1.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).
2.Effects of Non-Pharmacological Interventions on Respiratory Viruses Other Than SARS-CoV-2: Analysis of Laboratory Surveillance and Literature Review From 2018 to 2021
Hye Jin SHI ; Nam Yee KIM ; Sun Ah EOM ; Myung Deok KIM-JEON ; Sung Suck OH ; Bag Sou MOON ; Mun Ju KWON ; Joong Sik EOM
Journal of Korean Medical Science 2022;37(21):e172-
Background:
Since the global coronavirus disease 2019 (COVID-19) pandemic, nonpharmacological interventions (NPIs) such as extensive and comprehensive hand hygiene, mask-wearing, and social distancing have been implemented globally. This study aimed to investigate changes in respiratory viruses other than severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) that occurred following the implementation of these NPIs.
Methods:
From January 2018 to December 2021, influenza-like illness patient specimens and specimens from the Korea Influenza and Respiratory Viruses Surveillance System were analyzed at the Incheon Metropolitan City Institute of Public Health and Environment.Oropharyngeal or nasopharyngeal swab samples from respiratory infection patients were transferred in a virus transport medium at 4°C. After RNA or DNA extraction, respiratory virus-specific genes for human influenza virus (IFV), adenovirus (ADV), parainfluenza virus (PIV), respiratory syncytial virus (RSV), human rhinovirus (hRV), human coronavirus, human bocavirus, and human metapneumovirus were detected by individual real-time reverse transcription polymerase chain reaction.
Results:
A total 3,334 samples were collected. After NPI was implemented, the detection of respiratory viruses other than SARS-CoV-2 decreased overall. The yearly detection rate of respiratory viruses was decreased from 69.5% (399/574) in 2018 and 73.3% (505/689) in 2019 to 19.8% (206/1,043) in 2020 and 34.9% (365/1,028) in 2021. The epidemic was more prominent in respiratory viruses such as IFV and RSV, which were considered dominant viruses, especially those with viral envelopes. Among viruses that were not considered dominant, hRV showed no clear change before and after NPI, while PIV showed a rapid increase compared to the existing dominant viruses between October–December 2021, after the increase in the number of gatherings started at the end of September and the “Relaxing COVID19 and mitigation policy,” which was implemented on November 1.
Conclusion
NPI seems to have influenced the isolation and transmission of respiratory viruses in South Korea. In the future, additional studies focusing on the isolation and transmission patterns of respiratory viruses following NPI are needed.
3.Efficacy and Safety of DWJ1252 Compared With Gasmotin in the Treatment of Functional Dyspepsia: A Multicenter, Randomized, Double-blind, Active-controlled Study
Jin Hwa PARK ; Kang Nyeong LEE ; Oh Young LEE ; Myung-Gyu CHOI ; Hyunsoo CHUNG ; Suck-Chei CHOI ; Nayoung KIM ; Hyojin PARK ; In-Kyung SUNG ; Chong Il SOHN ; Sam Ryong JEE ; Jae Young JANG ; Poong-Lyul RHEE ; Moo In PARK ; Joong Goo KWON ; Kyung Sik PARK ; Kwang Jae LEE ; Joon Seong LEE
Journal of Neurogastroenterology and Motility 2021;27(1):87-96
Background/Aims:
Prokinetics such as mosapride citrate CR (conventional-release; Gasmotin) are commonly used in functional dyspepsia (FD). This study aims to evaluate the efficacy and safety of once-a-day mosapride citrate SR (DWJ1252), a sustained-release formulation of mosapride citrate, compared with mosapride citrate CR 3 times a day, in patients with FD.
Methods:
In this multicenter, randomized, double-blind, active-controlled, non-inferiority study, 119 patients with FD (by the Rome III criteria, 60 for mosapride citrate SR and 59 for mosapride citrate CR) were randomly allocated to mosapride citrate SR once daily or mosapride citrate CR thrice daily for 4 weeks in 16 medical institutions. Primary end point was the change in gastrointestinal symptom (GIS) score from baseline, assessed by GIS questionnaires on 5-point Likert scale after 4-week treatment. Secondary end points and safety profiles were also analyzed.
Results:
The study included 51 and 49 subjects in the mosapride citrate SR and mosapride citrate CR groups, respectively. GIS scores at week 4 were significantly reduced in both groups (mean ± SD: − 10.04 ± 4.45 and − 10.86 ± 5.53 in the mosapride citrate SR and mosapride citrate CR groups, respectively; P < 0.001), and the GIS changes from baseline did not differ between the 2 groups (difference, 0.82 point; 95% CI, − 1.17, 2.81; P = 0.643). Changes in GIS at weeks 2 and 4 and quality of life at week 4, and the improvement rates of global assessments at weeks 2 and 4, did not differ between the groups. Adverse events were similar in the 2 groups, and there were no serious adverse events.
Conclusion
In patients with FD, mosapride citrate SR once daily is as effective as mosapride citrate CR thrice daily, with a similar safety profile.
4.Monitoring Culicine Mosquitoes (Diptera: Culicidae) as a Vector of Flavivirus in Incheon Metropolitan City and Hwaseong-Si, Gyeonggi-Do, Korea, during 2019
Young Yil BAHK ; Seo Hye PARK ; Myung-Deok KIM-JEON ; Sung-Suck OH ; Haneul JUNG ; Hojong JUN ; Kyung-Ae KIM ; Jong Myong PARK ; Seong Kyu AHN ; Jinyoung LEE ; Eun-Jeong CHOI ; Bag-Sou MOON ; Young Woo GONG ; Mun Ju KWON ; Tong-Soo KIM
The Korean Journal of Parasitology 2020;58(5):551-558
The flaviviruses are small single-stranded RNA viruses that are typically transmitted by mosquitoes or tick vectors and are etiological agents of acute zoonotic infections. The viruses are found around the world and account for significant cases of human diseases. We investigated population of culicine mosquitoes in central region of Korean Peninsula, Incheon Metropolitan City and Hwaseong-si. Aedes vexans nipponii was the most frequently collected mosquitoes (56.5%), followed by Ochlerotatus dorsalis (23.6%), Anopheles spp. (10.9%), and Culex pipiens complex (5.9%). In rural regions of Hwaseong, Aedes vexans nipponii was the highest population (62.9%), followed by Ochlerotatus dorsalis (23.9%) and Anopheles spp. (12.0%). In another rural region of Incheon (habitat of migratory birds), Culex pipiens complex was the highest population (31.4%), followed by Ochlerotatus dorsalis (30.5%), and Aedes vexans vexans (27.5%). Culex pipiens complex was the predominant species in the urban region (84.7%). Culicine mosquitoes were identified at the species level, pooled up to 30 mosquitoes each, and tested for flaviviral RNA using the SYBR Green-based RT-PCR and confirmed by cDNA sequencing. Three of the assayed 2,683 pools (989 pools without Anopheles spp.) were positive for Culex flaviviruses, an insect-specific virus, from Culex pipiens pallens collected at the habitats for migratory birds in Incheon. The maximum likelihood estimation (the estimated number) for Culex pipiens pallens positive for Culex flavivirus was 25. Although viruses responsible for mosquito-borne diseases were not identified, we encourage intensified monitoring and long-term surveillance of both vector and viruses in the interest of global public health.
5.2019 Seoul Consensus on Esophageal Achalasia Guidelines
Hye-Kyung JUNG ; Su Jin HONG ; Oh Young LEE ; John PANDOLFINO ; Hyojin PARK ; Hiroto MIWA ; Uday C GHOSHAL ; Sanjiv MAHADEVA ; Tadayuki OSHIMA ; Minhu CHEN ; Andrew S B CHUA ; Yu Kyung CHO ; Tae Hee LEE ; Yang Won MIN ; Chan Hyuk PARK ; Joong Goo KWON ; Moo In PARK ; Kyoungwon JUNG ; Jong Kyu PARK ; Kee Wook JUNG ; Hyun Chul LIM ; Da Hyun JUNG ; Do Hoon KIM ; Chul-Hyun LIM ; Hee Seok MOON ; Jung Ho PARK ; Suck Chei CHOI ; Hidekazu SUZUKI ; Tanisa PATCHARATRAKUL ; Justin C Y WU ; Kwang Jae LEE ; Shinwa TANAKA ; Kewin T H SIAH ; Kyung Sik PARK ; Sung Eun KIM ;
Journal of Neurogastroenterology and Motility 2020;26(2):180-203
Esophageal achalasia is a primary motility disorder characterized by insufficient lower esophageal sphincter relaxation and loss of esophageal peristalsis. Achalasia is a chronic disease that causes progressive irreversible loss of esophageal motor function. The recent development of high-resolution manometry has facilitated the diagnosis of achalasia, and determining the achalasia subtypes based on high-resolution manometry can be important when deciding on treatment methods. Peroral endoscopic myotomy is less invasive than surgery with comparable efficacy. The present guidelines (the “2019 Seoul Consensus on Esophageal Achalasia Guidelines”) were developed based on evidence-based medicine; the Asian Neurogastroenterology and Motility Association and Korean Society of Neurogastroenterology and Motility served as the operating and development committees, respectively. The development of the guidelines began in June 2018, and a draft consensus based on the Delphi process was achieved in April 2019. The guidelines consist of 18 recommendations: 2 pertaining to the definition and epidemiology of achalasia, 6 pertaining to diagnoses, and 10 pertaining to treatments. The endoscopic treatment section is based on the latest evidence from meta-analyses. Clinicians (including gastroenterologists, upper gastrointestinal tract surgeons, general physicians, nurses, and other hospital workers) and patients could use these guidelines to make an informed decision on the management of achalasia.
6.Comparison of medical resources usage between young adult patients and elderly patients: a single center, retrospective observational study
Eunchan OH ; Suck Ju CHO ; Il Jae WANG ; Hyung Bin KIM ; Soon Chang PARK ; Sung Hwa LEE ; Byung Kwan BAE ; Young Mo CHO ; Dae Sup LEE ; Kwang Hee YEO ; Seong Yeon HWANG
Journal of the Korean Society of Emergency Medicine 2019;30(6):490-500
OBJECTIVE:
Under the overcrowding conditions of large emergency departments, the proportion of elderly patients is increasing in Korea. This paper describes the necessity of the preparedness of Korean emergency departments and society for the rapidly aging population.
METHODS:
This was a retrospective observational study. Patients who presented to a tertiary hospital emergency department (ED) in one year were included. The use of medical resources between young adult (≥20 and <65 years of age) and elderly patients (≥65 years of age) was compared.
RESULTS:
This study included 26,712 patients. The young adult group and the elderly group was 15,021 (56.2%) and 11,691 (43.8%), respectively. The ratio of firehouse ambulance visit mode (28.6%) and inter-facility transfer visit mode (18.9%) of the elderly group was higher compared to those of the young adult group (26.4% and 10.6%, P<0.001). The elderly group visited more at daytime (P<0.001). With aging, the admission ratios of the elderly group to the general ward (38.9%) and intensive care unit (13.0%) were higher than the young adult group (9.8% and 4.3%, P<0.001). The mean ED length of stay and mean length of hospitalization of the elderly group was longer than that of the young adult group (P<0.001). The medical cost of the elderly group was approximately three times higher than that of the young adult group.
CONCLUSION
Elderly patients required more emergency medical resources in both the prehospital and hospital stages. Korean emergency departments and society require efforts for not only expansion but also the appropriate use of medical resources in a rapidly aging population.
7.Female Gender is a Poor Predictive Factor of Functional Dyspepsia Resolution after Helicobacter pylori Eradication: A Prospective, Multi-center Korean Trial.
Sung Eun KIM ; Nayoung KIM ; Seon Mee PARK ; Won Hee KIM ; Gwang Ho BAIK ; Yunju JO ; Kyung Sik PARK ; Ju Yup LEE ; Ki Nam SHIM ; Gwang Ha KIM ; Bong Eun LEE ; Su Jin HONG ; Seon Young PARK ; Suck Chei CHOI ; Jung Hwan OH ; Hyun Jin KIM
The Korean Journal of Gastroenterology 2018;72(6):286-294
BACKGROUND/AIMS: The predictive factors of functional dyspepsia (FD) remain controversial. Therefore, we sought to investigate symptom responses in FD patients after Helicobacter pylori (H. pylori) eradication and used predictive factor analysis to identify significant factors of FD resolution at one-year after commencing eradication therapy. METHODS: This prospective, multi-center clinical trial was performed on 65 FD patients that met Rome III criteria and had H. pylori infection. Symptom responses and factors that predicted poor response were determined by analysis one year after commencing H. pylori eradication therapy. RESULTS: A total of 63 patients completed the one-year follow-up. When an eradication success group (n=60) and an eradication failure group (n=3) were compared with respect to FD response rate at one year, results were as follows; complete response 73.3% and 0.0%, satisfactory response 1.7% and 0.0%, partial response 10.0% and 33.3%, and refractory response 15.0% and 66.7%, respectively (p=0.013). Univariate analysis showed persistent H. pylori infection (p=0.021), female gender (p=0.025), and medication for FD during the study period (p=0.013) were associated with poor FD response at one year. However, age, smoking, alcohol consumption, and underlying disease were not found to affect response. Finally, multivariate analysis showed that female gender (OR, 4.70; 95% CI, 1.17-18.88) was the sole independent risk factor of poor FD response at one year after commencing H. pylori eradication therapy. CONCLUSIONS: Female gender was found to predict poor response in FD patients despite H. pylori eradication. Furthermore, successful H. pylori eradication appears to be associated with FD improvement, but the number of non-eradicated patients was too small to conclude.
Alcohol Drinking
;
Dyspepsia*
;
Female*
;
Follow-Up Studies
;
Helicobacter pylori*
;
Helicobacter*
;
Humans
;
Multivariate Analysis
;
Prospective Studies*
;
Risk Factors
;
Smoke
;
Smoking
;
Symptom Assessment
8.A Case of Unilateral Compensatory Hyperhidrosis Developed after Thoracotomy.
Sung Soo HAN ; Eui Hyun OH ; Jae Min SHIN ; Joo Yeon KO ; Young Suck RO ; Jeong Eun KIM
Korean Journal of Dermatology 2017;55(4):274-275
No abstract available.
Hyperhidrosis*
;
Thoracotomy*
9.Evaluation of the Efficacy and Safety of DA-9601 versus Its New Formulation, DA-5204, in Patients with Gastritis: Phase III, Randomized, Double-Blind, Non-Inferiority Study.
Yoon Jin CHOI ; Dong Ho LEE ; Myung Gyu CHOI ; Sung Joon LEE ; Sung Kook KIM ; Geun Am SONG ; Poong Lyul RHEE ; Hwoon Yong JUNG ; Dae Hwan KANG ; Yong Chan LEE ; Si Hyung LEE ; Suck Chei CHOI ; Ki Nam SHIM ; Sang Yong SEOL ; Jeong Seop MOON ; Yong Woon SHIN ; Hyun Soo KIM ; Soo Teik LEE ; Jin Woong CHO ; Eun Kwang CHOI ; Oh Young LEE ; Jin Seok JANG
Journal of Korean Medical Science 2017;32(11):1807-1813
This study compared the efficacy of DA-9601 (Dong-A ST Co., Seoul, Korea) and its new formulation, DA-5204 (Dong-A ST Co.), for treating erosive gastritis. This phase III, randomized, multicenter, double-blind, non-inferiority trial randomly assigned 434 patients with endoscopically proven gastric mucosal erosions into two groups: DA-9601 3 times daily or DA-5,204 twice daily for 2 weeks. The final analysis included 421 patients (DA-5204, 209; DA-9601, 212). The primary endpoint (rate of effective gastric erosion healing) and secondary endpoints (cure rate of endoscopic erosion and gastrointestinal [GI] symptom relief) were assessed using endoscopy after the treatment. Drug-related adverse events (AEs), including GI symptoms, were also compared. At week 2, gastric healing rates with DA-5204 and DA-9601 were 42.1% (88/209) and 42.5% (90/212), respectively. The difference between the groups was −0.4% (95% confidence interval, −9.8% to 9.1%), which was above the non-inferiority margin of −14%. The cure rate of gastric erosion in both groups was 37.3%. The improvement rates of GI symptoms with DA-5204 and DA-9601 were 40.4% and 40.8%, respectively. There were no statistically significant differences between the two groups in both secondary endpoints. AEs were reported in 18 (8.4%) patients in the DA-5204 group and 19 (8.8%) in the DA-9601 group. Rates of AE were not different between the two groups. No serious AE or adverse drug reaction (ADR) occurred. These results demonstrate the non-inferiority of DA-5204 compared to DA-9601. DA-5204 is as effective as DA-9601 in the treatment of erosive gastritis. Registered randomized clinical trial at ClinicalTrials.gov (NCT02282670)
Artemisia
;
Double-Blind Method
;
Drug-Related Side Effects and Adverse Reactions
;
Endoscopy
;
Gastritis*
;
Humans
;
Seoul
10.Levofloxacin-induced Fixed Drug Eruption: A Case Report.
Sung Soo HAN ; Eui Hyun OH ; Hyoung Il KWON ; Joo Yeon KO ; Young Suck RO ; Jeong Eun KIM
Korean Journal of Dermatology 2017;55(7):445-448
Fixed drug eruptions (FDEs) are characterized by the presence of site-specific recurrence of a solitary or multiple, well-circumscribed, erythematous macules or patches that recur with each exposure to a particular medication. Several drugs including non-steroidal anti-inflammatory drugs, non-opioid analgesics, sedatives, anticonvulsants, sulfonamides, and tetracycline have been associated with an increased risk of inducing FDE. A 45-year-old woman with known history of levofloxacin use presented with erythematous patches on her face and left forearm. Although a patch test to levofloxacin showed a negative reaction, intradermal tests to assess hypersensitivity to levofloxacin were positive, and she was diagnosed with levofloxacin-induced FDE. Her antibiotic was switched to moxifloxacin, which she tolerated well. Moxifloxacin did not show cross-reactivity. Because of the widespread use of fluoroquinolones, it is important to consider these as possible etiological agents in cases of FDE. We describe a case of FDE diagnosed using positive intradermal tests to detect sensitivity to levofloxacin.
Analgesics
;
Anticonvulsants
;
Drug Eruptions*
;
Female
;
Fluoroquinolones
;
Forearm
;
Humans
;
Hypersensitivity
;
Hypnotics and Sedatives
;
Intradermal Tests
;
Levofloxacin
;
Middle Aged
;
Patch Tests
;
Recurrence
;
Sulfonamides
;
Tetracycline

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