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.Changes in High-Density Lipoprotein Cholesterol and Risks of Cardiovascular Events: A Post Hoc Analysis from the PICASSO Trial
Eun-Jae LEE ; Sun U. KWON ; Jong-Ho PARK ; Yong-Jae KIM ; Keun-Sik HONG ; Sungwook YU ; Yang-Ha HWANG ; Ji Sung LEE ; Juneyoung LEE ; Joung-Ho RHA ; Sung Hyuk HEO ; Sung Hwan AHN ; Woo-Keun SEO ; Jong-Moo PARK ; Ju-Hun LEE ; Jee-Hyun KWON ; Sung-Il SOHN ; Jin-Man JUNG ; Hahn Young KIM ; Eung-Gyu KIM ; Sung Hun KIM ; Jae-Kwan CHA ; Man-Seok PARK ; Hyo Suk NAM ; Dong-Wha KANG ;
Journal of Stroke 2020;22(1):108-118
Background:
and purpose Whether pharmacologically altered high-density lipoprotein cholesterol (HDL-C) affects the risk of cardiovascular events is unknown. Recently, we have reported the Prevention of Cardiovascular Events in Asian Patients with Ischaemic Stroke at High Risk of Cerebral Haemorrhage (PICASSO) trial that demonstrated the non-inferiority of cilostazol to aspirin and superiority of probucol to non-probucol for cardiovascular prevention in ischemic stroke patients (clinicaltrials.gov: NCT01013532). We aimed to determine whether on-treatment HDL-C changes by cilostazol and probucol influence the treatment effect of each study medication during the PICASSO study.
Methods:
Of the 1,534 randomized patients, 1,373 (89.5%) with baseline cholesterol parameters were analyzed. Efficacy endpoint was the composite of stroke, myocardial infarction, and cardiovascular death. Cox proportional hazards regression analysis examined an interaction between the treatment effect and changes in HDL-C levels from randomization to 1 month for each study arm.
Results:
One-month post-randomization mean HDL-C level was significantly higher in the cilostazol group than in the aspirin group (1.08 mmol/L vs. 1.00 mmol/L, P<0.001). The mean HDL-C level was significantly lower in the probucol group than in the non-probucol group (0.86 mmol/L vs. 1.22 mmol/L, P<0.001). These trends persisted throughout the study. In both study arms, no significant interaction was observed between HDL-C changes and the assigned treatment regarding the risk of the efficacy endpoint.
Conclusions
Despite significant HDL-C changes, the effects of cilostazol and probucol treatment on the risk of cardiovascular events were insignificant. Pharmacologically altered HDL-C levels may not be reliable prognostic markers for cardiovascular risk.
3.Transradial versus transfemoral intervention in ST-segment elevation myocardial infarction patients in Korean population.
Hu LI ; Seung Woon RHA ; Byoung Geol CHOI ; Min Suk SHIM ; Se Yeon CHOI ; Cheol Ung CHOI ; Eung Ju KIM ; Dong Joo OH ; Byung Ryul CHO ; Moo Hyun KIM ; Doo Il KIM ; Myung Ho JEONG ; Sang Yong YOO ; Sang Sik JEONG ; Byung Ok KIM ; Min Su HYUN ; Young Jin YOUN ; Junghan YOON
The Korean Journal of Internal Medicine 2018;33(4):716-726
BACKGROUND/AIMS: Transradial intervention (TRI) is becoming the preferred method over transfemoral intervention (TFI) because TRI is associated with lower incidence of major bleeding and vascular complications. However, there has been limited published data regarding the clinical outcomes of TRI versus TFI in Korean patients with ST-elevation myocardial infarction (STEMI). METHODS: A total of 689 consecutive STEMI patients who underwent primary percutaneous coronary intervention (PCI) with drug-eluting stents (DESs) from January to December of 2009 at nine university hospitals were enrolled in this study. Mid-term angiographic and 12-month cumulative clinical outcomes of the TRI group (n = 220, 31.9%) were compared to those of the TFI group (n = 469, 28.1%). RESULTS: After propensity score matching, in-hospital complications and the 12-month major clinical outcomes during follow-up in the two groups were similar to each other. However, the incidence rates of repeat revascularization (6.4% vs. 0.5%, p = 0.003), target vessel revascularization (6.4% vs. 0.5%, p = 0.003), and major adverse cardiac events (MACE; 11.6% vs. 4.6%, p = 0.018) in the TFI group were higher than those in the TRI group during the 12-month of follow-up. CONCLUSIONS: In our study, TRI in STEMI patients undergoing primary PCI with DESs was associated with lower incidence of access site hematoma, 12-month repeat revascularization, and MACE compared to TFI. Therefore, TRI might play an important role in reducing bleeding complications while improving major clinical outcomes in STEMI patients undergoing primary PCI with DESs.
Drug-Eluting Stents
;
Follow-Up Studies
;
Hematoma
;
Hemorrhage
;
Hospitals, University
;
Humans
;
Incidence
;
Methods
;
Myocardial Infarction*
;
Percutaneous Coronary Intervention
;
Propensity Score
4.The Factors Associated with the Decision of r-tPA Use in Acute Ischemic Stroke Patients Aged 80 Years or Older.
Min Gyeong JEONG ; Yerim KIM ; Yeo Jin KIM ; Mi Sun OH ; Kyung Ho YU ; Byung Chul LEE ; Ju Hun LEE ; Jee Hyun KWON ; Sun Uck KWON ; Sung Hyuk HEO ; Jay Chol CHOI ; Hyung Min KWON ; Jong Moo PARK ; Eung Gyu KIM ; Joung Ho RHA ; Hee Kwon PARK ; Hee Joon BAE ; Moon Ku HAN ; Keun Sik HONG ; Yong Jin CHO ; Man Seok PARK ; Ki Hyun CHO ; Hahn Young KIM ; Jun LEE ; Dong Eog KIM ; Soo Joo LEE ; Kyung Bok LEE ; Tai Hwan PARK ; Myoung Jin CHA ; Ji Hoe HEO ; Hyo Suk NAM ; Jae Kwan CHA ; Chul Ho KIM ; Byung Woo YOON
Korean Journal of Stroke 2011;13(2):79-84
BACKGROUND: Small proportions of all the elderly stroke patients receive recombinant tissue plasminogen activator (r-tPA) therapy, although old age is not a proven contraindication to intravenous thrombolytic therapy for acute ischemic stroke. The purpose of this study was to identify reasons for exclusion from r-tPA therapy and factors associated with the decision of r-tPA use in elderly patients with acute ischemic stroke. METHODS: From the acute stroke registries of 22 domestic university hospitals taking the r-tPA therapy from January 2007 to May 2010, we extracted data of all acute ischemic stroke patients who were aged 80 or over and arrived within onset 3 hours. For all patients, we assessed the eligibility of r-tPA therapy using National Institute of Neurological Disorders and Stroke (NINDS) r-tPA trial criteria. For eligible patients, we compared all clinical variables between patients who were treated with r-tPA and those who were not, and analyzed potential factors related to the decision of r-tPA use. RESULTS: A total of 494 patients were included in this study. 255 patients (51.6%) were excluded by NINDS r-tPA trial criteria and the major reasons for exclusion were minor neurological deficit (53.7%) and clinical improvement (17.3%). Among 239 patients who were eligible for r-tPA, 162 (32.8%) patients received r-tPA and 77 (15.6%) did not. Multivariable analysis showed that younger age, shorter time-delay from onset to admission, non-smoker, no history of prior stroke, good pre-stroke functional status and severe initial neurological deficit were independently associated with the decision of r-tPA use in the elderly stroke patients predictors for r-tPA treatment. CONCLUSION: In very elderly patients, mild neurological deficit on arrival and rapid clinical improvement in neurological symptoms were the main reasons for exclusion from thrombolytic therapy.
Aged
;
Hospitals, University
;
Humans
;
National Institute of Neurological Disorders and Stroke
;
Registries
;
Stroke
;
Thrombolytic Therapy
;
Tissue Plasminogen Activator
5.Adnexal Clear Cell Carcinoma with Comedonecrosis: A Case Report.
Seo Hee KIM ; Sun Hee HAN ; Jung Suk AN ; Ju Han LEE ; Eung Seok LEE ; Heum Rye PARK ; Young Sik KIM
Korean Journal of Pathology 2010;44(1):92-96
Adnexal clear cell carcinoma with comedonecrosis (ACCCC) is a very rare malignancy of the skin with an aggressive clinical course and a predilection for the scalp. This is the first reported case of ACCCC in Korea. A 79-year-old male presented with left abdominal masses that proved to be two subcutaneous nodules. The tumors histologically consisted of epithelial nests that showed a distinctive zonal arrangement. The centrally located clear cell areas with comedonecroses were merged with the peripheral squamoid cells, often exhibiting retraction artifacts and an infiltrating border. Nuclear pleomorphism and frequent mitoses were prominent. The clear cells were immunopositive for carcinoembryonic antigen and epithelial membrane antigen. We report here on a case of ACCCC involving the abdominal skin, and this tumor should be distinguished from the more indolent squamous cell and tricholemmal carcinomas.
Abdomen
;
Aged
;
Artifacts
;
Carcinoembryonic Antigen
;
Fluconazole
;
Humans
;
Korea
;
Male
;
Mitosis
;
Mucin-1
;
Necrosis
;
Neoplasms, Adnexal and Skin Appendage
;
Scalp
;
Skin
6.Expression of p16, Rb and FHIT Proteins in Urothelial Carcinoma of the Urinary Bladder.
Sun Hee HAN ; Ju Han LEE ; Seo Hee KIM ; Jungsuk AN ; Eung Seok LEE ; Young Sik KIM
Korean Journal of Pathology 2008;42(5):294-298
BACKGROUND: The goal of this study was to investigate the expression of p16, retinoblastoma (Rb) and fragile histidine triad (FHIT) proteins in urothelial carcinomas of the urinary bladder, and to evaluate the relationship between clinicopathlogic parameters and each protein expression level. METHODS: The expression of p16, Rb, and FHIT proteins were studied in 176 patients with urothelial carcinoma of the urinary bladder by immunohistochemistry. RESULTS: The diffuse positive expression of the p16 protein was significantly associated with high grade and advanced tumor depth (p=0.007 and p=0.020). The loss of the Rb protein was significantly associated with old age and disease recurrence (p=0.020 and 0.037). The loss of the FHIT protein was significantly associated with advanced tumor depth (p=0.002). CONCLUSION: Our data suggest that p16 and FHIT proteins may be involved in the progression of urothelial carcinoma. In addition, p16 may be a useful prognostic marker for individual urothelial carcinoma patients.
7.Risk Factors of Postoperative Delirium in Elderly Patients with Hip Fractures.
Ki Hwan KIM ; Duk Hwan KHO ; Ju Yong SHIN ; Jin Yong CHOI ; Eung Sik KIM ; Dong Heon KIM
Journal of the Korean Fracture Society 2008;21(3):189-194
PURPOSE: To find out the relationship between various risk factors and post-operative delirium in elderly patients with hip fractures. MATERIALS AND METHODS: Out of 135 patients older than 65 years old who underwent the surgery for hip fracture in our department, between the periods of March 2003 to March 2005, 14 patients (10.4%) developed post-operative delirium and 121 patients (89.6%) did not. We studied risk factors of post-operative delirium in two groups. RESULTS: In chi-square test between delirium group and non-delirium group, the patients were more likely to develop post-operative delirium if they had previous episodes of delirium, abnormal cognitive function, low walking ability before admission, high dependency on ADL (Activities of Daily Living), other medical accompanying diseases, history of dementia, post-operative hypoxia, post-operative electrolyte imbalance, low post-operative hemoglobin and hematocrit, low post-operative albumin and were older than 75 years old (p<0.05). Sex, type of fracture, anesthesia and the time between admission and operation did not show much difference between the two groups. CONCLUSION: The risk factors of postoperative delirium in elderly patients with hip fracture have a tendency to be multifactorial. Therefore, we conclude that being prepared by thorough understanding of the risk factors and their relationships will help prevent post-operative delirium and result in good postoperative prognosis.
Activities of Daily Living
;
Aged
;
Anesthesia
;
Anoxia
;
Delirium
;
Dementia
;
Dependency (Psychology)
;
Hematocrit
;
Hemoglobins
;
Hip
;
Hip Fractures
;
Humans
;
Prognosis
;
Risk Factors
;
Walking
8.Bipolar Hemiarthroplasty for Femoral Neck Fractures in the Elderly.
Ju Yong SHIN ; Hyeung June KIM ; Eung Sik KIM ; Dong Heon KIM
Journal of the Korean Hip Society 2008;20(3):188-196
PURPOSE: To evaluate outcomes after treatment of femoral neck fractures in patients 75 years of age or older. MATERIALS AND METHODS: We reviewed the records of 186 patients 75 years of age or older who underwent bipolar hemiarthroplasty between March 1995 and March 2005 and who were followed for more than two years after surgery. The mean patient age was 84.3 years (range 75~99 years). Forty-eight patients were men, and 138 patients were women. The mean follow-up period was 68.4 months (range 24~113 months). We evaluated the results by analyzing modified Harris hip score, walking ability, activities of daily living, complications, osteoporosis, and radiologic findings. RESULTS: The mean Harris hip score was 89.2 (range 74~95). Walking ability was recovered in 87.6% of cases (163 cases), and activities of daily living were achieved in 85.4% of cases (159 cases). There were 3 cases of acetabular erosion or proximal migration and 3 cases of aseptic loosening in a cemented stem. Thigh pain occurred in 8 cemented stems and in 4 cementless stems. CONCLUSION: We believe bipolar hemiarthroplasty is a useful treatment in elderly patients with femoral neck fractures and severe osteoporosis, especially in view of the stable and rigid fixation of the femoral stem, early ambulation, and the low rate of complications and death, even if the operation is technically very difficult.
Activities of Daily Living
;
Aged
;
Early Ambulation
;
Female
;
Femoral Neck Fractures
;
Femur Neck
;
Follow-Up Studies
;
Hemiarthroplasty
;
Hip
;
Humans
;
Male
;
Osteoporosis
;
Thigh
;
Walking
9.Comparison of Sporadic Sclerotic Fibroma and Solitary Fibrous Tumor in the Oral Cavity.
Ju Han LEE ; Jung Suk AN ; Eung Seok LEE ; Soon Young KWON ; Young Sik KIM
Yonsei Medical Journal 2007;48(3):535-539
Sporadic sclerotic fibroma (SF) and solitary fibrous tumor (SFT) arising in the oral cavity are very rare. In this report, we describe two cases of oral pathology, one involving SF and the other involving SFT. Both cases presented with well- circumscribed, firm nodules with similar gross findings. However, the histologic findings of the SF and SFT showed rather distinct features. The SF was composed of hyalinized sclerotic collagen bundles arranged in a whorled pattern, whereas the SFT was formed by spindles cells arranged in hypo- and hypercellular areas. The immunohistochemical findings were similar in both cases; there was positivity for vimentin, CD34, and CD99, but bcl-2 positivity was only seen in the SFT. Although their histopathologies are similar, SF and SFT should be considered in the differential diagnosis of soft tissue tumors in the oral cavity.
Adult
;
Antigens, CD/analysis
;
Antigens, CD34/analysis
;
Cell Adhesion Molecules/analysis
;
Diagnosis, Differential
;
Female
;
Fibroma/*diagnosis/metabolism
;
Humans
;
Immunohistochemistry
;
Mouth/chemistry/*pathology
;
Mouth Neoplasms/*diagnosis/metabolism
;
Neoplasms, Fibrous Tissue/*diagnosis/metabolism
;
Proto-Oncogene Proteins c-bcl-2/analysis
;
Vimentin/analysis
10.Sclerosing Mucoepidermoid Carcinoma of the Parotid Gland: A Case Report.
Hyunchul KIM ; Ju Han LEE ; Eung Seok LEE ; Soon Young KWON ; Taik Kun KIM ; Young Sik KIM
Korean Journal of Pathology 2007;41(3):193-197
Sclerosing mucoepidermoid carcinoma (SMEC) is a very rare tumor of the salivary gland. There have been eight cases of SMEC reported in the medical literature; this is the first reported case in Korea. A 51-year-old woman presented with a right infra-auricular mass that she had for 3 years. We performed superficial parotidectomy. Grossly, the resected parotid gland showed a well-circumscribed firm mass. Histologically, the tumor consisted of central solid or ductal tumor nests within a dense fibrous stroma surrounded by peripheral lymphoid infiltration. The tumor nests were composed of squamous, intermediate and mucin-secreting cells. However, the tumor cells lacked mitosis and nuclear anaplasia. The lymphoid cells were mostly composed of lymphocytes and plasma cells with occasional eosinophils and neutrophils. Immunohistochemically, the tumor cells were positive for high- and low- molecular weight cytokeratins, cytokeratin 7, p16INK4A, Bcl-2 and cyclin D1. The patient also underwent radiation therapy. We report here on a case of SMEC of the parotid gland along with the immunohistochemical characteristics, and we review the relevant literature.
Anaplasia
;
Carcinoma, Mucoepidermoid*
;
Cyclin D1
;
Eosinophils
;
Female
;
Humans
;
Keratin-7
;
Keratins
;
Korea
;
Lymphocytes
;
Middle Aged
;
Mitosis
;
Molecular Weight
;
Neutrophils
;
Parotid Gland*
;
Plasma Cells
;
Salivary Glands
;
Sclerosis

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