1.Safety and efficacy of nilotinib in adult patients with chronic myeloid leukemia: a post-marketing surveillance study in Korea
Seo-Yeon AHN ; Sang Kyun SON ; Gyu Hyung LEE ; Inho KIM ; June-Won CHEONG ; Won Sik LEE ; Byung Soo KIM ; Deog-Yeon JO ; Chul Won JUNG ; Chu Myoung SEONG ; Jae Hoon LEE ; Young Jin YUH ; Min Kyoung KIM ; Hun-Mo RYOO ; Moo-Rim PARK ; Su-Hee CHO ; Hoon-Gu KIM ; Dae Young ZANG ; Jinny PARK ; Hawk KIM ; Seryeon LEE ; Sung-Hyun KIM ; Myung Hee CHANG ; Ho Sup LEE ; Chul Won CHOI ; Jihyun KWON ; Sung-Nam LIM ; Suk-Joong OH ; Inkyung JOO ; Dong-Wook KIM
Blood Research 2022;57(2):144-151
Background:
Nilotinib is a tyrosine kinase inhibitor approved by the Ministry of Food and Drug Safety for frontline and 2nd line treatment of Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML). This study aimed to confirm the safety and efficacy of nilotinib in routine clinical practice within South Korea.
Methods:
An open-label, multicenter, single-arm, 12-week observational post-marketing surveillance (PMS) study was conducted on 669 Korean adult patients with Ph + CML from December 24, 2010, to December 23, 2016. The patients received nilotinib treatment in routine clinical practice settings. Safety was evaluated by all types of adverse events (AEs) during the study period, and efficacy was evaluated by the complete hematological response (CHR) and cytogenetic response.
Results:
During the study period, AEs occurred in 61.3% (410 patients, 973 events), adverse drug reactions (ADRs) in 40.5% (271/669 patients, 559 events), serious AEs in 4.5% (30 patients, 37 events), and serious ADRs in 0.7% (5 patients, 8 events). Furthermore, unexpected AEs occurred at a rate of 6.9% (46 patients, 55 events) and unexpected ADRs at 1.2% (8 patients, 8 events). As for the efficacy results, CHR was achieved in 89.5% (442/494 patients), and minor cytogenetic response or major cytogenetic response was achieved in 85.8% (139/162 patients).
Conclusion
This PMS study shows consistent results in terms of safety and efficacy compared with previous studies. Nilotinib was well tolerated and efficacious in adult Korean patients with Ph + CML in routine clinical practice settings.
2.Clinical Score System to Differentiate Severe Fever with Thrombocytopenia Syndrome Patients from Patients with Scrub Typhus or Hemorrhagic Fever with Renal Syndrome in Korea
Dae Hyuk HEO ; Yu Min KANG ; Kyoung Ho SONG ; Jun Won SEO ; Jeong Han KIM ; June Young CHUN ; Kang Il JUN ; Chang Kyung KANG ; Song Mi MOON ; Pyoeng Gyun CHOE ; Wan Beom PARK ; Ji Hwan BANG ; Eu Suk KIM ; Hong Bin KIM ; Sang Won PARK ; Won Sup OH ; Nam Joong KIM ; Myoung don OH
Journal of Korean Medical Science 2020;35(11):77-
BACKGROUND: Severe fever with thrombocytopenia syndrome (SFTS) is an emerging infectious disease with high mortality in East Asia. This study aimed to develop, for primary care providers, a prediction score using initial symptoms and basic laboratory blood tests to differentiate between SFTS and other endemic zoonoses in Korea.METHODS: Patients aged ≥ 18 years diagnosed with endemic zoonoses during a 3-year period (between January 2015 and December 2017) were retrospectively enrolled from 4 tertiary university hospitals. A prediction score was built based on multivariate logistic regression analyses.RESULTS: Of 84 patients, 35 with SFTS and 49 with other endemic zoonoses were enrolled. In multivariate logistic regression analysis, independent predictors of SFTS included neurologic symptoms (odds ratio [OR], 12.915; 95% confidence interval [CI], 2.173–76.747), diarrhea (OR, 10.306; 95% CI, 1.588–66.895), leukopenia (< 4,000/mm3) (OR, 19.400; 95% CI, 3.290–114.408), and normal C-reactive protein (< 0.5 mg/dL) (OR, 24.739; 95% CI, 1.812–337.742). We set up a prediction score by assigning one point to each of these four predictors. A score of ≥ 2 had 82.9% sensitivity (95% CI, 71.7%–87.5%) and 95.9% specificity (95% CI, 88.0%–99.2%). The area under the curve of the clinical prediction score was 0.950 (95% CI, 0.903–0.997).CONCLUSION: This study finding suggests a simple and useful scoring system to predict SFTS in patients with endemic zoonoses. We expect this strategic approach to facilitate early differentiation of SFTS from other endemic zoonoses, especially by primary care providers, and to improve the clinical outcomes.
3.Clinical Score System to Differentiate Severe Fever with Thrombocytopenia Syndrome Patients from Patients with Scrub Typhus or Hemorrhagic Fever with Renal Syndrome in Korea
Dae Hyuk HEO ; Yu Min KANG ; Kyoung Ho SONG ; Jun Won SEO ; Jeong Han KIM ; June Young CHUN ; Kang Il JUN ; Chang Kyung KANG ; Song Mi MOON ; Pyoeng Gyun CHOE ; Wan Beom PARK ; Ji Hwan BANG ; Eu Suk KIM ; Hong Bin KIM ; Sang Won PARK ; Won Sup OH ; Nam Joong KIM ; Myoung don OH
Journal of Korean Medical Science 2020;35(11):e77-
BACKGROUND:
Severe fever with thrombocytopenia syndrome (SFTS) is an emerging infectious disease with high mortality in East Asia. This study aimed to develop, for primary care providers, a prediction score using initial symptoms and basic laboratory blood tests to differentiate between SFTS and other endemic zoonoses in Korea.
METHODS:
Patients aged ≥ 18 years diagnosed with endemic zoonoses during a 3-year period (between January 2015 and December 2017) were retrospectively enrolled from 4 tertiary university hospitals. A prediction score was built based on multivariate logistic regression analyses.
RESULTS:
Of 84 patients, 35 with SFTS and 49 with other endemic zoonoses were enrolled. In multivariate logistic regression analysis, independent predictors of SFTS included neurologic symptoms (odds ratio [OR], 12.915; 95% confidence interval [CI], 2.173–76.747), diarrhea (OR, 10.306; 95% CI, 1.588–66.895), leukopenia (< 4,000/mm3) (OR, 19.400; 95% CI, 3.290–114.408), and normal C-reactive protein (< 0.5 mg/dL) (OR, 24.739; 95% CI, 1.812–337.742). We set up a prediction score by assigning one point to each of these four predictors. A score of ≥ 2 had 82.9% sensitivity (95% CI, 71.7%–87.5%) and 95.9% specificity (95% CI, 88.0%–99.2%). The area under the curve of the clinical prediction score was 0.950 (95% CI, 0.903–0.997).
CONCLUSION
This study finding suggests a simple and useful scoring system to predict SFTS in patients with endemic zoonoses. We expect this strategic approach to facilitate early differentiation of SFTS from other endemic zoonoses, especially by primary care providers, and to improve the clinical outcomes.
4.Current Status of Bariatric and Metabolic Surgery in Daejeon and Chungcheong Province: Early Experiences after Public Medical Insurance Coverage in 2019
Dong-Wook KIM ; Dae Hoon KIM ; Jeong Goo KIM ; Myoung Won SON ; Geum Jong SONG ; Seong-il OH ; Han Mo YOO ; Moon-Soo LEE ; Sang Kuon LEE ; Sang Eok LEE ; Ye Seob JEE ; Seong Ho HWANG ; Si Eun HWANG ; Sang-Il LEE
Journal of Metabolic and Bariatric Surgery 2020;9(1):7-12
Purpose:
This study aimed to investigate the current status of bariatric and metabolic surgery in Daejeon and Chungcheong province and to describe the early experiences after public medical insurance coverage in 2019.
Materials and Methods:
Between January 2019 and August 2019, 64 cases of bariatric and metabolic surgery were performed in patients with morbid obesity or uncontrolled type 2 diabetes. We prospectively collected and analyzed data regarding the patients’ demographics and comorbidities, surgical results, and early complications. The patient information before and after the insurance coverage was also compared.
Results:
The number of surgeries in 9 years has been caught up only in the last 8 months after insurance coverage (58 vs. 64 patients). The mean body mass index was 37.7±5.8 kg/m2 (range, 22.7-52.1 kg/m2). The most frequently performed surgery was sleeve gastrectomy (53 cases, 82.8%), followed by Roux-en-Y gastric bypass (9 cases, 14.1%), and adjustable gastric banding (2 cases, 3.1%). Postoperative complications occurred in 6 patients (9.4%), and there was no mortality. The mean operation time (225.3±85.4 vs. 156.1±61.8 min, P<0.001) and postoperative stay (5.9±4.5 vs. 4.3±2.0 days, P=0.013) after the insurance coverage were significantly shorter than those before the insurance coverage.
Conclusion
We could assess the patients who had bariatric and metabolic surgery in Daejeon and Chungcheong province after public medical insurance coverage in 2019.
5.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
6.Delays in Isolating Patients Admitted to Hospital with Pulmonary Tuberculosis in Korea
Dae Hyuk HEO ; Jun Won SEO ; Jeong Han KIM ; June Young CHUN ; Kang Il JUN ; Chang Kyung KANG ; Song Mi MOON ; Kyoung Ho SONG ; Pyoeng Gyun CHOE ; Wan Beom PARK ; Ji Hwan BANG ; Eu Suk KIM ; Sang Won PARK ; Nam Joong KIM ; Myoung don OH ; Hong Bin KIM
Journal of Korean Medical Science 2019;34(43):e270-
BACKGROUND: Delays in isolating patients admitted to hospital with active pulmonary tuberculosis (PTB) can contribute to nosocomial transmission; however, in Korea, patients with clinically diagnosed PTB are not routinely isolated while awaiting microbiological confirmation of the diagnosis. We aimed to assess the extent of delays in isolating patients admitted with PTB and to identify the factors associated with delayed isolation. METHODS: We retrospectively reviewed the electronic medical records of patients aged ≥ 18 years with active PTB, between January 2008 and December 2017, from two Korean hospitals. RESULTS: Among 1,062 patients, 612 (57.6%) were not isolated on admission day. The median time from admission to isolation was 1 day (interquartile range: 0–2 days). The independent risk factor most strongly associated with delayed isolation was admission to departments other than pulmonology or infectious diseases departments (adjusted odds ratio [aOR], 5.302; 95% confidence interval [CI], 3.177–8.847; P < 0.001). Factors associated with isolation on admission day were a past history of tuberculosis (TB) (aOR, 0.669; 95% CI, 0.494–0.906; P = 0.009), night sweats (aOR, 0.530; 95% CI, 0.330–0.851; P = 0.009), and apical infiltrates on chest radiographs (aOR, 0.452; 95% CI, 0.276–0.740; P = 0.002). CONCLUSION: Concerning patients subsequently diagnosed with active PTB, > 50% were not isolated on admission day. We suggest that the patients with clinically suspected PTB including the elderly who have a past history of TB, night sweats, or apical infiltration on chest radiographs, be presumptively isolated on admission, without waiting for microbiological confirmation of the diagnosis.
Aged
;
Communicable Diseases
;
Diagnosis
;
Electronic Health Records
;
Humans
;
Korea
;
Odds Ratio
;
Pulmonary Medicine
;
Radiography, Thoracic
;
Retrospective Studies
;
Risk Factors
;
Sweat
;
Tuberculosis
;
Tuberculosis, Pulmonary
7.Prognostic Value of MicroRNAs in Coronary Artery Diseases: A Meta-Analysis.
Ji Suk KIM ; Kyoungjune PAK ; Tae Sik GOH ; Dae Cheon JEONG ; Myoung Eun HAN ; Jihyun KIM ; Sae Ock OH ; Chi Dae KIM ; Yun Hak KIM
Yonsei Medical Journal 2018;59(4):495-500
PURPOSE: Coronary artery diseases (CADs) are the leading causes of death in the world. Recent studies have reported that differentially expressed microRNAs (miRNAs) are associated with prognosis or major adverse cardiac events (MACEs) in CAD patients. In a previous meta-analysis, the authors made serious mistakes that we aimed to correct through an updated systematic review and meta-analysis of the prognostic value of altered miRNAs in patients with CADs. MATERIALS AND METHODS: We performed a systematic search of MEDLINE (from inception to May 2017) and EMBASE (from inception to May 2017) for English-language publications. Studies of CADs with results on miRNAs that reported survival data or MACEs were included. Data were extracted from each publication independently by two reviewers. RESULTS: After reviewing 515 articles, a total eight studies were included in this study. We measured pooled hazard ratios (HRs) and 95% confidence intervals (CIs) of miRNA 133a with a fixed-effect model (pooled HR, 2.35; 95% CI, 1.56–3.55). High expression of miRNA 133a, 208b, 126, 197, 223, and 122-5p were associated with high mortality. Additionally, high levels of miRNA 208b, 499-5p, 134, 328, and 34a were related with MACEs. CONCLUSION: The present study confirmed that miRNA 133a, which was associated with high mortality in CAD patients, holds prognostic value in CAD. More importantly, this study corrected issues raised against a prior meta-analysis and provides accurate information.
Cause of Death
;
Coronary Artery Disease*
;
Coronary Vessels*
;
Humans
;
MicroRNAs*
;
Mortality
;
Prognosis
;
Publications
8.Characteristics of South Korean Patients with Hereditary Transthyretin Amyloidosis.
Kyomin CHOI ; Jin Myoung SEOK ; Byoung Joon KIM ; Young Cheol CHOI ; Ha Young SHIN ; Il Nam SUNWOO ; Dae Seong KIM ; Jung Joon SUNG ; Ga Yeon LEE ; Eun Seok JEON ; Nam Hee KIM ; Ju Hong MIN ; Jeeyoung OH
Journal of Clinical Neurology 2018;14(4):537-541
BACKGROUND AND PURPOSE: This retrospective cross-sectional study included 18 patients from unrelated families harboring mutations of the transthyretin gene (TTR), and analyzed their characteristics and geographical distribution in South Korea. METHODS: The included patients had a diagnosis of systemic amyloidosis, clinical symptoms, such as amyloid neuropathy or cardiomyopathy, and confirmation of a TTR gene mutation using genetic analysis recorded between April 1995 and November 2014. RESULTS: The mean age at disease onset was 49.6 years, and the mean disease duration from symptom onset to diagnosis was 3.67 years. Fifteen of the 18 patients were classified as mixed phenotype, 2 as the neurological phenotype, and only 1 patient as the cardiac phenotype. The most-common mutation pattern in South Korea was Asp38Ala, which was detected in eight patients. Thirteen patients reported their family hometowns, and five of the eight harboring the Asp38Ala mutation were from the Gyeongsang province in southeast Korea. The other eight patients exhibited a widespread geographical distribution. A particularly noteworthy finding was that the valine at position 30 (Val30Met) mutation, which was previously reported as the most-common TTR mutation worldwide and also the most common in the Japanese population, was not detected in the present South Korean patients. CONCLUSIONS: South Korean patients with hereditary TTR amyloidosis exhibited heterogeneous TTR genotypes and clinical phenotypes. The findings of this study suggest that the distribution of TTR amyloidosis in South Korea is due to de novo mutations and/or related to the other countries in East Asia.
Amyloid Neuropathies
;
Amyloidosis*
;
Asian Continental Ancestry Group
;
Cardiomyopathies
;
Cross-Sectional Studies
;
Diagnosis
;
Far East
;
Genotype
;
Humans
;
Korea
;
Phenotype
;
Prealbumin*
;
Retrospective Studies
;
Valine
9.Current Status of Metabolic and Bariatric Surgery in Daejeon/Chungcheong Area
Dong Wook KIM ; Dae Hoon KIM ; Jeong Goo KIM ; Myoung Won SON ; Geum Jong SONG ; Seong Il OH ; Han Mo YOO ; Moon Soo LEE ; Sang Kuon LEE ; Sang Il LEE ; Ye Seob JEE ; Si Eun HWANG ; Sang Eok LEE
Journal of Metabolic and Bariatric Surgery 2018;7(2):54-57
PURPOSE: The aim of our study is to investigate the current status of metabolic and bariatric surgery in Daejeon and Chungcheong province and examine the role and necessity of the community research society. MATERIALS AND METHODS: In this retrospective study, 58 patients who underwent bariatric and metabolic surgery from January 2010 to June 2018 were included. Patients' demographics and comorbidities, operation type and early complications were analyzed. RESULTS: Mean age was 36.9±11.4 (range, 18–64) years, and mean preoperative body mass index was 39.2±6.9 (range, 24.6–56.1) kg/m². The most frequently performed operation was sleeve gastrectomy (48 cases, 82.8%), followed by adjustable gastric banding (8 cases, 13.8%) and Roux-en-Y gastric bypass (2 cases, 3.4%). Postoperative complications were reported in two patients; however, no mortality was reported. CONCLUSION: We investigated the patients who underwent metabolic and bariatric surgery in Daejeon Chungcheong province. Our research society will continue to ensure safe operation and proper management of morbidly obese patients in our community.
Bariatric Surgery
;
Body Mass Index
;
Comorbidity
;
Demography
;
Gastrectomy
;
Gastric Bypass
;
Humans
;
Mortality
;
Obesity
;
Postoperative Complications
;
Retrospective Studies
10.Clinical Practice Guideline for Stroke Rehabilitation in Korea 2016.
Deog Young KIM ; Yun Hee KIM ; Jongmin LEE ; Won Hyuk CHANG ; Min Wook KIM ; Sung Bom PYUN ; Woo Kyoung YOO ; Suk Hoon OHN ; Ki Deok PARK ; Byung Mo OH ; Seong Hoon LIM ; Kang Jae JUNG ; Byung Ju RYU ; Sun IM ; Sung Ju JEE ; Han Gil SEO ; Ueon Woo RAH ; Joo Hyun PARK ; Min Kyun SOHN ; Min Ho CHUN ; Hee Suk SHIN ; Seong Jae LEE ; Yang Soo LEE ; Si Woon PARK ; Yoon Ghil PARK ; Nam Jong PAIK ; Sam Gyu LEE ; Ju Kang LEE ; Seong Eun KOH ; Don Kyu KIM ; Geun Young PARK ; Yong Il SHIN ; Myoung Hwan KO ; Yong Wook KIM ; Seung Don YOO ; Eun Joo KIM ; Min Kyun OH ; Jae Hyeok CHANG ; Se Hee JUNG ; Tae Woo KIM ; Won Seok KIM ; Dae Hyun KIM ; Tai Hwan PARK ; Kwan Sung LEE ; Byong Yong HWANG ; Young Jin SONG
Brain & Neurorehabilitation 2017;10(Suppl 1):e11-
“Clinical Practice Guideline for Stroke Rehabilitation in Korea 2016” is the 3rd edition of clinical practice guideline (CPG) for stroke rehabilitation in Korea, which updates the 2nd edition published in 2014. Forty-two specialists in stroke rehabilitation from 21 universities and 4 rehabilitation hospitals and 4 consultants participated in this update. The purpose of this CPG is to provide optimum practical guidelines for stroke rehabilitation teams to make a decision when they manage stroke patients and ultimately, to help stroke patients obtain maximal functional recovery and return to the society. The recent two CPGs from Canada (2015) and USA (2016) and articles that were published following the 2nd edition were used to develop this 3rd edition of CPG for stroke rehabilitation in Korea. The chosen articles' level of evidence and grade of recommendation were decided by the criteria of Scotland (2010) and the formal consensus was derived by the nominal group technique. The levels of evidence range from 1++ to 4 and the grades of recommendation range from A to D. Good Practice Point was recommended as best practice based on the clinical experience of the guideline developmental group. The draft of the developed CPG was reviewed by the experts group in the public hearings and then revised. “Clinical Practice Guideline for Stroke Rehabilitation in Korea 2016” consists of ‘Chapter 1; Introduction of Stroke Rehabilitation’, ‘Chapter 2; Rehabilitation for Stroke Syndrome, ‘Chapter 3; Rehabilitation for Returning to the Society’, and ‘Chapter 4; Advanced Technique for Stroke Rehabilitation’. “Clinical Practice Guideline for Stroke Rehabilitation in Korea 2016” will provide direction and standardization for acute, subacute and chronic stroke rehabilitation in Korea.
Canada
;
Consensus
;
Consultants
;
Humans
;
Korea*
;
Practice Guidelines as Topic
;
Rehabilitation*
;
Scotland
;
Specialization
;
Stroke*

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