Background: Umeclidinium/vilanterol (UMEC/VI; ANORO ELLIPTA, GSK) is a commonly used dual bronchodilator. This study evaluated the safety and effectiveness of UMEC/VI in Korean patients with chronic obstructive pulmonary disease (COPD) over a 6-year period. Methods: This was an open-label, multicentre, observational, post-marketing surveillance study. A total of 3,375 patients were enrolled consecutively in 52 hospitals, by 53 physicians, between July 2014 and July 2020. Patients who were administered UMEC/VI (fixed-dose 62.5 μg/25 μg) at least once and were monitored for safety and effectiveness were included in the analysis. Incidence and severity of adverse events (AEs) reported after administrating at least one dose of UMEC/VI were monitored, including unexpected adverse events (UAEs) and adverse drug reactions (ADRs). Effectiveness of UMEC/VI after 24 weeks of administration was also assessed using physician’s evaluation (effective, ineffectiveo change, worsening, indeterminable) and lung function improvement. Results: Of 3,375 patients, 3,086 were included in the safety assessment group (mean age±standard deviation: 69.76±8.80 years; 85.9% male [n=2,652]; 73.1% aged ≥65 years [n=2,255]). The overall incidence of AEs was 28.8% (n=890), of which 2.2% (n=67) were ADRs. Serious AEs and UAEs were reported in 181 (5.9%) and 665 (21.6%) patients, respectively, and two patients (<0.1%) reported unexpected severe ADR. Of the 903/3,086 patients analysed for effectiveness, most (82.8%, n=748) showed overall disease improvement after UMEC/VI treatment. Conclusion This study confirmed UMEC/VI administered to Korean patients according to the prescribing information was well-tolerated and can be considered an effective option for COPD treatment.

Background: The integrase strand transfer inhibitor dolutegravir has been indicated in Korea since 2014 for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in combination with other antiretroviral agents. This regulatory post-marketing surveillance (PMS) study evaluated the real-life safety and effectiveness of dolutegravir in patients with HIV-1 in clinical practice in Korea. Materials and Methods: This open-label PMS study examined data from consecutive patients (aged ≥12 years) with HIV-1 infection receiving dolutegravir according to locally approved prescribing information; treatment-naïve and treatment-experienced patients were permitted. Data regarding patient demographics, medical history, clinical characteristics, medications (HIV-related and concomitant), and comorbidities were extracted from patient records over a 1-year treatment period. Outcomes included the safety of dolutegravir (primary endpoint) and real-life effectiveness according to the Physician Global Assessment (PGA) and the proportion of patients with plasma HIV-1 RNA count <50 copies/mL at 48 weeks. Results: Of 147 patients treated with dolutegravir at 18 centers in Korea (August 2014 – August 2020), 139 were eligible for the safety analyses and 75 for effectiveness analyses.Patients (mean age 47 years) were mostly male (92.8%) and received dolutegravir in combination with nucleoside reverse transcriptase inhibitor (70.5%) or protease inhibitors (21.6%). Adverse events (AEs) (n = 179 in total) were mostly mild in severity, with the most common being nasopharyngitis (5.0%), dyspepsia (5.0%), pruritus (4.3%), and rash (4.3%).Of 16 adverse drug reactions (ADRs), the most frequent were rash, diarrhea, headache, insomnia, and somnolence (1.4% each). Of 2 serious ADRs, only 1 (gastroenteritis) was unexpected, and both resolved. The risk of experiencing an AE while receiving dolutegravir appeared to be especially increased in patients receiving concomitant medications for other conditions. Dolutegravir effectively suppressed HIV-1 (93.3% of patients had plasma HIV-1 RNA <50 copies/mL), and 100% of patients showed symptom improvement based on physician global assessment. Conclusion Results of this PMS study showed that dolutegravir administered as highly active antiretroviral therapy was well tolerated and effective in patients with HIV-1 infection.

BACKGROUND: Extended-spectrum beta-lactamase (ESBL)-producing Escherichia coli and Klebsiella pneumoniae are main pathogens of bloodstream infection. We compared the epidemiology of ESBL-producing E. coli and K. pneumoniae. METHODS: From January 2003 through March 2007, we retrospectively investigated the clinical characteristics and comorbidities of patients with bloodstream infection by ESBL-producing E. coli and K. pneumoniae. RESULTS: During the study period, 79 patients (54 with E. coli and 25 with K. pneumoniae) with blood cultures positive for ESBL-producing E. coli or K. pneumoniae were studied. When comparing the source of bloodstream infections, urinary tract infections (UTIs) were more commonly caused by E. coli (24% vs. 0; P=0.007), and respiratory tract and soft tissue infection (36% vs. 15%; P=0.04, 12% vs. 0; P=0.03, respectively) were more commonly associated with K. pneumoniae. Among hospital-acquired bloodstream infection, third-generation cephalosporin was more commonly used in patients with E. coli than patients with K. pneumoniae (81% vs. 24%, P<0.001). Medical devices (central venous catheter and urinary catheter) were more commonly used in patients with K. pneumoniae. CONCLUSION: ESBL-producing E. coli bloodstream infection is more common in urinary tract infections. ESBL-producing K. pneumoniae is more common in respiratory tract infections and in skin and soft tissue infections. In hospital-acquired infections, ESBL-producing E. coli bloodstream infection is more common in biliary tract infection. ESBL-producing E. coli was more commonly associated with prior frequent antibiotics use and K. pneumoniae was more commonly associated with use of medical devices.
Anti-Bacterial Agents ; beta-Lactamases ; Biliary Tract ; Catheters ; Comorbidity ; Epidemiology* ; Escherichia coli* ; Humans ; Klebsiella pneumoniae* ; Pneumonia ; Respiratory System ; Respiratory Tract Infections ; Retrospective Studies ; Skin ; Soft Tissue Infections ; Urinary Tract Infections

The autonomic nervous system plays an important role in maintaining homeostasis mediated by the parasympathetic, sympathetic and enteric systems. Autonomic failure adversely affects body function and may increase morbidity and mortality. Therefore, the scoring systems, such as Ewing’s classification and Composite Autonomic Scoring Scale (CASS), were developed to detect and quantify autonomic deficits, primarily focusing on the cardiovascular reflex system. Autonomic disorders manifest with a myriad of symptoms resulting from the dysfunction of the gastrointestinal, genitourinary, secretomotor, pupillomotor systems as well as cardiovascular system. Several self-report questionnaires, such as Composite Autonomic Symptom Scale (COMPASS), Scale for Outcomes in Parkinson’s disease for Autonomic Symptoms (SCOPA-AUT), Survey of Autonomic Symptom (SAS), were also used to support to detect various signs and symptoms of autonomic dysfunction in clinical settings. In this review, we introduce clinically useful assessment scales in autonomic nervous system disorders.

The autonomic nervous system plays an important role in maintaining homeostasis mediated by the parasympathetic, sympathetic and enteric systems. Autonomic failure adversely affects body function and may increase morbidity and mortality. Therefore, the scoring systems, such as Ewing’s classification and Composite Autonomic Scoring Scale (CASS), were developed to detect and quantify autonomic deficits, primarily focusing on the cardiovascular reflex system. Autonomic disorders manifest with a myriad of symptoms resulting from the dysfunction of the gastrointestinal, genitourinary, secretomotor, pupillomotor systems as well as cardiovascular system. Several self-report questionnaires, such as Composite Autonomic Symptom Scale (COMPASS), Scale for Outcomes in Parkinson’s disease for Autonomic Symptoms (SCOPA-AUT), Survey of Autonomic Symptom (SAS), were also used to support to detect various signs and symptoms of autonomic dysfunction in clinical settings. In this review, we introduce clinically useful assessment scales in autonomic nervous system disorders.

Orthostatic dizziness is a common type of dizziness. In general, orthostatic dizziness is provoked by standing or tilting, and subsided by supine position. The patient with orthostatic intolerance complains multiple symptoms such as dizziness, palpitation, lightheadness, fatigue and rarely syncope. Common orthostatic intolerance is orthostatic hypotension (classic, initial, transient, and delayed orthostatic hypotension) and postural orthostatic tachycardia syndrome. Transcranial Doppler is a noninvasive technique that provides real-time measurement of cerebral blood flow velocity. It can be useful for understanding the relationship between orthostatic symptoms and cerebral autoregulatory function. The reciprocal causal relationship between vestibular and autonomic dysfunction should always be kept in mind.
Cerebrovascular Circulation ; Dizziness ; Fatigue ; Humans ; Hypotension, Orthostatic ; Orthostatic Intolerance ; Postural Orthostatic Tachycardia Syndrome ; Supine Position ; Syncope

Head ; Lipoma ; Neck Muscles ; Neck ; Recurrence ; Shoulder ; Subcutaneous Tissue

Objectives: This study examined whether the polygenic risk score (PRS) calculated from the most recent genome-wide association study for bipolar disorder (BD) of European ancestry patients is significantly associated with BD diagnosis in the Korean population. Methods: The study included 417 Korean patients with BD and 497 healthy controls. Genotyping was performed using the Korean Biobank Array. Summary statistics of the European samples from the Psychiatric Genomic Consortium were used as base data to generate the PRS for each individual. The program PRSice-2 was used to calculate the PRS. Logistic regression was conducted to determine the association between BD diagnosis and PRS for BD after adjusting for age and sex. Results: PRS for BD was significantly higher in patients diagnosed with BD compared to healthy controls. The PRS at the p-value threshold of 0.01 best explained the variance of BD after adjusting for age and sex (R2 =0.0061, p=0.039). Subgroup analyses were performed for bipolar I and II subgroups. In bipolar I patients, the PRS at the p-value threshold of 0.01 best explained the diagnosis (R2 =0.0165, p=0.0055), whereas no significant result was found for bipolar II patients. Conclusion PRS for BD calculated for the Korean sample showed a significant association with the BD diagnosis. This result suggests an overlapping genetic risk for BD between the European and Korean populations.

Objectives: This study examined whether the polygenic risk score (PRS) calculated from the most recent genome-wide association study for bipolar disorder (BD) of European ancestry patients is significantly associated with BD diagnosis in the Korean population. Methods: The study included 417 Korean patients with BD and 497 healthy controls. Genotyping was performed using the Korean Biobank Array. Summary statistics of the European samples from the Psychiatric Genomic Consortium were used as base data to generate the PRS for each individual. The program PRSice-2 was used to calculate the PRS. Logistic regression was conducted to determine the association between BD diagnosis and PRS for BD after adjusting for age and sex. Results: PRS for BD was significantly higher in patients diagnosed with BD compared to healthy controls. The PRS at the p-value threshold of 0.01 best explained the variance of BD after adjusting for age and sex (R2 =0.0061, p=0.039). Subgroup analyses were performed for bipolar I and II subgroups. In bipolar I patients, the PRS at the p-value threshold of 0.01 best explained the diagnosis (R2 =0.0165, p=0.0055), whereas no significant result was found for bipolar II patients. Conclusion PRS for BD calculated for the Korean sample showed a significant association with the BD diagnosis. This result suggests an overlapping genetic risk for BD between the European and Korean populations.

Objective: To identify the clinical characteristics of patients with myasthenia gravis (MG) according to age at onset. Methods: We retrospectively recruited 227 non-thymomatous MG patients with adult onset who had been followed up for more than one year. The patients were classified based on the age of symptom onset as “early-onset MG” (EOMG,18–50 years; N=135), “late-onset MG” (LOMG, 50–64 years; N=53), and “very late-onset MG” (VLOMG, 65 years; N=39). Clinical features and serological findings were compared between these groups. Results: LOMG patients showed more frequent ocular MG (55%) and less frequent thymic hyperplasia (9%) compared to EOMG patients (31% and 38%; p=0.006 and p<0.001, respectively), and no female preponderance compared to VLOMG patients (female, 49% vs.77%; p=0.014). However, there were no significant differences between VLOMG and EOMG patients, except for more frequent thymic hyperplasia (p<0.001) in EOMG patients. When analyzing female patients only, less frequent secondary generalization (10%) were additionally found in LOMG patients, compared to EOMG (47%, p= 0.008) and VLOMG (59%, p=0.004) patients. Anti-acetylcholine receptor antibody (HR, 5.48; 95% CI, 1.73–17.37; p=0.004) was independently associated with secondary generalization in female EOMG patients. Conclusion: Our study suggests that LOMG patients, especially female, were characterized by frequent ocular MG and less frequent secondary generalization, distinguished from EOMG and VLOMG patients. Further large epidemiologic studies in Korea are needed to determine the characteristics of MG patients according to the age at onset and gender.