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.Comparison of Short-Term Outcomes and Safety Profiles between Androgen Deprivation Therapy+Abiraterone/Prednisone and Androgen Deprivation Therapy+Docetaxel in Patients with De Novo Metastatic Hormone-Sensitive Prostate Cancer
Dong Jin PARK ; Tae Gyun KWON ; Jae Young PARK ; Jae Young JOUNG ; Hong Koo HA ; Seong Soo JEON ; Sung-Hoo HONG ; Sungchan PARK ; Seung Hwan LEE ; Jin Seon CHO ; Sung-Woo PARK ; Se Yun KWON ; Jung Ki JO ; Hong Seok PARK ; Sang-Cheol LEE ; Dong Deuk KWON ; Sun Il KIM ; Sang Hyun PARK ; Soodong KIM ; Chang Wook JEONG ; Cheol KWAK ; Seock Hwan CHOI ;
The World Journal of Men's Health 2024;42(3):620-629
Purpose:
This study aimed to compare the short-term outcomes and safety profiles of androgen-deprivation therapy (ADT)+abiraterone/prednisone with those of ADT+docetaxel in patients with de novo metastatic hormone-sensitive prostate cancer (mHSPC).
Materials and Methods:
A web-based database system was established to collect prospective cohort data for patients with mHSPC in Korea. From May 2019 to November 2022, 928 patients with mHSPC from 15 institutions were enrolled. Among these patients, data from 122 patients who received ADT+abiraterone/prednisone or ADT+docetaxel as the primary systemic treatment for mHSPC were collected. The patients were divided into two groups: ADT+abiraterone/prednisone group (n=102) and ADT+docetaxel group (n=20). We compared the demographic characteristics, medical histories, baseline cancer status, initial laboratory tests, metastatic burden, oncological outcomes for mHSPC, progression after mHSPC treatment, adverse effects, follow-up, and survival data between the two groups.
Results:
No significant differences in the demographic characteristics, medical histories, metastatic burden, and baseline cancer status were observed between the two groups. The ADT+abiraterone/prednisone group had a lower prostate-specific antigen (PSA) progression rate (7.8% vs. 30.0%; p=0.011) and lower systemic treatment discontinuation rate (22.5% vs. 45.0%; p=0.037). No significant differences in adverse effects, oncological outcomes, and total follow-up period were observed between the two groups.
Conclusions
ADT+abiraterone/prednisone had lower PSA progression and systemic treatment discontinuation rates than ADT+docetaxel. In conclusion, further studies involving larger, double-blinded randomized trials with extended follow-up periods are necessary.
3.Efficacy and Safety of Fexuprazan in Patients with Acute or Chronic Gastritis
Gwang Ha KIM ; Myung-Gyu CHOI ; Jin Il KIM ; Soo Teik LEE ; Hoon Jai CHUN ; Kook Lae LEE ; Suk Chei CHOI ; Jae-Young JANG ; Yong Chan LEE ; Jae Gyu KIM ; Ki Bae KIM ; Ki-Nam SHIM ; Chong Il SOHN ; Sung Kook KIM ; Sang Gyun KIM ; Jin Seok JANG ; Nayoung KIM ; Hwoon-Yong JUNG ; Hyojin PARK ; Kyu Chan HUH ; Kwang Jae LEE ; Su Jin HONG ; Song BAEK ; Jin Joo HAN ; Oh Young LEE
Gut and Liver 2023;17(6):884-893
Background/Aims:
Fexuprazan is a novel potassium-competitive acid blocker that could be of benefit to patients with gastric mucosal injury. The aim of this study was to assess the 2-week efficacy and safety of fexuprazan in patients with acute or chronic gastritis.
Methods:
In this study, 327 patients with acute or chronic gastritis who had one or more gastric erosions on endoscopy and subjective symptoms were randomized into three groups receiving fexuprazan 20 mg once a day (q.d.), fexuprazan 10 mg twice a day (b.i.d.), or placebo for 2 weeks. The posttreatment assessments were the primary endpoint (erosion improvement rate), secondary endpoints (cure rates of erosion and edema and improvement rates of redness, hemorrhage, and subjective symptoms), and drug-related adverse events.
Results:
Among the patients, 57.8% (59/102), 65.7% (67/102), and 40.6% (39/96) showed erosion improvement 2 weeks after receiving fexuprazan 20 mg q.d., fexuprazan 10 mg b.i.d., and placebo, respectively. Both fexuprazan 20 mg q.d. and 10 mg b.i.d. showed superior efficacy to the placebo (p=0.017 and p<0.001, respectively). Likewise, both fexuprazan 20 mg q.d. and 10 mg b.i.d. also showed higher erosion healing rates than the placebo (p=0.033 and p=0.010, respectively). No difference was noted in the edema healing rate and the improvement rates for redness, hemorrhage, and subjective symptoms between the fexuprazan and placebo groups.No significant difference was noted in the incidence of adverse drug reactions.
Conclusions
Fexuprazan 20 mg q.d. and 10 mg b.i.d. for 2 weeks showed therapeutic efficacy superior to that of placebo in patients with acute or chronic gastritis (ClinicalTrials.gov identifier NCT04341454).
4.Epidemiology of Staphylococcus aureus Bacteremia in Children at a Single Center from 2002 to 2016
Seonhee LIM ; Seok Gyun HA ; Hann TCHAH ; In Sang JEON ; Eell RYOO ; Dong Woo SON ; Hye Jung CHO ; Yong Han SUN ; Hyo Jung KIM ; Jung Min AHN ; Hye Kyung CHO
Pediatric Infection & Vaccine 2019;26(1):11-21
PURPOSE: We aimed to investigate the epidemiological characteristics of Staphylococcus aureus bacteremia in Korean children. METHODS: We retrospectively collected and analyzed data from the medical records of the patients with S. aureus bacteremia ≤18 years of age in Gil Medical Center from 2002 to 2016. RESULTS: A total of 212 SAB cases were detected. The annual incidence of SAB from 2002 to 2016 ranged from 0.77 to 1.95 per 1,000 patients hospitalized. The neonate group (<28 days of age) and the pediatric group (28–18 years of age) were 51.4% (n=109) and 48.6% (n=103), respectively. According to the origin of infection, there were 93 cases (43.9%) of community-associated (CA)-SAB and 119 cases (56.1%) of healthcare-associated (HA)-SAB. The rates of HA-SAB among the neonate group and among the pediatric group were 64.2% and 47.6%, respectively (P=0.015). There was no difference in complications between CA-SAB and HA-SAB, but mortality was higher in HA-SAB. The proportion of methicillin-resistance S. aureus (MRSA) was the highest in neonates (88.1%), decreased with age, and was 36.4%–37.5% among children aged ≥5 years. The MRSA proportion was 72.2%, showing no consistent trend over the period. CONCLUSIONS: The annual incidence of SAB and the proportion of MRSA in SAB remained constant in the recent 15 years in children. Judicious decision of antimicrobial agents for treatment considering the patient's age and the origin of infection is necessary.
Anti-Infective Agents
;
Bacteremia
;
Child
;
Epidemiology
;
Humans
;
Incidence
;
Infant
;
Infant, Newborn
;
Medical Records
;
Methicillin-Resistant Staphylococcus aureus
;
Mortality
;
Retrospective Studies
;
Staphylococcus aureus
;
Staphylococcus
5.Selection Criteria for Active Surveillance of Patients with Prostate Cancer in Korea: A Multicenter Analysis of Pathology after Radical Prostatectomy
Chang Wook JEONG ; Sung Kyu HONG ; Seok Soo BYUN ; Seong Soo JEON ; Seong Il SEO ; Hyun Moo LEE ; Hanjong AHN ; Dong Deuk KWON ; Hong Koo HA ; Tae Gyun KWON ; Jae Seung CHUNG ; Cheol KWAK ; Hyung Jin KIM
Cancer Research and Treatment 2018;50(1):265-274
PURPOSE: Korean patients with prostate cancer (PC) typically present with a more aggressive disease than patients in Western populations. Consequently, it is unclear if the current criteria for active surveillance (AS) can safely be applied to Korean patients. Therefore, this study was conducted to define appropriate selection criteria for AS for patients with PC in Korea. MATERIALS AND METHODS: We conducted a multicenter retrospective study of 2,126 patients with low risk PC who actually underwent radical prostatectomy. The primary outcome was an unfavorable disease, which was defined by non-organ confined disease or an upgrading of the Gleason score to ≥ 7 (4+3). Predictive variables of an unfavorable outcome were identified by multivariate analysis using randomly selected training samples (n=1,623, 76.3%). We compared our selected criteria to various Western criteria for the primary outcome and validated our criteria using the remaining validation sample (n=503, 23.7%). RESULTS: A non-organ confined disease rate of 14.9% was identified, with an increase in Gleason score ≥ 7 (4+3) of 8.7% and a final unfavorable disease status of 20.8%. The following criteria were selected: Gleason score ≤ 6, clinical stage T1-T2a, prostate-specific antigen (PSA) ≤ 10 ng/mL, PSA density < 0.15 ng/mL/mL, number of positive cores ≤ 2, and maximum cancer involvement in any one core ≤ 20%. These criteria provided the lowest unfavorable disease rate (11.7%) when compared to Western criteria (13.3%-20.7%), and their validity was confirmed using the validation sample (5.9%). CONCLUSION: We developed AS criteria which are appropriate for Korean patients with PC. Prospective studies using these criteria are now warranted.
Humans
;
Korea
;
Multivariate Analysis
;
Neoplasm Grading
;
Pathology
;
Patient Selection
;
Prospective Studies
;
Prostate
;
Prostate-Specific Antigen
;
Prostatectomy
;
Prostatic Neoplasms
;
Retrospective Studies
6.EEG can Predict Neurologic Outcome in Children Resuscitated from Cardiac Arrest.
Dong Hwa YANG ; Seok Gyun HA ; Hyo Jeong KIM
Journal of the Korean Child Neurology Society 2018;26(4):240-245
PURPOSE: Early prediction of prognosis of children resuscitated from cardiac arrest is a major challenge. We investigated the utility of electroencephalography (EEG) and laboratory studies for predicting of neurologic outcome in children resuscitated from cardiac arrest. METHODS: We retrospectively analyzed medical records of patients who were resuscitated from cardiac arrest from 2006 to 2015 at the Gil Medical Center. Patients aged one month to 18 years were included. EEG analysis included background scoring, reactivity and seizure burden. EEG background was classified score 0 (normal/organized), score 1 (slow and disorganized), score 2 (discontinuous or burst suppression), and score 3 (suppressed and featureless). Neurologic outcome was evaluated by Pediatric Cerebral Performance Category (PCPC) at least 6 months after cardiac arrest. RESULTS: Total 26 patients were evaluated. Nine patients showed good neurologic outcome (PCPC 1, 2, 3) and 17 patients showed poor neurologic outcome (PCPC 4, 5, 6). Patients of poor neurologic outcome group showed EEG background score 3 in 88.2%, whereas 44.4% in patients of good neurologic outcome group (P=0.028). Electrographic ictal discharges except non-convulsive status epilepticus were presented in 44.4% of good neurologic outcome group and 5.9% of poor neurologic outcome group (P=0.034). Ammonia and lactate levels were higher and pH levels were lower in poor outcome group than good neurologic outcome group. CONCLUSION: Suppressed and featureless EEG background is associated with poor neurologic outcome and electrographic seizures are associated with good neurologic outcome.
Ammonia
;
Child*
;
Electroencephalography*
;
Heart Arrest*
;
Humans
;
Hydrogen-Ion Concentration
;
Lactic Acid
;
Medical Records
;
Prognosis
;
Retrospective Studies
;
Seizures
;
Status Epilepticus
7.Therapeutic Efficacy and Safety of Prolonged Macrolide, Corticosteroid, Doxycycline, and Levofloxacin against Macrolide-Unresponsive Mycoplasma pneumoniae Pneumonia in Children.
Seok Gyun HA ; Kyung Jin OH ; Kwang Pil KO ; Yong Han SUN ; Eell RYOO ; Hann TCHAH ; In Sang JEON ; Hyo Jeong KIM ; Jung Min AHN ; Hye Kyung CHO
Journal of Korean Medical Science 2018;33(43):e268-
BACKGROUND: We aimed to compare the therapeutic efficacy of prolonged macrolide (PMC), corticosteroids (CST), doxycycline (DXC), and levofloxacin (LFX) against macrolide-unresponsive Mycoplasma pneumoniae (MP) pneumonia in children and to evaluate the safety of the secondary treatment agents. METHODS: We retrospectively analyzed the data of patients with MP pneumonia hospitalized between January 2015 and April 2017. Macrolide-unresponsiveness was clinically defined with a persistent fever of ≥ 38.0°C at ≥ 72 hours after macrolide treatment. The cases were divided into four groups: PMC, CST, DXC, and LFX. We compared the time to defervescence (TTD) after secondary treatment and the TTD after initial macrolide treatment in each group with adjustment using propensity score-matching analysis. RESULTS: Among 1,165 cases of MP pneumonia, 190 (16.3%) were unresponsive to macrolides. The proportion of patients who achieved defervescence within 48 hours in CST, DXC, and LFX groups were 96.9% (31/33), 85.7% (12/14), and 83.3% (5/6), respectively. The TTD after initial macrolide treatment did not differ between PMC and CST groups (5.1 vs. 4.2 days, P = 0.085), PMC and DXC groups (4.9 vs. 5.7 days, P = 0.453), and PMC and LFX groups (4.4 vs. 5.0 days, P = 0.283). No side effects were observed in the CST, DXC, and LFX groups. CONCLUSION: The change to secondary treatment did not show better efficacy compared to PMC in children with macrolide-unresponsive MP pneumonia. Further studies are needed to guide appropriate treatment in children with MP pneumonia.
Adrenal Cortex Hormones
;
Anti-Bacterial Agents
;
Child*
;
Doxycycline*
;
Fever
;
Humans
;
Levofloxacin*
;
Macrolides
;
Mycoplasma pneumoniae*
;
Mycoplasma*
;
Pneumonia*
;
Pneumonia, Mycoplasma*
;
Retrospective Studies
8.Impact of the ASA Physical Status Score on Adjuvant Chemotherapy Eligibility and Survival of Upper Tract Urothelial Carcinoma Patients: a Multicenter Study.
Ho Won KANG ; Sung Pil SEO ; Won Tae KIM ; Yong June KIM ; Seok Joong YUN ; Sang Cheol LEE ; Young Deuk CHOI ; Yun Sok HA ; Tae Hwan KIM ; Tae Gyun KWON ; Seok Soo BYUN ; Seong Uk JEH ; Wun Jae KIM
Journal of Korean Medical Science 2017;32(2):335-342
The aim of the present multi-institutional study was to assess the influence of the American Society of Anesthesiologists Physical Status (ASA-PS) classification on adjuvant chemotherapy eligibility and survival in a multi-institutional cohort of patients treated with radical nephroureterectomy (RNU) for upper tract urothelial carcinoma (UTUC). We retrospectively reviewed data from 416 patients who underwent RNU for UTUC at four Korean institutions between 2001 and 2013. The ASA-PS classification was obtained from the anesthesia chart. Locally advanced UTUC was defined as ≥ pT3 and/or pN1 disease. The influence of ASA-PS score on survival was evaluated by Kaplan-Meier analyses and a multivariate Cox regression model. Patients with a higher ASA-PS class were less likely to be eligible for adjuvant chemotherapy in locally advanced UTUC (P = 0.016). Kaplan-Meier estimates showed that the high-risk ASA-PS group has a poorer overallsurvival (OS) and cancer-specific survival (CSS) compared to low risk ASA-PS groups in both the total and locally advanced UTUC cohorts. Based on multivariate Cox regression analysis, the high-risk ASA-PS category was an independent predictor for overall mortality (OM) (hazard ratio [HR], 1.919; 95% confidence interval [CI], 1.017–3.619; P = 0.044) and cancer-specific mortality (CSM) (HR, 2.120; 95% CI, 1.023–4.394; P = 0.043). In conclusion, high-risk ASA-PS score was independently associated with a lower survival rate in patients with UTUC after RNU. However, the influence of ASA-PS classification on survival was limited to locally advanced UTUC. The lower eligibility of patients in the high-risk ASA category for adjuvant chemotherapy may contribute to the lower survival rate in this group.
Anesthesia
;
Chemotherapy, Adjuvant*
;
Classification
;
Cohort Studies
;
Humans
;
Mortality
;
Retrospective Studies
;
Survival Rate
9.Erratum: Increased Expression of Herpes Virus-Encoded hsv1-miR-H18 and hsv2-miR-H9-5p in Cancer-Containing Prostate Tissue Compared to That in Benign Prostate Hyperplasia Tissue.
Seok Joong YUN ; Pildu JEONG ; Ho Won KANG ; Helen Ki SHINN ; Ye Hwan KIM ; Chunri YAN ; Young Ki CHOI ; Dongho KIM ; Dong Hee RYU ; Yun Sok HA ; Tae Hwan KIM ; Tae Gyun KWON ; Jung Min KIM ; Sang Heon SUH ; Seon Kyu KIM ; Seon Young KIM ; Sang Tae KIM ; Won Tae KIM ; Ok Jun LEE ; Sung Kwon MOON ; Nam Hyung KIM ; Isaac Yi KIM ; Jayoung KIM ; Hee Jae CHA ; Yung Hyun CHOI ; Eun Jong CHA ; Wun Jae KIM
International Neurourology Journal 2016;20(4):374-374
In this article, a part of fund and grant supports was omitted unintentionally.
10.Histiocytic Sarcoma of the Cervical Spinal Cord with Secondary Involvement of the Skin.
Hyung Kwon PARK ; Hyun Seok CHOI ; Young Gyun KIM ; Young Ha OH ; Hee Joon YU ; Joung Soo KIM
Korean Journal of Dermatology 2016;54(3):199-202
Histiocytic sarcoma is a rare, lymphohematopoietic malignant tumor comprised of tumor cells with the morphological and immunophenotypic features of mature histiocytes. A 35-year-old man presented with a disseminated histiocytic sarcoma that first occurred in the spinal cord and metastasized to the skin and lymph nodes. The tumor cells of the primary histiocytic sarcoma of the spinal cord were very large epithelioid cells with abundant eosinophilic cytoplasms and large, round-to-oval nuclei. In contrast, the metastatic histiocytic sarcoma of the skin was composed of relatively small polygonal cells with well-defined cell borders and high N/C (nucleus/cytoplasm) ratios. Immunohistochemically, both tumors were diffusely positive for histiocyte-associated antigens; but negative for epithelial, melanocyte, lymphoid, and dendritic cell antigens. It is important to recognize the morphological features and immunohistochemical characteristics of metastatic cells in order to ensure accurate diagnoses.
Adult
;
Cytoplasm
;
Dendritic Cells
;
Diagnosis
;
Eosinophils
;
Epithelioid Cells
;
Histiocytes
;
Histiocytic Sarcoma*
;
Humans
;
Lymph Nodes
;
Melanocytes
;
Skin*
;
Spinal Cord*

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