Purpose: We investigated the consistent efficacy and safety of eflapegrastim, a novel long-acting granulocyte-colony stimulating factor (G-CSF), in Koreans and Asians compared with the pooled population of two global phase 3 trials. Materials and Methods: Two phase 3 trials (ADVANCE and RECOVER) evaluated the efficacy and safety of fixed-dose eflapegrastim (13.2 mg/0.6 mL [3.6 mg G-CSF equivalent]) compared to pegfilgrastim (6 mg based on G-CSF) in breast cancer patients who received neoadjuvant or adjuvant docetaxel/cyclophosphamide. The primary objective was to demonstrate non-inferiority of eflapegrastim compared to pegfilgrastim in mean duration of severe neutropenia (DSN) in cycle 1, in Korean and Asian subpopulations. Results: Among a total of 643 patients randomized to eflapegrastim (n=314) or pegfilgrastim (n=329), 54 Asians (29 to eflapegrastim and 25 to pegfilgrastim) including 28 Koreans (14 to both eflapegrastim and pegfilgrastim) were enrolled. The primary endpoint, DSN in cycle 1 in the eflapegrastim arm was non-inferior to the pegfilgrastim arm in Koreans and Asians. The DSN difference between the eflapegrastim and pegfilgrastim arms was consistent across populations: –0.120 days (95% confidence interval [CI], –0.227 to –0.016), –0.288 (95% CI, –0.714 to 0.143), and –0.267 (95% CI, –0.697 to 0.110) for pooled population, Koreans and Asians, respectively. There were few treatment-related adverse events that caused discontinuation of eflapegrastim (1.9%) or pegfilgrastim (1.5%) in total and no notable trends or differences across patient populations. Conclusion This study may suggest that eflapegrastim showed non-inferior efficacy and similar safety compared to pegfilgrastim in Koreans and Asians, consistently with those of pooled population.

The depth of double-lumen endobronchial tube (DLT) is reportedly known tobe directly proportional to height and several height-based recommendations have beensuggested. This retrospective study was designed to find out the difference between calculated depths using height-based formulae and realistic depths in clinical practice of DLTplacement by analyzing pooled data from patients intubated with left-sided DLT.Methods: The electronic medical records of adults, intubated with DLT from February 2018to December 2020, were reviewed. Data retrieved included age, sex, height, weight, andsize and depth of DLT. The finally documented DLT depth (depth final, DF) was comparedwith the calculated depths, and the relationship between height and DF was also evaluated.A questionnaire on endobronchial intubation method was sent to anesthesiologists.Results: A total of 503 out of 575 electronic records of consecutive patients were analyzed.Although the relationship between height and DF was shown to have significant correlation(Spearman’s rho = 0.63, P < 0.001), DF was shown to be significantly greater than calculated depths (P < 0.001). Despite 57.1% of anesthesiologists have knowledge of clinical recommendations to anticipate size and depth of DLT, no one routinely utilizes those recommendations.Conclusions: Anesthesiologists tend to place DLTs in a deeper position than expected whendepths are calculated using height-based recommendations. Although such discrepanciesmay not be clinically meaningful, efforts are needed to standardize the methods of endobronchial intubation to prevent potential complications associated with malposition.

The Committee of Clinical Practice Guidelines of the Korean Diabetes Association (KDA) updated the previous clinical practice guidelines for Korean adults with diabetes and prediabetes and published the seventh edition in May 2021. We performed a comprehensive systematic review of recent clinical trials and evidence that could be applicable in real-world practice and suitable for the Korean population. The guideline is provided for all healthcare providers including physicians, diabetes experts, and certified diabetes educators across the country who manage patients with diabetes or the individuals at the risk of developing diabetes mellitus. The recommendations for screening diabetes and glucose-lowering agents have been revised and updated. New sections for continuous glucose monitoring, insulin pump use, and non-alcoholic fatty liver disease in patients with diabetes mellitus have been added. The KDA recommends active vaccination for coronavirus disease 2019 in patients with diabetes during the pandemic. An abridgement that contains practical information for patient education and systematic management in the clinic was published separately.

The Committee of Clinical Practice Guidelines of the Korean Diabetes Association (KDA) updated the previous clinical practice guidelines for Korean adults with diabetes and prediabetes and published the seventh edition in May 2021. We performed a comprehensive systematic review of recent clinical trials and evidence that could be applicable in real-world practice and suitable for the Korean population. The guideline is provided for all healthcare providers including physicians, diabetes experts, and certified diabetes educators across the country who manage patients with diabetes or the individuals at the risk of developing diabetes mellitus. The recommendations for screening diabetes and glucose-lowering agents have been revised and updated. New sections for continuous glucose monitoring, insulin pump use, and non-alcoholic fatty liver disease in patients with diabetes mellitus have been added. The KDA recommends active vaccination for coronavirus disease 2019 in patients with diabetes during the pandemic. An abridgement that contains practical information for patient education and systematic management in the clinic was published separately.

Background: Obesity has become a concern globally. The incidence of metabolic syndrome has increased rapidly in Korea over the past decades.Previous studies have reported obesity as a major cause of metabolic syndrome. Body mass index (BMI) and body weight perception have beenwidely used as indirect predictors of the risk of metabolic syndrome. Therefore, we aimed to evaluate subjective body weight perception and therisk of metabolic syndrome in adults over 20 years of age and confirm the gap between body weight perception and the objective measure of BMI. Methods: This study was conducted aming 9,842 Korean adults over 20 years of age using data from the VI-3 (2015) and VII-1 (2016) Korea NationalHealth and Nutrition Survey. The BMI criteria were set according to the WHO Asia Pacific Standard criteria. Perceived body weight status wasmeasured according to the question, “How would you describe your body shape?”. The patients were grouped as “obese,” “slightly obese,” “rightweight,” and “under weight” according to the original responses (“very obese,” “slightly obese,” “normal,” “slightly thin,” and “very thin”). Data analysiswas performed using chi-square test, analysis of variance, and logistic regression. Results: Among the participants, the risk of metabolic syndrome was progressively higher with the body weight perception as obese. Additionally, therisk of metabolic syndrome was higher in those with a higher BMI than in those with subjective body weight perception. Conclusion In this Korean population, increased risk of metabolic syndrome showed higher associated with higher BMI than with body weightperception.

BACKGROUND: This study was conducted to identify the types and incidence of adverse events associated with midazolam, which is the most widely used drug to induce conscious sedation during gastrointestinal endoscopy, and to analyze the factors associated with hypoxemia and sedation failure.METHODS: Of 87,740 patients who underwent gastrointestinal endoscopy between February 2015 and May 2017, the electronic medical records of 335 who reportedly developed adverse events were retrospectively reviewed, and analysis was performed to determine the risk factors for hypoxemia and sedation failure, the two most frequent adverse events among those manifested during gastrointestinal endoscopy.RESULTS: The overall adverse event rate was 0.38% (n = 335); hypoxemia was most frequent, accounting for 40.7% (n = 90), followed by sedation failure (34.8%, n = 77), delayed discharge from the recovery room (22.1%, n = 49), and hypotension (2.2%, n = 5). Compared with the control group, the hypoxemia group did not show any significant differences in sex and body weight, but mean age was significantly older (P < 0.001) and a significantly lower dose of midazolam was administered (P < 0.001). In the group with sedation failure, the mean rate was higher in men (P < 0.001) and a significantly higher dose of midazolam was administered (P < 0.001), but no age difference was found.CONCLUSIONS: Midazolam-based conscious sedation during gastrointestinal endoscopy can lead to various adverse events. In particular, as elderly patients are at higher risk of developing hypoxemia, midazolam dose adjustment and careful monitoring are required in this group.
Aged ; Anoxia ; Body Weight ; Conscious Sedation ; Electronic Health Records ; Endoscopy, Gastrointestinal ; Humans ; Hypotension ; Incidence ; Male ; Midazolam ; Recovery Room ; Retrospective Studies ; Risk Factors

PURPOSE: We aimed to investigate the effectiveness of ferritin as a contrast agent and a potential reporter gene for tracking tumor cells or macrophages in mouse cancer models. MATERIALS AND METHODS: Adenoviral human ferritin heavy chain (Ad-hFTH) was administrated to orthotopic glioma models and subcutaneous colon cancer mouse models using U87MG and HCT116 cells, respectively. Brain MR images were acquired before and daily for up to 6 days after the intracranial injection of Ad-hFTH. In the HCT116 tumor model, MR examinations were performed before and at 6, 24, and 48 h after intratumoral injection of Ad-hFTH, as well as before and every two days after intravenous injection of ferritin-labeled macrophages. The contrast effect of ferritin in vitro was measured by MR imaging of cell pellets. MRI examinations using a 7T MR scanner comprised a T1-weighted (T1w) spin-echo sequence, T2-weighted (T2w) relaxation enhancement sequence, and T2*-weighted (T2*w) fast low angle shot sequence. RESULTS: Cell pellet imaging of Ad-hFTH in vitro showed a strong negatively enhanced contrast in T2w and T2*w images, presenting with darker signal intensity in high concentrations of Fe. T2w images of glioma and subcutaneous HCT116 tumor models showed a dark signal intensity around or within the Ad-hFTH tumor, which was distinct with time and apparent in T2*w images. After injection of ferritin-labeled macrophages, negative contrast enhancement was identified within the tumor. CONCLUSION: Ferritin could be a good candidate as an endogenous MR contrast agent and a potential reporter gene that is capable of maintaining cell labeling stability and cellular safety.
Animals ; Brain Neoplasms/*diagnostic imaging/pathology ; Cell Line, Tumor ; Cell Tracking/*methods ; Colonic Neoplasms/*diagnostic imaging/pathology ; *Contrast Media/administration & dosage ; Disease Models, Animal ; Female ; *Ferritins/administration & dosage ; Genes, Reporter ; Glioma/*diagnostic imaging/pathology ; Humans ; Injections, Intravenous ; Macrophages ; Magnetic Resonance Imaging/*methods ; Male ; Mice ; Neoplasm Transplantation ; Skin Neoplasms/*diagnostic imaging/pathology ; Time Factors

The Editorial Office of Obstet Gynecol Sci would like to correct the author list.

BACKGROUND: Abacavir is a widely-used nucleoside reverse transcriptase inhibitor for the treatment of human immunodeficiency virus (HIV) infection. Mandatory postmarketing surveillance was conducted in Korea to monitor the safety and evaluate the effectiveness of Ziagen® (abacavir sulfate 300 mg; ViiV Healthcare, Middlesex, UK). MATERIALS AND METHODS: An open-label, multi-center, non-interventional postmarketing surveillance study was conducted from June 2010 to June 2016 to monitor the safety and effectiveness of Ziagen across 12 hospitals in Korea. Subjects older than 18 years taking Ziagen according to prescribing information were enrolled. The primary outcome was defined as the occurrence of any adverse events after Ziagen administration. Secondary outcomes included the occurrence of adverse drug reactions, occurrence of serious adverse events, and effectiveness of Ziagen administration. RESULTS: A total of 669 patients were enrolled in this study, with a total observation period of 1047.8 person-years. Of these, 90.7% of patients were male. The mean age of patients was 45.8±11.9 years. One-hundred ninety-six (29.3%) patients reported 315 adverse events, and four patients reported seven serious adverse events, without any fatal events. There was one potential case of an abacavir hypersensitivity reaction. Among the 97 adverse drug reactions that were reported from 75 patients, the most frequent adverse drug reactions included diarrhea (12 events), dyspepsia (10 events), and rash (9 events). No ischemic heart disease was observed. In the effectiveness analysis, 91% of patients achieved HIV-1 RNA under 50 copies/mL after 24 months of observation with abacavir administration. CONCLUSION: Our data showed the safety and effectiveness of Ziagen in a real-world setting. During the study period, Ziagen was well-tolerated, with one incident of a clinically suspected abacavir hypersensitivity reaction. The postmarketing surveillance of Ziagen did not highlight any new safety information. These data may be helpful in understanding abacavir and the HIV treatment practices in Korea.
Delivery of Health Care ; Diarrhea ; Drug-Related Side Effects and Adverse Reactions ; Dyspepsia ; Exanthema ; HIV ; HIV-1 ; Humans ; Hypersensitivity ; Korea ; Male ; Myocardial Ischemia ; Pharmacoepidemiology ; RNA ; RNA-Directed DNA Polymerase

BACKGROUND AND PURPOSE: Hemicraniectomy is a decompressive surgery used to remove a large bone flap to allow edematous brain tissue to bulge extracranially. However, early indicators of the decompressive effects of hemicraniectomy are unclear. We investigated whether reduction of midline shift following hemicraniectomy is associated with improved consciousness and survival in patients with malignant middle cerebral artery infarctions. METHODS: We studied 70 patients with malignant middle cerebral artery infarctions (MMI) who underwent hemicraniectomies. Midline shift was measured preoperatively and postoperatively using computed tomography (CT). Consciousness level was evaluated using the Glasgow Coma Scale on postoperative day 1. Patient survival was assessed six months after stroke onset. RESULTS: The median time interval between preoperative and postoperative CT was 8.3 hours (interquartile range, 6.1–10.2 hours). Reduction in midline shift was associated with higher postoperative Glasgow Coma Scale scores (P<0.05). Forty-three patients (61.4%) were alive at six months after the stroke. Patients with reductions in midline shifts following hemicraniectomy were more likely to be alive at six months post-stroke than those without (P<0.001). Reduction of midline shift was associated with lower mortality at six months after stroke, after adjusting for age, sex, National Institutes of Health Stroke Scale score, and preoperative midline shift (adjusted hazard ratio, 0.71; 95% confidence interval, 0.62–0.81; P<0.001). CONCLUSIONS: Reduction in midline shift following hemicraniectomy was associated with improved consciousness and six-month survival in patients with MMI. Hence, it may be an early indicator of effective decompression following hemicraniectomy.
Brain ; Consciousness ; Decompression ; Decompressive Craniectomy ; Glasgow Coma Scale ; Humans ; Infarction ; Infarction, Middle Cerebral Artery* ; Middle Cerebral Artery* ; Mortality ; National Institutes of Health (U.S.) ; Stroke