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.

Background/Aims: Despite increasing awareness of the burden of chronic obstructive pulmonary disease (COPD) in women, knowledge regarding gender differences in COPD outcomes is limited. Therefore, we aimed to evaluate whether COPD outcomes, including exacerbations, lung , and symptoms differ by gender. Methods: We recruited patients with COPD from two Korean multicenter prospective cohorts. After propensity score matching, the main outcome, the incidence of moderate or severe exacerbations was analyzed using a negative binomial regression model. We also assessed changes in lung function and symptom scores including the St. George’s respiratory questionnaire for COPD (SGRQ-C), COPD assessment test (CAT), and the modified Medical Research Council (mMRC) dyspnea score. Results: After propensity score matching, 74 women and 74 men with COPD were included. The incidence rates of exacerbations in women and men were not significantly different (incidence rate ratio, 1.49; 95% confidence interval [CI], 0.88 to 2.54). There was no significant difference in the incidence rates adjusted for medication possession ratios of long-acting muscarinic antagonists, long-acting β-agonists, and inhaled corticosteroids during the follow-up period (incidence rate ratio, 1.47; 95% CI, 0.86 to 2.52). Rates of decline in post-bronchodilator forced expiratory volume in 1 second and forced vital capacity did not differ between women and men during 48 months of follow-up. The changes in scores on the SGRQ-C, CAT, and mMRC Questionnaire in women were also similar to those in men. Conclusions We observed no gender differences in the rate of exacerbations of COPD in a prospective longitudinal study. Further studies are needed to confirm these findings in the general COPD population.

Despite advancements in treating ruptured cerebral aneurysms, an aneurysmal subarachnoid hemorrhage (aSAH) is still a grave cerebrovascular disease associated with a high rate of morbidity and mortality. Based on the literature published to date, worldwide academic and governmental committees have developed clinical practice guidelines (CPGs) to propose standards for disease management in order to achieve the best treatment outcomes for aSAHs. In 2013, the Korean Society of Cerebrovascular Surgeons issued a Korean version of the CPGs for aSAHs. The group researched all articles and major foreign CPGs published in English until December 2015 using several search engines. Based on these articles, levels of evidence and grades of recommendations were determined by our society as well as by other related Quality Control Committees from neurointervention, neurology and rehabilitation medicine. The Korean version of the CPGs for aSAHs includes risk factors, diagnosis, initial management, medical and surgical management to prevent rebleeding, management of delayed cerebral ischemia and vasospasm, treatment of hydrocephalus, treatment of medical complications and early rehabilitation. The CPGs are not the absolute standard but are the present reference as the evidence is still incomplete, each environment of clinical practice is different, and there is a high probability of variation in the current recommendations. The CPGs will be useful in the fields of clinical practice and research.
Aneurysm ; Brain Ischemia ; Cerebrovascular Disorders ; Diagnosis ; Disease Management ; Hydrocephalus ; Intracranial Aneurysm ; Mortality ; Neurology ; Quality Control ; Rehabilitation ; Risk Factors ; Search Engine ; Subarachnoid Hemorrhage ; Surgeons

BACKGROUND: Compared with other chronic diseases, hearing loss is generally overlooked from the perspective of disease burden. However, hearing loss is emerging as an important issue in the current society. The objective of this study was to investigate disease burdens and marginal utilities associated with hearing loss and other chronic diseases. METHODS: This study analyzed the cross-sectional data of 32,986 participants aged 19 years and older who completed the Korea National Health and Nutrition Examination Surveys between 2009 and 2013. Additionally, this study used the pure tone audiometric test, European Quality of Life-Five Dimensions Questionnaire, and chronic disease status. The data were analyzed using a multiple linear regression method. RESULTS: The data of 23,297 people who underwent a pure tone audiogram and completed the European Quality of Life-Five Dimensions Questionnaire were used in this analysis. The marginal utility of hearing loss ranked fifth among nine chronic diseases. The estimated loss of quality-adjusted life years associated with hearing loss was −93.69 years per 100,000 people, which is similar to other chronic diseases. CONCLUSION: This study assessed the marginal utilities and public burdens of hearing loss and eight chronic diseases in a South Korean population. Although the values may vary depending on country and race, this study may provide an indispensable foundation for more detailed studies on hearing loss.
Chronic Disease* ; Continental Population Groups ; Hearing Loss* ; Hearing* ; Humans ; Korea ; Linear Models ; Methods ; Quality-Adjusted Life Years

PURPOSE: This study was performed to evaluate the effects of cyclosporine-A (CsA) on linear growth in pediatric patients with steroid-dependent (SDNS) or resistant nephrotic syndrome (SRNS). METHODS: Thirty-five pediatric patients with SDNS or SRNS undergoing glucocorticoid (GC) and/or CsA treatment were retrospectively reviewed. Seventeen patients were treated with GC alone and 18 were treated with GC and CsA. The cumulative doses of GC and CsA were quantified (mg/kg/day). Linear growth during the follow-up period was defined as the difference in Z-score between the initial and final height according to the follow-up period (Δ height Z score/year). The associations between linear growth and clinical parameters were analyzed. RESULTS: The linear growth of patients in the two groups was not significantly different (P=0.262). The Δ height Z score/year did not show a significant correlation with the cumulative doses of CsA, but was negatively correlated with the cumulative dose of GC and positively correlated with the Z score for height at the time of diagnosis. CONCLUSION: In children with SDNS or SRNS undergoing GC therapy, added CsA treatment may not have harmful effects on linear growth.
Child ; Cyclosporine ; Diagnosis ; Follow-Up Studies ; Humans ; Nephrotic Syndrome* ; Retrospective Studies

Lyme disease is a tick-borne zoonotic infectious disease caused by Borrelia burgdorferi. The present study assessed the infection status of B. burgdorferi among horses reared in Korea using ELISA and PCR. Between 2009 and 2013, blood samples were collected from 727 horses throughout Korea. Data for each animal including age, gender, breed, and region of sample collection were used for epidemiological analysis. Overall, 38 (5.2%; true prevalence: 5.5%) of 727 horses were seropositive by ELISA. There were statistically significant differences according to breed and region (P<0.001) whose differences might be attributed to the ecology of vector ticks and climate conditions. Using 2 nested PCR, none of the samples tested positive for B. burgdorferi. Thus, a positive ELISA result can indicate only that the tested horse was previously exposed to B. burgdorferi, with no certainty over the time of exposure. Since global warming is likely to increase the abundance of ticks in Korea, continuous monitoring of tick-borne diseases in Korean horses is needed.
Animals ; Antibodies, Bacterial/blood ; Borrelia burgdorferi/*physiology ; Enzyme-Linked Immunosorbent Assay/veterinary ; Female ; Horse Diseases/*epidemiology ; Horses ; Lyme Disease/epidemiology/*veterinary ; Male ; Republic of Korea/epidemiology

We assessed the success rate of empirical antifungal therapy with itraconazole and evaluated risk factors for predicting the failure of empirical antifungal therapy. A multicenter, prospective, observational study was performed in patients with hematological malignancies who had neutropenic fever and received empirical antifungal therapy with itraconazole at 22 centers. A total of 391 patients who had abnormal findings on chest imaging tests (31.0%) or a positive result of enzyme immunoassay for serum galactomannan (17.6%) showed a 56.5% overall success rate. Positive galactomannan tests before the initiation of the empirical antifungal therapy (P=0.026, hazard ratio [HR], 2.28; 95% confidence interval [CI], 1.10-4.69) and abnormal findings on the chest imaging tests before initiation of the empirical antifungal therapy (P=0.022, HR, 2.03; 95% CI, 1.11-3.71) were significantly associated with poor outcomes for the empirical antifungal therapy. Eight patients (2.0%) had premature discontinuation of itraconazole therapy due to toxicity. It is suggested that positive galactomannan tests and abnormal findings on the chest imaging tests at the time of initiation of the empirical antifungal therapy are risk factors for predicting the failure of the empirical antifungal therapy with itraconazole. (Clinical Trial Registration on National Cancer Institute website, NCT01060462)
14-alpha Demethylase Inhibitors/adverse effects/therapeutic use ; Adolescent ; Adult ; Aged ; Antifungal Agents/adverse effects/*therapeutic use ; Aspergillosis/complications/*drug therapy ; Candidiasis/complications/*drug therapy ; Coccidioidomycosis/complications/drug therapy ; Febrile Neutropenia/complications/drug therapy ; Female ; Hematologic Neoplasms/complications/drug therapy/*microbiology ; Humans ; Itraconazole/adverse effects/*therapeutic use ; Male ; Mannans/blood ; Middle Aged ; Prospective Studies ; Treatment Outcome ; Young Adult

To determine the approximate incidence and clinical features of pernicious anemia in a Korean population, we retrospectively analyzed clinical data for patients with pernicious anemia who were diagnosed between 1995 and 2010 at five hospitals in Chungnam province. Ninety-seven patients were enrolled, who accounted for 24% of patients with vitamin B12 deficiency anemia. The approximate annual incidence of pernicious anemia was 0.3 per 100,000. The median age was 66 (range, 32-98) yr, and the male/female ratio was 1.25. Anemia-associated discomfort was the most common symptom (79.4%), followed by gastrointestinal and neurological symptoms (78.4% and 38.1%, respectively). Pancytopenia was found in 36 patients (37.1%), and autoimmune disorders were found in 15 patients (15.5%). Antibody to intrinsic factor was detected in 62 (77.5%) of 80 patients examined, and antibody to parietal cells was detected in 35 (43.2%) of 81 patients examined. Of the 34 patients who underwent tests for Helicobacter pylori, 7 (12.5%) were positive. The anemia-associated and gastrointestinal symptoms resolved completely in all patients after intramuscular injection of cobalamin, whereas neurological symptoms remained in some. In conclusion, pernicious anemia is less frequent in Koreans than in Western populations; however, the clinical features of this disorder in Koreans do not differ from those of Western cases.
Adult ; Aged ; Anemia, Pernicious/complications/*diagnosis/epidemiology ; Asian Continental Ancestry Group ; Autoimmune Diseases/complications/epidemiology ; Female ; Gastrointestinal Diseases/complications/drug therapy/epidemiology ; Helicobacter Infections/diagnosis ; Helicobacter pylori ; Humans ; Isoantibodies/blood ; Male ; Middle Aged ; Nervous System Diseases/complications/epidemiology ; Parietal Cells, Gastric/immunology ; Republic of Korea/epidemiology ; Retrospective Studies ; Vitamin B 12/blood/therapeutic use

While it is reasonably well known that certain dental procedures increase the temperature of the tooth's surface, of greater interest is their potential damaging effect on the pulp and tooth-supporting tissues. Previous studies have investigated the responses of the pulp, periodontal ligament, and alveolar bone to thermal irritation and the temperature at which thermal damage is initiated. There are also many in vitro studies that have measured the temperature increase of the pulp and tooth-supporting tissues during restorative and endodontic procedures. This review article provides an overview of studies measuring temperature increases in tooth structures during several restorative and endodontic procedures, and proposes clinical guidelines for reducing potential thermal hazards to the pulp and supporting tissues.
Periodontal Ligament ; Root Canal Obturation ; Tooth ; Tooth Preparation ; Ultrasonics

BACKGROUND: A chronic obstructive pulmonary disease (COPD) assessment test (CAT) has recently been developed as a short and simple method for assessing the quality of life in COPD patients. The object of this study was to assess the usefulness of the Korean version of the CAT for assessing COPD patients in an outpatient clinic. METHODS: The study included 60 COPD patients in a stable state from an outpatient clinic. The authors investigated the frequency of acute exacerbation during aprevious year through reviewing medical records. We evaluated the spirometry test, a 6-min walk distance test, and obtained the MMRC dyspnea scale, the Korean version of the CAT, and the BODE index at the time of visit. To assess the usefulness of the CAT, correlations between the CAT and other methods were evaluated. RESULTS: The mean age of patients was 68.3+/-8.6 years and 95% of patients were male. There was a significant correlation between the CAT score and FEV1% (r=-0.323, p=0.012), the frequency of acute exacerbation (r=0.292, p=0.024), the MMRC dyspnea scale (r=0.554, p<0.001), the BODE index (r=0.380, p=0.003), and 6 MWD (r=-0.372, p=0.004). The mean CAT score increased according to the GOLD stage (stage 1, 10.7+/-4.5; stage 2, 13.1+/-7.9; stage 3, 16.3+/-6.2; stage 4, 16.5+/-14.8; p=0.746). CONCLUSION: The CAT was shown to be useful for the assessment of COPD severity. Therefore, the CAT is an easily applied and simple method for assessing COPD severity in an outpatient clinic.
Ambulatory Care Facilities ; Animals ; Body Mass Index ; Cats ; Disease Progression ; Dyspnea ; Humans ; Male ; Medical Records ; Outpatients ; Pulmonary Disease, Chronic Obstructive ; Quality of Life ; Spirometry