1.Efficacy and Safety of Glecaprevir/Pibrentasvir in Korean Patients with Chronic Hepatitis C: A Pooled Analysis of Five Phase II/III Trials
Jeong HEO ; Yoon Jun KIM ; Jin-Woo LEE ; Ji Hoon KIM ; Young-Suk LIM ; Kwang-Hyub HAN ; Sook-Hyang JEONG ; Mong CHO ; Ki Tae YOON ; Si Hyun BAE ; Eric D. CROWN ; Linda M. FREDRICK ; Negar Niki ALAMI ; Armen ASATRYAN ; Do Hyun KIM ; Seung Woon PAIK ; Youn-Jae LEE
Gut and Liver 2021;15(6):895-903
Background/Aims:
Glecaprevir/pibrentasvir (G/P) is the first pan-genotypic direct-acting antiviral combination therapy approved in Korea. An integrated analysis of five phase II and III trials was conducted to evaluate the efficacy and safety of G/P in Korean patients with chronic hepatitis C virus (HCV) infection.
Methods:
The study analyzed pooled data on Korean patients with HCV infection enrolled in the ENDURANCE 1 and 2, SURVEYOR II part 4 and VOYAGE I and II trials, which evaluated the efficacy and safety of 8 or 12 weeks of G/P treatment. The patients were either treatment-naïve or had received sofosbuvir or interferon-based treatment. Efficacy was evaluated by assessing the rate of sustained virologic response at 12 weeks posttreatment (SVR12). Safety was evaluated by monitoring adverse events (AEs) and laboratory assessments.
Results:
The analysis included 265 patients; 179 (67.5%) were HCV treatment-naïve, and most patients were either subgenotype 1B (48.7%) or 2A (44.5%). In the intention-to-treat population, 262 patients (98.9%) achieved SVR12. Three patients did not achieve SVR12: one had virologic failure and two had non-virologic failures. Most AEs were grade 1/2; eight patients (3.0%) expe-rienced at least one grade ≥3 AE. No serious AEs related to G/P treatment were reported, and grade ≥3 hepatic laboratory abnormalities were rare (0.8%).
Conclusions
G/P therapy was highly efficacious and well tolerated in Korean patients with HCV infection, with most patients achieving SVR12. The safety profile was comparable to that observed in a pooled analysis of a global pan-genotypic population of patients with HCV infection who received G/P.
2.A Case of Generalized Annular Syphilid Presenting as Extensive Figurate Cutaneous Lesion
Kyung Nam BAE ; Tae Wook KIM ; Sung Min PARK ; Hyun Joo LEE ; Hyunju JIN ; Hyang Suk YOU ; Woo Haing SHIM ; Hoon Soo KIM ; Hyun Chang KO ; Byung Soo KIM ; Moon Bum KIM ; Gun Wook KIM
Korean Journal of Dermatology 2019;57(2):106-108
No abstract available.
Syphilis
;
Syphilis, Cutaneous
3.Treatment by Transradial Urokinase Infusion and Percutaneus Transhepatic Thrombectomy in Superior Mesenteric Veno us Thrombosis with Intestinal Infarction
Suk Hyang BAE ; Kyung Han KIM ; Jin Yeon WHANG ; Jeong Min LEE ; Jeong Min KIM ; Jeong Mo KU ; Jonghun LEE
Korean Journal of Medicine 2018;93(1):55-60
Mesenteric venous thrombosis has a low prevalence and nonspecific clinical symptoms, and it may cause bowel infarction and death. Early diagnosis and prompt surgical intervention with anticoagulants are important to patients. We examined a 27-year-old woman complaining of diffuse abdominal pain and hematochezia, and diagnosed extensive mesenteric venous thrombosis with intestinal infarction and pulmonary thromboembolism. In light of the patient's symptoms, an operation seemed necessary. However, because of the high risk of mortality, we decided to look for another option. The patient was successfully treated with intensive medical care and a radiological procedure in spite of intestinal infarction.
Abdominal Pain
;
Adult
;
Anticoagulants
;
Early Diagnosis
;
Female
;
Gastrointestinal Hemorrhage
;
Humans
;
Infarction
;
Mesenteric Ischemia
;
Mesenteric Vascular Occlusion
;
Mortality
;
Prevalence
;
Pulmonary Embolism
;
Thrombectomy
;
Thrombolytic Therapy
;
Thrombosis
;
Urokinase-Type Plasminogen Activator
4.Treatment by Transradial Urokinase Infusion and Percutaneus Transhepatic Thrombectomy in Superior Mesenteric Veno us Thrombosis with Intestinal Infarction
Suk Hyang BAE ; Kyung Han KIM ; Jin Yeon WHANG ; Jeong Min LEE ; Jeong Min KIM ; Jeong Mo KU ; Jonghun LEE
Korean Journal of Medicine 2018;93(1):55-60
Mesenteric venous thrombosis has a low prevalence and nonspecific clinical symptoms, and it may cause bowel infarction and death. Early diagnosis and prompt surgical intervention with anticoagulants are important to patients. We examined a 27-year-old woman complaining of diffuse abdominal pain and hematochezia, and diagnosed extensive mesenteric venous thrombosis with intestinal infarction and pulmonary thromboembolism. In light of the patient's symptoms, an operation seemed necessary. However, because of the high risk of mortality, we decided to look for another option. The patient was successfully treated with intensive medical care and a radiological procedure in spite of intestinal infarction.
5.Association between the Red Cell Distribution Width and Vasospastic Angina in Korean Patients.
Mi Hyang JUNG ; Dong Il SHIN ; Ik Jun CHOI ; Suk Min SEO ; Sooa CHOI ; Mahn Won PARK ; Pum Joon KIM ; Sang Hong BAEK ; Ki Bae SEUNG
Yonsei Medical Journal 2016;57(3):614-620
PURPOSE: The association between the red cell distribution width (RDW) and vasospastic angina (VSA) has not been elucidated. We investigated the association of the RDW with the incidence and angiographic subtypes of VSA in Korean patients. MATERIALS AND METHODS: A total of 460 patients who underwent intracoronary ergonovine provocation tests were consecutively enrolled and classified into two groups: the VSA group (n=147, 32.0%) and non-VSA group (n=313, 68.0%). The subjects were classified into 3 subgroups (tertiles) according to the baseline level of RDW assessed before the angiographic provocation test. RESULTS: The VSA group had a higher RDW than the non-VSA group (12.9±0.8% vs. 12.5±0.7%, p=0.013). The high RDW level demonstrated an independent association with the high incidence of VSA [second tertile: hazard ratio (HR) 1.96 (1.13-2.83), third tertile: HR 2.33 (1.22-3.47), all p<0.001]. Moreover, the highest RDW tertile level had a significant association with the prevalence of the mixed-type coronary spasm [HR 1.29 (1.03-1.59), p=0.037]. CONCLUSION: The high level of RDW was significantly associated with the prevalence of VSA and the high-risk angiographic subtype of coronary spasm, suggesting that a proactive clinical investigation for VSA could be valuable in Korean patients with an elevated RDW.
Aged
;
Aged, 80 and over
;
Angina Pectoris/*blood/ethnology
;
Coronary Angiography/methods
;
Coronary Vasospasm/*blood/ethnology
;
Erythrocyte Indices/*physiology
;
Female
;
Humans
;
Incidence
;
Male
;
Middle Aged
;
Prevalence
;
Proportional Hazards Models
;
Republic of Korea/epidemiology
6.Reliability and validity of Korean version of modified: Yale preoperative anxiety scale.
Kyuwhan JUNG ; Mi Hyang IM ; Jeong Min HWANG ; Ah Young OH ; Moon Seok PARK ; Woo Jin JEONG ; Seong Chan KIM ; Sun Woo JUNG ; Hyejin SOHN ; Mi Ok YOON ; Mi Suk JANG ; Suk Bae MOON
Annals of Surgical Treatment and Research 2016;90(1):43-48
PURPOSE: The modified Yale Preoperative Anxiety Scale (mYPAS) was developed for evaluating the level of preoperative anxiety in children. The purpose of this study was to develop a Korean version of the mYPAS (K-mYPAS) and to establish its validity and reliability based on the Korean preoperative pediatric patients. METHODS: K-mYPAS was made through stringent back-translation procedure. Total enrolled 102 patients answered questionnaires of Korean version of State-Trait Anxiety Inventory for Children (K-STAIC), and were videotaped for 2 to 5 minutes before induction of anesthesia. Three observers of experienced psychiatrist, surgeon, and nurse analyzed videotape with K-mYPAS comparing to K-STAIC. The inter- and intraobservers reliability, concurrent and construct validity, sensitivity, specificity, and predictive value were analyzed. RESULTS: The value of Cronbach alpha for interobservers reliability was 0.939 and intraobserver reliability was statistically significant (P < 0.001). Concurrent and construct validity were also statistically significant (P < 0.001 and P < 0.001, respectively). Sensitivity, specificity, positive predictive value, negative predictive value, and accuracy were 81.3%, 91.4%, 81.3%, 91.4%, and 88.2%, respectively. CONCLUSION: The K-mYPAS had good psychometric properties and can be used as a reliable and valid instrument for the assessment of preoperative anxiety in children.
Anesthesia
;
Anxiety*
;
Child
;
Humans
;
Psychiatry
;
Psychometrics
;
Reproducibility of Results*
;
Sensitivity and Specificity
;
Videotape Recording
7.Population Pharmacokinetic Analysis of Piperacillin/Tazobactam in Korean Patients with Acute Infections.
Yong Kyun KIM ; Jin Ah JUNG ; Hyang Ki CHOI ; In Gyu BAE ; Won Suk CHOI ; Jian HUR ; Sung Joon JIN ; Shin Woo KIM ; Ki Tae KWON ; Sang Rok LEE ; Jae Gook SHIN ; Sungmin KIEM
Infection and Chemotherapy 2016;48(3):209-215
BACKGROUND: For more effective and safer usage of antibiotics, the dosing strategy should be individualized based on the patients’ characteristics, including race. The aim of this study was to investigate the population pharmacokinetic (PK) profiles of piperacillin and tazobactam in Korean patients with acute infections. MATERIALS AND METHODS: At least four consecutive 2/0.25 g or 4/0.5 g doses of piperacillin/tazobactam (TZP) were intravenously infused over 1 h every 8 h for patients with creatinine clearance (CL(cr)) ≤50 ml/min or CL(cr) >50 mL/min, respectively. Blood samples from 33 patients at a steady-state were taken pre-dose and at 0 min, 30 min, and 4-6 h after the fourth infusion. The population PK analysis was conducted using a non-linear mixed-effects method. A likelihood ratio test was used to select significant covariates, with significance levels of P <0.05 for selection and P <0.01 for elimination. RESULTS: Both piperacillin PK and tazobactam PK were well described by a two-compartment model with first-order elimination. Creatinine clearance and body weight, as covariates on clearance (CL) and volume of central compartment (V1), were selected among the covariates possibly affecting PK parameters of both drugs. CL was defined as CL = 2.9 + 4.03 × CL(cr)/47 for piperacillin and CL = 1.76 + 4.81 × CL(cr)/47 for tazobactam. V1 was defined as V1 = 19.5 × weight/60 for piperacillin and V1 = 22.6 × weight/60 for tazobactam. CONCLUSION: The PK profiles of TZP at a steady-state in Korean patients with acute infections were well described by a two-compartment model with first-order elimination. Both piperacillin and tazobactam clearances were significantly influenced by creatinine clearance.
Anti-Bacterial Agents
;
Body Weight
;
Continental Population Groups
;
Creatinine
;
Humans
;
Methods
;
Piperacillin
8.Clinical and Pathological Features of Korean Patients with DNM2-Related Centronuclear Myopathy.
Young Eun PARK ; Young Chul CHOI ; Jong Suk BAE ; Chang Hoon LEE ; Hyang Suk KIM ; Jin Hong SHIN ; Dae Seong KIM
Journal of Clinical Neurology 2014;10(1):24-31
BACKGROUND AND PURPOSE: Centronuclear myopathy (CNM) is characterized by the presence of central nuclei within a large number of muscle fibers. Mutations of the dynamin 2 gene (DNM2) are common causes of autosomal dominant or sporadic CNM. The aim of this study was to characterize the clinical and pathological features of CNM relative to the presence of DNM2 mutations. METHODS: Six patients with clinical and pathological features of CNM were recruited. Detailed clinical and pathological findings were analyzed according to the presence of DNM2 mutations. RESULTS: We detected DNM2 mutations in four of the six sporadic CNM patients, and identified the following distinct clinical and pathological features in those patients with DNM2 mutations: preferential involvement of the distal lower limbs, typical nuclear centralization, and radially distributed sarcoplasmic strands in muscle pathology. In contrast, those without DNM2 mutations exhibited rather diffuse muscular involvement, and nuclear internalization and myofibrillar disorganization were more pronounced features of their muscle pathology. CONCLUSIONS: These findings suggest the presence of specific features in Korean CNM patients. A detailed clinical and pathological examination of CNM patients would be helpful for molecular genetic analyses of this condition.
Dynamin II
;
Humans
;
Lower Extremity
;
Molecular Biology
;
Muscles
;
Myopathies, Structural, Congenital*
;
Pathology
9.Association of BRAF(V600E) Mutation with Poor Clinical Prognostic Factors and Ultrasonographic Findings in Cases of Papillary Thyroid Carcinoma.
Hyang Suk CHOI ; Kwang Min KIM ; Joon Beom PARK ; Keum Seok BAE ; Seong Joon KANG
Korean Journal of Endocrine Surgery 2012;12(1):16-20
PURPOSE: This study evaluated the association of the BRAF(V600E) mutation with known prognostic factors and ultrasonographic characteristics in cases of papillary thyroid carcinoma. METHODS: Subjects included 169 patients who received thyroidectomy at Wonju Christian Hospital under the diagnosis of papillary thyroid cancer from February 2010 to October 2011. RESULTS: Of the total patients who received thyroidectomy, there were 128 cases (75,7%) of BRAF(V600E) mutation. Neither age nor sex were associated with the BRAF(V600E) mutation. Tumor size, shape, margin, extrathyroidal extension, central node metastasis and lateral node metastasis were found not to be associated with the BRAF(V600E) mutation. Tumor calcification, echogenicity and vascularity were also not associated with the mutation. CONCLUSION: As debate remains about the association between the BRAF(V600E) mutation and clincopathologic factors and ultrasonographic characteristics in cases of papillary thyroid carcinoma, further study is needed.
Diagnosis
;
Gangwon-do
;
Humans
;
Neoplasm Metastasis
;
Thyroid Gland*
;
Thyroid Neoplasms*
;
Thyroidectomy
10.WHO Classification of Malignant Lymphomas in Korea: Report of the Third Nationwide Study.
Jin Man KIM ; Young Hyeh KO ; Seung Sook LEE ; Jooryung HUH ; Chang Suk KANG ; Chul Woo KIM ; Yun Kyung KANG ; Jai Hyang GO ; Min Kyung KIM ; Wan Seop KIM ; Yoon Jung KIM ; Hyun Jung KIM ; Hee Kyung KIM ; Jong Hee NAM ; Hyung Bae MOON ; Chan Kum PARK ; Tae In PARK ; Young Ha OH ; Dong Wha LEE ; Jong Sil LEE ; Juhie LEE ; Hyekyung LEE ; Sung Chul LIM ; Kyu Yun JANG ; Hee Kyung CHANG ; Yoon Kyung JEON ; Hye Ra JUNG ; Min Sun CHO ; Hee Jeong CHA ; Suk Jin CHOI ; Jae Ho HAN ; Sook Hee HONG ; Insun KIM
Korean Journal of Pathology 2011;45(3):254-260
BACKGROUND: The aim of study was to determine the relative frequency of malignant lymphoma according to World Health Organization (WHO) classification in Korea. METHODS: A total of 3,998 cases diagnosed at 31 institutes between 2005 and 2006 were enrolled. Information including age, gender, pathologic diagnosis, site of involvement and immunophenotypes were obtained. RESULTS: The relative frequency of non-Hodgkin lymphoma (NHL) and Hodgkin lymphoma (HL) was 95.4% and 4.6%, respectively. B-cell lymphomas accounted for 77.6% of all NHL, while T/natural killer (T/NK)-cell lymphomas accounted for 22.4%. The most frequent subtypes of NHL were diffuse large B-cell lymphoma (42.7%), extranodal marginal zone B-cell lymphoma (MZBCL) of mucosa-associated lymphoid tissue (19.0%), NK/T-cell lymphoma (6.3%) and peripheral T-cell lymphoma (PTCL), unspecified (6.3%), in decreasing order. The relative frequency of HL was nodular sclerosis (47.4%), mixed cellularity (30.6%), and nodular lymphocyte predominant (12.1%) subtypes. Compared with a previous study in 1998, increase in gastric MZBCL and nodular sclerosis HL, and slight decrease of follicular lymphoma, PTCL, and NK/T-cell lymphoma were observed. CONCLUSIONS: Korea had lower rates of HL and follicular lymphoma, and higher rates of extranodal NHL, extranodal MZBCL, and NK/T-cell lymphoma of nasal type compared with Western countries. Changes in the relative frequency of lymphoma subtypes are likely ascribed to refined diagnostic criteria and a change in national health care policy.
Academies and Institutes
;
Delivery of Health Care
;
Hodgkin Disease
;
Korea
;
Lymphocytes
;
Lymphoid Tissue
;
Lymphoma
;
Lymphoma, B-Cell
;
Lymphoma, B-Cell, Marginal Zone
;
Lymphoma, Follicular
;
Lymphoma, Non-Hodgkin
;
Lymphoma, T-Cell, Peripheral
;
Sclerosis
;
World Health Organization

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