1.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).
2.Changes in Shoulder Trauma during the COVID-19 Pandemic: A South Korean Survey
Su Cheol KIM ; Jae Chul YOO ; Jong Hun PARK ; Hashem BUKHARY ; Yang Seon CHOI ; Kyu Tae KANG ; Chul-Ho KIM
Clinics in Orthopedic Surgery 2023;15(2):300-307
Background:
This study aimed to investigate the changes in the incidence of shoulder trauma and surgery 1 year after the outbreak of coronavirus disease 2019 (COVID-19) with social restriction compared with 1 year before the pandemic.
Methods:
Patients managed in our orthopedic trauma center between February 18, 2020, and February 17, 2021 (COVID-19 period) for shoulder trauma were compared with patients managed for the same duration a year ago (non–COVID-19 period; February 18, 2019, to February 17, 2020). The incidence of shoulder trauma, surgery, and mechanism of injury were compared between these periods.
Results:
The total number of shoulder trauma cases was lower in the COVID-19 period than in the non–COVID-19 period, although the difference was not significant (160 vs. 180 cases, p = 0.278). In addition, traumatic shoulder surgeries decreased during the COVID-19 period (57 vs. 69 cases, p = 0.285). The incidence of shoulder trauma according to four diagnostic classifications (contusion, sprain/subluxation, fracture, and dislocation) and fracture/dislocation types did not differ between the periods. During the COVID-19 period, accidental falls outdoors (45 vs. 67, p = 0.038) and sports-related injuries (15 vs. 29, p = 0.035) significantly decreased, but accidental falls at home (52 vs. 37, p = 0.112) increased compared with those during the non–COVID-19 period, although the difference was not significant. The monthly incidence of shoulder trauma decreased 2 months after the first outbreak (significant in March, p = 0.019), then steadily increased and significantly decreased during the second outbreak (August, p = 0.012).However, the third outbreak (December, p = 0.077) had little effect on the incidence of shoulder trauma. The number of monthly traumatic shoulder surgeries showed a similar pattern to the monthly incidence of shoulder trauma.
Conclusions
During the COVID-19 pandemic, annual shoulder trauma cases and surgeries decreased compared to those in the non–COVID-19 period, even though the difference was insignificant. The incidence of shoulder trauma and surgery was significantly reduced in the early COVID-19 period; however, the effect of the pandemic on orthopedic trauma practice was minimal after approximately half a year. Decreases in falls outdoors and sports-related injuries, but an increase in falls at home, were observed during the COVID-19 pandemic.
3.Erratum: Correction of Affiliations in the Article “Establishment of a Nationwide Korean Imaging Cohort of Coronavirus Disease 2019”
Soon Ho YOON ; Soo-Youn HAM ; Bo Da NAM ; Kum Ju CHAE ; Dabee LEE ; Jin Young YOO ; So Hyeon BAK ; Jin Young KIM ; Jin Hwan KIM ; Ki Beom KIM ; Jung Im JUNG ; Jae-Kwang LIM ; Jong Eun LEE ; Myung Jin CHUNG ; Young Kyung LEE ; Young Seon KIM ; Ji Eun JO ; Sang Min LEE ; Woocheol KWON ; Chang Min PARK ; Yun-Hyeon KIM ; Yeon Joo JEONG
Journal of Korean Medical Science 2023;38(34):e298-
4.Korean Society of Nephrology 2022 Recommendations on controversial issues in diagnosis and management ofhyponatremia
Yeonhee LEE ; Kyung Don YOO ; Seon Ha BAEK ; Yang Gyun KIM ; Hyo Jin KIM ; Ji Young RYU ; Jin Hyuk PAEK ; Sang Heon SUH ; Se Won OH ; Jeonghwan LEE ; Jong Hyun JHEE ; Jin-Soon SUH ; Eun Mi YANG ; Young Ho PARK ; Yae Lim KIM ; Miyoung CHOI ; Kook-Hwan OH ; Sejoong KIM ;
Kidney Research and Clinical Practice 2022;41(4):393-411
The Korean Society for Electrolyte and Blood Pressure Research, in collaboration with the Korean Society of Nephrology, has published a clinical practice guideline (CPG) document for hyponatremia treatment. The document is based on an extensive evidence-based review of the diagnosis, evaluation, and treatment of hyponatremia with the multidisciplinary participation of representative experts in hyponatremia with methodologist support for guideline development. This CPG consists of 12 recommendations (two for diagnosis, eight for treatment, and two for special situations) based on eight detailed topics and nine key questions. Each recommendation begins with statements graded by the strength of the recommendations and the quality of the evidence. Each statement is followed by rationale supporting the recommendations. The committee issued conditional recommendations in favor of rapid intermittent bolus administration of hypertonic saline in severe hyponatremia, the use of vasopressin receptor antagonists in heart failure with hypervolemic hyponatremia, and syndrome of inappropriate antidiuresis with moderate to severe hyponatremia, the individualization of desmopressin use, and strong recommendation on the administration of isotonic fluids as maintenance fluid therapy in hospitalized pediatric patients. We hope that this CPG will provide useful recommendations in practice, with the aim of providing clinical support for shared decision-making to improve patient outcomes.
5.Korean Society of Nephrology 2022 recommendations on controversial issues in diagnosis and management of hyponatremia
Yeonhee LEE ; Kyung Don YOO ; Seon Ha BAEK ; Yang Gyun KIM ; Hyo Jin KIM ; Ji Young RYU ; Jin Hyuk PAEK ; Sang Heon SUH ; Se Won OH ; Jeonghwan LEE ; Jong Hyun JHEE ; Jin-Soon SUH ; Eun Mi YANG ; Young Ho PARK ; Yae Lim KIM ; Miyoung CHOI ; Kook-Hwan OH ; Sejoong KIM ;
The Korean Journal of Internal Medicine 2022;37(6):1120-1137
The Korean Society for Electrolyte and Blood Pressure Research, in collaboration with the Korean Society of Nephrology, has published a clinical practice guideline (CPG) document for hyponatremia treatment. The document is based on an extensive evidence-based review of the diagnosis, evaluation, and treatment of hyponatremia with the multidisciplinary participation of representative experts in hyponatremia with methodologist support for guideline development. This CPG consists of 12 recommendations (two for diagnosis, eight for treatment, and two for special situations) based on eight detailed topics and nine key questions. Each recommendation begins with statements graded by the strength of the recommendations and the quality of the evidence. Each statement is followed by rationale supporting the recommendations. The committee issued conditional recommendations in favor of rapid intermittent bolus administration of hypertonic saline in severe hyponatremia, the use of vasopressin receptor antagonists in heart failure with hypervolemic hyponatremia, and syndrome of inappropriate antidiuresis with moderate to severe hyponatremia, the individualization of desmopressin use, and strong recommendation on the administration of isotonic fluids as maintenance fluid therapy in hospitalized pediatric patients. We hope that this CPG will provide useful recommendations in practice, with the aim of providing clinical support for shared decision-making to improve patient outcomes.
6.Real-life experience of ledipasvir and sofosbuvir for HCV infected Korean patients: a multicenter cohort study
Soon Kyu LEE ; Sung Won LEE ; Hae Lim LEE ; Hee Yeon KIM ; Chang Wook KIM ; Do Seon SONG ; U Im CHANG ; Jin Mo YANG ; Sun Hong YOO ; Jung Hyun KWON ; Soon Woo NAM ; Seok-Hwan KIM ; Myeong Jun SONG ; Jaejun LEE ; Hyun YANG ; Si Hyun BAE ; Ji Won HAN ; Heechul NAM ; Pil Soo SUNG ; Jeong Won JANG ; Jong Young CHOI ; Seung Kew YOON
The Korean Journal of Internal Medicine 2022;37(6):1167-1175
Background/Aims:
To evaluate the efficacy and safety of ledipasvir/sofosbuvir (LDV/SOF) therapy in hepatitis C virus (HCV)-infected Korean patients in a real clinical setting.
Methods:
A total of 273 patients who received LDV/SOF therapy between May 2016 and February 2021 were consecutively enrolled and analyzed. A per-protocol analysis was performed to evaluate the virologic response.
Results:
Seventy-five percent were infected with genotype 1, and 25% were infected with genotype 2. A hundred eightyone (66.3%) patients had chronic hepatitis, 74 (27.1%) had compensated cirrhosis, eight (2.9%) had decompensated cirrhosis, and 10 (3.7%) had undergone liver transplantation. Undetectable HCV RNA at week 4 was achieved in 90.2% (231/256) of patients, 99.2% (250/252) achieved the end of treatment response, and 98.1% (202/206) achieved sustained virologic response at 12 weeks post-treatment (SVR12). According to liver function, the SVR12 rates were 99.3% (135/136) in chronic hepatitis, 96.4% (53/55) in compensated cirrhosis, and 100% (6/6) in decompensated cirrhosis. The SVR12 rates according to the genotype were 98.2% (167/170) for genotype 1 and 97.2% (35/36) for genotype 2. An 8-week LDV/SOF treatment in treatment-naïve chronic hepatitis patients with HCV RNA < 6,000,000 IU/mL at baseline resulted in 100% (23/23) SVR12 rates. Overall, LDV/SOF was tolerated well, with a 0.7% (2/273) discontinuation rate due to adverse events that were unrelated to LDV/SOF.
Conclusions
LDV/SOF is effective and safe for treating HCV-infected Korean patients with high SVR12 rates.
7.Safety and effectiveness of direct-acting antivirals in patients with chronic hepatitis C and chronic kidney disease
Ji Eun RYU ; Myeong Jun SONG ; Seok-Hwan KIM ; Jung Hyun KWON ; Sun Hong YOO ; Soon Woo NAM ; Hee Chul NAM ; Hee Yeon KIM ; Chang Wook KIM ; Hyun YANG ; Si Hyun BAE ; Do Seon SONG ; U Im CHANG ; Jin Mo YANG ; Sung Won LEE ; Hae Lim LEE ; Soon Kyu LEE ; Pil Soo SUNG ; Jeong Won JANG ; Jong Young CHOI ; Seung Kew YOON
The Korean Journal of Internal Medicine 2022;37(5):958-968
Background/Aims:
To evaluate the effectiveness and safety of direct acting antivirals (DAAs) available in chronic kidney disease (CKD) patients with hepatitis C virus (HCV) infection in Korea.
Methods:
In a retrospective, multicenter cohort study, 362 patients were enrolled from 2015 to 2019. The effectiveness and safety of DAAs including glecaprevir/pibrentasvir, sofosubvir/ribavirin, ledipasvir/sofosbuvir, and daclatasvir/asunaprevir were analyzed for patients according to CKD stage. We evaluated sustained virologic response at week 12 after treatment (SVR12) as primary endpoint. The effectiveness and safety were also evaluated according to CKD stage.
Results:
Among 362 patients, 307 patients completed DAAs treatment and follow-up period after end of treatment. The subjects comprised 87 patients (62 with CKD stage 3 and 25 with CKD stage (4–5), of whom 22 were undergoing hemodialysis). HCV patients with CKD stage 1 and 2 (estimated glomerular filtration rate [eGFR] ≥ 60 mL/min/1.73 m2) showed SVR12 of 97.2% and 95.4% respectively. SVR12 of CKD stage 3 and 4–5 (eGFR < 60 mL/min/1.73 m2) patients was 91.9% and 91.6% respectively. Patients undergoing hemodialysis achieved SVR12 (90.9%). Treatment failure of DAAs in stage 1, 2, 3, and 4–5 was 2.8%, 2.7%, 1.6%, and 4%. DAAs showed good safety profile and did not affect deterioration of renal function.
Conclusions
DAAs shows comparable SVR12 and safety in CKD patients (stage 3, 4, and 5) with HCV compared with patients with stage 1 and 2. The effectiveness and safety of DAAs may be related to the treatment duration. Therefore, it is important to select adequate regimens of DAAs and to increase treatment adherence.
8.Prediction of successful caudal epidural injection using color Doppler ultrasonography in the paramedian sagittal oblique view of the lumbosacral spine
Seon Woo YOO ; Min-Jong KI ; A Ram DOO ; Cheol Jong WOO ; Ye Sull KIM ; Ji-Seon SON
The Korean Journal of Pain 2021;34(3):339-345
Background:
Ultrasound-guided caudal epidural injection (CEI) is limited in that it cannot confirm drug distribution at the target site without fluoroscopy. We hypothesized that visualization of solution flow through the inter-laminar space of the lumbosacral spine using color Doppler ultrasound alone would allow for confirmation of drug distribution. Therefore, we aimed to prospectively evaluate the usefulness of this method by comparing the color Doppler image in the paramedian sagittal oblique view of the lumbosacral spine (LS-PSOV) with the distribution of the contrast medium observed during fluoroscopy.
Methods:
Sixty-five patients received a 10-mL CEI of solution containing contrast medium under ultrasound guidance. During injection, flow was observed in the LSPSOV using color Doppler ultrasonography, following which it was confirmed using fluoroscopy. The presence of contrast image at L5-S1 on fluoroscopy was defined as “successful CEI.” We then calculated prediction accuracy for successful CEI using color Doppler ultrasonography in the LS-PSOV. We also investigated the correlation between the distribution levels measured via color Doppler and fluoroscopy.
Results:
Prediction accuracy with color Doppler ultrasonography was 96.9%. The sensitivity, specificity, positive predictive value, and negative predictive value were 96.7%, 100%, 100%, and 60.0%, respectively. In 52 of 65 patients (80%), the highest level at which contrast image was observed was the same for both color Doppler ultrasonography and fluoroscopy.
Conclusions
Our findings demonstrate that color Doppler ultrasonography in the LS-PSOV is a new method for determining whether a drug solution reaches the lumbosacral region (i.e., the main target level) without the need for fluoroscopy.
9.Intracerebral Hemorrhage due to Thrombosis with Thrombocytopenia Syndrome after Vaccination against COVID-19: the First Fatal Case in Korea
Jae-Ki CHOI ; Sunghan KIM ; Seo Ree KIM ; Jong-Youl JIN ; Seon Woong CHOI ; Hoon KIM ; Jin-Hong YOO ; Ik Seong PARK ; Seong-Rim KIM
Journal of Korean Medical Science 2021;36(31):e223-
Vaccination with an adenoviral vector vaccine against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) can result in the rare development of thrombosis with thrombocytopenia mediated by platelet-activating antibodies against platelet factor 4 (PF4). This is a life-threating condition that may be accompanied by bleeding due to thrombocytopenia with thrombosis of the cerebral venous sinus or splanchnic vein. Herein, we describe the first fatal case of thrombosis with thrombocytopenia syndrome in Korea, presenting with intracranial hemorrhage caused by cerebral venous sinus thrombosis. A 33-year-old Korean man received the first dose of the ChAdOx1 nCoV-19 vaccination. He developed severe headache with vomiting 9 days after the vaccination. Twelve days after vaccination, he was admitted to the hospital with neurological symptoms and was diagnosed with cerebral venous sinus thrombosis, which was accompanied by intracranial hemorrhage.Thrombocytopenia and D-dimer elevation were observed, and the result of the PF4 enzymelinked immunosorbent assay antibody test was reported to be strongly positive. Despite intensive treatment, including intravenous immunoglobulin injection and endovascular mechanical thrombectomy, the patient died 19 days after vaccination. Physicians need to be aware of thrombosis with thrombocytopenia syndrome (TTS) in adenoviral vector-vaccinated patients. Endovascular mechanical thrombectomy might be a useful therapeutic option for the treatment of TTS with cerebral venous sinus thrombosis.
10.Influence of the Amount of Fresh Specimen on the Isolation of Tumor Mesenchymal Stem-Like Cells from High-Grade Glioma
Soon Haeng KONG ; Jihwan YOO ; Dongkyu LEE ; Sohyung MOON ; Kyoung Su SUNG ; So Hee PARK ; Jin-Kyoung SHIM ; Ran Joo CHOI ; Seon Jin YOON ; Ju Hyung MOON ; Eui-Hyun KIM ; Su Jae LEE ; Jong Hee CHANG ; Seok-Gu KANG
Yonsei Medical Journal 2021;62(10):936-942
Purpose:
A critical indicator of the overall survival of patients with high-grade glioma is the successful isolation of tumor mesenchymal stem-like cells (tMSLCs), which play important roles in glioma progression. However, attempts to isolate tMSLCs from surgical specimens have not always been successful, and the reasons for this remain unclear. Considering that the amount of surgical high-grade glioma specimens varies, we hypothesized that larger surgical specimens would be better for tMSLC isolation.
Materials and Methods:
We assessed 51 fresh, high-grade glioma specimens and divided them into two groups according to the success or failure of tMSLC isolation. The success of tMSLC isolation was confirmed by plastic adherence, presenting antigens, tri-lineage differentiation, and non-tumorigenicity. Differences in characteristics between the two groups were tested using independent two sample t-tests, chi-square tests, or Kaplan-Meier survival analysis.
Results:
The mean specimen weights of the groups differed from each other (tMSLC-negative group: 469.9±341.9 mg, tMSLC positive group: 546.7±618.9 mg), but the difference was not statistically significant. The optimal cut-off value of specimen weight was 180 mg, and the area under the curve value was 0.599.
Conclusion
Our results suggested a minimum criterion for specimen collection, and found that the specimen amount was not deeply related to tMSLC detection. Collectively, our findings imply that the ability to isolate tMSLCs is determined by factors other than the specimen amount.

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