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.A Randomized, Double-Blind, Active-Control, Noninferiority, Multicenter, Phase 4 Study to Evaluate the Efficacy and Safety of Esomeprazole/Sodium Bicarbonate 20/800 mg in Patients with Nonerosive Gastroesophageal Reflux Disease
Su Hyun PARK ; Kang Nyeong LEE ; Oh Young LEE ; Myung Gyu CHOI ; Jie-Hyun KIM ; In-Kyung SUNG ; Jae Young JANG ; Kyung Sik PARK ; Hoon Jai CHUN ; Eun Young KIM ; Jun Kyu LEE ; Jin Seok JANG ; Gwang Ha KIM ; Su Jin HONG ; Yong Chan LEE ; Suck-Chei CHOI ; Hyun Soo KIM ; Tae Oh KIM ; Gwang Ho BAIK ; Yong Cheol JEON
Gut and Liver 2023;17(2):226-233
Background/Aims:
Efficacy of proton pump inhibitors is limited in patients with nonerosive reflux disease (NERD). The aim of this study was to comparatively evaluate the efficacy and safety of esomeprazole with sodium bicarbonate and esomeprazole alone.
Methods:
This was a multicenter, randomized, double-blind, active-controlled, noninferiority comparative study. A total of 379 patients with NERD were randomly allocated to receive either EsoduoⓇ/sup> (esomeprazole 20 mg with sodium bicarbonate 800 mg) or NexiumⓇ/sup> (esomeprazole 20 mg) once daily for 4 weeks from January 2019 to December 2019. The patients had a history of heartburn for at least 2 days in the week before randomization as well as in the last 3 months and no esophageal mucosal breaks on endoscopy. The primary endpoint was a complete cure of heartburn at week 4. The secondary and exploratory endpoints as well as the safety profiles were compared in the groups at weeks 2 and 4.
Results:
A total of 355 patients completed the study (180 in the EsoduoⓇ/sup> group and 175 in the NexiumⓇ/sup> group). The proportions of patients without heartburn in the entire 4th week of treatment were not different between the two groups (33.33% in the EsoduoⓇ/sup> group and 35% in the NexiumⓇ/sup> group, p=0.737). There were no significant differences in most of the secondary and exploratory endpoints as well as the safety profiles.
Conclusions
EsoduoⓇ/sup> is as effective and safe as NexiumⓇ/sup> for managing typical symptoms in patients with NERD (ClinicalTrial.gov identifier: NCT03928470).
3.Triple Therapy-Based on Tegoprazan, a New Potassium-Competitive Acid Blocker, for First-Line Treatment of Helicobacter pylori Infection: A Randomized, Double-Blind, Phase III, Clinical Trial
Yoon Jin CHOI ; Yong Chan LEE ; Jung Mogg KIM ; Jin Il KIM ; Jeong Seop MOON ; Yun Jeong LIM ; Gwang Ho BAIK ; Byoung Kwan SON ; Hang Lak LEE ; Kyoung Oh KIM ; Nayoung KIM ; Kwang Hyun KO ; Hye-Kyung JUNG ; Ki-Nam SHIM ; Hoon Jai CHUN ; Byung-Wook KIM ; Hyuk LEE ; Jie-Hyun KIM ; Hyunsoo CHUNG ; Sang Gyun KIM ; Jae Young JANG
Gut and Liver 2022;16(4):535-546
Background/Aims:
We examined the efficacy and safety of tegoprazan as a part of first-line triple therapy for Helicobacter pylori eradication.
Methods:
A randomized, double-blind, controlled, multicenter study was performed to evaluate whether tegoprazan (50 mg)-based triple therapy (TPZ) was noninferior to lansoprazole (30 mg)-based triple therapy (LPZ) (with amoxicillin 1 g and clarithromycin 500 mg; all administered twice daily for 7 days) for treating H. pylori. The primary endpoint was the H. pylori eradication rate. Subgroup analyses were performed according to the cytochrome P450 (CYP) 2C19 genotype, the minimum inhibitory concentration (MIC) of amoxicillin and clarithromycin, and underlying gastric diseases.
Results:
In total, 350 H. pylori-positive patients were randomly allocated to the TPZ or LPZ group. The H. pylori eradication rates in the TPZ and LPZ groups were 62.86% (110/175) and 60.57% (106/175) in an intention-to-treat analysis and 69.33% (104/150) and 67.33% (101/150) in a per-protocol analysis (non-inferiority test, p=0.009 and p=0.013), respectively. Subgroup analyses according to MICs or CYP2C19 did not show remarkable differences in eradication rate. Both first-line triple therapies were well-tolerated with no notable differences.
Conclusions
TPZ is as effective as proton pump inhibitor-based triple therapy and is as safe as first-line H. pylori eradication therapy but does not overcome the clarithromycin resistance of H. pylori in Korea
4.Influence of dental implantation on bone mineral density distribution: a pilot study
Damian Jae-whan LEE ; Eun-sang MOON ; Kenneth STEPHEN ; Jie LIU ; Do-Gyoon KIM
The Journal of Advanced Prosthodontics 2022;14(3):143-149
PURPOSE:
Masticatory loading triggers active bone remodeling, altering alveolar bone mineral density (BMD). While dental implants are placed to bear masticatory loading, their influence on changing bone properties has not been fully investigated. Objective of this pilot study was to examine whether the dental implantation has an effect on BMD distribution of bone by comparing dentate, edentulous, and edentulous patients with implants.
MATERIALS AND METHODS:
Cone beam computed tomography (CBCT) images of 19 partially edentulous patients (Dent), 19 edentulous patients (Edent), and 16 edentulous patients who received implants in the mandible (Edent+Im), were obtained. CBCT images were also obtained from 5 patients within Edent+Im group, before implant placement and after implant loading. Basal cortical bone region of the mandible was digitally isolated. A histogram of gray levels proportional to BMD was obtained to assess mean, histogram standard deviation (HSD), fifth percentile of low and high values (Low5 and High5) of the BMD distribution. Multivariate analysis of variance and paired t-test were used to compare the BMD parameters among the 3 dental status groups and between pre- and post-implantation, respectively.
RESULTS:
Edentulous patients with implants had significantly greater HSD and High5 values compared to edentulous patients (P < .013). All other comparisons were not significant (P > .097). Mean, HSD, and High5 values significantly increased after receiving implants (P < .022).
CONCLUSION
The current findings suggested that receiving dental implants promoted oral bone mineralization for edentulous patients. The longitudinal investigation could provide valuable information on understanding the effects of implantation on the behavior of oral bone quality.
5.Elimination of Anti-CD47 Interference in Pretransfusion Testing by Multiple Platelet Alloadsorption: A Case Report
Heerah LEE ; Yee Jie KIM ; Jin Seok KIM ; John Jeongseok YANG ; Sang-Hyun HWANG ; Heun-Bum OH ; Dae-Hyun KO
Laboratory Medicine Online 2020;10(4):330-333
Hu5F9-G4, an immunoglobulin 4 (IgG4) monoclonal humanized antibody targeting CD47, is under active clinical trials as a novel immunotherapeutic for hematologic and solid malignancies and can cause pretransfusion testing interference. In this study, we demonstrate our first experience of Hu5F9-G4 interference with serologic testing and mitigate this interference through multiple platelet alloadsorption. A 69-year-old woman with a history of ureter cancer presented with anemia. On routine blood group typing, the patient showed strong agglutination (4+) with anti-A, A, and B cells. Unexpectedly, antibody screening and identification showed panreactivity to all panel cells, although the autocontrol result was negative. Medical records revealed that she was enrolled in an anti-CD47 clinical trial. To eliminate interference by the drug, we attempted alloadsorption using pooled platelets that were prepared from segments of random single donor platelets. After seven alloadsorption sessions using pooled allogeneic platelets, the ABO discrepancy and panreactivity was resolved. To our knowledge, this is the first demonstration of anti-CD47 interference elimination in Korea.
6.Elimination of Anti-CD47 Interference in Pretransfusion Testing by Multiple Platelet Alloadsorption: A Case Report
Heerah LEE ; Yee Jie KIM ; Jin Seok KIM ; John Jeongseok YANG ; Sang-Hyun HWANG ; Heun-Bum OH ; Dae-Hyun KO
Laboratory Medicine Online 2020;10(4):330-333
Hu5F9-G4, an immunoglobulin 4 (IgG4) monoclonal humanized antibody targeting CD47, is under active clinical trials as a novel immunotherapeutic for hematologic and solid malignancies and can cause pretransfusion testing interference. In this study, we demonstrate our first experience of Hu5F9-G4 interference with serologic testing and mitigate this interference through multiple platelet alloadsorption. A 69-year-old woman with a history of ureter cancer presented with anemia. On routine blood group typing, the patient showed strong agglutination (4+) with anti-A, A, and B cells. Unexpectedly, antibody screening and identification showed panreactivity to all panel cells, although the autocontrol result was negative. Medical records revealed that she was enrolled in an anti-CD47 clinical trial. To eliminate interference by the drug, we attempted alloadsorption using pooled platelets that were prepared from segments of random single donor platelets. After seven alloadsorption sessions using pooled allogeneic platelets, the ABO discrepancy and panreactivity was resolved. To our knowledge, this is the first demonstration of anti-CD47 interference elimination in Korea.
7.Driving pressure guided ventilation
Hyun Joo AHN ; MiHye PARK ; Jie Ae KIM ; Mikyung YANG ; Susie YOON ; Bo Rim KIM ; Jae-Hyon BAHK ; Young Jun OH ; Eun-Ho LEE
Korean Journal of Anesthesiology 2020;73(3):194-204
Protective ventilation is a prevailing ventilatory strategy these days and is comprised of small tidal volume, limited inspiratory pressure, and application of positive end-expiratory pressure (PEEP). However, several retrospective studies recently suggested that tidal volume, inspiratory pressure, and PEEP are not related to patient outcomes, or only related when they influence the driving pressure. Therefore, this review introduces the concept of driving pressure and looks into the possibility of driving pressure-guided ventilation as a new ventilatory strategy, especially in thoracic surgery where postoperative pulmonary complications are common, and thus, lung protection is of utmost importance.
8.Crosstalk between the Producers and Immune Targets of IL-9
Van Anh DO-THI ; Jie-Oh LEE ; Hayyoung LEE ; Young Sang KIM
Immune Network 2020;20(6):e45-
IL-9 has been reported to play dual roles in the pathogenesis of autoimmune disorders and cancers. The collaboration of IL-9 with microenvironmental factors including the broader cytokine milieu and other cellular components may provide important keys to explain its conflicting effects in chronic conditions. In this review, we summarize recent findings on the cellular sources of, and immunological responders to IL-9, in order to interpret the role of IL-9 in the regulation of immune responses. This knowledge will provide new perspectives to improve clinical benefits and limit adverse effects of IL-9 when treating pathologic conditions.
9.A case of rapid desensitization for rituximab-induced delayed hypersensitivity reaction
Su Ho LEE ; Jae Ha LEE ; Nam Hee KIM ; Dong Yoon KANG ; Ju Yeun LEE ; Soo Jie CHUNG ; Ji Hyun OH ; Hye Ryun KANG
Allergy, Asthma & Respiratory Disease 2019;7(2):109-112
Rituximab is a monoclonal antibody used for the treatment of B-cell malignancies, including diffuse large B-cell lymphoma. Infusion-related hypersensitivity reactions to rituximab is well known, and delayed hypersensitivity reactions to rituximab are also reported. Desensitization is commonly used to prevent immediate hypersensitivity reactions, but recently there have been cases of successful desensitization therapy for delayed hypersensitivity reactions. A 66-year-old patient who underwent rituximab treatment for diffuse large B-cell lymphoma showed repeated rituximab-induced delayed hypersensitivity reactions with whole body rashes. Intravenous rapid desensitization was performed by using a 1-bottle, 11-step protocol for 6 cycles and thereafter hypersensitivity reaction did not recur. We herein reported a case of delayed hypersensitivity reaction caused by rituximab, which was successfully desensitized using our 11-step protocol.
Aged
;
B-Lymphocytes
;
Desensitization, Immunologic
;
Exanthema
;
Humans
;
Hypersensitivity
;
Hypersensitivity, Delayed
;
Hypersensitivity, Immediate
;
Lymphoma, B-Cell
;
Rituximab
10.Validity and Reliability of the Korean Version of the Hyperthyroidism Symptom Scale.
Jie Eun LEE ; Dong Hwa LEE ; Tae Jung OH ; Kyoung Min KIM ; Sung Hee CHOI ; Soo LIM ; Young Joo PARK ; Do Joon PARK ; Hak Chul JANG ; Jae Hoon MOON
Endocrinology and Metabolism 2018;33(1):70-78
BACKGROUND: Thyrotoxicosis is a common disease resulting from an excess of thyroid hormones, which affects many organ systems. The clinical symptoms and signs are relatively nonspecific and can vary depending on age, sex, comorbidities, and the duration and cause of the disease. Several symptom rating scales have been developed in an attempt to assess these symptoms objectively and have been applied to diagnosis or to evaluation of the response to treatment. The aim of this study was to assess the reliability and validity of the Korean version of the hyperthyroidism symptom scale (K-HSS). METHODS: Twenty-eight thyrotoxic patients and 10 healthy subjects completed the K-HSS at baseline and after follow-up at Seoul National University Bundang Hospital. The correlation between K-HSS scores and thyroid function was analyzed. K-HSS scores were compared between baseline and follow-up in patient and control groups. Cronbach's α coefficient was calculated to demonstrate the internal consistency of K-HSS. RESULTS: The mean age of the participants was 34.7±9.8 years and 13 (34.2%) were men. K-HSS scores demonstrated a significant positive correlation with serum free thyroxine concentration and decreased significantly with improved thyroid function. K-HSS scores were highest in subclinically thyrotoxic subjects, lower in patients who were euthyroid after treatment, and lowest in the control group at follow-up, but these differences were not significant. Cronbach's α coefficient for the K-HSS was 0.86. CONCLUSION: The K-HSS is a reliable and valid instrument for evaluating symptoms of thyrotoxicosis in Korean patients.
Comorbidity
;
Diagnosis
;
Follow-Up Studies
;
Healthy Volunteers
;
Humans
;
Hyperthyroidism*
;
Male
;
Reproducibility of Results*
;
Seoul
;
Thyroid Gland
;
Thyroid Hormones
;
Thyrotoxicosis
;
Thyroxine
;
Weights and Measures

Result Analysis
Print
Save
E-mail