Background: Sterility and safety assurance of hematopoietic stem cell (HSC) products is critical in transplantation. Microbial contamination can lead to product disposal and increases the risk of unsuccessful clinical outcomes. Therefore, it is important to implement and maintain good practice guidelines and regulations for the HSC collection and processing unit in each hospital. We aimed to share our experiences and suggest strategies to improve the quality assurance of HSC processing. Methods: We retrospectively analyzed microbial culture results of 11,743 HSC products processed over a 25-year period (January 1996 to May 2021). Because of reorganization of the HSC management system in 2008, the 25-year period was divided into periods 1 (January 1996 to December 2007) and 2 (January 2008 to May 2021). We reviewed all culture results of the HSC products and stored aliquot samples and collected culture results for peripheral blood and catheter samples. Results: Of the 11,743 products in total, 35 (0.3%) were contaminated by microorganisms, including 19 (0.5%) of 3,861 products during period 1 and 16 (0.2%) of 7,882 products during period 2. Penicillium was the most commonly identified microorganism (15.8%) during period 1 and coagulase-negative Staphylococcus was the most commonly identified (31.3%) during period 2. HSC product contamination occurred most often during HSC collection and processing. Conclusions The contamination rate decreased significantly during period 2, when the HSC management system was reorganized. Our results imply that handling HSC products by trained personnel and adopting established protocols, including quality assurance programs, aid in decreasing the contamination risk.

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.

Purpose: To find biomarkers for disease, there have been constant attempts to investigate the genes that differ from those in the disease groups. However, the values that lie outside the overall pattern of a distribution, the outliers, are frequently excluded in traditional analytical methods as they are considered to be ‘some sort of problem.’ Such outliers may have a biologic role in the disease group. Thus, this study explored new biomarker using outlier analysis, and verified the suitability of therapeutic potential of two genes (TM4SF4 and LRRK2). Materials and Methods: Modified Tukey’s fences outlier analysis was carried out to identify new biomarkers using the public gene expression datasets. And we verified the presence of the selected biomarkers in other clinical samples via customized gene expression panels and tissue microarrays. Moreover, a siRNA-based knockdown test was performed to evaluate the impact of the biomarkers on oncogenic phenotypes. Results: TM4SF4 in lung cancer and LRRK2 in breast cancer were chosen as candidates among the genes derived from the analysis. TM4SF4 and LRRK2 were overexpressed in the small number of samples with lung cancer (4.20%) and breast cancer (2.42%), respectively. Knockdown of TM4SF4 and LRRK2 suppressed the growth of lung and breast cancer cell lines. The LRRK2 overexpressing cell lines were more sensitive to LRRK2-IN-1 than the LRRK2 under-expressing cell lines Conclusion Our modified outlier-based analysis method has proved to rescue biomarkers previously missed or unnoticed by traditional analysis showing TM4SF4 and LRRK2 are novel target candidates for lung and breast cancer, respectively.

Purpose: This preliminary in-vitro study was designed to evaluate the risk factors of compression injury from use of a circular stapler for end-to-end anastomosis. Methods: Transparent collagen plates were prepared in dry and wet conditions. Physical properties of collagen plates and porcine colon tissue were examined using a rheometer. Adjustable and fixed-type circular staplers were applied on the collagen plates and the gap distance and compressive pressure were measured during anvil approximation. Tissue injury was evaluated using a compression injury scale. Compression properties were accessed to optimal or overcompression based on gap distance. Results: Unacceptable injuries were rarely observed on the dry collagens, regardless of compression device. In the adjustable compression, the compressibility ratio was similar between dry and wet collagen. Overcompression and unacceptable injury increased on the wet collagens. In the fixed compression, the compressibility ratio increased significantly and unacceptable injuries were observed in more than 50% of wet collagens. Peak pressure was significantly higher in the fixed-compression types than those of adjustable type. On bivariate correlation analysis, fixed-compression type and wet collagens were respectively associated with overcompression. On multivariate analysis, edematous collagen condition was the most important risk factor and proximal anvil side, fixed compression type, and overcompression were also independent risk factors for unacceptable compression injury. Conclusion In the edematous tissue condition, unintentional overcompression could be increased and result in tissue injury on the compression line of the circular stapler.

Background: This study aimed to investigate the cardiac manifestations of coronavirus disease 2019 (COVID-19). Methods: From February to March 2020, we prospectively and retrospectively enrolled consecutive patients diagnosed with COVID-19. Patient's data such as the demographic characteristics, symptoms, vital signs, laboratory and radiologic findings, electrocardiographic, and echocardiographic data, including the global longitudinal strain (GLS) of both ventricles, were obtained. Results: Forty patients (median age, 58 years; 50% men) were enrolled in the initial analysis. Patients were classified into severe and nonsevere groups based on the current guidelines. The 13 patients in the severe group were significantly older, had a greater prevalence of bilateral pneumonia and leukocytosis, and higher aspartate transaminase levels than patients in the nonsevere group. Patients in the severe group had a slightly lower left ventricular ejection fraction (LVEF) than those in the nonsevere group (median [interquartile range], 61.0% [58.5%, 62.3%] vs. 66.7% [60.6%, 69.8%], P = 0.015). In a subgroup of 34 patients in whom GLS could be analyzed, patients in the severe group had a significantly impaired left ventricular GLS (LVGLS) than those in the nonsevere group (−18.1% [−18.8%, −17.1%] vs. −21.7% [−22.9%, −19.9%], P = 0.001). There were no significant differences in total wall (RVGLS total , −19.3% [−23.9%, −18.4%] vs. −24.3% [−26.0%, −22.6%], P = 0.060) and free wall (RVGLS fw , −22.7% [−27.2%, −18.6%] vs. −28.8% [−30.4%, −24.1%], P = 0.066) right ventricle GLS (RVGLS). Conclusion Patients with severe COVID-19 had lower LVEF and LVGLS. RVGLS was not different between patients with severe and nonsevere COVID-19.

BACKGROUND AND OBJECTIVES: This study was to evaluate whether high body mass index (BMI) or thyroid stimulating hormone (TSH) level would affect selecting thyroid nodule for fine-needle aspiration biopsy (FNA) after ultrasound (US) evaluation. MATERIALS AND METHODS: A total of 3155 thyroid nodules (2159 benign and 996 malignant nodules) were included. Four grades of BMI and three levels of TSH were applied for grouping. US features of the thyroid nodules were divided into ‘probably benign’ and ‘suspicious for malignancy’ categories. Patients were grouped according to gender and univariate and multivariate logistic regression analysis were used to find the association between variables and malignancy. RESULTS: TSH levels were significantly higher in the malignant group (p<0.001). The grades of BMI did not show difference between the malignant and benign groups (females, p=0.074 and males, p=0.157). Younger age and ‘suspicious for malignancy’ US category were independent risk factors for malignancy in both genders. In females, a high TSH level (odds ratio=1.010, p<0.001) had significant association with malignancy. Except for younger age (odds ratio=0.998, p<0.001), no variable in nodules with ‘probably benign’ US category was significantly associated with malignancy. CONCLUSION: High TSH levels were more frequent in thyroid malignancy group, but neither high BMI nor high TSH level give additional information for FNA selection after US.
Biopsy, Fine-Needle ; Body Mass Index ; Female ; Humans ; Logistic Models ; Male ; Obesity ; Risk Factors ; Thyroid Gland ; Thyroid Neoplasms ; Thyroid Nodule ; Thyrotropin ; Ultrasonography

“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*

We present a case report indicating that the administration of phentermine, an appetite suppressant with sympathomimetic activity, can provoke an intracerebral hemorrhage. A 48-year-old woman with no previously established cerebrovascular risk fa ctors and who had taken phentermine for 30 days developed sudden-onset left hemiparesis. Brain magnetic resonance imaging revealed an acute intracerebral hemorrhage involving the right thalamus. This case indicates that physicians should be aware of the relevant cause of medication history including appetite suppressants in young patients with an acute intracerebral hemorrhage.
Appetite Depressants ; Appetite* ; Brain ; Cerebral Hemorrhage* ; Female ; Humans ; Magnetic Resonance Imaging ; Middle Aged ; Paresis ; Phentermine* ; Thalamus

BACKGROUND: The objective of this study was to assess the serum 25-hydroxyvitamin D (25OHD) status and evaluate the associated factors in a Korean pediatric population aged 0-18 yr. METHODS: Serum 25OHD levels were retrospectively analyzed in 13,236 Korean children and adolescents. 25OHD tests by chemiluminescent immunoassay were requested from 332 medical institutions nationwide in Korea between January 2014 and December 2014. Prevalence of vitamin D deficiency (VDD) and insufficiency (VDI) and the associated factors were analyzed. VDD and VDI were defined as serum 25OHD levels of <20.0 ng/mL and 20.0-29.9 ng/mL, respectively. RESULTS: The 25OHD levels negatively correlated with age (r=-0.4033, P<0.001). Overall, 79.8% boys and 83.8% girls had hypovitaminosis D (VDI or VDD). The Odds ratios (ORs) of being in the VDD/VDI category as against the reference category of VDS (vitamin D sufficiency) were as follows: increase in age by 1 yr (OR=1.42/1.25, all P<0.001); girls (OR=1.32/1.16, P<0.001/P=0.004) compared to boys, spring (OR=1.61/1.80), fall (OR=1.31/1.28), and winter (OR=1.44/2.03, all P<0.001) compared to summer season; living in urban areas (OR=1.23, P<0.001) compared to rural areas. CONCLUSIONS: VDD and VDI are highly prevalent in children and adolescents in Korea. Serum 25OHD levels decreased significantly according to increasing age. Winter and spring seasons, increasing age, female sex, and living in urban areas are the factors associated with a high risk of VDD or VDI.
Adolescent* ; Child* ; Female ; Humans ; Immunoassay ; Korea ; Odds Ratio ; Prevalence* ; Retrospective Studies ; Seasons ; Vitamin D Deficiency* ; Vitamin D* ; Vitamins*

PURPOSE: The effect of different peritoneal dialysis (PD) modalities on the decline in residual renal function (RRF) is unclear due to inconsistencies among studies. In particular, the effect of automated peritoneal dialysis (APD) modalities [continuous cyclic peritoneal dialysis (CCPD) and nightly intermittent peritoneal dialysis (NIPD)] on RRF has not been examined in a large cohort. MATERIALS AND METHODS: We conducted a single-center retrospective study to investigate the association between PD modalities and decline in RRF in 142 incident PD patients [34 on CCPD, 36 on NIPD, and 72 on continuous ambulatory peritoneal dialysis (CAPD)]. RRF was measured within 2 months from PD start and at 1 year after PD initiation. RESULTS: The RRF at 1 year after PD initiation was 1.98+/-2.20 mL/min/1.73 m2 in CCPD patients and 3.63+/-3.67 mL/min/1.73 m2 in NIPD patients, which were moderately lower than 4.23+/-3.51 mL/min/1.73 m2 in CAPD patients (p=0.064). Moreover, there was no significant difference in the 1-year rate of decline of RRF between CCPD and NIPD patients, although APD patients had a faster 1-year RRF decline rate than CAPD patients (CCPD and NIPD vs. CAPD: -45.68 and -36.69 vs. 1.17%/year, p=0.045). APD was associated with a more rapid decline in RRF in patients with end-stage renal disease undergoing PD, although multivariate analysis attenuated the significance of this finding (beta=-31.50; 95% CI, -63.61 to 0.62; p=0.052). CONCLUSION: Our results suggest that CAPD might be more helpful than APD for preserving RRF during the first year of dialysis therapy, although there was no significant difference in the 1-year rate of decline of RRF between the two APD modalities.
Adult ; Female ; Glomerular Filtration Rate/physiology ; Humans ; Kidney/pathology/physiopathology ; Kidney Failure, Chronic/*therapy ; Male ; Middle Aged ; Peritoneal Dialysis/*adverse effects ; Retrospective Studies