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.Transradial Versus Transfemoral Access for Bifurcation Percutaneous Coronary Intervention Using SecondGeneration Drug-Eluting Stent
Jung-Hee LEE ; Young Jin YOUN ; Ho Sung JEON ; Jun-Won LEE ; Sung Gyun AHN ; Junghan YOON ; Hyeon-Cheol GWON ; Young Bin SONG ; Ki Hong CHOI ; Hyo-Soo KIM ; Woo Jung CHUN ; Seung-Ho HUR ; Chang-Wook NAM ; Yun-Kyeong CHO ; Seung Hwan HAN ; Seung-Woon RHA ; In-Ho CHAE ; Jin-Ok JEONG ; Jung Ho HEO ; Do-Sun LIM ; Jong-Seon PARK ; Myeong-Ki HONG ; Joon-Hyung DOH ; Kwang Soo CHA ; Doo-Il KIM ; Sang Yeub LEE ; Kiyuk CHANG ; Byung-Hee HWANG ; So-Yeon CHOI ; Myung Ho JEONG ; Hyun-Jong LEE
Journal of Korean Medical Science 2024;39(10):e111-
Background:
The benefits of transradial access (TRA) over transfemoral access (TFA) for bifurcation percutaneous coronary intervention (PCI) are uncertain because of the limited availability of device selection. This study aimed to compare the procedural differences and the in-hospital and long-term outcomes of TRA and TFA for bifurcation PCI using secondgeneration drug-eluting stents (DESs).
Methods:
Based on data from the Coronary Bifurcation Stenting Registry III, a retrospective registry of 2,648 patients undergoing bifurcation PCI with second-generation DES from 21 centers in South Korea, patients were categorized into the TRA group (n = 1,507) or the TFA group (n = 1,141). After propensity score matching (PSM), procedural differences, in-hospital outcomes, and device-oriented composite outcomes (DOCOs; a composite of cardiac death, target vessel-related myocardial infarction, and target lesion revascularization) were compared between the two groups (772 matched patients each group).
Results:
Despite well-balanced baseline clinical and lesion characteristics after PSM, the use of the two-stent strategy (14.2% vs. 23.7%, P = 0.001) and the incidence of in-hospital adverse outcomes, primarily driven by access site complications (2.2% vs. 4.4%, P = 0.015), were significantly lower in the TRA group than in the TFA group. At the 5-year follow-up, the incidence of DOCOs was similar between the groups (6.3% vs. 7.1%, P = 0.639).
Conclusion
The findings suggested that TRA may be safer than TFA for bifurcation PCI using second-generation DESs. Despite differences in treatment strategy, TRA was associated with similar long-term clinical outcomes as those of TFA. Therefore, TRA might be the preferred access for bifurcation PCI using second-generation DES.
3.Effectiveness and Safety of Zotarolimus-Eluting Stent (Resolute™ Integrity) in Patients with Diffuse Long Coronary Artery Disease
Keun Ho PARK ; Youngkeun AHN ; Young Youp KOH ; Young Jae KI ; Sung Soo KIM ; Hyun Kuk KIM ; Dong Hyun CHOI ; Young Joon HONG ; Jin Yong HWANG ; Do Hoi KIM ; Jay Young RHEW ; Jae Kean RYU ; Jong Seon PARK ; Tae Ho PARK ; Tae Hyun YANG ; Seok Kyu OH ; Bong Ryeol LEE ; Seung Uk LEE ; Sang Gon LEE ; Kook Jin CHUN ; Jang Hyun CHO ; Kwang Soo CHA ; Jei Keon CHAE ; Seung Ho HUR ; Sun Ho HWANG ; Hun Sik PARK ; Doo Il KIM
Korean Circulation Journal 2019;49(8):709-720
BACKGROUND AND OBJECTIVES: Diffuse long coronary artery disease (DLCAD) still has unfavorable clinical outcomes after successful percutaneous coronary intervention (PCI). Therefore, we aimed to evaluate the effectiveness and safety of Resolute™ zotarolimus-eluting stent (R-ZES; Resolute™ Integrity) for patients with DLCAD. METHODS: From December 2011 to December 2014, 1,011 patients who underwent PCI using R-ZES for CAD with longer than 25 mm lesion were prospectively enrolled from 21 hospitals in Korea. We assessed the clinical outcome of major adverse cardiac events (MACE) defined as the composite of cardiac death, non-fatal myocardial infarction (MI), and clinically-driven target vessel revascularization at 12 months. RESULTS: Mean age was 63.8±10.8 years, 701 (69.3%) patients were male, 572 (87.0%) patients had hypertension, 339 (33.8%) patients had diabetes, 549 (54.3%) patients diagnosed with acute MI and 545 (53.9%) patients had multi-vessel disease (MVD). A total of 1,697 stents were implanted into a total of 1,472 lesions. The mean diameter was 3.07±0.38 mm and the length was 28.27±6.97 mm. Multiple overlapping stents were performed in 205 (13.8%) lesions. A 12-month clinical follow-up was available in 1,004 patients (99.3%). The incidences of MACE and definite stent thrombosis at 12-month were 3.0% and 0.3% respectively. On multivariate Cox-regression analysis, multiple overlapping stents implantation, previous congestive heart failure, MVD, and age ≥75 years were independent predictors of one-year MACE. CONCLUSIONS: Our study shows that R-ZES has an excellent 1-year clinical outcome in Korean patients with DLCAD.
Coronary Artery Disease
;
Coronary Vessels
;
Death
;
Drug-Eluting Stents
;
Follow-Up Studies
;
Heart Failure
;
Humans
;
Hypertension
;
Incidence
;
Korea
;
Male
;
Myocardial Infarction
;
Percutaneous Coronary Intervention
;
Prospective Studies
;
Stents
;
Thrombosis
;
Treatment Outcome
4.Effectiveness and Safety of Zotarolimus-Eluting Stent (Resoluteâ„¢ Integrity) in Patients with Diffuse Long Coronary Artery Disease
Keun Ho PARK ; Youngkeun AHN ; Young Youp KOH ; Young Jae KI ; Sung Soo KIM ; Hyun Kuk KIM ; Dong Hyun CHOI ; Young Joon HONG ; Jin Yong HWANG ; Do Hoi KIM ; Jay Young RHEW ; Jae Kean RYU ; Jong Seon PARK ; Tae Ho PARK ; Tae Hyun YANG ; Seok Kyu OH ; Bong Ryeol LEE ; Seung Uk LEE ; Sang Gon LEE ; Kook Jin CHUN ; Jang Hyun CHO ; Kwang Soo CHA ; Jei Keon CHAE ; Seung Ho HUR ; Sun Ho HWANG ; Hun Sik PARK ; Doo Il KIM
Korean Circulation Journal 2019;49(8):709-720
BACKGROUND AND OBJECTIVES:
Diffuse long coronary artery disease (DLCAD) still has unfavorable clinical outcomes after successful percutaneous coronary intervention (PCI). Therefore, we aimed to evaluate the effectiveness and safety of Resoluteâ„¢ zotarolimus-eluting stent (R-ZES; Resoluteâ„¢ Integrity) for patients with DLCAD.
METHODS:
From December 2011 to December 2014, 1,011 patients who underwent PCI using R-ZES for CAD with longer than 25 mm lesion were prospectively enrolled from 21 hospitals in Korea. We assessed the clinical outcome of major adverse cardiac events (MACE) defined as the composite of cardiac death, non-fatal myocardial infarction (MI), and clinically-driven target vessel revascularization at 12 months.
RESULTS:
Mean age was 63.8±10.8 years, 701 (69.3%) patients were male, 572 (87.0%) patients had hypertension, 339 (33.8%) patients had diabetes, 549 (54.3%) patients diagnosed with acute MI and 545 (53.9%) patients had multi-vessel disease (MVD). A total of 1,697 stents were implanted into a total of 1,472 lesions. The mean diameter was 3.07±0.38 mm and the length was 28.27±6.97 mm. Multiple overlapping stents were performed in 205 (13.8%) lesions. A 12-month clinical follow-up was available in 1,004 patients (99.3%). The incidences of MACE and definite stent thrombosis at 12-month were 3.0% and 0.3% respectively. On multivariate Cox-regression analysis, multiple overlapping stents implantation, previous congestive heart failure, MVD, and age ≥75 years were independent predictors of one-year MACE.
CONCLUSIONS
Our study shows that R-ZES has an excellent 1-year clinical outcome in Korean patients with DLCAD.
5.Designing Tyrosinase siRNAs by Multiple Prediction Algorithms and Evaluation of Their Anti-Melanogenic Effects.
Ok Seon KWON ; Soo Jung KWON ; Jin Sang KIM ; Gunbong LEE ; Han Joo MAENG ; Jeongmi LEE ; Gwi Seo HWANG ; Hyuk Jin CHA ; Kwang Hoon CHUN
Biomolecules & Therapeutics 2018;26(3):282-289
Melanin is a pigment produced from tyrosine in melanocytes. Although melanin has a protective role against UVB radiation-induced damage, it is also associated with the development of melanoma and darker skin tone. Tyrosinase is a key enzyme in melanin synthesis, which regulates the rate-limiting step during conversion of tyrosine into DOPA and dopaquinone. To develop effective RNA interference therapeutics, we designed a melanin siRNA pool by applying multiple prediction programs to reduce human tyrosinase levels. First, 272 siRNAs passed the target accessibility evaluation using the RNAxs program. Then we selected 34 siRNA sequences with ΔG ≥−34.6 kcal/mol, i-Score value ≥65, and siRNA scales score ≤30. siRNAs were designed as 19-bp RNA duplexes with an asymmetric 3′ overhang at the 3′ end of the antisense strand. We tested if these siRNAs effectively reduced tyrosinase gene expression using qRT-PCR and found that 17 siRNA sequences were more effective than commercially available siRNA. Three siRNAs further tested showed an effective visual color change in MNT-1 human cells without cytotoxic effects, indicating these sequences are anti-melanogenic. Our study revealed that human tyrosinase siRNAs could be efficiently designed using multiple prediction algorithms.
Dihydroxyphenylalanine
;
Gene Expression
;
Humans
;
Melanins
;
Melanocytes
;
Melanoma
;
Monophenol Monooxygenase*
;
RNA
;
RNA Interference
;
RNA, Small Interfering*
;
Skin Pigmentation
;
Tyrosine
;
Weights and Measures
6.Prepuncture Ultrasound Examination Facilitates Safe and Accurate Common Femoral Artery Access for Transfemoral Cerebral Angiography.
Seon Yong SON ; Kwang Chun CHO ; Pyunggoo CHO ; Ju Hyung LEE ; Seong Uk MYOUNG ; Jai Ho CHOI
Journal of Cerebrovascular and Endovascular Neurosurgery 2017;19(4):276-283
OBJECTIVE: We aimed to introduce our method involving prepuncture ultrasound scan for cannulation of the common femoral artery (CFA) during transfemoral cerebral angiography (TFCA), and to assess the clinical and radiological outcomes. MATERIAL AND METHODS: Our study included 90 patients who underwent prepuncture ultrasound examination of the inguinal area for TFCA between April 2015 and June 2015. Prior to skin preparation and draping of the inguinal area, we identified the CFA and its bifurcation using ultrasound. Based on the ultrasound findings, we marked cruciate lines in the inguinal area. Thereafter, we inserted a puncture needle at the interface between the horizontal and vertical lines at a 30–45° angle, simultaneously palpating the pulsation of the femoral artery. After TFCA was completed, femoral artery angiography was performed in the anteroposterior and oblique directions. Clinical and radiological parameters, including CFA cannulation, the ultrasound scan time, the first pass success rate, the time required for the passage of the wire, and complications, were evaluated. RESULTS: The mean ultrasound scan time of the CFA and its bifurcation was 72.6 seconds, and the mean time between administration of local anesthesia and wire passage was 67.44 seconds. The first pass success rate was 77.8% (70/90 patients), and the CFA puncture rate was 98.8% (89/90 patients). Although minor complications were noted in 7 patients, no patient reported serious complications (a large hematoma [≥ 5 cm], pseudoaneurysms, dissection, and/or a retroperitoneal hematoma.) CONCLUSION: Prepuncture ultrasound examination might be a simple, safe, and accurate technique for cannulation of the CFA during TFCA.
Anesthesia, Local
;
Aneurysm, False
;
Angiography
;
Catheterization
;
Cerebral Angiography*
;
Femoral Artery*
;
Hematoma
;
Humans
;
Methods
;
Needles
;
Punctures
;
Skin
;
Ultrasonography*
7.SEALONE (Safety and Efficacy of Coronary Computed Tomography Angiography with Low Dose in Patients Visiting Emergency Room) trial: study protocol for a randomized controlled trial.
Joonghee KIM ; Joon Won KANG ; Kyuseok KIM ; Sang Il CHOI ; Eun Ju CHUN ; Yeo Goon KIM ; Won Young KIM ; Dong Woo SEO ; Jonghwan SHIN ; Huijai LEE ; Kwang Nam JIN ; Soyeon AHN ; Seung Sik HWANG ; Kwang Pyo KIM ; Ru Bi JEONG ; Sang Ook HA ; Byungho CHOI ; Chang Hwan YOON ; Jung Won SUH ; Hack Lyoung KIM ; Ju Kyoung KIM ; Sujin JANG ; Ji Seon SEO
Clinical and Experimental Emergency Medicine 2017;4(4):208-213
OBJECTIVE: Chest pain is one of the most common complaints in the emergency department (ED). Cardiac computed tomography angiography (CCTA) is a frequently used tool for the early triage of patients with low- to intermediate-risk acute chest pain. We present a study protocol for a multicenter prospective randomized controlled clinical trial testing the hypothesis that a low-dose CCTA protocol using prospective electrocardiogram (ECG)-triggering and limited-scan range can provide sufficient diagnostic safety for early triage of patients with acute chest pain. METHODS: The trial will include 681 younger adult (aged 20 to 55) patients visiting EDs of three academic hospitals for acute chest pain or equivalent symptoms who require further evaluation to rule out acute coronary syndrome. Participants will be randomly allocated to either low-dose or conventional CCTA protocol at a 2:1 ratio. The low-dose group will undergo CCTA with prospective ECG-triggering and restricted scan range from sub-carina to heart base. The conventional protocol group will undergo CCTA with retrospective ECG-gating covering the entire chest. Patient disposition is determined based on computed tomography findings and clinical progression and all patients are followed for a month. The primary objective is to prove that the chance of experiencing any hard event within 30 days after a negative low-dose CCTA is less than 1%. The secondary objectives are comparisons of the amount of radiation exposure, ED length of stay and overall cost. RESULTS AND CONCLUSION: Our low-dose protocol is readily applicable to current multi-detector computed tomography devices. If this study proves its safety and efficacy, dose-reduction without purchasing of expensive newer devices would be possible.
Acute Coronary Syndrome
;
Adult
;
Angiography*
;
Chest Pain
;
Coronary Angiography
;
Electrocardiography
;
Emergencies*
;
Emergency Service, Hospital
;
Heart
;
Humans
;
Length of Stay
;
Prospective Studies
;
Radiation Exposure
;
Retrospective Studies
;
Thorax
;
Triage
8.Internal Fixation Using Clavicle Hook Plates for Distal Clavicle Fractures.
Kwang Yul KIM ; Hyung Chun KIM ; Sung Jun CHO ; Su Han AHN ; Dong Seon KIM
Clinics in Shoulder and Elbow 2015;18(1):21-27
BACKGROUND: To report the radiological and clinical outcomes of internal fixation using distal clavicle hook plates for distal clavicle fractures. METHODS: From April 2008 to December 2012, 32 patients with distal clavicle fractures underwent surgery using an AO hook plate. The reduction was qualified and evaluated according to the radiological findings. The evaluation of the clinical outcomes was performed with the University of California at Los Angeles (UCLA) score, the Korean Shoulder score, and the visual analogue scale (VAS) pain score. RESULTS: By radiological evaluation, we found that 31 of 32 patients showed anatomical reduction and solid bone union. Although we obtained satisfactory UCLA scores, Korean Shoulder Scale scores, and VAS pain scores, 12 cases of complications were present. We found 4 cases of osteolysis of the acromion, 1 case of nonunion, 3 cases of periprosthetic fractures, 3 cases of subacromial pain, and 1 case of skin irritation. We performed re-operations in 2 patients. CONCLUSIONS: To avoid complications associated with clavicle hook plates, choosing the appropriate hook size and bending of the hook according to the slope of the acromion undersurface is critical. Also, we believe that early removal of clavicle plates may help reduce complications.
Acromion
;
California
;
Clavicle*
;
Humans
;
Osteolysis
;
Periprosthetic Fractures
;
Shoulder
;
Skin
9.Internal Fixation Using Clavicle Hook Plates for Distal Clavicle Fractures
Kwang Yul KIM ; Hyung Chun KIM ; Sung Jun CHO ; Su Han AHN ; Dong Seon KIM
Journal of the Korean Shoulder and Elbow Society 2015;18(1):21-27
BACKGROUND: To report the radiological and clinical outcomes of internal fixation using distal clavicle hook plates for distal clavicle fractures. METHODS: From April 2008 to December 2012, 32 patients with distal clavicle fractures underwent surgery using an AO hook plate. The reduction was qualified and evaluated according to the radiological findings. The evaluation of the clinical outcomes was performed with the University of California at Los Angeles (UCLA) score, the Korean Shoulder score, and the visual analogue scale (VAS) pain score. RESULTS: By radiological evaluation, we found that 31 of 32 patients showed anatomical reduction and solid bone union. Although we obtained satisfactory UCLA scores, Korean Shoulder Scale scores, and VAS pain scores, 12 cases of complications were present. We found 4 cases of osteolysis of the acromion, 1 case of nonunion, 3 cases of periprosthetic fractures, 3 cases of subacromial pain, and 1 case of skin irritation. We performed re-operations in 2 patients. CONCLUSIONS: To avoid complications associated with clavicle hook plates, choosing the appropriate hook size and bending of the hook according to the slope of the acromion undersurface is critical. Also, we believe that early removal of clavicle plates may help reduce complications.
Acromion
;
California
;
Clavicle
;
Humans
;
Osteolysis
;
Periprosthetic Fractures
;
Shoulder
;
Skin
10.Peroneus Tendon Dislocation Associated with Fracture of Lateral Process of Talus: A Case Report.
Youn Soo HWANG ; Sung Jun JO ; Kwang Yeol KIM ; Hyung Chun KIM ; Dong Seon KIM
Journal of the Korean Fracture Society 2014;27(3):222-226
Traumatic peroneal tendon dislocation in association with fracture of the lateral process of the talus is a rare injury, which is difficult to diagnose. As a result, early detection is often delayed, which in turn leads to ankle pain and dysfunction. We treated a patient by open reduction and screw fixation in fracture of the lateral process of talus and primary repair of the superior peroneal retinaculum. We report this case with a brief review of the literature.
Ankle
;
Dislocations*
;
Humans
;
Talus*
;
Tendons*

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