Purpose: This postmarketing surveillance (PMS) study aimed to evaluate real-world data on the effectiveness and safety of abiraterone acetate plus prednisone (AAP) in patients with metastatic hormone-sensitive prostate cancer (mHSPC). Materials and Methods: This prospective, multicenter observational study was conducted at 27 centers in South Korea between June 2018 and April 2021. Among 117 enrolled patients, 108 were included in the final analysis. Median follow-up period was 40.4 weeks (interquartile range, 22.8–49.2 weeks). Patients aged ≥18 years with mHSPC treated with AAP were included. Effectiveness endpoints included radiographic progression-free survival (rPFS), time to prostate-specific antigen (PSA) progression (TTPP), and PSA response (≥50%, ≥90% reduction). Adverse events (AEs) were assessed and graded based on severity. Results: A total of 108 patients were included in the analysis. Radiographic and PSA progression were observed in 13 (12.0%) and 26 patients (24.1 %), respectively. In the Kaplan-Meier analysis, the median rPFS and TTPP were not reached. The PSA response rates were 85.2% (≥50% reduction) and 75.9% (≥90% reduction) during the study period. AEs were reported in 31 patients (28.7%), with grade 3 or 4 AEs reported in 6 patients (5.6%). The most frequently observed AE was elevated aspartate aminotransferase level (5.6%). Conclusion This PMS study found that AAP is effective and well-tolerated in the real-world management of mHSPC.

BACKGROUND: Blood culture is an important method for identifying infectious microorganisms and confirming that a selected antimicrobial treatment is appropriate. In this study, we investigated the annual changes in the frequencies of blood isolates and antibiotic susceptibility test (AST) results. METHODS: We created a large database comprising data on all patient-unique blood cultures obtained from January 2007 through December 2016. Blood specimens were cultured using the BD BACTEC FX system, and species identification and AST were performed using the VITEK 2 system. RESULTS: During the 10-year study period, a total of 203,651 blood culture results were collected. Of these, gram-positive cocci, gram-negative rods, and fungi were isolated in 2.15%, 0.55%, and 0.12% of the blood cultures, respectively. Escherichia coli was the most commonly isolated species (22.8%), followed by Staphylococcus epidermidis (16.8%), Klebsiella pneumoniae (8.1%), and Staphylococcus aureus (8.0%). Fungal species were isolated in 3.0% of all positive blood cultures. Candida albicans was the most commonly isolated species (1.1%), followed by Candida parapsilosis (0.6%). Methicillin resistance was seen in 55.2% of S. aureus isolates. The frequencies of vancomycin-resistant Enterococcus (VRE) and carbapenem-resistant Pseudomonas aeruginosa (CRPA) were 13.1% and 10.9%, respectively. The isolation rates of MRSA, VRE, and CRPA showed different patterns each year. CONCLUSIONS: Among the isolates, E. coli was the most common, followed by S. epidermidis and K. pneumoniae. This study represents a long-term analysis of bloodstream infections, and the results can be used to identify trends in the microorganisms isolated and their drug resistance.
Bacteremia ; Candida ; Candida albicans ; Drug Resistance ; Enterococcus ; Escherichia coli ; Fungi ; Gram-Positive Cocci ; Klebsiella pneumoniae ; Korea ; Methicillin Resistance ; Methicillin-Resistant Staphylococcus aureus ; Methods ; Pneumonia ; Pseudomonas aeruginosa ; Staphylococcus aureus ; Staphylococcus epidermidis

Psychrobacter sanguinis has been described as a Gram-negative, aerobic coccobacilli originally isolated from environments and seaweed samples. To date, 6 cases of P. sanguinis infection have been reported. A 53-year-old male was admitted with a generalized tonic seizure lasting for 1 minute with loss of consciousness and a mild fever of 37.8℃. A Gram stain revealed Gram-negative, small, and coccobacilli-shaped bacteria on blood culture. Automated microbiology analyzer identification using the BD BACTEC FX (BD Diagnostics, Germany) and VITEK2 (bioMérieux, France) systems indicated the presence of Methylobacterium spp., Aeromonas salmonicida, and the Moraxella group with low discrimination. The GenBank Basic Local Alignment Search Tool and an Ez-Taxon database search revealed that the 16S rRNA gene sequence of the isolate showed 99.30% and 99.88% homology to 859 base-pairs of the corresponding sequences of P. sanguinis, respectively (GenBank accession numbers JX501674.1 and HM212667.1). To the best of our knowledge, this is the first human case of P. sanguinis bacteremia in Korea. It is notable that we identified a case based on blood specimens that previously had been misidentified by a commercially automated identification analyzer. We utilized 16S rRNA gene sequencing as a secondary method for correctly identifying this microorganism.
Aeromonas salmonicida ; Bacteremia* ; Bacteria ; Databases, Nucleic Acid ; Discrimination (Psychology) ; Fever ; Genes, rRNA ; Humans ; Korea ; Male ; Methods ; Methylobacterium ; Middle Aged ; Moraxella ; Psychrobacter* ; RNA, Ribosomal, 16S ; Seaweed ; Seizures ; Unconsciousness

BACKGROUND: The use of point-of-care (POC) devices for evaluating HbA1c is increasing; accordingly, comparisons between these devices and central laboratory methods are important. In the present study, we evaluated the analytical performance of the cobas b 101 analyzer for POC HbA1c testing. METHODS: The analytical quality of the cobas b 101 system was assessed based on repeatability, within-laboratory precision, linearity, and lot-to-lot reproducibility. Two specimen types, i.e., EDTA whole blood and capillary blood, were examined using the cobas b 101 system and the Variant II Turbo instrument. RESULTS: The coefficient of variation for within laboratory precision was 5.22% for a normal HbA1c level and 2.56% for a higher HbA1c level. The method showed good linearity, with a coefficient of correlation of 0.990. In a comparison of two different HbA1c disk lots, a strong correlation (r=0.986) and a mean %difference of −2.9% were observed. The cobas b 101 results using EDTA whole blood were strongly correlated with the Variant II Turbo results (r=0.958), with a mean %difference of 0.8%; the cobas b 101 results using capillary blood were strongly correlated with the Variant II Turbo results, using EDTA whole blood (r=0.976), with a mean %difference of 2.0%. A comparison between HbA1c levels in EDTA whole blood and capillary blood obtained using the cobas b 101 showed a strong correlation (r=0.985) and a mean %difference of 1.3%. CONCLUSIONS: The cobas b 101 analyzer is convenient for the measurement of HbA1c levels for diabetes management.
Capillaries ; Edetic Acid ; Methods ; Point-of-Care Systems* ; Point-of-Care Testing*

No abstract available.
Bacteremia* ; Korea*

No abstract available.
Bacteremia* ; Korea*