1.Efficacy and Safety of Galcanezumab as a Preventive Treatment for Episodic Migraine in South Korean Patients: A Post-Hoc Analysis of a Phase 3 Clinical Trial
Byung-Kun KIM ; Soo-Jin CHO ; Jeong Hee HAN ; Grazia DELL’AGNELLO ; Tommaso PANNI ; Manho KIM ; Kyungmi OH ; Heui-Soo MOON ; Min Kyung CHU
Journal of Clinical Neurology 2023;19(5):483-494
Background:
and Purpose The estimated prevalence of migraines in South Korea is 6.0%, with affected patients having unmet needs. The efficacy, safety, and tolerability of galcanezumab, a humanized monoclonal antibody, for episodic migraine (EM) prevention was evaluated in South Korean patients.
Methods:
During the double-blind period of the EVOLVE-2 phase 3 trial, patients with EM were randomized into placebo, 120 mg-galcanezumab, and 240-mg galcanezumab treatment groups. The primary endpoint was the overall mean change from baseline in the number of monthly migraine headache days during the 6-month double-blind period. We conducted a post-hoc analysis of the South Korean cohort in EVOLVE-2.
Results:
Among 98 South Korean patients in the intent-to-treat population, significant changes from baseline were observed in the number of monthly migraine headache days in the 240-mg galcanezumab group compared with the placebo group (-2.64, p=0.013), in the percentage of patients with ≥50% reduction in the number of monthly migraine headache days (120 mg: odds ratio=2.43, p=0.030; 240 mg: odds ratio=2.60, p=0.019), in the number of monthly migraine headache days with acute medication use (120 mg: -2.22, p=0.006; 240 mg: -2.23, p=0.005), and in the Migraine-Specific Quality-of-Life Role Function-Restrictive (120 mg: 8.34, p=0.040). Numerical improvements from baseline were observed relative to the placebo group in at least one galcanezumab group for: the percentage of patients with ≥75% reduction in the number of monthly migraine headache days functional impairment, and disease severity. The most common treatment-emergent adverse event in the combined galcanezumab group was injection site reaction, which led to treatment discontinuation for one patient.
Conclusions
Galcanezumab treatment demonstrated efficacy and a favorable safety and tolerability profile in South Korean patients with EM.
2.Updates of Evidence-Based Nursing Practice Guideline for Prevention of Venous Thromboembolism
Yong Ae CHO ; Young EUN ; Seon Heui LEE ; Mi Yang JEON ; Jin Hee JUNG ; Min Young HAN ; Nari KIM ; Jin Hyung HUH
Journal of Korean Clinical Nursing Research 2023;29(1):24-41
Purpose:
This study aimed to update the previously published nursing practice guideline for prevention of venous thromboembolism (VTE).
Methods:
The guideline was updated according to the manuals developed by National Institute for Health and Care Excellence (NICE) and Scottish Intercollegiate Guidelines Network (SIGN), and a Handbook for Clinical Practice Guideline Developer Version 10.
Results:
The updated nursing practice guideline for prevention of VTE was consisted of 16 domains, 46 subdomains, and 216 recommendations. The recommendations in each domain were: 4 general issues, 8 assessment of risk and bleeding factors, 5 interventions for prevention of VTE, 18 mechanical interventions, 36 pharmacological interventions, 36 VTE prevention starategies for medical patients, 25 for cancer patients, 13 for pregnancy, 8 for surgical patients, 7 for thoractic and cardiac surgery, 16 for orthopedic surgery, 10 for cranial and spinal surgery, 5 for vascular surgery, 13 for other surgery, 3 educations and information, and 2 documentation and report. For these recommendations, the level of evidence was 32.1% for level I, 51.8% for level II, and 16.1% for level III according to the infectious diseases society of America (IDSA) rating system. A total of 112 new recommendations were developed and 49 previous recommendations were deleted.
Conclusion
The updated nursing practice guideline for prevention of VTE is expected to serve as an evidence-based practice guideline for prevention of VTE in South Korea. It is recommended that this guideline will disseminate to clinical nursing settings nationwide to improve the effectiveness of prevention of VTE practice.
3.Evaluation of Current Resources Available for Community-Based Cardiac Rehabilitation in Korea:A Nationwide Survey Study
Chul KIM ; Jidong SUNG ; Jae-Young HAN ; Sungju JEE ; Jang Woo LEE ; Jong Hwa LEE ; Won-Seok KIM ; Heui Je BANG ; Sora BAEK ; Kyung Lim JOA ; Ae Ryoung KIM ; So Young LEE ; Jihee KIM ; Chung Reen KIM ; Oh Pum KWON
Journal of Korean Medical Science 2022;37(14):e109-
Background:
In Korea, the actual distribution of cardiac rehabilitation (CR) to the clinical field is insufficient due to the many barriers for cardiovascular patients to participate in CR. Community-based CR is a useful alternative to overcome these obstacles. Through a nationwide survey, we investigated the possibility of regional medical and public health management institutes which can be in charge of community-based CR in Korea.
Methods:
The questionnaires on recognition of CR and current available resources in health-related institutions were developed with reference to the CR evaluation tools of York University and the International Council of Cardiovascular Prevention and Rehabilitation.The questionnaires were sent to regional public and private medical institutions and public health management institutions.
Results:
In total, 2,267 questionnaires were sent to 1,186 institutions. There were 241 and 242 responses from 173 and 179 regional private and public medical institutions, respectively. And a total of 244 responses were gathered from 180 public health management institutions. Although many institutions were equipped with the necessary facilities for exercise training, there were few patient-monitoring systems during exercise. Most institutions were aware of the need for CR, but were burdened with the cost of establishing personnel and facilities to operate CR.
Conclusion
Most regional medical, and public health management institutions in Korea are unprepared for the implementation of community-based CR programs. To encourage the utilization of such, there should be efforts to establish a national consensus.
4.Change of Dendritic Cell Subsets Involved in Protection Against Listeria monocytogenes Infection in ShortTerm-Fasted Mice
Young-Jun JU ; Kyung-Min LEE ; Girak KIM ; Yoon-Chul KYE ; Han Wool KIM ; Hyuk CHU ; Byung-Chul PARK ; Jae-Ho CHO ; Pahn-Shick CHANG ; Seung Hyun HAN ; Cheol-Heui YUN
Immune Network 2022;22(2):e16-
The gastrointestinal tract is the first organ directly affected by fasting. However, little is known about how fasting influences the intestinal immune system. Intestinal dendritic cells (DCs) capture antigens, migrate to secondary lymphoid organs, and provoke adaptive immune responses. We evaluated the changes of intestinal DCs in mice with short-term fasting and their effects on protective immunity against Listeria monocytogenes(LM). Fasting induced an increased number of CD103 + CD11b − DCs in both small intestinal lamina propria (SILP) and mesenteric lymph nodes (mLN). The SILP CD103 + CD11b − DCs showed proliferation and migration, coincident with increased levels of GM-CSF and C-C chemokine receptor type 7, respectively. At 24 h post-infection with LM, there was a significant reduction in the bacterial burden in the spleen, liver, and mLN of the short-term-fasted mice compared to those fed ad libitum. Also, short-term-fasted mice showed increased survival after LM infection compared with ad libitum-fed mice. It could be that significantly high TGF-β2 and Aldh1a2 expression in CD103 + CD11b - DCs in mice infected with LM might affect to increase of Foxp3 + regulatory T cells. Changes of major subset of DCs from CD103 + to CD103 - may induce the increase of IFN-γ–producing cells with forming Th1-biased environment.Therefore, the short-term fasting affects protection against LM infection by changing major subset of intestinal DCs from tolerogenic to Th1 immunogenic.
5.Regional Differences in Blood-Brain Barrier Permeability in Cognitively Normal Elderly Subjects: A Dynamic Contrast-Enhanced MRI-Based Study
Il Heon HA ; Changmok LIM ; Yeahoon KIM ; Yeonsil MOON ; Seol-Heui HAN ; Won-Jin MOON
Korean Journal of Radiology 2021;22(7):1152-1162
Objective:
This study aimed to determine whether there are regional differences in the blood-brain barrier (BBB) permeability of cognitively normal elderly participants and to identify factors influencing BBB permeability with a clinically feasible, 10-minute dynamic contrast-enhanced (DCE) MRI protocol.
Materials and Methods:
This IRB-approved prospective study recruited 35 cognitively normal adults (26 women; mean age, 64.5 ± 5.6 years) who underwent DCE T1-weighted imaging. Permeability maps (Ktrans) were coregistered with masks to calculate the mean regional values. The paired t test and Friedman test were used to compare Ktrans between different regions. The relationships between Ktrans and the factors of age, sex, education, cognition score, vascular risk burden, vascular factors on imaging, and medial temporal lobar atrophy were assessed using Pearson correlation and the Spearman rank test.
Results:
The mean permeability rates of the right and left hippocampi, as assessed with automatic segmentation, were 0.529 ± 0.472 and 0.585 ± 0.515 (Ktrans, x 10-3 min-1 ), respectively. Concerning the deep gray matter, the Ktrans of the thalamus was significantly greater than those of the putamen and hippocampus (p = 0.007, p = 0.041). Regarding the white matter, the Ktrans value of the occipital white matter was significantly greater than those of the frontal, cingulate, and temporal white matter (p < 0.0001, p = 0.0007, p = 0.0002). The variations in Ktrans across brain regions were not related to age, cognitive score, vascular risk burden, vascular risk factors on imaging, or medial temporal lobar atrophy in the study group.
Conclusion
Our study demonstrated regional differences in BBB permeability (Ktrans) in cognitively normal elderly adults using a clinically acceptable 10-minutes DCE imaging protocol. The regional differences suggest that the integrity of the BBB varies across the brains of cognitively normal elderly adults. We recommend considering regional differences in Ktrans values when evaluating BBB permeability in patients with neurodegenerative diseases.
6.Intranasal Vaccination with OuterMembrane Protein of Orientia tsutsugamushi induces Protective Immunity Against Scrub Typhus
Sung-Moo PARK ; Min Jeong GU ; Young-Jun JU ; In Su CHEON ; Kyu-Jam HWANG ; Byoungchul GILL ; Byoung-Shik SHIM ; Hang-Jin JEONG ; Young Min SON ; Sangho CHOI ; Woonhee JEUNG ; Seung Hyun HAN ; Hyuk CHU ; Cheol-Heui YUN
Immune Network 2021;21(2):e14-
Scrub typhus develops after the individual is bitten by a trombiculid mite infected with Orientia tsutsugamushi. Since it has been reported that pneumonia is frequently observed in patients with scrub typhus, we investigated whether intranasal (i.n.) vaccination with the outer membrane protein of O. tsutsugamushi (OMPOT) would induce a protective immunity against O. tsutsugamushi infection. It was particular interest that when mice were infected with O. tsutsugamushi, the bacteria disseminated into the lungs, causing pneumonia. The i.n. vaccination with OMPOT induced IgG responses in serum and bronchoalveolar lavage (BAL) fluid. The anti-O. tsutsugamushi IgA Abs in BAL fluid after the vaccination showed a high correlation of the protection against O. tsutsugamushi. The vaccination induced strong Ag-specific Th1 and Th17 responses in the both spleen and lungs. In conclusion, the current study demonstrated that i.n. vaccination with OMPOT elicited protective immunity against scrub typhus in mouse with O. tsutsugamushi infection causing subsequent pneumonia.
7.Regional Differences in Blood-Brain Barrier Permeability in Cognitively Normal Elderly Subjects: A Dynamic Contrast-Enhanced MRI-Based Study
Il Heon HA ; Changmok LIM ; Yeahoon KIM ; Yeonsil MOON ; Seol-Heui HAN ; Won-Jin MOON
Korean Journal of Radiology 2021;22(7):1152-1162
Objective:
This study aimed to determine whether there are regional differences in the blood-brain barrier (BBB) permeability of cognitively normal elderly participants and to identify factors influencing BBB permeability with a clinically feasible, 10-minute dynamic contrast-enhanced (DCE) MRI protocol.
Materials and Methods:
This IRB-approved prospective study recruited 35 cognitively normal adults (26 women; mean age, 64.5 ± 5.6 years) who underwent DCE T1-weighted imaging. Permeability maps (Ktrans) were coregistered with masks to calculate the mean regional values. The paired t test and Friedman test were used to compare Ktrans between different regions. The relationships between Ktrans and the factors of age, sex, education, cognition score, vascular risk burden, vascular factors on imaging, and medial temporal lobar atrophy were assessed using Pearson correlation and the Spearman rank test.
Results:
The mean permeability rates of the right and left hippocampi, as assessed with automatic segmentation, were 0.529 ± 0.472 and 0.585 ± 0.515 (Ktrans, x 10-3 min-1 ), respectively. Concerning the deep gray matter, the Ktrans of the thalamus was significantly greater than those of the putamen and hippocampus (p = 0.007, p = 0.041). Regarding the white matter, the Ktrans value of the occipital white matter was significantly greater than those of the frontal, cingulate, and temporal white matter (p < 0.0001, p = 0.0007, p = 0.0002). The variations in Ktrans across brain regions were not related to age, cognitive score, vascular risk burden, vascular risk factors on imaging, or medial temporal lobar atrophy in the study group.
Conclusion
Our study demonstrated regional differences in BBB permeability (Ktrans) in cognitively normal elderly adults using a clinically acceptable 10-minutes DCE imaging protocol. The regional differences suggest that the integrity of the BBB varies across the brains of cognitively normal elderly adults. We recommend considering regional differences in Ktrans values when evaluating BBB permeability in patients with neurodegenerative diseases.
8.Successful Endotracheal Intubation Using Suction-Assisted Laryngoscopy Assisted Decontamination Technique and a Head-Down Tilt Position during Massive Regurgitation
Insung CHOI ; Young Woong CHOI ; Sang Hyuk HAN ; Ji Heui LEE
Soonchunhyang Medical Science 2020;26(2):75-79
Some of the challenges in intensive care, anesthesia, and emergency medicine would be airway management in an actively vomiting patient or a bloody airway. We experienced a patient with an excessively full stomach (at least 3 L) due to gastric outlet obstruction, although he was scheduled for elective surgery. Despite such circumstances, we successfully intubated him using the suctionassisted laryngoscopy assisted decontamination technique with the patient in a head-down tilt position during massive regurgitation while avoiding resultant pulmonary aspiration.
9.Applicability of the 48/6 Model of Care as a Health Screening Tool, and its Association with Mobility in Community-Dwelling Older Adults
Kyeong Eun UHM ; Mooyeon OH-PARK ; Yoon Sook KIM ; Jae Min PARK ; Jaekyung CHOI ; Yeonsil MOON ; Seol Heui HAN ; Jeong Hae HWANG ; Kun Sei LEE ; Jongmin LEE
Journal of Korean Medical Science 2020;35(7):43-
BACKGROUND: The 48/6 Model of Care is an integrative care initiative for improving the health outcomes of hospitalized older patients; however, its applicability in community-dwelling older adults as a health screening tool has not been investigated. The present study aimed to examine the applicability of this model, prevalence of dysfunction in 6 care areas, and its relationship with self-reported mobility in community-dwelling older adults.METHODS: This was a cross-sectional survey study of community-dwelling adults aged 65 or older. Participants were screened for problems using 9 items corresponding to the 6 care areas of the 48/6 Model of Care (cognitive functioning, functional mobility, pain management, nutrition and hydration, bladder and bowel management, and medication management). Mobility was assessed via the Life-Space Assessment (LSA). We examined the correlation between each screening item and the LSA.RESULTS: A total of 444 older adults (260 women, 58.6%) participated. The mean number of health problems was 2.3 ± 2.1, with the most common being pain, cognitive impairment, and urinary incontinence. These problems and LSA scores were significantly different by age groups. A multiple regression analysis showed that polypharmacy (β = −10.567, P < 0.001), dysphagia (β = −9.610, P = 0.021), and pain (β = −7.369, P = 0.004) were significantly associated with life-space mobility after controlling for age.CONCLUSION: The 48/6 Model of Care is applicable to community-dwelling older adults, who show high prevalence of dysfunction in the 6 care areas. This study supports the role of the model in screening for the health status of older adults living in the community, and in estimating mobility.
Adult
;
Cognition Disorders
;
Cross-Sectional Studies
;
Deglutition Disorders
;
Female
;
Humans
;
Mass Screening
;
Pain Management
;
Polypharmacy
;
Prevalence
;
Urinary Bladder
;
Urinary Incontinence
10.Successful Endotracheal Intubation Using Suction-Assisted Laryngoscopy Assisted Decontamination Technique and a Head-Down Tilt Position during Massive Regurgitation
Insung CHOI ; Young Woong CHOI ; Sang Hyuk HAN ; Ji Heui LEE
Soonchunhyang Medical Science 2020;26(2):75-79
Some of the challenges in intensive care, anesthesia, and emergency medicine would be airway management in an actively vomiting patient or a bloody airway. We experienced a patient with an excessively full stomach (at least 3 L) due to gastric outlet obstruction, although he was scheduled for elective surgery. Despite such circumstances, we successfully intubated him using the suctionassisted laryngoscopy assisted decontamination technique with the patient in a head-down tilt position during massive regurgitation while avoiding resultant pulmonary aspiration.

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