We are now in the middle of an unprecedented coronavirus disease 2019 (COVID-19) pandemic, and efforts to prevent the spread of infections are more important than ever. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which causes COVID-19, is transmitted through respiratory droplets or contaminated surfaces, and air transmission may be possible during some aerosol-generating procedures, requiring systematic infection control of the surrounding environment. Prior to endoscopy, suspected COVID-19 patients need to be screened, and all workers in the endoscopy room need to wear appropriate personal protective equipment. Isolate and move with a distance of 1-1.8 m or more between patients, and prevent close contact and cross-infection by limiting parental visits and minimizing latency in the waiting room or recovery room. If a COVID-19 infection is suspected or confirmed, it is recommended to postpone the endoscopic examination as much as possible, but if emergency endoscopy is necessary, a minimum number of people shall perform it in the negative pressure room. It is recommended to clean and sterilize the endoscope and accessories based on the current disinfection guidelines, and the treatment room should resume the procedure after a certain period of time after disinfection. In the endoscopy room, thorough infection control will be important for the safety of patients and medical staff, and as new information on SARS-CoV-2 is updated, continuous efforts will be needed to ensure the quality and safety of endoscopy until the end of COVID-19.

We are now in the middle of an unprecedented coronavirus disease 2019 (COVID-19) pandemic, and efforts to prevent the spread of infections are more important than ever. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which causes COVID-19, is transmitted through respiratory droplets or contaminated surfaces, and air transmission may be possible during some aerosol-generating procedures, requiring systematic infection control of the surrounding environment. Prior to endoscopy, suspected COVID-19 patients need to be screened, and all workers in the endoscopy room need to wear appropriate personal protective equipment. Isolate and move with a distance of 1-1.8 m or more between patients, and prevent close contact and cross-infection by limiting parental visits and minimizing latency in the waiting room or recovery room. If a COVID-19 infection is suspected or confirmed, it is recommended to postpone the endoscopic examination as much as possible, but if emergency endoscopy is necessary, a minimum number of people shall perform it in the negative pressure room. It is recommended to clean and sterilize the endoscope and accessories based on the current disinfection guidelines, and the treatment room should resume the procedure after a certain period of time after disinfection. In the endoscopy room, thorough infection control will be important for the safety of patients and medical staff, and as new information on SARS-CoV-2 is updated, continuous efforts will be needed to ensure the quality and safety of endoscopy until the end of COVID-19.

Tenofovir is the representative treatment for human immunodeficiency virus and hepatitis B virus infection. This study was conducted to assess the pharmacokinetics (PKs) and safety characteristics after a single administration of tenofovir disoproxil phosphate compared to tenofovir disoproxil fumarate in healthy male subjects. An open-label, randomized, single administration, two-treatment, two-sequence crossover study was conducted in 37 healthy volunteers. Serial blood samples were collected up to 72 hours. Non-compartmental analysis was used to calculate the PK parameters. The 90% confidence intervals (90% CIs) of the geometric mean ratio (GMR) were calculated for comparing tenofovir disoproxil phosphate to tenofovir disoproxil fumarate. Safety assessments were performed including clinical laboratory tests, adverse events, etc. during the study. The GMR and 90% CIs were 1.0514 (0.9527–1.1603) for C max and 1.0375 (0.9516–1.1311) for AUC last , respectively, and both fell within the conventional bioequivalence range of 0.8–1.25. Both tenofovir salt forms were tolerable. This study demonstrated that tenofovir disoproxil phosphate (292 mg) was bioequivalent to tenofovir disoproxil fumarate (300 mg).

A fixed-dose combination (FDC) of gemigliptin/metformin can improve the medication adherence in patients with type 2 diabetes mellitus (T2DM). In this study, the pharmacokinetic (PK) and pharmacodynamic (PD) profiles of gemigliptin and metformin were compared between FDC and the corresponding loose combination under fasted and fed states. A two-part, randomized, open label, single-dose, two-way crossover study was conducted in healthy male subjects. Under fasted (part 1) or fed (part 2) state, 2 FDC tablets of gemigliptin/metformin sustained release (SR) 25/500 mg or loose combination with one tablet of gemigliptin 50 mg and two tablets of metformin extended release (XR) 500 mg were orally administered in each period with a 7-day washout. Serial blood samples were collected up to 48 hours to determine the drug concentration and the dipeptidyl peptidase 4 (DPP-4) activity. The concentration-time profiles of gemigliptin and metformin were similar between FDC and loose combination in both the fasted and fed states. Geometric mean ratios and 90% confidence intervals of FDC to loose combination for area under the concentration-time curve and maximum plasma concentration of gemigliptin and metformin were within the bioequivalence range (0.8–1.25) in both states. DPP-4 activity-time profiles of FDC were comparable to that of the loose combination, showing similar area under the DPP-4 inhibition-time curve and maximum DPP-4 inhibition between FDC and loose combination, regardless of the fasted or fed state. In conclusion, the PK/PD characteristics of gemigliptin and metformin were similar in FDC tablets and loose combination both in fasted and fed states.

Background: This study aimed to identify the effect of histamine-2 receptor antagonist (H2RA) and proton pump inhibitor (PPI) use on the positivity rate and clinical outcomes of coronavirus disease 2019 (COVID-19). Methods: We performed a nationwide cohort study with propensity score matching using medical claims data and general health examination results from the Korean National Health Insurance Service. Individuals aged ≥ 20 years who were tested for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) between 1 January and 4 June 2020 were included.Patients who were prescribed H2RA or PPI within 1 year of the test date were defined as H2RA and PPI users, respectively. The primary outcome was SARS-CoV-2 test positivity, and the secondary outcome was the instance of severe clinical outcomes of COVID-19, including death, intensive care unit admission, and mechanical ventilation administration. Results: Among 59,094 patients tested for SARS-CoV-2, 21,711 were H2RA users, 12,426 were PPI users, and 24,957 were non-users. After propensity score matching, risk of SARS-CoV-2 infection was significantly lower in H2RA users (odds ratio [OR], 0.85; 95% confidence interval [CI], 0.74–0.98) and PPI users (OR, 0.62; 95% CI, 0.52–0.74) compared to non-users. In patients with comorbidities including diabetes, dyslipidemia, and hypertension, the effect of H2RA and PPI against SARS-CoV-2 infection was not significant, whereas the protective effect was maintained in patients without such comorbidities. Risk of severe clinical outcomes in COVID-19 patients showed no difference between users and non-users after propensity score matching either in H2RA users (OR, 0.89; 95% CI, 0.52–1.54) or PPI users (OR, 1.22; 95% CI, 0.60–2.51). Conclusion H2RA and PPI use is associated with a decreased risk for SARS-CoV-2 infection but does not affect clinical outcome. Comorbidities including diabetes, hypertension, and dyslipidemia seem to offset the protective effect of H2RA and PPI.

BACKGROUND: We compared the yields of mobilized PBSCs from single day of normal volume leukapheresis (NVL) in children and adults, and factors affecting the yields, to understand differences in mobilization efficiency between adults and small children with healthy marrows.METHODS: This study involved 18 adult volunteer donors and 47 small children weighing less than 20 kg who participated in a clinical trial of cell therapy in children with cerebral palsy. Donor factors analyzed to identify predictors of the yield of apheresis included age, gender, weight and complete blood cell count (CBC) with differential counts as well as equipment parameters.RESULTS: The yields of total nucleated cells (TNCs) and CD34⁺cells in the apheresis products of the children were significantly lower than in those from healthy adults. However, the efficiency of recovery of PBSCs (total CD34⁺ cell counts/TNCs) was significantly higher in small children (0.48±0.30%) than in adults (0.10±0.05%) (P < 0.05). Multivariable analysis of adult donor factors showed that the processed volume and flow rate of apheresis were significantly associated with the yield of TNCs (P < 0.05, for both), but not of CD34⁺cells. However, in multivariable analysis of child donor factors, body weight and circulating WBC count on the day of apheresis were significantly associated with the yield of TNCs (P < 0.05, for both) and of CD34⁺cells (P < 0.05, for both).CONCLUSION: The predictors of PBSC yields from a single day of NVL in adults and small children are different. Also mobilization is more effective in small children than in adults.
Adult ; Blood Cell Count ; Blood Component Removal ; Body Weight ; Bone Marrow ; Cell- and Tissue-Based Therapy ; Cerebral Palsy ; Child ; Hematopoietic Stem Cell Mobilization ; Humans ; Leukapheresis ; Tissue Donors ; Volunteers

Background and Objectives: We aimed to compare the efficacy of a novel powered irrigation system with that of the manual bottle-squeeze method for postoperative healing after endoscopic sinonasal surgery (ESS).Subjects and Method In this prospective randomized clinical trial, 29 patients were enrolled for nasal irrigation (NI) with either NOSSHA® (Womens Care Co., Ltd.) powered irrigation system (NOSSHA® group, n=14) or manual irrigation (control group, n=15). Objective findings were evaluated using the modified Lund-Kennedy scores. Subjective outcomes were assessed using the total nasal endoscopic score (TNES), total nasal symptom score (TNSS), visual analog scale (VAS), and quality of life (QOL) questionnaires in each group at baseline, and 1, 2, 4, 6, and 8 weeks after ESS. We compared the postoperative changes between both groups. Results: The mean TNES of patients were significantly higher in the NOSSHA® group than in the control group (p=0.015); however, the improvement in TNES was achieved 2 weeks earlier in the NOSSHA® group. The improvement in TNES (p<0.001) and TNSS (p<0.001) was statistically significant in both groups. The improvement in QOL was statistically significant in the NOSSHA® (p<0.001) and control group (p=0.007). The improvement in the TNSS and QOL was earlier in the NOSSHA® group by 4 and 7 weeks, respectively; no early improvement occurred in the NOSSHA® group for the VAS score. Conclusion We validated the usefulness of postoperative NI using a powered device, which may be useful for patients who cannot tolerate manual NI.

Purpose: As the rate of endoscopic resection for early gastric cancer (EGC) has increased in patients with comorbid diseases, it is necessary to elucidate the efficacy of endoscopic submucosal dissection (ESD) for EGC in patients with comorbidities. This study aimed to analyze the clinical outcomes of ESD for EGC in patients with comorbidities. Materials and Methods: A total of 969 patients with 1,015 lesions who underwent ESD for EGC at Seoul National University Hospital between 2010 and 2014 were analyzed. The shortand long-term clinical outcomes were evaluated according to the comorbidity status. Results: Comorbidities were observed in 558 patients (57.6%). The comorbidity group had a higher proportion of patients using antithrombotic agents (29.5% vs. 0.9%; P<0.0001).Although procedure-related complications (bleeding and perforation) were not significantly different between the two groups, the length of hospital stay was significantly longer (1.8 vs.1.4 days, P=0.023), while survival was significantly shorter in the comorbidity group (5-year overall survival rate: 90.5% vs. 97.2%, P<0.0001; 5-year disease-specific survival rate: 97.9% vs. 100%, P=0.018; 5-year disease-free survival rate: 83.4% vs. 89.2%, P=0.007). Conclusions Gastric ESD can be performed in patients with comorbidities without increasing the risk of complications.

BACKGROUND: Flow cytometric analysis is the standard method for enumerating CD34+ stem cells in hematopoietic stem cell transplantation. However, it has some limitations such as expensive instrumentation, high reagent costs, and discrepancies between technicians and laboratories. We compared counts of total nucleated cells (TNCs) and CD34+ cells counts obtained from a flow cytometer with a newly-developed image-based microscopic cell counter (ADAM II) to evaluate the possibility of clinical application of the ADAM II.METHODS: We used 18 samples of circulating peripheral blood (PB) and waste tube fractions of peripheral blood stem cells (PBSCs) harvested by apheresis after G-CSF mobilization from adult volunteer donors. We assessed the reproducibility and linearity of the new procedure and compared the numbers of TNCs and viable CD34+ cells determined with the ADAM II and two different flow cytometers (FACSCalibur, FACSCanto II).RESULTS: Numbers of viable CD34+ cells determined with the ADAM II were accurate over the expected range; the intra-assay coefficient of variation was ≤19.8%. Linearity was also satisfactory (R²=0.99). TNC counts obtained with the ADAM II were highly correlated with those obtained with the FACSCalibur (R²>0.9841, P<0.0001) and FACSCanto II (R²>0.9620, P<0.0001), as were the numbers of viable CD34+ cells obtained with the ADAM II and the FACSCalibur and FACSCanto II (R²>0.9911, P<0.0001 and R²>0.9791, P<0.0001), respectively.CONCLUSION: The newly developed image-based microscopic cell counter (ADAM II) appears to be suitable for enumerating TNCs and viable CD34+ cells.
Adult ; Blood Component Removal ; Cell Count ; Granulocyte Colony-Stimulating Factor ; Hematopoietic Stem Cell Transplantation ; Humans ; Methods ; Stem Cells ; Tissue Donors ; Volunteers

OBJECTIVE: To explore the incidence, characteristics, complications and socioeconomic impacts associated with falls in community-dwelling elderly. METHODS: From September 1, 2015 to October 12, 2015, a questionnaire-based survey was conducted involving a total of 2,012 elderly who lived in Guro-gu (Seoul), Yeongdeungpo-gu (Seoul), Yangpyeong-gu (Gyeonggi-do), Dalseong-gu (Daegu), and Jung-gu (Daegu). The subjects were interviewed using a structured questionnaire to obtain demographic characteristics and comprehensive falling histories. The socioeconomic cost related to falls was estimated using the statistical data provided by the Health Insurance Review and Assessment Service. RESULTS: Falls were recorded in 666 out of the 2,012 subjects (33.1%) during the past year. Frequent falls occurred during December, in the afternoons, when the floor was slippery. The most common injuries included the low back and the most common injury type was sprain. The total direct costs related to falls involving the 2,012 subjects were 303,061,019 KRW (Korean won). The average medical cost related to falls in the 2,012 subjects was 150,627 KRW and the average medical cost of 666 subjects who experienced falls was 455,047 KRW. Estimates of the total population over the age of 60 years showed that the annual direct costs associated with falls in Korea over the age of 60 years were about 1.378 trillion KRW. CONCLUSION: This study was conducted to explore the incidence, characteristics, complications, and socioeconomic impacts of falls in community-dwelling elderly. This study is expected to be used as a source of basic data for the establishment of medical policy for the elderly and the development of a fall prevention program for the elderly in Korea.
Accidental Falls ; Aged ; Humans ; Incidence ; Insurance, Health ; Korea ; Socioeconomic Factors ; Sprains and Strains