1.Efficacy and safety of sofosbuvir–velpatasvir and sofosbuvir–velpatasvir–voxilaprevir for hepatitis C in Korea: a Phase 3b study
Jeong HEO ; Yoon Jun KIM ; Sung Wook LEE ; Youn-Jae LEE ; Ki Tae YOON ; Kwan Soo BYUN ; Yong Jin JUNG ; Won Young TAK ; Sook-Hyang JEONG ; Kyung Min KWON ; Vithika SURI ; Peiwen WU ; Byoung Kuk JANG ; Byung Seok LEE ; Ju-Yeon CHO ; Jeong Won JANG ; Soo Hyun YANG ; Seung Woon PAIK ; Hyung Joon KIM ; Jung Hyun KWON ; Neung Hwa PARK ; Ju Hyun KIM ; In Hee KIM ; Sang Hoon AHN ; Young-Suk LIM
The Korean Journal of Internal Medicine 2023;38(4):504-513
Despite the availability of direct-acting antivirals (DAAs) for chronic hepatitis C virus (HCV) infection in Korea, need remains for pangenotypic regimens that can be used in the presence of hepatic impairment, comorbidities, or prior treatment failure. We investigated the efficacy and safety of sofosbuvir–velpatasvir and sofosbuvir–velpatasvir–voxilaprevir for 12 weeks in HCV-infected Korean adults. Methods: This Phase 3b, multicenter, open-label study included 2 cohorts. In Cohort 1, participants with HCV genotype 1 or 2 and who were treatment-naive or treatment-experienced with interferon-based treatments, received sofosbuvir–velpatasvir 400/100 mg/day. In Cohort 2, HCV genotype 1 infected individuals who previously received an NS5A inhibitor-containing regimen ≥ 4 weeks received sofosbuvir–velpatasvir–voxilaprevir 400/100/100 mg/day. Decompensated cirrhosis was an exclusion criterion. The primary endpoint was SVR12, defined as HCV RNA < 15 IU/mL 12 weeks following treatment. Results: Of 53 participants receiving sofosbuvir–velpatasvir, 52 (98.1%) achieved SVR12. The single participant who did not achieve SVR12 experienced an asymptomatic Grade 3 ASL/ALT elevation on day 15 and discontinued treatment. The event resolved without intervention. All 33 participants (100%) treated with sofosbuvir–velpatasvir–voxilaprevir achieved SVR 12. Overall, sofosbuvir–velpatasvir and sofosbuvir–velpatasvir–voxilaprevir were safe and well tolerated. Three participants (5.6%) in Cohort 1 and 1 participant (3.0%) in Cohort 2 had serious adverse events, but none were considered treatment-related. No deaths or grade 4 laboratory abnormalities were reported. Conclusions: Treatment with sofosbuvir–velpatasvir or sofosbuvir–velpatasvir–voxilaprevir was safe and resulted in high SVR12 rates in Korean HCV patients.
2.Imaging Assessment of Visceral Pleural Surface Invasion by Lung Cancer: Comparison of CT and Contrast-Enhanced Radial T1-Weighted Gradient Echo 3-Tesla MRI
Yu ZHANG ; Woocheol KWON ; Ho Yun LEE ; Sung Min KO ; Sang-Ha KIM ; Won-Yeon LEE ; Suk Joong YONG ; Soon-Hee JUNG ; Chun Sung BYUN ; JunHyeok LEE ; Honglei YANG ; Junhee HAN ; Jeanne B. ACKMAN
Korean Journal of Radiology 2021;22(5):829-839
Objective:
To compare the diagnostic performance of contrast-enhanced radial T1-weighted gradient-echo 3-tesla (3T) magnetic resonance imaging (MRI) and computed tomography (CT) for the detection of visceral pleural surface invasion (VPSI). Visceral pleural invasion by non-small-cell lung cancer (NSCLC) can be classified into two types: PL1 (without VPSI), invasion of the elastic layer of the visceral pleura without reaching the visceral pleural surface, and PL2 (with VPSI), full invasion of the visceral pleura.
Materials and Methods:
Thirty-three patients with pathologically confirmed VPSI by NSCLC were retrospectively reviewed.Multidetector CT and contrast-enhanced 3T MRI with a free-breathing radial three-dimensional fat-suppressed volumetric interpolated breath-hold examination (VIBE) pulse sequence were compared in terms of the length of contact, angle of mass margin, and arch distance-to-maximum tumor diameter ratio. Supplemental evaluation of the tumor-pleura interface (smooth versus irregular) could only be performed with MRI (not discernible on CT).
Results:
At the tumor-pleura interface, radial VIBE MRI revealed a smooth margin in 20 of 21 patients without VPSI and an irregular margin in 10 of 12 patients with VPSI, yielding an accuracy, sensitivity, specificity, positive predictive value, negative predictive value, and F-score for VPSI detection of 91%, 83%, 95%, 91%, 91%, and 87%, respectively. The McNemar test and receiver operating characteristics curve analysis revealed no significant differences between the diagnostic accuracies of CT and MRI for evaluating the contact length, angle of mass margin, or arch distance-to-maximum tumor diameter ratio as predictors of VPSI.
Conclusion
The diagnostic performance of contrast-enhanced radial T1-weighted gradient-echo 3T MRI and CT were equal in terms of the contact length, angle of mass margin, and arch distance-to-maximum tumor diameter ratio. The advantage of MRI is its clear depiction of the tumor-pleura interface margin, facilitating VPSI detection.
3.Imaging Assessment of Visceral Pleural Surface Invasion by Lung Cancer: Comparison of CT and Contrast-Enhanced Radial T1-Weighted Gradient Echo 3-Tesla MRI
Yu ZHANG ; Woocheol KWON ; Ho Yun LEE ; Sung Min KO ; Sang-Ha KIM ; Won-Yeon LEE ; Suk Joong YONG ; Soon-Hee JUNG ; Chun Sung BYUN ; JunHyeok LEE ; Honglei YANG ; Junhee HAN ; Jeanne B. ACKMAN
Korean Journal of Radiology 2021;22(5):829-839
Objective:
To compare the diagnostic performance of contrast-enhanced radial T1-weighted gradient-echo 3-tesla (3T) magnetic resonance imaging (MRI) and computed tomography (CT) for the detection of visceral pleural surface invasion (VPSI). Visceral pleural invasion by non-small-cell lung cancer (NSCLC) can be classified into two types: PL1 (without VPSI), invasion of the elastic layer of the visceral pleura without reaching the visceral pleural surface, and PL2 (with VPSI), full invasion of the visceral pleura.
Materials and Methods:
Thirty-three patients with pathologically confirmed VPSI by NSCLC were retrospectively reviewed.Multidetector CT and contrast-enhanced 3T MRI with a free-breathing radial three-dimensional fat-suppressed volumetric interpolated breath-hold examination (VIBE) pulse sequence were compared in terms of the length of contact, angle of mass margin, and arch distance-to-maximum tumor diameter ratio. Supplemental evaluation of the tumor-pleura interface (smooth versus irregular) could only be performed with MRI (not discernible on CT).
Results:
At the tumor-pleura interface, radial VIBE MRI revealed a smooth margin in 20 of 21 patients without VPSI and an irregular margin in 10 of 12 patients with VPSI, yielding an accuracy, sensitivity, specificity, positive predictive value, negative predictive value, and F-score for VPSI detection of 91%, 83%, 95%, 91%, 91%, and 87%, respectively. The McNemar test and receiver operating characteristics curve analysis revealed no significant differences between the diagnostic accuracies of CT and MRI for evaluating the contact length, angle of mass margin, or arch distance-to-maximum tumor diameter ratio as predictors of VPSI.
Conclusion
The diagnostic performance of contrast-enhanced radial T1-weighted gradient-echo 3T MRI and CT were equal in terms of the contact length, angle of mass margin, and arch distance-to-maximum tumor diameter ratio. The advantage of MRI is its clear depiction of the tumor-pleura interface margin, facilitating VPSI detection.
4.Characteristics of Medication Administration Error Alerts in Application of Mobile Medication System
Suk-Hee SONG ; Ju-Won BACK ; In-Seon HAN ; Eun-Hye KIM ; Nyeon-Im BYUN ; Eun-Mi CHO ; Ta-Sea AN ; Hui-Joeng HONG
Journal of Korean Academy of Fundamental Nursing 2021;28(2):149-155
Purpose:
To assess characteristics the application of mobile medication system and medication administration error (MAE) alerts in a general hospital.
Methods:
The subject hospital adopted a mobile medication system in 2016. All medication administrations in the general wards and ICUs were automatically recorded in real-time using identification barcodes, drug barcodes, and hand-held point-of-care devices. MAE alert logs were recorded from April 1st 2017 to March 31st 2018. For this study analysis was done using Pearson’s chi-squared test for potentially related factors of MAE alerts included administration time, order type, medication route, and length of nurse’s employment.
Results:
The total number of medications during the period of this study was 3,227,990. Among them, 2,698,317 medication doses were recorded, resulting in the system application rate of 83.6%. The system application rate was significantly correlated with all factors related to potential MAE alters. In this study 23,314 MAE alerts(0.9% of the total medication doses) were identified. The MAE alerts were related to new (OR=2.26, p<.001) and emergency (OR=2.25, p<.001) orders, and administration at a non-standard time (OR=2.032, p<.001). Medication route (p<.001), and nurse’s employment duration(p<.001) were also related.
Conclusion
A mobile medication system contributes to improving patient safety by preventing potential MAEs. The MAE alerts were related to administration time, order type, medication route, and duration of nurse’s employment. In order to prevent medication administration errors, it is necessary to standardize the process of medication and create an environment in which medication administration can be performed in a planned situation.
5.Primary Cutaneous Nodular Amyloidosis in Both Lip Angles
Ji Hye HEO ; Seon Bok LEE ; Hee Seong YOON ; Si Hyub LEE ; Suk Jin CHOI ; Ji Won BYUN ; Gwang Seong CHOI ; Jeonghyun SHIN
Korean Journal of Dermatology 2020;58(8):547-550
Primary cutaneous nodular amyloidosis is a rare variant of primary cutaneous amyloidosis and manifests as nodular, light-chain, amyloid deposits that are localized to the skin. The pathogenesis of the disease is still unclear. It usually originates in the lower extremities, face, scalp, and genitals and presents clinically as waxy, yellowish erythematous colored nodules. Histological characteristics include diffuse homogenous eosinophilic deposits in the dermis or subcutaneous regions along with interspersed plasma cells. We report a case of a 72-year-old man who presented with fissured, erythematous, waxy nodules on the bilateral lip angles. To the best of our knowledge, this is the first case report of primary cutaneous nodular amyloidosis of the lip angles in Korean dermatological literature.
6.Comparison of Acute Abdominal Surgical Outcomes of Extremely-Low-Birth-Weight Neonates according to Differential Diagnosis
Jeik BYUN ; Hyun Young KIM ; Sung Eun JUNG ; Hee Beom YANG ; Ee Kyung KIM ; Seung Han SHIN ; Han Suk KIM
Journal of Korean Medical Science 2019;34(35):e222-
BACKGROUND: Improvements in perinatal intensive care have improved survival of extremely-low-birth-weight (ELBW) neonates, although the risk of acute abdomen has increased. The differential diagnosis resulting in abdominal surgery can be categorized into necrotizing enterocolitis (NEC), spontaneous intestinal perforation (SIP), meconium-related ileus (MRI), and meconium non-related ileus (MNRI). The purpose of this study was to review our experience with abdominal surgery for ELBW neonates, and to evaluate characteristics and prognosis according to the differential diagnosis. METHODS: Medical records of ELBW neonates treated between 2003 and 2015 were retrospectively reviewed. RESULTS: Of 805 ELBW neonates, 65 (8.1%) received abdominal surgery. The numbers of cases by disease category were 29 for NEC, 18 for SIP, 13 for MRI, and 5 for MNRI. Ostoma formation was performed in 61 (93.8%) patients; primary anastomosis without ostoma was performed in 4 (6.2%). All patients without ostoma formation experienced re-perforation of the anastomosis site. Seven patients had 30-day postoperative mortality (6 had NEC). Long-term survival of the surgical and non-surgical groups was not statistically different. NEC was a poor prognostic factor for survival outcome (P = 0.033). CONCLUSION: Abdominal surgery for ELBW neonates is feasible. Ostoma formation can lead to reduced complications compared to primary anastomosis.
Abdomen, Acute
;
Critical Care
;
Diagnosis, Differential
;
Enterocolitis, Necrotizing
;
Humans
;
Ileus
;
Infant, Newborn
;
Intestinal Perforation
;
Magnetic Resonance Imaging
;
Meconium
;
Medical Records
;
Mortality
;
Prognosis
;
Retrospective Studies
7.The impact of primary tumor location in patients with metastatic colorectal cancer: a Korean Cancer Study Group CO12-04 study.
Jae Ho BYUN ; Joong Bae AHN ; Sun Young KIM ; Jung Hun KANG ; Dae Young ZANG ; Seok Yun KANG ; Myoung Joo KANG ; Byoung Yong SHIM ; Sun Kyung BAEK ; Bong Seog KIM ; Kyung Hee LEE ; Soon Il LEE ; Sang Hee CHO ; Byeong Seok SOHN ; Samyong KIM ; In Gyu HWANG ; Eun Mi NAM ; Bong Gun SEO ; Sang Cheul OH ; Myung Ah LEE ; Sang Cheol LEE ; Ji Hyung HONG ; Young Suk PARK
The Korean Journal of Internal Medicine 2019;34(1):165-177
BACKGROUND/AIMS: Colorectal cancer is associated with different anatomical, biological, and clinical characteristics. We determined the impact of the primary tumor location in patients with metastatic colorectal cancer (mCRC). METHODS: Demographic data and clinical information were collected from 1,115 patients from the Republic of Korea, who presented with mCRC between January 2009 and December 2011, using web-based electronic case report forms. Associations between the primary tumor location and the patient's clinical characteristics were assessed, and factors inf luencing overall survival were analyzed using Cox proportional hazards regression models. RESULTS: Of the 1,115 patients recruited to the study, 244 (21.9%) had right colon cancer, 483 (43.3%) had left colon cancer, and 388 (34.8%) had rectal cancer. Liver and lung metastases occurred more frequently in patients with left colon and rectal cancer (p = 0.005 and p = 0.006, respectively), while peritoneal and ovarian metastases occurred more frequently in patients with right and left colon cancer (p < 0.001 and p = 0.031, respectively). The median overall survival of patients with tumors originating in the right colon was significantly shorter than that of patients whose tumors had originated in the left colon or rectum (13.7 months [95% confidence interval (CI), 12.0 to 15.5] vs. 18.0 months [95% CI, 16.3 to 19.7] or 19.9 months [95% CI, 18.5 to 21.3], respectively; p = 0.003). Tumor resection, the number of metastatic sites, and primary tumor location correlated with overall survival in the univariate and multivariate analyses. CONCLUSIONS: Primary tumor location influences the metastatic sites and prognosis of patients with mCRC.
Colon
;
Colonic Neoplasms
;
Colorectal Neoplasms*
;
Humans
;
Liver
;
Lung
;
Multivariate Analysis
;
Neoplasm Metastasis
;
Prognosis
;
Rectal Neoplasms
;
Rectum
;
Republic of Korea
8.Intraindividual Comparison between Gadoxetate-Enhanced Magnetic Resonance Imaging and Dynamic Computed Tomography for Characterizing Focal Hepatic Lesions: A Multicenter, Multireader Study
Chansik AN ; Chang Hee LEE ; Jae Ho BYUN ; Min Hee LEE ; Woo Kyoung JEONG ; Sang Hyun CHOI ; Do Young KIM ; Young Suk LIM ; Young Seok KIM ; Ji Hoon KIM ; Moon Seok CHOI ; Myeong Jin KIM
Korean Journal of Radiology 2019;20(12):1616-1626
OBJECTIVE: To compare the diagnostic accuracy of dynamic computed tomography (CT) and gadoxetate-enhanced magnetic resonance imaging (MRI) for characterization of hepatic lesions by using the Liver Imaging Reporting and Data System (LI-RADS) in a multicenter, off-site evaluation.MATERIALS AND METHODS: In this retrospective multicenter study, we evaluated 231 hepatic lesions (114 hepatocellular carcinomas [HCCs], 58 non-HCC malignancies, and 59 benign lesions) confirmed histologically in 217 patients with chronic liver disease who underwent both gadoxetate-enhanced MRI and dynamic CT at one of five tertiary hospitals. Four radiologists at different institutes independently reviewed all MR images first and the CT images 4 weeks later. They evaluated the major and ancillary imaging features and categorized each hepatic lesion according to the LI-RADS v2014. Diagnostic performance was calculated and compared using generalized estimating equations.RESULTS: MRI showed higher sensitivity and accuracy than CT for diagnosing hepatic malignancies; the pooled sensitivities, specificities, and accuracies for categorizing LR-5/5V/M were 59.0% vs. 72.4% (CT vs. MRI; p < 0.001), 83.5% vs. 83.9% (p = 0.906), and 65.3% vs. 75.3% (p < 0.001), respectively. CT and MRI showed comparable capabilities for differentiating between HCC and other malignancies, with pooled accuracies of 79.9% and 82.4% for categorizing LR-M, respectively (p = 0.139).CONCLUSION: Gadoxetate-enhanced MRI showed superior accuracy for categorizing LR-5/5V/M in hepatic malignancies in comparison with dynamic CT. Both modalities had comparable accuracies for distinguishing other malignancies from HCC.
Academies and Institutes
;
Carcinoma, Hepatocellular
;
Contrast Media
;
Humans
;
Information Systems
;
Liver
;
Liver Diseases
;
Magnetic Resonance Imaging
;
Retrospective Studies
;
Tertiary Care Centers
9.Can More Aggressive Treatment Improve Prognosis in Patients with Hepatocellular Carcinoma? A Direct Comparison of the Hong Kong Liver Cancer and Barcelona Clinic Liver Cancer Algorithms
Young Sun LEE ; Yeon Seok SEO ; Ji Hoon KIM ; Juneyoung LEE ; Hae Rim KIM ; Yang Jae YOO ; Tae Suk KIM ; Seong Hee KANG ; Sang Jun SUH ; Moon Kyung JOO ; Young Kul JUNG ; Beom Jae LEE ; Hyung Joon YIM ; Jong Eun YEON ; Jae Seon KIM ; Jong Jae PARK ; Soon Ho UM ; Young Tae BAK ; Kwan Soo BYUN
Gut and Liver 2018;12(1):94-101
BACKGROUND/AIMS: In addition to the globally endorsed Barcelona Clinic Liver Cancer (BCLC) staging system, other algorithms or staging systems have been developed, including the Hong Kong Liver Cancer (HKLC) staging system. This study aimed to validate the HKLC staging system relative to the BCLC staging system for predicting survival for hepatocellular carcinoma (HCC) patients in Korea. METHODS: From 2004 to 2013, 2,571 patients newly diagnosed with HCC were consecutively enrolled at three Korea University medical centers. RESULTS: Both staging systems differentiated survival well (p < 0.001). However, 1-year and 3-year survival were predicted better using the HKLC system than the BCLC system (area under the receiver operating characteristic curve: 0.869 vs 0.856 for 1 year, p=0.002; 0.841 vs 0.827 for 3 years, p=0.010). In hypothetical survival curves, the HKLC system exhibited better median overall survival than the BCLC system (33.1 months vs 19.2 months). In evaluations of prognosis according to either BCLC or HKLC treatment guidelines, risk of death was reduced in the group following only HKLC guidelines compared with the group following only BCLC guidelines (hazard ratio, 0.601; 95% confidence interval, 0.443 to 0.816; p=0.001). CONCLUSIONS: Although both staging systems predicted and discriminated HCC prognoses well, the HKLC system showed more encouraging survival benefits than the BCLC system.
Academic Medical Centers
;
Carcinoma, Hepatocellular
;
Hong Kong
;
Humans
;
Korea
;
Liver Neoplasms
;
Liver
;
Neoplasm Staging
;
Prognosis
;
ROC Curve
10.The Factors Affecting the Use of Empirical Antibiotics in Febrile Infants from 1 Month to Less than 3 Months
Joung Hee BYUN ; Bo Kyung SONG ; Young A KIM ; Hoon KO ; Suk dong YOO ; Taek Jin LIM ; Su Eun PARK
Pediatric Infection & Vaccine 2018;25(2):91-100
PURPOSE: This study investigated the factors affecting the use of empirical antibiotics in febrile infants from 1 month to less than 3 months. METHODS: We retrospectively reviewed the medical records of hospitalized previously healthy infants with fever in Pusan National University Children's Hospital from January 2010 to December 2016. Clinical features, laboratory findings and antibiotic therapy were analyzed. Respiratory viruses were identified by multiplex reverse transcriptase polymerase chain reaction (RT-PCR) and were reported after 1–3 days. Enterovirus were identified by real time polymerase chain reaction (PCR) and were reported in several hours. RESULTS: The 129 of 366 subjects used empirical antibiotics and 237 patients didn't used empirical antibiotics. Empirical antibiotics were used more frequently when the fever was longer before admission, respiratory symptoms and ill being appearances were present and C-reactive protein was elevated. The rate of readmission was low in the group not used empirical antibiotics. Most of the patients detected by enterovirus PCR in cerebrospinal fluid didn't used empirical antibiotics. The results of respiratory virus multiplex RT-PCR showed no difference in the use of empirical antibiotics. CONCLUSIONS: In our study, empirical antibiotic prescriptions were affected not respiratory virus multiplex RT-PCR but enterovirus PCR. If multiplex RT-PCR were reported more rapid turn around time, it will affect antibiotic use.
Anti-Bacterial Agents
;
Busan
;
C-Reactive Protein
;
Cerebrospinal Fluid
;
Enterovirus
;
Fever
;
Humans
;
Infant
;
Medical Records
;
Polymerase Chain Reaction
;
Prescriptions
;
Real-Time Polymerase Chain Reaction
;
Retrospective Studies
;
Reverse Transcriptase Polymerase Chain Reaction

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