1.Efficacy and Safety of Lurasidone vs. Quetiapine XR in Acutely Psychotic Patients With Schizophrenia in Korea: A Randomized, Double-Blind, Active-Controlled Trial
Se Hyun KIM ; Do-Un JUNG ; Do Hoon KIM ; Jung Sik LEE ; Kyoung-Uk LEE ; Seunghee WON ; Bong Ju LEE ; Sung-Gon KIM ; Sungwon ROH ; Jong-Ik PARK ; Minah KIM ; Sung Won JUNG ; Hong Seok OH ; Han-yong JUNG ; Sang Hoon KIM ; Hyun Seung CHEE ; Jong-Woo PAIK ; Kyu Young LEE ; Soo In KIM ; Seung-Hwan LEE ; Eun-Jin CHEON ; Hye-Geum KIM ; Heon-Jeong LEE ; In Won CHUNG ; Joonho CHOI ; Min-Hyuk KIM ; Seong-Jin CHO ; HyunChul YOUN ; Jhin-Goo CHANG ; Hoo Rim SONG ; Euitae KIM ; Won-Hyoung KIM ; Chul Eung KIM ; Doo-Heum PARK ; Byung-Ook LEE ; Jungsun LEE ; Seung-Yup LEE ; Nuree KANG ; Hee Yeon JUNG
Psychiatry Investigation 2024;21(7):762-771
Objective:
This study was performed to evaluate the efficacy and safety of lurasidone (160 mg/day) compared to quetiapine XR (QXR; 600 mg/day) in the treatment of acutely psychotic patients with schizophrenia.
Methods:
Patients were randomly assigned to 6 weeks of double-blind treatment with lurasidone 160 mg/day (n=105) or QXR 600 mg/day (n=105). Primary efficacy measure was the change from baseline to week 6 in Positive and Negative Syndrome Scale (PANSS) total score and Clinical Global Impressions severity (CGI-S) score. Adverse events, body measurements, and laboratory parameters were assessed.
Results:
Lurasidone demonstrated non-inferiority to QXR on the PANSS total score. Adjusted mean±standard error change at week 6 on the PANSS total score was -26.42±2.02 and -27.33±2.01 in the lurasidone and QXR group, respectively. The mean difference score was -0.91 (95% confidence interval -6.35–4.53). The lurasidone group showed a greater reduction in PANSS total and negative subscale on week 1 and a greater reduction in end-point CGI-S score compared to the QXR group. Body weight, body mass index, and waist circumference in the lurasidone group were reduced, with significantly lower mean change compared to QXR. Endpoint changes in glucose, cholesterol, triglycerides, and low-density lipoprotein levels were also significantly lower. The most common adverse drug reactions with lurasidone were akathisia and nausea.
Conclusion
Lurasidone 160 mg/day was found to be non-inferior to QXR 600 mg/day in the treatment of schizophrenia with comparable efficacy and tolerability. Adverse effects of lurasidone were generally tolerable, and beneficial effects on metabolic parameters can be expected.
2.Efficacy and Safety of Treatment with Quadruple Oral Hypoglycemic Agents in Uncontrolled Type 2 Diabetes Mellitus: A Multi-Center, Retrospective, Observational Study
Jun Sung MOON ; Sunghwan SUH ; Sang Soo KIM ; Heung Yong JIN ; Jeong Mi KIM ; Min Hee JANG ; Kyung Ae LEE ; Ju Hyung LEE ; Seung Min CHUNG ; Young Sang LYU ; Jin Hwa KIM ; Sang Yong KIM ; Jung Eun JANG ; Tae Nyun KIM ; Sung Woo KIM ; Eonju JEON ; Nan Hee CHO ; Mi-Kyung KIM ; Hye Soon KIM ; Il Seong NAM-GOONG ; Eun Sook KIM ; Jin Ook CHUNG ; Dong-Hyeok CHO ; Chang Won LEE ; Young Il KIM ; Dong Jin CHUNG ; Kyu Chang WON ; In Joo KIM ; Tae Sun PARK ; Duk Kyu KIM ; Hosang SHON
Diabetes & Metabolism Journal 2021;45(5):675-683
Only few studies have shown the efficacy and safety of glucose-control strategies using the quadruple drug combination. Therefore, the aim of the present study was to investigate the usefulness of the quadruple combination therapy with oral hypoglycemic agents (OHAs) in patients with uncontrolled type 2 diabetes mellitus (T2DM). From March 2014 to December 2018, data of patients with T2DM, who were treated with quadruple hypoglycemic medications for over 12 months in 11 hospitals in South Korea, were reviewed retrospectively. We compared glycosylated hemoglobin (HbA1c) levels before and 12 months after quadruple treatment with OHAs. The safety, maintenance rate, and therapeutic patterns after failure of the quadruple therapy were also evaluated. In total, 357 patients were enrolled for quadruple OHA therapy, and the baseline HbA1c level was 9.0%±1.3% (74.9±14.1 mmol/mol). After 12 months, 270 patients (75.6%) adhered to the quadruple therapy and HbA1c was significantly reduced from 8.9%±1.2% to 7.8%±1.3% (mean change, −1.1%±1.2%; This study shows the therapeutic efficacy of the quadruple OHA regimen T2DM and demonstrates that it can be an option for the management of T2DM patients who cannot use insulin or reject injectable therapy.
3.Efficacy and Safety of Treatment with Quadruple Oral Hypoglycemic Agents in Uncontrolled Type 2 Diabetes Mellitus: A Multi-Center, Retrospective, Observational Study
Jun Sung MOON ; Sunghwan SUH ; Sang Soo KIM ; Heung Yong JIN ; Jeong Mi KIM ; Min Hee JANG ; Kyung Ae LEE ; Ju Hyung LEE ; Seung Min CHUNG ; Young Sang LYU ; Jin Hwa KIM ; Sang Yong KIM ; Jung Eun JANG ; Tae Nyun KIM ; Sung Woo KIM ; Eonju JEON ; Nan Hee CHO ; Mi-Kyung KIM ; Hye Soon KIM ; Il Seong NAM-GOONG ; Eun Sook KIM ; Jin Ook CHUNG ; Dong-Hyeok CHO ; Chang Won LEE ; Young Il KIM ; Dong Jin CHUNG ; Kyu Chang WON ; In Joo KIM ; Tae Sun PARK ; Duk Kyu KIM ; Hosang SHON
Diabetes & Metabolism Journal 2021;45(5):675-683
Only few studies have shown the efficacy and safety of glucose-control strategies using the quadruple drug combination. Therefore, the aim of the present study was to investigate the usefulness of the quadruple combination therapy with oral hypoglycemic agents (OHAs) in patients with uncontrolled type 2 diabetes mellitus (T2DM). From March 2014 to December 2018, data of patients with T2DM, who were treated with quadruple hypoglycemic medications for over 12 months in 11 hospitals in South Korea, were reviewed retrospectively. We compared glycosylated hemoglobin (HbA1c) levels before and 12 months after quadruple treatment with OHAs. The safety, maintenance rate, and therapeutic patterns after failure of the quadruple therapy were also evaluated. In total, 357 patients were enrolled for quadruple OHA therapy, and the baseline HbA1c level was 9.0%±1.3% (74.9±14.1 mmol/mol). After 12 months, 270 patients (75.6%) adhered to the quadruple therapy and HbA1c was significantly reduced from 8.9%±1.2% to 7.8%±1.3% (mean change, −1.1%±1.2%; This study shows the therapeutic efficacy of the quadruple OHA regimen T2DM and demonstrates that it can be an option for the management of T2DM patients who cannot use insulin or reject injectable therapy.
4.A New Self-management Scale with a Hierarchical Structure for Patients with Type 2 Diabetes
Eun-Hyun LEE ; Young Whee LEE ; Duck hee CHAE ; Kwan-Woo LEE ; Jin Ook CHUNG ; Seong bin HONG ; So Hun KIM ; Eun Hee KANG
Asian Nursing Research 2020;14(4):249-256
Purpose:
The aims of this study were to develop a new instrument for measuring self-management with a hierarchical structure [the Diabetes Self-Management Scale (DSMS)] in patients with type 2 diabetes, and evaluate its psychometric properties.
Methods:
The DSMS instrument was developed in three phases: (1) conceptualization and item generation; (2) content validity and pilot testing; and (3) field testing of its psychometric properties. A convenience sample of 473 participants was recruited in three university hospitals and one regional health center, South Korea.
Results:
Exploratory and confirmatory factor analyses yielded two second-order component models explaining the common variance among six first-order factors. Principal axis factoring with a varimax rotation accounted for 60.88% of the variance. Confirmatory factor analysis of the hierarchical structure revealed the following fit indices: χ2/df = 1.373, standardized root-mean-square residual = .050, goodness-of-fit index = .935, incremental fit index = .975, comparative fit index = .974, and root-mean-square error of approximation = .039. All Cronbach' α values for internal consistency exceeded the criterion of .70. All of the intraclass correlation coefficients for test–retest reliability exceeded .70 except that for the taking-medication subscale. The components of the DSMS were moderately correlated with the comparator measures of self-efficacy and health literacy administered for convergent validity.
Conclusion
The DSMS is a new instrument for measuring the complex nature of self-management in patients with type 2 diabetes, comprising 17 items scored on a five-point Likert scale. The DSMS exhibits satisfactory psychometric properties for five reliability and validity metrics, and so is a suitable instrument to apply in both research and clinical practices.
5.Efficacy and Safety of Treatment with Quadruple Oral Hypoglycemic Agents in Uncontrolled Type 2 Diabetes Mellitus: A Multi-Center, Retrospective, Observational Study
Jun Sung MOON ; Sunghwan SUH ; Sang Soo KIM ; Heung Yong JIN ; Jeong Mi KIM ; Min Hee JANG ; Kyung Ae LEE ; Ju Hyung LEE ; Seung Min CHUNG ; Young Sang LYU ; Jin Hwa KIM ; Sang Yong KIM ; Jung Eun JANG ; Tae Nyun KIM ; Sung Woo KIM ; Eonju JEON ; Nan Hee CHO ; Mi-Kyung KIM ; Hye Soon KIM ; Il Seong NAM-GOONG ; Eun Sook KIM ; Jin Ook CHUNG ; Dong-Hyeok CHO ; Chang Won LEE ; Young Il KIM ; Dong Jin CHUNG ; Kyu Chang WON ; In Joo KIM ; Tae Sun PARK ; Duk Kyu KIM ; Hosang SHON
Diabetes & Metabolism Journal 2020;44(S1):e46-
Background:
Only few studies have shown the efficacy and safety of glucose-control strategies using the quadruple drug combination. Therefore, the aim of the present study was to investigate the usefulness of the quadruple combination therapy with oral hypoglycemic agents (OHAs) in patients with uncontrolled type 2 diabetes mellitus (T2DM).
Methods:
From March 2014 to December 2018, data of patients with T2DM, who were treated with quadruple hypoglycemic medications for over 12 months in 11 hospitals in South Korea, were reviewed retrospectively. We compared glycosylated hemoglobin (HbA1c) levels before and 12 months after quadruple treatment with OHAs. The safety, maintenance rate, and therapeutic patterns after failure of the quadruple therapy were also evaluated.
Results:
In total, 357 patients were enrolled for quadruple OHA therapy, and the baseline HbA1c level was 9.0%±1.3% (74.9± 14.1 mmol/mol). After 12 months, 270 patients (75.6%) adhered to the quadruple therapy and HbA1c was significantly reduced from 8.9%±1.2% to 7.8%±1.3% (mean change, –1.1%±1.2%; P<0.001). The number of patients with HbA1c <7% increased significantly from 5 to 68 (P<0.005). In addition, lipid profiles and liver enzyme levels were also improved whereas no changes in body weight. There was no significant safety issue in patients treated with quadruple OHA therapy.
Conclusion
This study shows the therapeutic efficacy of the quadruple OHA regimen T2DM and demonstrates that it can be an option for the management of T2DM patients who cannot use insulin or reject injectable therapy.
6.A New Self-management Scale with a Hierarchical Structure for Patients with Type 2 Diabetes
Eun-Hyun LEE ; Young Whee LEE ; Duck hee CHAE ; Kwan-Woo LEE ; Jin Ook CHUNG ; Seong bin HONG ; So Hun KIM ; Eun Hee KANG
Asian Nursing Research 2020;14(4):249-256
Purpose:
The aims of this study were to develop a new instrument for measuring self-management with a hierarchical structure [the Diabetes Self-Management Scale (DSMS)] in patients with type 2 diabetes, and evaluate its psychometric properties.
Methods:
The DSMS instrument was developed in three phases: (1) conceptualization and item generation; (2) content validity and pilot testing; and (3) field testing of its psychometric properties. A convenience sample of 473 participants was recruited in three university hospitals and one regional health center, South Korea.
Results:
Exploratory and confirmatory factor analyses yielded two second-order component models explaining the common variance among six first-order factors. Principal axis factoring with a varimax rotation accounted for 60.88% of the variance. Confirmatory factor analysis of the hierarchical structure revealed the following fit indices: χ2/df = 1.373, standardized root-mean-square residual = .050, goodness-of-fit index = .935, incremental fit index = .975, comparative fit index = .974, and root-mean-square error of approximation = .039. All Cronbach' α values for internal consistency exceeded the criterion of .70. All of the intraclass correlation coefficients for test–retest reliability exceeded .70 except that for the taking-medication subscale. The components of the DSMS were moderately correlated with the comparator measures of self-efficacy and health literacy administered for convergent validity.
Conclusion
The DSMS is a new instrument for measuring the complex nature of self-management in patients with type 2 diabetes, comprising 17 items scored on a five-point Likert scale. The DSMS exhibits satisfactory psychometric properties for five reliability and validity metrics, and so is a suitable instrument to apply in both research and clinical practices.
7.Current Status of Patient Education in the Management of Atopic Dermatitis in Korea
Min Kyung LEE ; Ju Hee SEO ; Howard CHU ; Hyunjung KIM ; Yong Hyun JANG ; Jae Won JEONG ; Hye Yung YUM ; Man Yong HAN ; Ho Joo YOON ; Sang Heon CHO ; Yeong Ho RHA ; Jin Tack KIM ; Young Lip PARK ; Seong Jun SEO ; Kwang Hoon LEE ; Chang Ook PARK
Yonsei Medical Journal 2019;60(7):694-699
Patient education is important for successful management of atopic dermatitis; however, due to limited time and resources, patient education remains insufficient. This study aimed to investigate the current state of education provided by Korean dermatologists, pediatric allergists, and allergists to patients with atopic dermatitis. A questionnaire survey consisting of items regarding educational programs for patients with atopic dermatitis was conducted via e-mail. In total, 153 participants responded to the questionnaires, and 26.8% indicated that they have had separate educational programs. The workforce involved in the educational program included nurses, residents or fellows, dieticians, pharmacists, and clinical psychologists. Most education protocols addressed the characteristics and natural course of atopic dermatitis and environmental management. Overall, 96.7% of the participants replied that an additional charge is needed for education; moreover, additional assistance from an academic society or association, in the form of medical staff, organized data, and advertisement, is required to develop and provide a well-structured educational program. A standardized education protocol will effectively provide appropriate education for patients with atopic dermatitis. Arrangement of education fees, covered by the National Health Insurance Service, will lead to the establishment of a structured educational program and participation of an additional medical workforce.
Dermatitis, Atopic
;
Education
;
Electronic Mail
;
Fees and Charges
;
Humans
;
Korea
;
Medical Staff
;
National Health Programs
;
Nutritionists
;
Patient Education as Topic
;
Pharmacists
;
Psychology
8.2014–2017 Nationwide Bariatric and Metabolic Surgery Report in Korea
In Gyu KWON ; Jong Won KIM ; Gil Ho KANG ; Dong Wook KIM ; Sung Geun KIM ; Seong Min KIM ; Seong Soo KIM ; Yong Jin KIM ; Wook KIM ; Jong Han KIM ; Ji Heon KIM ; Jin Jo KIM ; Ho Goon KIM ; Seung Wan RYU ; Do Joong PARK ; Dong Jin PARK ; Sung Soo PARK ; Yoon Chan PARK ; Joong Min PARK ; Ji Yeon PARK ; Kyung Won SEO ; Byoung Jo SUH ; Soo Min AHN ; Hye Seong AHN ; Moon Won YOO ; Sang Kuon LEE ; Han Hong LEE ; Hyuk Joon LEE ; Kyong Hwa JUN ; Kyung Ook JUNG ; Minyoung CHO ; Seung Ho CHOI ; Man ho HA ; Tae Kyung HA ; Sang Moon HAN ; Sang Uk HAN ; Yoon Seok HEO ; Woo Jin HYUNG ; Joo Ho LEE ;
Journal of Metabolic and Bariatric Surgery 2018;7(2):49-53
PURPOSE: The information committee of the Korean Society for Metabolic and Bariatric Surgery (KSMBS) performed the nationwide survey of bariatric and metabolic operations to report IFSO (International Federation for the Surgery of Obesity and Metabolic Disorders) worldwide survey annually. This study aimed to report the trends of bariatric and metabolic surgery in Korea in 2014–2017. MATERIALS AND METHODS: We analyzed the accumulated nationwide survey data conducted for annual ISFO survey from 2014 to 2017. Trends such as the number of operations by hospital type and the number of operations by surgical method were analyzed. RESULTS: The number of operations has decreased sharply in 2015 comparing to 2014 (913⇒550). The number of operations performed in private hospitals dropped sharply from 529 to 250, 198, and 103 cases. The number of revisional surgeries increased to 223 in 2015. The primary surgery number fell from 757 in 2014 to 327 in 2015. In primary surgery, sleeve gastrectomy was gradually increased from 2014 to 143 (18.9%), 105 (32.1%), 167 (47.2%) and 200 (56.3%) and became the most frequently performed surgery. On the other hand, the incidence of adjustable gastric band decreased gradually from 439 (58.0%) to 117 (35.8%), 112 (31.6%) and 59 (16.6%). CONCLUSION: The overall number of obesity metabolic operations has decreased since 2014, especially the number of adjustable gastric band, and the number of operations in private hospitals declined sharply. On the other hand, the number of operations in university hospitals did not change much, and the number of sleeve gastrectomy increased.
Bariatric Surgery
;
Gastrectomy
;
Hand
;
Hospitals, Private
;
Hospitals, University
;
Incidence
;
Korea
;
Methods
;
Obesity
9.A Unique Mutational Spectrum of MLC1 in Korean Patients With Megalencephalic Leukoencephalopathy With Subcortical Cysts: p.Ala275Asp Founder Mutation and Maternal Uniparental Disomy of Chromosome 22.
Sun Ah CHOI ; Soo Yeon KIM ; Jihoo YOON ; Joongmoon CHOI ; Sung Sup PARK ; Moon Woo SEONG ; Hunmin KIM ; Hee HWANG ; Ji Eun CHOI ; Jong Hee CHAE ; Ki Joong KIM ; Seunghyo KIM ; Yun Jin LEE ; Sang Ook NAM ; Byung Chan LIM
Annals of Laboratory Medicine 2017;37(6):516-521
BACKGROUND: Megalencephalic leukoencephalopathy with subcortical cysts (MLC) is a rare inherited disorder characterized by infantile-onset macrocephaly, slow neurologic deterioration, and seizures. Mutations in the causative gene, MLC1, are found in approximately 75% of patients and are inherited in an autosomal recessive manner. We analyzed MLC1 mutations in five unrelated Korean patients with MLC. METHODS: Direct Sanger sequencing was used to identify MLC1 mutations. A founder effect of the p.Ala275Asp variant was demonstrated by haplotype analysis using single-nucleotide polymorphic (SNP) markers. Multiple ligation-dependent probe amplification (MLPA) and comparative genomic hybridization plus SNP array were used to detect exonic deletions or uniparental disomy (UPD). RESULTS: The most prevalent pathogenic variant was c.824C>A (p.Ala275Asp) found in 7/10 (70%) alleles. Two pathogenic frameshift variants were found: c.135delC (p.Cys46Alafs*12) and c.337_353delinsG (p.Ile113Glyfs*4). Haplotype analysis suggested that the Korean patients with MLC harbored a founder mutation in p.Ala275Asp. The p.(Ile113Glyfs*4) was identified in a homozygous state, and a family study revealed that only the mother was heterozygous for this variant. Further analysis of MLPA and SNP arrays for this patient demonstrated loss of heterozygosity of chromosome 22 without any deletion, indicating UPD. The maternal origin of both chromosomes 22 was demonstrated by haplotype analysis. CONCLUSIONS: This study is the first to describe the mutational spectrum of Korean patients with MLC, demonstrating a founder effect of the p.Ala275Asp variant. This study also broadens our understanding of the mutational spectrum of MLC1 by demonstrating a homozygous p.(Ile113Glyfs*4) variant resulting from UPD of chromosome 22.
Alleles
;
Chromosomes, Human, Pair 22*
;
Comparative Genomic Hybridization
;
Exons
;
Founder Effect
;
Haplotypes
;
Humans
;
Leukoencephalopathies*
;
Loss of Heterozygosity
;
Megalencephaly
;
Mothers
;
Seizures
;
Uniparental Disomy*
10.Short-Term Change of Exercise Capacity in Patients with Pulmonary Valve Replacement after Tetralogy of Fallot Repair.
Tae Woong HWANG ; Sung Ook KIM ; Moon Sun KIM ; So Ick JANG ; Seong Ho KIM ; Sang Yun LEE ; Eun Young CHOI ; Su Jin PARK ; Hye Won KWON ; Hyo Bin LIM
Korean Circulation Journal 2017;47(2):254-262
BACKGROUND AND OBJECTIVES: The aim of this study was to investigate the effect of pulmonary valve replacement (PVR) on exercise capacity and determine cardiopulmonary exercise (CPEX) parameters associated with improvement in right ventricle (RV) function. SUBJECTS AND METHODS: We retrospectively analyzed CPEX and magnetic resonance imaging parameters in a total of 245 patients who underwent PVR from January 1998 to October 2015. In addition, we analyzed the characteristics of the patients who showed improved exercise capacity after PVR. RESULTS: Twenty-eight patients met the inclusion criteria for the study. CPEX parameters after PVR showed no significant changes in all patients. However, baseline predicted peak oxygen uptake (VO2(peak)) (%) value was significantly lower in patients with significant improvement in exercise capacity after PVR, as compared to patients who showed decreased exercise capacity after PVR (60.83±10.28 vs. 75.81±13.83) (p=0.003). In addition, patients with improved exercise capacity showed a positive correlation between the change of right ventricular ejection fraction (RVEF) (%) and the change of anaerobic threshold (r=0.733, p=0.007); whereas, patients with decreased exercise capacity showed a negative correlation between the change of RVEF (%) and the change of predicted VO2(peak) (%) (r=−0.575, p=0.020). CONCLUSION: The importance of predicted VO2(peak) (%) in evaluating exercise capacity differentiated from other CPEX variables. The change of anaerobic threshold and predicted VO2(peak) (%) might be a useful predictor of the change in RV function after PVR.
Anaerobic Threshold
;
Exercise Test
;
Heart Ventricles
;
Humans
;
Magnetic Resonance Imaging
;
Oxygen
;
Pulmonary Valve*
;
Retrospective Studies
;
Stroke Volume
;
Tetralogy of Fallot*

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