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.Dosimetric Analysis of a Phase I Study of PSMA-Targeting Radiopharmaceutical Therapy With 177 LuLudotadipep in Patients With Metastatic Castration-Resistant Prostate Cancer
Seunggyun HA ; Joo Hyun O ; Chansoo PARK ; Sun Ha BOO ; Ie Ryung YOO ; Hyong Woo MOON ; Dae Yoon CHI ; Ji Youl LEE
Korean Journal of Radiology 2024;25(2):179-188
Objective:
177 Lutetium [Lu] Ludotadipep is a novel prostate-specific membrane antigen targeting therapeutic agent with an albumin motif added to increase uptake in the tumors. We assessed the biodistribution and dosimetry of [ 177 Lu]Ludotadipep in patients with metastatic castration-resistant prostate cancer (mCRPC).
Materials and Methods:
Data from 25 patients (median age, 73 years; range, 60–90) with mCRPC from a phase I study with activity escalation design of single administration of [ 177 Lu]Ludotadipep (1.85, 2.78, 3.70, 4.63, and 5.55 GBq) were assessed. Activity in the salivary glands, lungs, liver, kidneys, and spleen was estimated from whole-body scan and abdominal SPECT/CT images acquired at 2, 24, 48, 72, and 168 h after administration of [ 177 Lu]Ludotadipep. Red marrow activity was calculated from blood samples obtained at 3, 10, 30, 60, and 180 min, and at 24, 48, and 72 h after administration. Organand tumor-based absorbed dose calculations were performed using IDAC-Dose 2.1.
Results:
Absorbed dose coefficient (mean ± standard deviation) of normal organs was 1.17 ± 0.81 Gy/GBq for salivary glands, 0.05 ± 0.02 Gy/GBq for lungs, 0.14 ± 0.06 Gy/GBq for liver, 0.77 ± 0.28 Gy/GBq for kidneys, 0.12 ± 0.06 Gy/GBq for spleen, and 0.07 ± 0.02 Gy/GBq for red marrow. The absorbed dose coefficient of the tumors was 10.43 ± 7.77 Gy/GBq.
Conclusion
[ 177 Lu]Ludotadipep is expected to be safe at the dose of 3.7 GBq times 6 cycles planned for a phase II clinical trial with kidneys and bone marrow being the critical organs, and shows a high tumor absorbed dose.
3.Comprehensive Analysis of Individual Anatomical Structures for Micturition Symptoms and Maximum Flow Rate in Men With Benign Prostatic Hyperplasia/Lower Urinary Tract Symptoms
Dae Ho KIM ; Kwang Suk LEE ; Kyo Chul KOO ; Byung Ha CHUNG ; Jeong Woo YOO
International Neurourology Journal 2023;27(2):146-154
Purpose:
Individual anatomical structural variations, including intravesical prostatic protrusion (IPP), prostatic urethral angle (PUA), prostatic urethral length, or prostatic apex shape, were correlated with micturition symptoms. We aimed to investigate the effects of these variables on micturition symptoms in men with benign prostatic hyperplasia (BPH)/lower urinary tract symptoms (LUTS).
Methods:
This observational study was based on data from 263 men with the first visit to health promotion center and without BPH/LUTS treatment between March 2020 and September 2022. A multivariate analysis was performed to determine the variables affecting total international prostate symptom score, maximum flow rate (Qmax), and voiding efficacy (postvoid residual volume to total bladder volume ratio).
Results:
Of 263 patients, decreasing PUA increases the severity of international prostate symptoms score (mild, 141.9°; moderate, 136.0°; severe, 131.2°; P<0.015). A multivariate analysis reported that the total international prostate symptom score was correlated with age (P=0.002), PUA (P=0.007), and Qmax (P=0.008). Qmax was negatively associated with IPP (P=0.002). In subanalysis for large prostate volume (≥30 mL, n=81), international prostate symptom score was correlated with PUA (P=0.013), Qmax was correlated with prostatic apex shape (P=0.017), and length of proximal prostatic urethra (P=0.007). IPP was not identified as a significant factor. For small prostate volume (<30 mL, n=182), age (P=0.011) and prostate volume (P=0.004) are correlated with increasing Qmax.
Conclusions
This study presented that individual anatomical structure variations influenced the micturition symptoms according to prostate volume. To identify the major resistant factors in men with BPH/LUTS, further studies are required to investigate which components played a role in major resistant factors for micturition symptoms.
4.Anti-inflammatory effects of ethanol extracts of the flower buds of Syzygium aromaticum L. on human gingival fibroblast cells treated with Porphyromonas gingivalis lipopolysaccharide
Yun Kyong LIM ; So Young YOO ; Ha Na OH ; Dae Sung LEE ; Joong-Ki KOOK
Korean Journal of Dental Materials 2023;50(1):9-16
This study was conducted to evaluate the cytotoxic and anti-inflammatory effects of the ethanol extract of Syzygium aromaticum L. (clove) buds. The cytotoxicity test was performed by cell counting method using hTERT-hNOF cells, a human immortalized gingival fibroblast cell line. To test the anti-inflammatory effects, the hTERT-hNOF cells were treated with lipopolysaccharide (LPS) extracted from Porphyromonas gingivalis KCOM 2804 (PgLPS) and ethanol extract of clove buds. The expression levels of PGE2, IL-6, and IL-8 were measured by enzyme-linked immunosorbent assay. The cytotoxicity test data showed a cell viability of ≧ 82% in hTERT-hNOF cells treated with 10 to 80 µg/mL of the ethanol extract of clove buds. The anti-inflammatory test data showed that the expression of PGE2 by PgLPS treatment was reduced to the level of the negative control group by treatment with 10 µg/mL or more of the ethanol extract of clove buds. In group treated with PgLPS and 40 µg/mL of clove bud ethanol extract, the expression levels of IL-6 and IL-8 in were inhibited by 75% and 77%, respectively (p<0.05), compared to the positive control (PgLPS treatment) group. These results suggest that the ethanol extract of clove buds can be used in developing oral hygine products for preventing periodontal disease.
5.Informed consent forms for gynecologic cancer surgery: recommendations from the Korean Society of Gynecologic Oncology
Ha Kyun CHANG ; Seung-Hyuk SHIM ; Maria LEE ; Won Moo LEE ; Kyung Jin EOH ; Heon Jong YOO ; Mi Kyung KIM ; Min Kyu KIM ; Kwang-Beom LEE ; Kyeong A SO ; Young Tae KIM ; Dae Woo LEE ; Doo-Yoon HYUN ; Jong-Min LEE
Journal of Gynecologic Oncology 2022;33(2):e42-
The sociomedical environment is changing. In the traditional physician-patient relationship, the physician was authoritative and the patient was obedient. The contractual relationship featured patient consent to the physician’s decision. Today, the physician must explain fully the planned medical treatment, and any alternative, to the patient, who has the right to choose her treatment after considering the benefits and side-effects. The Korean Society of Gynecologic Oncology (KSGO) thus decided to standardize the surgical consent forms to meet the legal requirements of modern medicine, improve patient understanding of the surgical details, and protect medical staff from legal disputes. To determine the format and content, subcommittees for each cancer type collected and reviewed all relevant articles and the current consent forms of domestic medical institutions. After several meetings, 16 basic items to be included for each type of gynecologic cancer were selected. Also, to help patients understand the surgical details, figures were included. The revised forms were legally reviewed in terms of the appropriateness of the format and content. We also developed English versions to provide adequate information for foreign patients. We hope that these efforts will promote trust between patients and physicians, and contribute to effective treatment by laying a foundation of mutual respect.
6.Informed consent forms for gynecologic cancer surgery: recommendations from the Korean Society of Gynecologic Oncology
Ha Kyun CHANG ; Seung-Hyuk SHIM ; Maria LEE ; Won Moo LEE ; Kyung Jin EOH ; Heon Jong YOO ; Mi Kyung KIM ; Min Kyu KIM ; Kwang-Beom LEE ; Kyeong A SO ; Young Tae KIM ; Dae Woo LEE ; Doo-Yoon HYUN ; Jong-Min LEE
Obstetrics & Gynecology Science 2022;65(2):105-112
The sociomedical environment is changing. In the traditional physician-patient relationship, the physician was authoritative and the patient was obedient. The contractual relationship featured patient consent to the physician’s decision. Today, the physician must explain fully the planned medical treatment, and any alternative, to the patient, who has the right to choose her treatment after considering the benefits and side-effects. The Korean Society of Gynecologic Oncology thus decided to standardize the surgical consent forms to meet the legal requirements of modern medicine, improve patient understanding of the surgical details, and protect medical staff from legal disputes. To determine the format and content, subcommittees for each cancer type collected and reviewed all relevant articles and the current consent forms of domestic medical institutions. After several meetings, 16 basic items to be included for each type of gynecologic cancer were selected. Also, to help patients understand the surgical details, figures were included. The revised forms were legally reviewed in terms of the appropriateness of the format and content. We also developed English versions to provide adequate information for foreign patients. We hope that these efforts will promote trust between patients and physicians, and contribute to effective treatment by laying a foundation of mutual respect.
7.Diabetic Retinopathy and Related Clinical Practice for People with Diabetes in Korea: A 10-Year Trend Analysis
Yoo-Ri CHUNG ; Kyoung Hwa HA ; Kihwang LEE ; Dae Jung KIM
Diabetes & Metabolism Journal 2020;44(S1):e35-
We performed a retrospective cohort study including people diagnosed with diabetes from 2006 to 2015 according to the Korean National Health Insurance Service-National Sample Cohort database, to analyze the changes in the prevalence, screening rate, and treatment patterns for diabetic retinopathy (DR) over 10 years. The proportion of people who underwent fundus screening for DR steadily increased over the past decade. The prevalence of DR increased from 13.4% in 2006 to 15.9% in 2015, while that of proliferative DR steadily decreased from 1.29% in 2006 to 1.16% in 2015. The proportion of patients undergoing retinal photocoagulation constantly decreased. The prevalence of DR increased over the past decade, while its severity seemed to have improved, with a decreased rate of proliferative DR and retinal photocoagulation. A higher proportion of patients underwent ophthalmic screening using fundus examination, but still less than 30% of patients with diabetes underwent comprehensive examination in 2015.
8.Exploratory Study of the Effectiveness of Oxygen Therapy Using Home Oxygen Concentrators for Cluster Headache
Yoo-ha HONG ; Soo-Jin CHO ; Dae Woong BAE ; Pil-Wook CHUNG ; Heui-Soo MOON ; Min Kyung CHU ; Byung-Su KIM ; Byung-Kun KIM
Journal of the Korean Neurological Association 2020;38(1):29-32
Cluster headache attacks can be successfully treated with oxygen. We report four patients with episodic cluster headache were treated with oxygen therapy from one or two oxygen concentrators. Oxygen therapy with two oxygen concentrators seems to be effective in reduction or cessation of pain of cluster headaches. Patients expressed excellent satisfaction to oxygen therapy with two oxygen concentrators. Oxygen concentrators can be considered as an effective and safe alternative of oxygen cylinder for patients with cluster headache.
9.Significance of Decreasing Rate of HIV and HBV Co-infection in a Nationwide Korean HIV/AIDS Cohort
Yoonjung KIM ; Shin Woo KIM ; Ki Tae KWON ; Hyun Ha CHANG ; Yoonhee JUN ; Jang Wook SOHN ; Dae Won PARK ; Joon Young SONG ; Jun Yong CHOI ; Hyo Youl KIM ; June Myung KIM ; Bo Youl CHOI ; Yunsu CHOI ; Mee Kyung KEE ; Myeong Su YOO ; Jung Gyu LEE
Journal of Korean Medical Science 2020;35(3):7-
10.Diabetic Retinopathy and Related Clinical Practice for People with Diabetes in Korea: A 10-Year Trend Analysis
Yoo-Ri CHUNG ; Kyoung Hwa HA ; Kihwang LEE ; Dae Jung KIM
Diabetes & Metabolism Journal 2020;44(6):928-932
We performed a retrospective cohort study including people diagnosed with diabetes from 2006 to 2015 according to the Korean National Health Insurance Service-National Sample Cohort database, to analyze the changes in the prevalence, screening rate, and treatment patterns for diabetic retinopathy (DR) over 10 years. The proportion of people who underwent fundus screening for DR steadily increased over the past decade. The prevalence of DR increased from 13.4% in 2006 to 15.9% in 2015, while that of proliferative DR steadily decreased from 1.29% in 2006 to 1.16% in 2015. The proportion of patients undergoing retinal photocoagulation constantly decreased. The prevalence of DR increased over the past decade, while its severity seemed to have improved, with a decreased rate of proliferative DR and retinal photocoagulation. A higher proportion of patients underwent ophthalmic screening using fundus examination, but still less than 30% of patients with diabetes underwent comprehensive examination in 2015.

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