut and Liver 2024;18(1):70-76
Background/Aims:
H2 receptor antagonists (H2RA) have been used to treat gastritis by inhibiting gastric acid. Proton pump inhibitors (PPIs) are more potent acid suppressants than H2RA.However, the efficacy and safety of low-dose PPI for treating gastritis remain unclear. The aim was to investigate the efficacy and safety of low-dose PPI for treating gastritis.
Methods:
A double-blind, noninferiority, multicenter, phase 3 clinical trial randomly assigned 476 patients with endoscopic erosive gastritis to a group using esomeprazole 10 mg (DW1903) daily and a group using famotidine 20 mg (DW1903R1) daily for 2 weeks. The full-analysis set included 319 patients (DW1903, n=159; DW1903R1, n=160) and the per-protocol set included 298 patients (DW1903, n=147; DW1903R1, n=151). The primary endpoint (erosion improvement rate) and secondary endpoint (erosion and edema cure rates, improvement rates of hemorrhage, erythema, and symptoms) were assessed after the treatment. Adverse events were compared.
Results:
According to the full-analysis set, the erosion improvement rates in the DW1903 and DW1903R1 groups were 59.8% and 58.8%, respectively. According to the per-protocol analysis, the erosion improvement rates in the DW1903 and DW1903R1 groups were 61.9% and 59.6%, respectively. Secondary endpoints were not significantly different between two groups except that the hemorrhagic improvement rate was higher in DW1903 with statistical tendency. The number of adverse events were not statistically different.
Conclusions
DW1903 of a low-dose PPI was not inferior to DW1903R1 of H2RA. Thus, lowdose PPI can be a novel option for treating gastritis (ClinicalTrials.gov Identifier: NCT05163756).
7.Actual sweating as a significant predict factor of acute coronary syndrome
Suk Ju YOUN ; Woo Ik CHOI ; Sang Chan JIN ; Jae Cheon JEON ; Tae Kwon KIM ; In-Cheol KIM ; Sang Hun LEE
Journal of the Korean Society of Emergency Medicine 2022;33(2):156-163
Objective:
This study aims to identify significant factors such as sweat that can be used as important predictors of acute coronary syndrome (ACS) in patients visiting the emergency department (ED) complaining of chest pain.
Methods:
This observational, retrospective, registry-based study conducted from May 2020 to November 2020 evaluated patients who visited the ED due to chest pain. Parameters associated with ACS were investigated, and the clinical characteristics and symptoms were analyzed.
Results:
A total of 230 patients visited the ED with chest pain. Of these, 94 (40.9%) were diagnosed with ACS. Univariate regression analysis showed that facial sweating (odds ratio [OR], 2.624; 95% confidence interval [CI], 1.241-5.549; P=0.012) and drench sweating (OR, 3.346; 95% CI, 1.602-6.991; P=0.001) were associated with ACS. Hence, we classified these patients as the actual sweating group. However, the sweaty feeling self-reported by patients with no visible sweat did not correlate with ACS. Multivariate logistic regression analysis showed that age (OR, 1.043; 95% CI, 1.016-1.071; P=0.002), quantum of smoking (OR, 1.023; 95% CI, 1.005-1.041; P=0.010), diastolic blood pressure (OR, 1.028; 95% CI, 1.004-1.049; P=0.009), squeezing chest pain (OR, 2.128; 95% CI, 1.000-4.531; P=0.050), and actual sweating (OR, 2.300; 95% CI, 1.209-4.374; P=0.011) were significantly associated with ACS.
Conclusion
Age, the quantum of smoking, diastolic blood pressure, squeezing chest pain, and actual sweating are useful predictors for ACS diagnosis. Unlike actual sweating, patient-reported sweating is not significantly related to the diagnosis of ACS. The results of this study will be beneficial in predicting ACS to ensure early and emergency medical care in the pre-hospital setting.
8.Correlation between the size of the ureter stone and the neutrophil-lymphocyte ratio, platelet lymphocyte ratio, and C-reactive protein in patients with ureter stone visiting the emergency department
Won Dong JEONG ; Woo-Ik CHOI ; Wonho JUNG ; Dong Jin PARK ; Young Jin SEO ; Kyung Seop LEE ; Jae Cheon JEON
Journal of the Korean Society of Emergency Medicine 2021;32(5):394-399
Objective:
The size and location of ureter stones are important factors in their spontaneous passage. We compared the clinical characteristics and neutrophil-lymphocyte ratio (NLR), platelet lymphocyte ratio (PLR), and C-reactive protein (CRP) of patients who visited the emergency department with ureter stones of ≥5 mm and <5 mm in size.
Methods:
We retrospectively reviewed 699 patients who visited the emergency department of two medical centers from January 2017 to December 2019. We compared microscopic hematuria, pyuria, NLR, PLR, CRP, the grade of hydronephrosis, and the location of ureteral calculi between the two groups.
Results:
There were 419 patients with ureter stones less than 5 mm and 280 patients with stones more than 5 mm in size. NLR was 2.82 (1.44-4.73) and 3.12 (1.94-5.75) in patients with stones <5 mm and ≥5 mm, respectively (P=0.001). PLR was 117.2 (88.2-164.9) and 136.0 (98.9-199.7) in patients with stones <5 mm and ≥5 mm, respectively (P=0.001). CRP was 0.29 (0.29-0.29) and 0.29 (0.29-1.04) in patients with stones <5 mm and ≥5 mm, respectively (P<0.001). The proportion of microscopic hematuria was 84.7% and 76.4% in patients with stones <5 mm and ≥5 mm, respectively (P=0.006). The proportion of pyuria was 20.5% and 41.8% in patients with stones <5 mm and ≥5 mm, respectively (P=0.01).
Conclusion
In patients with ureter stones ≥5 mm, CRP, NLR, and PLR were significantly higher than patients with ureter stones <5 mm. However, further studies are needed before using these indicators to make clinical decisions regarding ureteral stone management.
9.The Fever in the Emergency Department: before Versus after COVID-19
Donguk YU ; Jae Cheon JEON ; Yaerim KIM ; Uijun PARK ; Keun Tae KIM
Keimyung Medical Journal 2021;40(2):108-113
A high body temperature, i.e. fever, is a crucial vital sign, and suggests the patient’s infection or inflammation. COVID-19 has changed the lifestyle, and led to the changes in medical use behavior of febrile patients. We investigated the change in etiologies of fever in the emergency department (ED) before and after COVID-19. The medical records of patients with fever who visited the ED of a university hospital before and after the outbreak of COVID-19 in Daegu metropolitan city, South Korea. The cause of fever and its classification were carefully decided and established by agreement through a discussion among board-certified clinicians in emergency medicine, neurology, general surgery, and internal medicine. The etiology of fever and its prevalence in ED were compared between before and after COVID-19. A total of 3,041 patients with fever (> 37.7°C) in the ED were investigated, with 1,400 men (46.0%). Their mean age was 55.88 ± 20.59, and the average number of patients with fever in ED was 8.16 ± 3.94 per a day. The most common etiology before COVID-19 was respiratory system infection (n = 535, 30.5%), followed by gastrointestinal (n = 313, 17.8%) and urinary tract infection (n = 209, 11.9%). However, after COVID-19, gastrointestinal cause became the most common (n = 247, 27.3%), followed by respiratory system (n = 126, 13.9%) and urinary tract infection (n = 102, 11.3%). There has been paradigm-shifting in fever etiology in the emergency department. It is necessary to cope with the changed fever etiology in the COVID-19 era.
10.The Etiologies of Altered Level of Consciousness in the Emergency Department: Before versus after Coronavirus Disease-19
Dong Hwan KIM ; Jae Cheon JEON ; In-Cheol KIM ; Yaerim KIM ; Yong Won CHO ; Keun Tae KIM
Journal of the Korean Neurological Association 2021;39(3):141-149
Background:
Altered level of consciousness (ALC) is a challenging condition in the emergency department (ED). We evaluated the clinical characteristics, causes, and prognosis of adult patients presenting with ALC at an ED of a university hospital.
Methods:
The medical records of patients with ALC who visited the ED of a university hospital from February 2019 to November 2020 were reviewed to compare before and after the outbreak of coronavirus disease-19 (COVID-19) in Daegu, South Korea. The cause of ALC, its classification, the patients’ destinations, and prognosis were carefully decided and compared.
Results:
A total of 1,851 patients with ALC in ED consisted of 1,068 before COVID-19 (BC; to February 17th, 2020) and 783 after COVID-19 (AC; from February 18th, 2020) were investigated. The all-time leading cause of ALC in ED was systemic infection (29.2% in BC, 25.0% in AC), followed by metabolic cause (21.0%) in BC and stroke (18.4%) in AC. Extra-cerebral etiologies of ALC were 1,206 (65.1%). The overall mortality of ALC in ED was 12.3%, consisting of 11.0% in BC and 14.2% in AC. During the daytime (07:00 to 18:59), patients in overall 1,179 patients (63.7%) with ALC visited ED, consisted of 665 (62.3%) in BC and 514 (65.5%) in AC.
Conclusions
This study demonstrated the extra-cerebral etiologies as the major causes of ALC in the ED. And there have been shifts in the etiology of ALC in ED.

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