1.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.
2.Clinical Outcomes Following Letrozole Treatment according to Estrogen Receptor Expression in Postmenopausal Women: LETTER Study (KBCSG-006)
Sung Gwe AHN ; Seok Jin NAM ; Sei Hyun AHN ; Yongsik JUNG ; Heung Kyu PARK ; Soo Jung LEE ; Sung Soo KANG ; Wonshik HAN ; Kyong Hwa PARK ; Yong Lai PARK ; Jihyoun LEE ; Hyun Jo YOUN ; Jun Hyun KIM ; Youngbum YOO ; Jeong-Yoon SONG ; Byung Kyun KO ; Geumhee GWAK ; Min Sung CHUNG ; Sung Yong KIM ; Seo Heon CHO ; Doyil KIM ; Myung-Chul CHANG ; Byung In MOON ; Lee Su KIM ; Sei Joong KIM ; Min Ho PARK ; Tae Hyun KIM ; Jihyoung CHO ; Cheol Wan LIM ; Young Tae BAE ; Gyungyub GONG ; Young Kyung BAE ; Ahwon LEE ; Joon JEONG
Journal of Breast Cancer 2021;24(2):164-174
Purpose:
In this trial, we investigated the efficacy and safety of adjuvant letrozole for hormone receptor (HR)-positive breast cancer. Here, we report the clinical outcome in postmenopausal women with HR-positive breast cancer treated with adjuvant letrozole according to estrogen receptor (ER) expression levels.
Methods:
In this multi-institutional, open-label, observational study, postmenopausal patients with HR-positive breast cancer received adjuvant letrozole (2.5 mg/daily) for 5 years unless they experienced disease progression or unacceptable toxicity or withdrew their consent. The patients were stratified into the following 3 groups according to ER expression levels using a modified Allred score (AS): low, intermediate, and high (AS 3–4, 5–6, and 7–8, respectively). ER expression was centrally reviewed. The primary objective was the 5-year disease-free survival (DFS) rate.
Results:
Between April 25, 2010, and February 5, 2014, 440 patients were enrolled. With a median follow-up of 62.0 months, the 5-year DFS rate in all patients was 94.2% (95% confidence interval [CI], 91.8–96.6). The 5-year DFS and recurrence-free survival (RFS) rates did not differ according to ER expression; the 5-year DFS rates were 94.3% and 94.1%in the low-to-intermediate and high expression groups, respectively (p = 0.6), and the corresponding 5-year RFS rates were 95.7% and 95.4%, respectively (p = 0.7). Furthermore, 25 patients discontinued letrozole because of drug toxicity.
Conclusion
Treatment with adjuvant letrozole showed very favorable treatment outcomes and good tolerability among Korean postmenopausal women with ER-positive breast cancer, independent of ER expression.
3.The effect of probiotics supplementation in postoperative cancer patients: a prospective pilot study
Hyeji KWON ; Song Hwa CHAE ; Hyo Jin JUNG ; Hyeon Min SHIN ; O-Hyun BAN ; Jungwoo YANG ; Jung Ha KIM ; Ji Eun JEONG ; Hae Myung JEON ; Yong Won KANG ; Chan Kum PARK ; Daeyoun DAVID WON ; Jong Kyun LEE
Annals of Surgical Treatment and Research 2021;101(5):281-290
Purpose:
Microbiota manipulation through selected probiotics may be a promising tool to prevent cancer development as well as onset, to improve clinical efficacy for cancer treatments. The purpose of this study was to evaluate change in microbiota composition after-probiotics supplementation and assessed the efficacy of probiotics in improving quality of life (QOL) in postoperative cancer patients.
Methods:
Stool samples were collected from 30 cancer patients from February to October 2020 before (group I) and after (group II) 8 weeks of probiotics supplementation. We performed 16S ribosomal RNA gene sequencing to evaluate differences in gut microbiota between groups by comparing gut microbiota diversity, overall composition, and taxonomic signature abundance. The health-related QOL was evaluated through the EORTC Quality of life Questionnaire Core 30 questionnaire.
Results:
Statistically significant differences were noted in group II; increase of Shannon and Simpson index (P = 0.004 and P = 0.001), decrease of Bacteroidetes and Fusobacteria at the phylum level (P = 0.032 and P = 0.014, retrospectively), increased of beneficial bacteria such as Weissella (0.096% vs. 0.361%, P < 0.004), Lactococcus (0.023% vs. 0.16%, P < 0.001), and Catenibacterium (0.0% vs. 0.005%, P < 0.042) at the genus level. There was a significant improvement in sleep disturbance (P = 0.039) in group II.
Conclusion
Gut microbiota in cancer patients can be manipulated by specific probiotic strains, result in an altered microbiota. Microbiota modulation by probiotics can be considered as part of a supplement that helps to increase gut microbiota diversity and improve QOL in cancer patients after surgery.
4.Clinical Outcomes Following Letrozole Treatment according to Estrogen Receptor Expression in Postmenopausal Women: LETTER Study (KBCSG-006)
Sung Gwe AHN ; Seok Jin NAM ; Sei Hyun AHN ; Yongsik JUNG ; Heung Kyu PARK ; Soo Jung LEE ; Sung Soo KANG ; Wonshik HAN ; Kyong Hwa PARK ; Yong Lai PARK ; Jihyoun LEE ; Hyun Jo YOUN ; Jun Hyun KIM ; Youngbum YOO ; Jeong-Yoon SONG ; Byung Kyun KO ; Geumhee GWAK ; Min Sung CHUNG ; Sung Yong KIM ; Seo Heon CHO ; Doyil KIM ; Myung-Chul CHANG ; Byung In MOON ; Lee Su KIM ; Sei Joong KIM ; Min Ho PARK ; Tae Hyun KIM ; Jihyoung CHO ; Cheol Wan LIM ; Young Tae BAE ; Gyungyub GONG ; Young Kyung BAE ; Ahwon LEE ; Joon JEONG
Journal of Breast Cancer 2021;24(2):164-174
Purpose:
In this trial, we investigated the efficacy and safety of adjuvant letrozole for hormone receptor (HR)-positive breast cancer. Here, we report the clinical outcome in postmenopausal women with HR-positive breast cancer treated with adjuvant letrozole according to estrogen receptor (ER) expression levels.
Methods:
In this multi-institutional, open-label, observational study, postmenopausal patients with HR-positive breast cancer received adjuvant letrozole (2.5 mg/daily) for 5 years unless they experienced disease progression or unacceptable toxicity or withdrew their consent. The patients were stratified into the following 3 groups according to ER expression levels using a modified Allred score (AS): low, intermediate, and high (AS 3–4, 5–6, and 7–8, respectively). ER expression was centrally reviewed. The primary objective was the 5-year disease-free survival (DFS) rate.
Results:
Between April 25, 2010, and February 5, 2014, 440 patients were enrolled. With a median follow-up of 62.0 months, the 5-year DFS rate in all patients was 94.2% (95% confidence interval [CI], 91.8–96.6). The 5-year DFS and recurrence-free survival (RFS) rates did not differ according to ER expression; the 5-year DFS rates were 94.3% and 94.1%in the low-to-intermediate and high expression groups, respectively (p = 0.6), and the corresponding 5-year RFS rates were 95.7% and 95.4%, respectively (p = 0.7). Furthermore, 25 patients discontinued letrozole because of drug toxicity.
Conclusion
Treatment with adjuvant letrozole showed very favorable treatment outcomes and good tolerability among Korean postmenopausal women with ER-positive breast cancer, independent of ER expression.
5.Development of the Stress and Anxiety to Viral Epidemics-9 (SAVE-9) Scale for Assessing Work-related Stress and Anxiety in Healthcare Workers in Response to Viral Epidemics
Seockhoon CHUNG ; Hwa Jung KIM ; Myung Hee AHN ; Sungook YEO ; Joohee LEE ; Kyumin KIM ; Solbi KANG ; Sooyeon SUH ; Yong-Wook SHIN
Journal of Korean Medical Science 2021;36(47):e319-
Background:
The coronavirus disease 2019, or COVID-19, has had a major psychological impact on healthcare workers. However, very few scales are available to specifically assess work-related stress and anxiety in healthcare workers responding to a viral epidemic. This study developed a new assessment tool, the Stress and Anxiety to Viral Epidemics-9 (SAVE-9) and aimed to validate it among healthcare workers directly affected by COVID-19 in Korea.
Methods:
A total of 1,019 healthcare workers responded through anonymous questionnaires during April 20–30, 2020. Exploratory factor analysis (EFA) was conducted to explore the construct validity, and the reliability was assessed using internal consistency measures of Cronbach's alpha coefficients. Receiver operating characteristic analysis was conducted to define the most appropriate cut-off point of SAVE-9 using the Generalized Anxiety Disorder-7 scale (GAD-7; ≥ 5). Second, Spearman's rank correlation coefficient was used to establish convergent validity for the SAVE-9 questionnaire with GAD-7 and the Patient Health Questionnaire-9.
Results:
The nine-item scale had satisfactory internal consistency (Cronbach's α = 0.795). It adopted a two-factor structure: 1) anxiety regarding viral epidemics and 2) work-related stress associated with viral epidemics. A cut-off score of 22 for the SAVE-9 ascertained levels of stress and anxiety in response to a viral epidemic in healthcare workers that warranted clinical attention. Correlations between the SAVE-9 and the other scales were statistically significant (P < 0.05).
Conclusion
The results suggest that the SAVE-9 is a useful, reliable, and valid tool to evaluate stress and anxiety responses in healthcare workers during viral epidemics.
6.The Influence of Non-Linear Frequency Compression on the Perception of Speech and Music in Patients with High Frequency Hearing Loss
Jungmin AHN ; Ji Eun CHOI ; Ju Yong KANG ; Ik Joon CHOI ; Myung-Chul LEE ; Byeong-Cheol LEE ; Sung Hwa HONG ; Il Joon MOON
Journal of Audiology & Otology 2021;25(2):80-88
Background and Objectives:
Non-linear frequency compression (NLFC) technology compresses and shifts higher frequencies into a lower frequency area that has better residual hearing. Because consonants are uttered in the high-frequency area, NLFC could provide better speech understanding. The aim of this study was to investigate the clinical effectiveness of NLFC technology on the perception of speech and music in patients with high-frequency hearing loss.
Subjects and Methods:
Twelve participants with high-frequency hearing loss were tested in a counter-balanced order, and had two weeks of daily experience with NLFC set on/off prior to testing. Performance was repeatedly evaluated with consonant tests in quiet and noise environments, speech perception in noise, music perception and acceptableness of sound quality rating tasks. Additionally, two questionnaires (the Abbreviated Profile of Hearing Aid Benefit and the Korean version of the International Outcome Inventory-Hearing Aids) were administered.
Results:
Consonant and speech perception improved with hearing aids (NLFC on/off conditions), but there was no significant difference between NLFC on and off states. Music perception performances revealed no notable difference among unaided and NLFC on and off states. The benefits and satisfaction ratings between NLFC on and off conditions were also not significantly different, based on questionnaires, however great individual variability preferences were noted.
Conclusions
Speech perception as well as music perception both in quiet and noise environments was similar between NLFC on and off states, indicating that real world benefits from NLFC technology may be limited in Korean adult hearing aid users.
7.2019 Tabletop Exercise for Laboratory Diagnosis and Analyses of Unknown Disease Outbreaks by the Korea Centers for Disease Control and Prevention
Il-Hwan KIM ; Jun Hyeong JANG ; Su-Kyoung JO ; Jin Sun NO ; Seung-Hee SEO ; Jun-Young KIM ; Sang-Oun JUNG ; Jeong-Min KIM ; Sang-Eun LEE ; Hye-Kyung PARK ; Eun-Jin KIM ; Jun Ho JEON ; Myung-Min CHOI ; Bo yeong RYU ; Yoon Suk JANG ; Hwa mi KIM ; Jin LEE ; Seung-Hwan SHIN ; Hee Kyoung KIM ; Eun-Kyoung KIM ; Ye Eun PARK ; Cheon-Kwon YOO ; Sang-Won LEE ; Myung-Guk HAN ; Gi-Eun RHIE ; Byung Hak KANG
Osong Public Health and Research Perspectives 2020;11(5):280-285
Objectives:
The Korea Centers for Disease Control and Prevention has published “A Guideline for Unknown Disease Outbreaks (UDO).” The aim of this report was to introduce tabletop exercises (TTX) to prepare for UDO in the future.
Methods:
The UDO Laboratory Analyses Task Force in Korea Centers for Disease Control and Prevention in April 2018, assigned unknown diseases into 5 syndromes, designed an algorithm for diagnosis, and made a panel list for diagnosis by exclusion. Using the guidelines and laboratory analyses for UDO, TTX were introduced.
Results:
Since September 9th , 2018, the UDO Laboratory Analyses Task Force has been preparing TTX based on a scenario of an outbreak caused by a novel coronavirus. In December 2019, through TTX, individual missions, epidemiological investigations, sample treatments, diagnosis by exclusions, and next generation sequencing analysis were discussed, and a novel coronavirus was identified as the causal pathogen.
Conclusion
Guideline and laboratory analyses for UDO successfully applied in TTX. Conclusions drawn from TTX could be applied effectively in the analyses for the initial response to COVID-19, an ongoing epidemic of 2019 - 2020. Therefore, TTX should continuously be conducted for the response and preparation against UDO.
8.Risk Factors and Comorbidities Associated With the Allergic Rhinitis Phenotype in Children According to the ARIA Classification
Sungsu JUNG ; So Yeon LEE ; Jisun YOON ; Hyun Ju CHO ; Young Ho KIM ; Dong In SUH ; Song I YANG ; Ji won KWON ; Gwang Cheon JANG ; Yong Han SUN ; Sung Il WOO ; You Sook YOUN ; Kang Seo PARK ; Eun LEE ; Hwa Jin CHO ; Myung Hee KOOK ; Hye Ryoung YI ; Hai Lee CHUNG ; Ja Hyeong KIM ; Hyung Young KIM ; Jin A JUNG ; Hyang Ok WOO ; Jeom Kyu LEE ; Woo Sung CHANG ; Nam Hee DO ; Hyejoo CHO ; Soo Jong HONG
Allergy, Asthma & Immunology Research 2020;12(1):72-85
PURPOSE: Data are lacking on the association between the allergic rhinitis (AR) phenotype and sensitization to specific allergens or bronchial hyperresponsiveness (BHR) in children. We here investigated risk factors and comorbidities, including sensitization to specific allergens and BHR, for the AR phenotype by AR and its Impact on Asthma (ARIA) classification in a general population-based birth cohort study. METHODS: We enrolled 606 children aged 7 years from the Panel Study of Korean Children. The AR phenotype was assigned in accordance with the ARIA classification in children. Skin prick tests and Provocholine provocation test were performed. Risk factors and comorbidities for AR phenotypes were then analyzed. RESULTS: The prevalence of mild and moderate to severe AR in our study cohort was 37.2% and 8.8%, respectively. Recent use of analgesics or antipyretics and current cat ownership were associated with the risk of mild persistent AR. Sensitizations to Dermatophagoides Pteronyssinus (Der p), Japanese hop and cat were associated with moderate to severe persistent AR. Children with moderate to severe AR had a higher risk of current asthma and BHR compared to mild AR cases (adjusted odds ratio [aOR], 5.26; 95% confidence interval [CI], 1.77–15.62). Moderate to severe AR with allergic sensitization was associated with the highest risk of BHR (aOR, 11.77; 95% CI, 3.40–40.74). CONCLUSIONS: Moderate to severe-persistent AR is more closely related to respiratory comorbidities and sensitizations than mild AR. Stratifying the AR phenotype by ARIA classification may assist in disease management.
Allergens
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Analgesics
;
Animals
;
Antipyretics
;
Asian Continental Ancestry Group
;
Asthma
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Bronchial Hyperreactivity
;
Cats
;
Child
;
Classification
;
Cohort Studies
;
Comorbidity
;
Dermatophagoides pteronyssinus
;
Disease Management
;
Humans
;
Methacholine Chloride
;
Odds Ratio
;
Ownership
;
Parturition
;
Phenotype
;
Prevalence
;
Rhinitis, Allergic
;
Risk Factors
;
Skin
9.Effects of Appointing a Full-Time Neurointensivist to Run a Closed-Type Neurological Intensive Care Unit
Myung Ah KO ; Jung Hwa LEE ; Joong Goo KIM ; Suyeon JEONG ; Dong Wha KANG ; Chae Man LIM ; Sang Ahm LEE ; Kwang Kuk KIM ; Sang Beom JEON
Journal of Clinical Neurology 2019;15(3):360-368
BACKGROUND AND PURPOSE: To investigate whether appointing a full-time neurointensivist to manage a closed-type neurological intensive care unit (NRICU) improves the quality of critical care and patient outcomes. METHODS: This study included patients admitted to the NRICU at a university hospital in Seoul, Korea. Two time periods were defined according to the presence of a neurointensivist in the preexisting open-type NRICU: the before and after periods. Hospital medical records were queried and compared between these two time periods, as were the biannual satisfaction survey results for the families of patients. RESULTS: Of the 15,210 patients in the neurology department, 2,199 were admitted to the NRICU (n=995 and 1,204 during the before and after periods, respectively; p<0.001). The length of stay was shorter during the after than during the before period in both the NRICU (3 vs. 4 days; p<0.001) and the hospital overall (12.5 vs. 14.0 days; p<0.001). Neurological consultations (2,070 vs. 3,097; p<0.001) and intrahospital transfers from general intensive care units to the NRICU (21 vs. 40; p=0.111) increased from the before to after the period. The mean satisfaction scores of the families of the patients also increased, from 78.3 to 89.7. In a Cox proportional hazards model, appointing a neurointensivist did not result in a statistically significant change in 6-month mortality (hazard ratio, 0.82; 95% confidence interval, 0.652–1.031; p=0.089). CONCLUSIONS: Appointing a full-time neurointensivist to manage a closed-type NRICU had beneficial effects on quality indicators and patient outcomes.
Critical Care Outcomes
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Critical Care
;
Humans
;
Intensive Care Units
;
Korea
;
Length of Stay
;
Medical Records
;
Mortality
;
Neurology
;
Proportional Hazards Models
;
Referral and Consultation
;
Seoul
10.Indoor pet ownership in infancy is a risk factor for the development of sensitization to pets and asthma in childhood
Sungsu JUNG ; Soo Ran NOH ; So Yeon LEE ; Jisun YOON ; Hyun Ju CHO ; Young Ho KIM ; Dong In SUH ; Song I YANG ; Ji won KWON ; Gwang Cheon JANG ; Yong Han SUN ; Sung Il WOO ; You Sook YOUN ; Kang Seo PARK ; Eun LEE ; Hwa Jin CHO ; Myung Hee KOOK ; Hye Ryoung YI ; Hai Lee CHUNG ; Ja Hyeong KIM ; Hyung Young KIM ; Jin A JUNG ; Hyang Ok WOO ; Soo Jong HONG
Allergy, Asthma & Respiratory Disease 2019;7(2):99-105
PURPOSE: It is controversial whether indoor pet exposure is either a risk or protective factor developing sensitization to pet allergens or asthma. Therefore, we investigated whether indoor pet ownership entails a risk for the development of asthma and sensitization in childhood. METHODS: The Panel Study of Korean Children (PSKC) is a general-population-based birth cohort study that recruited 2,078 mother-baby dyads in Korea between April and July of 2008. Among 1,577 children who were followed up in 2015, 559 underwent skin prick tests, spirometry and bronchial provocation tests using Provocholine. Having a cat or a dog and the prevalence of asthma were evaluated by using self-reported questionnaires and physicians’ medical records. RESULTS: During infancy, the rate of dog ownership was 4.5% (71 of 1,574) and that of cat ownership was 0.5% (8 of 1,574). Of the subjects, 7.9% (n=109) currently had at least 1 dog and 2.5% (n=34) had at least 1 cat. Pet ownership during infancy was associated with sensitization to cats or dogs (adjusted odds ratio [aOR], 4.24; 95% confidence interval [CI], 1.29–13.98), wheezing within 12 months (aOR, 5.56; 95% CI, 1.65–18.75) and current asthma (wheezing episode in the last 12 months+diagnosed asthma by physicians) (aOR, 6.36; 95% CI, 1.54–26.28). In contrast, pet ownership during the last 12 months was not associated with sensitization to cats or dogs or current asthma. CONCLUSION: Indoor pet exposure during infancy can be critical for developing sensitization to cats or dogs and asthma in childhood. Avoidance of pet exposure in early life may reduce sensitization to cats or dogs and development of asthma.
Allergens
;
Animals
;
Asthma
;
Bronchial Provocation Tests
;
Cats
;
Child
;
Cohort Studies
;
Dogs
;
Humans
;
Infant
;
Korea
;
Medical Records
;
Methacholine Chloride
;
Odds Ratio
;
Ownership
;
Parturition
;
Pets
;
Prevalence
;
Protective Factors
;
Respiratory Sounds
;
Risk Factors
;
Skin
;
Spirometry

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