• Title/Summary/Keyword: Multicenter clinical study

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Efficacy and Safety of Raltitrexed Combinations with Uracil-Tegafur or Mitomycin C as Salvage Treatment in Advanced Colorectal Cancer Patients: A Multicenter Study of Anatolian Society of Medical Oncology (ASMO)

  • Bozkurt, Oktay;Karaca, Halit;Ciltas, Aydin;Kaplan, M. Ali;Benekli, Mustafa;Sevinc, Alper;Demirci, Umut;Eren, Tulay;Kodaz, Hilmi;Isikdogan, Abdurrahman;Ozkan, Metin;Buyukberber, Suleyman
    • Asian Pacific Journal of Cancer Prevention
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    • v.15 no.4
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    • pp.1845-1849
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    • 2014
  • Background: There is no standard treatment for patients with colorectal cancer (CRC) progressing after irinotecan and oxaliplatin treatment. Here we aimed to retrospectively evaluate the efficacy and tolerability of raltitrexed in combination with oral 5-fluoropyrimidine (uracil tegafur-UFT) or mitomycin C as salvage therapy in mCRC patients. Materials and Methods: A total of 62 patients who had received raltitrexed combined with UFT or mitomycin C were identified between December 2008 and June 2013. They were given raltitrexed 2.6 $mg/m^2$ (max 5 mg) i.v. on day 1 in combination with either oral UFT 500 mg/day on days 1-14 every 3 weeks (group A) or mitomycin C 6 $mg/m^2$ i.v. on day every 3 weeks (group B). Results: Forty-two patients (67.7%) were in group A and 20 (32.2%) in group B. In 15 patients (24%) grade 3/4 toxicity was observed, resulting in dose reduction, and in 13 patients (20.9%) dose delay was necessary. The median progression free survival (PFS) was 3 months (95%CI 2.65-3.34) and median overall survival (OS) was 6 months (95%CI 2.09-9.90) in the whole group. Median PFS was 3 months (95%CI 2.60-3.39) in group A vs 3 months (95%CI 1.64-4.35) in group B (p=0.90). Median OS was 6 months (95%CI 2.47-9.53) in group A vs 12 months (95%CI 2.83-21.1) in group B (p=0.46). Conclusions: The combination of raltitrexed with UFT or mitomycin C seem to be a salvage therapy option due to safety profile and moderate clinical activity in heavily-pretreated mCRC patients.

The Assessment Tools in Palliative Medicine (완화 의학에서의 평가도구)

  • Gwak, Jung-Im;Suh, Sang-Yeon
    • Journal of Hospice and Palliative Care
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    • v.12 no.4
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    • pp.177-193
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    • 2009
  • The assessment of patient status in palliative medicine is essential for determining treatments and for clinical outcomes. The objective of assessment tools is to raise the quality of care for individual patients and their families. There are a number of tools available to assess pain, non-pain symptoms and quality of life. The tools are either uni-dimensional or multi-dimensional measures. Unfortunately, however, no single tool is recommended to be a superior to others in symptoms or quality of life assessment. Therefore, to select an appropriate assessment tool, one should consider the time frame and unique characteristics of tools depending on purpose and setting. The combination of prognostic index is highly recommended in prognostication, and web-based prognostic tools are available. Recently, a new objective prognostic score has been constructed through multicenter study in Korea. It does not include clinicalestimates of survival, but includes new objective prognostic factors, therefore, anyone can easily use it. For beginners in palliative medicine, relatively easy-to-use tools would be convenient. We recommend Eastern Cooperative Oncology Group performance status to assess functional status, numeric rating scale for pain assessment and the Korean version of brief pain inventory for initial pain assessment. Asking directly with numeric rating scale or the Korean version of MD Anderson Symptom Inventory would be desirable to assess various symptoms together. We think that European Organization Research and Treatment Quality of Life Questionnaire Core 15 for Palliative Care is good to assess the quality of life, while Objective Prognostic Score is convenient as prognostic index for beginners.

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Prevalence of Inflammatory Bowel Disease Unclassified, as Estimated Using the Revised Porto Criteria, among Korean Pediatric Patients with Inflammatory Bowel Disease

  • Sung Hee Lee;Minsoo Shin;Seo Hee Kim;Seong Pyo Kim;Hyung-Jin Yoon;Yangsoon Park;Jaemoon Koh;Seak Hee Oh;Jae Sung Ko;Jin Soo Moon;Kyung Mo Kim
    • Pediatric Gastroenterology, Hepatology & Nutrition
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    • v.27 no.4
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    • pp.206-214
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    • 2024
  • Purpose: Few studies have reported the prevalence of inflammatory bowel disease unclassified (IBDU) among Korean pediatric IBD (PIBD) population. To address this gap, we used two tertiary centers and nationwide population-based healthcare administrative data to estimate the prevalence of Korean pediatric IBDU at the time of diagnosis. Methods: We identified 136 patients aged 2-17 years with newly diagnosed IBD (94 Crohn's disease [CD] and 42 ulcerative colitis [UC]) from two tertiary centers in Korea between 2005 and 2017. We reclassified these 136 patients using the revised Porto criteria. To estimate the population-based prevalence, we analyzed Korean administrative healthcare data between 2005 and 2016, which revealed 3,650 IBD patients, including 2,538 CD and 1,112 UC. By extrapolating the reclassified results to a population-based dataset, we estimated the prevalence of PIBD subtypes. Results: Among the 94 CD, the original diagnosis remained unchanged in 93 (98.9%), while the diagnosis of one (1.1%) patient was changed to IBDU. Among the 42 UC, the original diagnosis remained unchanged in 13 (31.0%), while the diagnoses in 11 (26.2%), 17 (40.5%), and one (2.4%) patient changed to atypical UC, IBDU, and CD, respectively. The estimated prevalences of CD, UC, atypical UC, and IBDU in the Korean population were 69.5%, 9.4%, 8.0%, and 13.1%, respectively. Conclusion: This study is the first in Korea to estimate the prevalence of pediatric IBDU. This prevalence (13.1%) aligns with findings from Western studies. Large-scale prospective multicenter studies on PIBDU are required to examine the clinical features and outcomes of this condition.

Efficacy and Safety of Long-Term Administration of Esomeprazole in Japanese Pediatric Patients Aged 1-14 Years with Chronic Gastric Acid-Related Disease

  • Masaaki Mori;Yoshiko Nakayama;Shigeo Nishimata;Tadafumi Yokoyama;Ryo Matsuoka;Reiko Hatori;Masaki Shimizu;Katsuhiro Arai;Yuri Etani;Tsuyoshi Sogo;Tomoko Ishizu;Masahiro Nii;Ryosuke Nakashima;Toshiaki Shimizu
    • Pediatric Gastroenterology, Hepatology & Nutrition
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    • v.27 no.5
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    • pp.274-285
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    • 2024
  • Purpose: To evaluate prolonged esomeprazole use in Japanese pediatric patients for reflux esophagitis (RE) maintenance therapy and prevention of gastric (GU) and/or duodenal ulcers (DU) while using non-steroidal anti-inflammatory drugs (NSAIDs) or low-dose aspirin (LDA). Methods: This multicenter, open-label, parallel-group, phase III study (NCT03553563) included patients who were administered esomeprazole according to body weight (10 mg/day [Groups 1 and 3] and up to 20 mg/day [Groups 2 and 4] for patients weighing 10-20 kg and ≥20 kg, respectively). Efficacy outcomes for Groups 1 and 2 (maintenance therapy for healed RE) and Groups 3 and 4 (prevention of long-term NSAID/LDA use-associated GU/DU) were the presence/absence of RE relapse and GU/DU recurrence, respectively. Results: Esomeprazole as maintenance therapy was associated with a low RE recurrence rate, independent of body weight or dosage. Recurrence rates of RE were 0.0% and 5.3% for Groups 1 and 2, respectively. In patients previously diagnosed with GU and/or DU due to long-term NSAID/LDA use, the recurrence rates of GU/DU during weeks 0-32 were 11.1% and 0.0% in Groups 3 and 4, respectively. Conclusion: Long-term use of 10- or 20-mg, once-daily esomeprazole demonstrated a favorable benefit-risk balance in preventing RE and suppressing recurrence of GU and/or DU secondary to NSAID or LDA therapy in Japanese pediatric patients. No new safety concerns were identified. Esomeprazole may be a viable option for managing RE and preventing GU and DU in Japanese pediatric patients.

Impacts of Pre-transplant Panel-Reactive Antibody on Post-transplantation Outcomes: A Study of Nationwide Heart Transplant Registry Data

  • Darae Kim;Jin-Oh Choi;Yang Hyun Cho;Kiick Sung;Jaewon Oh;Hyun Jai Cho;Sung-Ho Jung;Hae-Young Lee;Jin Joo Park;Dong-Ju Choi;Seok-Min Kang;Myoung Soo Kim;Jae-Joong Kim
    • Korean Circulation Journal
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    • v.54 no.6
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    • pp.325-335
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    • 2024
  • Background and Objectives: The number of sensitized heart failure patients on waiting lists for heart transplantation (HTx) is increasing. Using the Korean Organ Transplantation Registry (KOTRY), a nationwide multicenter database, we investigated the prevalence and clinical impact of calculated panel-reactive antibody (cPRA) in patients undergoing HTx. Methods: We retrospectively reviewed 813 patients who underwent HTx between 2014 and 2021. Patients were grouped according to peak PRA level as group A: patients with cPRA ≤10% (n= 492); group B: patients with cPRA >10%, <50% (n=160); group C patients with cPRA ≥50% (n=161). Post-HTx outcomes were freedom from antibody-mediated rejection (AMR), acute cellular rejection, coronary allograft vasculopathy, and all-cause mortality. Results: The median follow-up duration was 44 (19-72) months. Female sex, re-transplantation, and pre-HTx renal replacement therapy were independently associated with an increased risk of sensitization (cPRA ≥50%). Group C patients were more likely to have longer hospital stays and to use anti-thymocyte globulin as an induction agent compared to groups A and B. Significantly more patients in group C had positive flow cytometric crossmatch and had a higher incidence of preformed donor-specific antibody (DSA) compared to groups A and B. During follow-up, group C had a significantly higher rate of AMR, but the overall survival rate was comparable to that of groups A and B. In a subgroup analysis of group C, post-transplant survival was comparable despite higher preformed DSA in a desensitized group compared to the non-desensitized group. Conclusions: Patients with cPRA ≥50% had significantly higher incidence of preformed DSA and lower freedom from AMR, but post-HTx survival rates were similar to those with cPRA <50%. Our findings suggest that sensitized patients can attain comparable post-transplant survival to non-sensitized patients when treated with optimal desensitization treatment and therapeutic intervention.

Omental Infarction Following Laparoscopy-assisted Gastrectomy (LAG) for Gastric Cancer (위암 환자의 복강경 위절제술 후 발생한 그물막 경색의 임상적 의의)

  • Kim, Min-Chan;Jung, Ghap-Joon;Oh, Jong-Young
    • Journal of Gastric Cancer
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    • v.10 no.1
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    • pp.13-18
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    • 2010
  • Purpose: Omental infarction (OI) following laparoscopy-assisted gastrectomy (LAG) for gastric cancer could become more common in the future because the indications for LAG are expected to expand. The aim of this study was to determine the clinical characteristics of OI following LAG. Materials and Methods: Three hundred ninety patients who underwent LAG for T1 or T2 gastric cancer from April 2003 to November 2007 were enrolled. OI was diagnosed by two radiologists using the patients' abdominal 16 row-detector CT scans. The clinicopathologic characteristics were retrospectively evaluated in the omental infarction (OI) group and the non-omental infarction (non-OI) group using the gastric cancer database of Dong-A University Medical Center and the medical record. Results: Nine omental infarctions (2.3%) of 390 LAGs were diagnosed. All the OIs could be discriminated from omental metastasis on the initial or follow up CT images. The location of the omental infarctions was on the epigastrium in 3 patients and in the left upper quadrant in 3 patients. The mean size of the OIs was 4.1 cm. Most patients with OI had no signs or symptoms. The body mass index of the OI group was higher than that of the non-OI group (P=0230), and OI was more common in patients who underwent total gastrectomy than in the patients who underwent subtotal gastrectomy (P=0.0011). Conclusion: Laparoscopy-assisted gastrectomy (LAG) with partial omentectomy for gastric cancer can be a cause of secondary OI. Omental infarction after LAG has different clinical characteristics and CT findings that those of other omental infarctions or postoperative omental metastases. Further multicenter study will be needed to evaluate in detail the clinical features of omental infarction after LAG.

Clinicopathological Analysis of Glomerulonephritis in Children (소아 사구체신염의 임상 및 병리학적 분석)

  • Park Gwang-Yong;Yoon Hye-Kyoung;Chung Woo-Yeong
    • Childhood Kidney Diseases
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    • v.1 no.1
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    • pp.4-12
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    • 1997
  • Purpose: To evaluate the prevalence and clinical manifestations of various glomerulonephritis (GN) in children, a clinicopathological anlysis of 310 biopsied cases were performed. Method: We conducted retrospective study with review of histopathologic findings and clinical manifestations of the 310 cases diagnosed as glomerulonephritis by percutaneous renal biopsy which were done between January 1986 and December 1996 at department of pediatrics, Pusan Paik hospital. Results: 1) Male to female ratio was 1.54:1 and the range of age was from 13 months to 15 years 10 months. 2) Among these, 217 (70.0%) patients were belong to primary GN and 93 (30.0%) patients were belong to secondary GN. As a whole, the most common pathologic diagnosis was minimal change lesion (MC, 32.6%), which was followed by IgA nephropathy (IgAN, 15.8%), $Henoch-Sch\"{o}nlein$ purpura nephritis (HSPN, 13.5%), Poststreptococcal glomerulonephritis (PSAGN, 8.1%). 3) Clinical manifestations of patients were asymptomatic urinary abnormality (43.2%), nephrotic syndrome (41.0%), acute glomerulonephritis (14.2%), chronic glomerulonephritis (1.0%), rapidly progressive glomerulonephritis (0.6%). 4) In primary GN, the most common pathologic diagnosis was MC (46.5%), IgAN (22.6%), thin glomerular basement membrane (GBM) disease (7.8%), membranoproliferative glomerulonephritis (MPGN, 5.5%), mesangial proliferative glomerulonephritis (MesPGN,4.6%), focal segmental glomerulosclerosis (FSGS, 4.6%), membranous nephropathy (MN, 0.9%), sclerosing glomerulonephritis (SCGN, 0.9%), crescentic glomerulonephritis (CreGN, 0.5%) and non-specific glomerulonephritis (NonspGN, 6.0%). 5) Major causes of secondary GN were HSPN (45.2%), PSAGN (26.9%), hepatitis B associated glomerulonephritis (HBGN, 17.2%), lupus nephritis (LN, 6.5%), Alport syndrome (2.2%), hemolytic uremic syndrome (1.0%), fibrillary glomerulonephritis (1.0%) in descending order. Conclusions: There are some differences of the results of clinicopathological stuidies of glomerulonephritis in children because of its different indications of renal biopsy, pathologic classification of renal disease and methods of analysis among investigators. In order to establish more reliable data of incidence and classification of childhood glomerulonephritis in Korea, multicenter cooperative study were necessary.

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A Multicenter, Randomized, Open, Comparative Study for the Efficacy and Safety of Oral Moxifloxacin 400 mg Once a Day and Clarithromycin 500 mg Twice Daily in Korean Patients with Acute Exacerbations of Chronic Bronchitis (한국인의 만성 기관지염의 급성 악화 환자를 대상으로 한 Moxifloxacin 400mg 1 일 1회 요법과 Clarithromycin 500mg 1일 2회 요법의 치료효과 및 안전성 비교)

  • Kim, Seung-Joon;Kim, Seok-Chan;Lee, Sook-Young;Yoon, Hyeong-Kyu;Kim, Tae-Yon;Kim, Young-Kyoon;Song, Jeong-Sup;Park, Sung-Hak;Kim, Ho-Joong;Chung, Man-Pyo;Suh, Gee-Young;Kwon, O-Jung;Lee, Shin -Hyung;Kang, Kyung-Ho;Lee, Eh-Hyung;Hwang, Sung-Chul;Han, Myung-Ho
    • Tuberculosis and Respiratory Diseases
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    • v.49 no.6
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    • pp.740-751
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    • 2000
  • Background : Moxifloxacin is a newly developed drug which is more potent and safe compared to previous fluoroquinolones. This drug effectively eradicates organisms such as beta-lactamase-producing or other resistant bacteria. Moxifloxacin is known to be effective in treating respiratory infections such as Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, Chlamydia pneumoniaeme, Legionella spp. and Mycoplasma pneumoniae. Methods : In a multicenter, randomized, open, comparative study, the efficacy and safety of oral moxifloxacin taken 400 mg once a day and clarithromycin taken 500 mg twice daily for 7 days were compared for the treatment of Korean patients with acute exacerbations of chronic bronchitis. Results : A total of 170 patients were enrolled, and they were divided into two groups: 87 in the moxifloxacin group and 83 in the clarithromycin group. Of those enrolled, 76 (35 for bacteriologic efficacy) in the moxifloxacin group and 77 (31 for bacteriologic efficacy) in the clarithromycin group were included in the efficacy analysis. All were included in the safety analysis. Clinical success was noted in 70 (92.1%) of 76 moxifloxacin-treated patients and 71 (92.2%) of 77 clarithromycin-treated patients. Bacteriologic success rate seemed to be higher in moxifloxacin group (73.5%) than in clarithromycin group (54.8%), but statistically insignificant (p=0.098). Drug susceptibility among organisms initially isolated was higher in moxifloxacin group on Streptococcus pneumoniae, Pseudomonas aeruginosa, Klebsiella pneumoniae (p<0.001). Adverse events were reported by 12.8% of 86 patients receiving moxifloxacin and 21.7% of 83 patients receiving clarithromycin. Headache (4.7% vs 4.8%, moxifloxacin group vs clarithromycin group, respectively) and indigestion (2.3% vs 6.0%, moxifloxacin group vs clarithromycin group, respectively) were the most frequent side effects in the two groups. Conclusion : This study demonstrated that for the treatment of acute exacerbations of chronic bronchitis a 7-day course of moxifloxacin 400 mg od was clinically equivalent and microbiologically superior to clarithromycin 500 mg bid.

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Multicenter clinical study on birth weight and associated anomalies of single umbilical artery (단일 배꼽 동맥 환아의 출생체중과 동반기형에 관한 다기관 연구)

  • Bae, Su-Nam;Lim, Jae-Woo;Ko, Kyong-Og;Jin, Hyun-Seung;Kim, Min-Hee;Lee, Bo-Young;Kim, Chun-Soo;Kim, Eun-Ryoung;Park, Sang-Kee;Lee, Jung-Joo
    • Clinical and Experimental Pediatrics
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    • v.52 no.6
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    • pp.655-660
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    • 2009
  • Purpose : To compare birth weight between infants with a single umbilical artery (SUA) and normal infants, investigate the associated anomalies of infants with SUA and isolated SUA (no abnormality of external appearance on birth, except SUA), and determine the prognosis of infants with isolated SUA. Methods : Live-born infants with SUA (n=59) detected by physical examination from among 15,193 live births in seven university hospitals in Korea between January 1, 2004, to August 1, 2007, were reviewed retrospectively, with 236 normal infants serving as the control group. Results : A statistical difference was observed between the groups in birth weight and in vitro fertilization. The incidence of infants with SUA was 0.37%. Congenital malformations were observed in 21 infants with cardiovascular (n=15, 25.4%), gastrointestinal (n=2, 3.4%), genitourinary (n=9, 15.3%), neuromusculoskeletal (n=6, 10.2%), central nervous system (n=1, 1.7%), chromosomal (n=1, 1.7%), and other (n=3, 5.1%) abnormalities. There were 49 (83.1%) infants with isolated SUA in this study population; among them, the associated congenital malformations were cardiovascular (n=6, 12.2%) and genitourinary (n=6, 12.2%) abnormalities. Two infants with cyanotic heart disease were operated and four infants with acyanotic heart disease showed improvements without any treatment. Six infants with genitourinary abnormalities on renal ultrasound had mild hydronephrosis without further consequences. Conclusion : The incidence of structural abnormalities in the cardiovascular and genitourinary systems is high and the genitourinary anomalies associated with isolated SUA have relatively good prognosis.

Quality of Anticoagulation and Treatment Satisfaction in Patients with Non-Valvular Atrial Fibrillation Treated with Vitamin K Antagonist: Result from the KORean Atrial Fibrillation Investigation II

  • Oh, Seil;Kim, June-Soo;Oh, Yong-Seog;Shin, Dong-Gu;Pak, Hui-Nam;Hwang, Gyo-Seung;Choi, Kee-Joon;Kim, Jin-Bae;Lee, Man-Young;Park, Hyung-Wook;Kim, Dae-Kyeong;Jin, Eun-Sun;Park, Jaeseok;Oh, Il-Young;Shin, Dae-Hee;Park, Hyoung-Seob;Kim, Jun Hyung;Kim, Nam-Ho;Ahn, Min-Soo;Seo, Bo-Jeong;Kim, Young-Joo;Kang, Seongsik;Lee, Juneyoung;Kim, Young-Hoon
    • Journal of Korean Medical Science
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    • v.33 no.49
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    • pp.323.1-323.12
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    • 2018
  • Background: Vitamin K antagonist (VKA) to prevent thromboembolism in non-valvular atrial fibrillation (NVAF) patients has limitations such as drug interaction. This study investigated the clinical characteristics of Korean patients treated with VKA for stroke prevention and assessed quality of VKA therapy and treatment satisfaction. Methods: We conducted a multicenter, prospective, non-interventional study. Patients with $CHADS_2{\geq}1$ and treated with VKA (started within the last 3 months) were enrolled from April 2013 to March 2014. Demographic and clinical features including risk factors of stroke and VKA treatment information was collected at baseline. Treatment patterns and international normalized ratio (INR) level were evaluated during follow-up. Time in therapeutic range (TTR) > 60% indicated well-controlled INR. Treatment satisfaction on the VKA use was measured by Treatment Satisfaction Questionnaire for Medication (TSQM) after 3 months of follow-up. Results: A total of 877 patients (age, 67; male, 60%) were enrolled and followed up for one year. More than half of patients (56%) had $CHADS_2{\geq}2$ and 83.6% had $CHA_2DS_2-VASc{\geq}2$. A total of 852 patients had one or more INR measurement during their follow-up period. Among those patients, 25.5% discontinued VKA treatment during follow-up. Of all patients, 626 patients (73%) had poor-controlled INR (TTR < 60%) measure. Patients' treatment satisfaction measured with TSQM was 55.6 in global satisfaction domain. Conclusion: INR was poorly controlled in Korean NVAF patients treated with VKA. VKA users also showed low treatment satisfaction.