This study aimed to identify metabolic biomarkers and investigate changes in intestinal microbiota in the feces of healthy participants following administration of Lactococcus lactis GEN-001. GEN-001 is a single-strain L. lactis strain isolated from the gut of a healthy human volunteer. The study was conducted as a parallel, randomized, phase 1, open design trial. Twenty healthy Korean males were divided into five groups according to the GEN-001 dosage and dietary control.Groups A, B, C, and D1 received 1, 3, 6, and 9 GEN-001 capsules (1 × 1011 colony forming units), respectively, without dietary adjustment, whereas group D2 received 9 GEN-001 capsules with dietary adjustment. All groups received a single dose. Fecal samples were collected 2 days before GEN-001 administration to 7 days after for untargeted metabolomics and gut microbial metagenomic analyses; blood samples were collected simultaneously for immunogenicity analysis. Levels of phenylalanine, tyrosine, cholic acid, deoxycholic acid, and tryptophan were significantly increased at 5–6 days after GEN-001 administration when compared with predose levels. Compared with predose, the relative abundance (%) of Parabacteroides and Alistipes significantly decreased, whereas that of Lactobacillus and Lactococcus increased; Lactobacillus and tryptophan levels were negatively correlated. A single administration of GEN-001 shifted the gut microbiota in healthy volunteers to a more balanced state as evidenced by an increased abundance of beneficial bacteria, including Lactobacillus, and higher levels of the metabolites that have immunogenic properties.

Background: Although rhythm control could be the best for symptomatic atrial fibrillation (AF), some patients fail to achieve sinus rhythm (SR). This study aimed to identify clinical risk factors of failed electrical cardioversion (ECV). Methods: A total of 248 patients who received ECV for persistent AF or atrial flutter (AFL) were retrospectivelyreviewed. Patients were divided into three groups: Group 1 maintained SR for > 1 year, group 2 maintained SR ≤ 1 yearafter ECV, and group 3 failed ECV. SR maintenance was assessed using regular electrocardiography or Holter monitoring. Results: Patients were divided into group 1 (73, 29%), group 2 (146, 59%), and group 3 (29, 12%). The mean ageof patients was 60 ± 10 years, and 197 (79%) were male. Age, sex, and baseline characteristics were similar amonggroups. However, increased cardiac size, digoxin use, heart failure (HF), and decreased left ventricular ejection frac‑ tion (LVEF) were more common in group 3. Univariate analysis of clinical risk factors for failed ECV was increasedcardiac size [hazard ratio (HR) 2.14 (95% confidence interval [CI], 1.06–4.34, p = 0.030)], digoxin use [HR 2.66 (95% CI, 1.15–6.14), p = 0.027], HF [HR 2.60 (95% CI, 1.32–5.09), p = 0.005], LVEF < 40% [HR 3.45 (95% CI, 1.00–11.85), p = 0.038], and decreased LVEF [HR 2.49 (95% CI, 1.18–5.25), p = 0.012]. Among them, HF showed clinical significance only by multivariate analysis [HR 3.01 (95% CI, 1.13–7.99), p = 0.027]. Conclusions Increased cardiac size, digoxin use, HF, LVEF < 40%, and decreased LVEF were related to failed ECV for persistent AF or AFL. Among these, HF was the most important risk factor. Further multi-center studies including greater number of participants are planned.

Objective: Emergency cricothyroidotomy is an infrequently performed procedure and post-procedural complications may result from attempting to pass a device with a large external diameter through the cricothyroid membrane. This study aimed to determine the maximum height of the cricothyroid membrane according to the patient’ s sex and age based on cervical-spine computed tomography (C-spine CT) in the emergency department (ED) and determine the appropriate endotracheal tube (ETT) size. Methods: A retrospective analysis of patients was conducted from May 2014 to April 2020 in the ED. The data were obtained from medical records. Electronic calipers were used to measure the maximum height of the cricothyroid membrane in C-spine CT by an emergency physician and an emergency medicine resident. Results: Six hundred and sixty-four patients were included in the study. The mean height of the cricothyroid membrane was 10.11±2.24 mm in males (n=351) and 8.90±1.84 mm in females (n=313) (P<0.001). In males, the cricothyroid membrane height showed significant variance between the ≥75-year-old and the 25-34-year-old groups (9.26±2.40 mm vs. 11.80±2.36 mm) (P<0.001). The tube size of the cricothyroidotomy equipment was suitable for more than 72.1% of patients when applied with an ETT (internal diameter ≤6.0 mm). Conclusion This study showed that the height of the cricothyroid membrane differed according to sex and also age in males. It may thus be necessary to consider anatomical differences according to sex and age when selecting the appropriate tube size to reduce complications during emergency cricothyroidotomy.

P-glycoprotein (P-gp) is a transporter that plays an excretory role in epithelial cells. It is encoded by ABCB1, and single nucleotide polymorphisms (SNPs) in this gene can affect systemic drug exposure. Dapagliflozin and sitagliptin, used in type 2 diabetes treatment, are P-gp substrates. Here, we aimed to investigate whether ABCB1 polymorphisms affect dapagliflozin and sitagliptin pharmacokinetics (PK) in healthy Korean subjects.The study population consisted of 100 healthy Korean subjects (94 men and 6 women) who participated in four different clinical trials and received dapagliflozin and sitagliptin doses of 10 and 100 mg, respectively. We determined ABCB1 genotypes for the C3435T, C1236T, and G2677T/A SNPs. The relationship between the genotypes and dapagliflozin PKs was examined.Dapagliflozin and sitagliptin PK parameters were not statistically significantly affected by ABCB1 SNP genotypes. However, homozygous 3435TT subjects showed higher dapagliflozin PK parameters than CT and CC subjects. In subjects with the 3435TT and those with 3435CC and 3435CT genotypes, mean Cmax, AUCinf, and AUC0-1 values of dapagliflozin were 223.06 ng/mL and 194.81 ng /mL (p = 0.2767), 673.58 ng*h/mL and 573.96 ng*h/mL (p = 0.0492), and 128.53 ng*h/mL and 104.61 ng*h/mL (p = 0.2678), respectively.In summary, dapagliflozin and sitagliptin PK parameters were not significantly different between individuals with C1236T and C2677T/A ABCB1 genetic polymorphisms. Dapagliflozin exhibited higher systemic exposure in 3435TT subjects than in CC/CT subjects.

Purpose: Although current guidelines recommend the administration of dual antiplatelet therapy (DAPT) for up to 12 months after the implantation of a drug-eluting stent (DES), extended DAPT is frequently used in real-world practice. Materials and Methods: From the Korean Multicenter Angioplasty Team registry, we identified a total of 1414 patients who used DAPT for >3 years after DES implantation (extended-DAPT group) and conducted a landmark analysis at 36 months after the index procedure. We evaluated the determinants for and long-term outcomes of extended DAPT and compared the occurrence of major adverse cardiovascular and cerebrovascular events (MACCE), defined as the composite of all-cause death, myocardial infarction, stent thrombosis, and stroke, between the extended-DAPT group and the guideline-DAPT group [DAPT <1 year after DES implantation (n=1273)]. Results: Multivariate analysis indicated the occurrence of acute coronary syndrome as the most significant clinical determinant of the use of extended DAPT. Bifurcation, stent diameter ≤3.0 mm, total stented length ≥28 mm, and use of first-generation DESs were also significant angiographic and procedural determinants. MACCE rates were similar between the extended-DAPT group and the guideline-DAPT group in crude analysis [hazard ratio (HR), 1.08; 95% confidence interval (CI), 0.69–1.68; p=0.739] and after propensity matching (HR, 1.22; 95% CI, 0.72–2.07; p=0.453). Major bleeding rates were comparable between the two groups. Conclusion In patients undergoing percutaneous coronary intervention, indefinite use of DAPT does not show superior outcomes to those of guideline-DAPT. Major bleeding rates are also similar.

The foot or lower extremity is rarely the initial site in adult-onset dystonia, whereas dystonia in children often begins in the foot. Isolated lower extremity dystonia in adults is rarely on a primary basis. Oral anti-dystonic medications have been found unsatisfactory in providing adequate symptomatic relief. On the other hand, botulinum toxin injections have been reported as beneficial. It is also known that personalized orthosis can be an effective solution for patients of dystonia. The purpose of this report is to demonstrate a case of primary focal foot dystonia that was effectively treated with botulinum toxin injection and the custom-made ankle-foot orthosis.

The foot or lower extremity is rarely the initial site in adult-onset dystonia, whereas dystonia in children often begins in the foot. Isolated lower extremity dystonia in adults is rarely on a primary basis. Oral anti-dystonic medications have been found unsatisfactory in providing adequate symptomatic relief. On the other hand, botulinum toxin injections have been reported as beneficial. It is also known that personalized orthosis can be an effective solution for patients of dystonia. The purpose of this report is to demonstrate a case of primary focal foot dystonia that was effectively treated with botulinum toxin injection and the custom-made ankle-foot orthosis.

Objective: The diagnostic accuracy of novice residents in evaluating the scrotal pathology by point-of-care (POC) ultrasonography(US) was compared with that by the conventional US to determine the level of experience required toachieve competency. Methods: Three novice residents underwent a one-day training course on identifying scrotal pathologies using POC US.They performed POC US on patients with an acute scrotum to identify five pathological findings. The diagnosis was confirmedby conventional scrotal US. The sensitivity and specificity of POC US by novice residents were calculated, and thechanges in sensitivity and specificity over time were observed. Results: Sixty-two patients were included; the overall sensitivity and specificity were 76.7% (95% confidence interval [CI],61.3%-88.2%) and 78.9% (95% CI, 54.4%-93.9%), respectively. Decreased blood flow in the testicle showed very goodspecificity (100%; 95% CI, 93.8%-100.0%). The sensitivity and accuracy were variable at first 18 scans of each resident,but increased after 18 scans and were maintained over time. Conclusion Although the diagnostic accuracy of novice residents in evaluating the scrotal pathology using POC US wasvariable at first, the accuracy improved over time, especially after 18 scans of each resident. Nevertheless, larger, longtermresearch is needed to confirm the results of this study.

Proton-pump inhibitors (PPIs) are effectively used to treat acid-related diseases, including gastroesophageal reflux disease (GERD); however, many unmet medical needs still exist. As a new treatment option, potassium-competitive acid blockers (P-CABs), such as tegoprazan, have been developed. This study was performed to compare the pharmacokinetics (PKs) between two formulations (test and reference drugs) of tegoprazan 100 mg tablets. A randomized, single oral dose, two-treatment, two-period, two-sequence study was conducted with 12 healthy subjects. Each subject received the test drug or reference drug in the first period and the alternative treatment in the second period. For PK evaluation, blood samples were collected up to 48 hours post-dose in each period. The plasma concentrations of tegoprazan and its active metabolite (M1) were measured by liquid chromatography-tandem mass spectrometry. PK parameters, including maximum plasma concentration (C(max)) and area under the concentration-time curve from zero to the last measurable time (AUC(last)), were estimated using a non-compartmental method. The plasma concentration-time profiles of the two formulations were comparable. The geometric mean ratios [90% confidence intervals (CIs)] of the test drug to the reference drug for C(max) and AUC(last) were 0.98 (0.85–1.12) and 1.03 (0.93–1.13), respectively. The corresponding values of M1 were 0.99 (0.89–1.11) and 1.01 (0.93–1.09), respectively. The two formulations of tegoprazan exhibited comparable PK profiles, fulfilling the regulatory criteria for bioequivalence.
Gastroesophageal Reflux ; Healthy Volunteers ; Humans ; Male ; Mass Spectrometry ; Methods ; Pharmacokinetics ; Plasma ; Tablets ; Therapeutic Equivalency

BACKGROUND: The surgical strategies for carotid endarterectomy (CEA) vary in terms of the anesthesia method, neurological monitoring, shunt usage, and closure technique, and no gold-standard procedure has been established yet. We aimed to analyze the feasibility and benefits of CEA under regional anesthesia (RA) and CEA under general anesthesia (GA).METHODS: Between June 2012 and December 2017, 65 patients who had undergone CEA were enrolled, and their medical records were prospectively collected and retrospectively reviewed. A total of 35 patients underwent CEA under RA with cervical plexus block, whereas 30 patients underwent CEA under GA. In the RA group, a carotid shunt was selectively used for patients who exhibited negative results on the awake test. In contrast, such a shunt was used for all patients in the GA group.RESULTS: There were no cases of postoperative stroke, cardiovascular events, or mortality. Nerve injuries were noted in 4 patients (3 in the RA group and 1 in the GA group), but they fully recovered prior to discharge. Operative time and clamp time were shorter in the RA group than in the GA group (119.29±27.71 min vs. 161.43±20.79 min, p<0.001; 30.57±6.80 min vs. 51.77±13.38 min, p<0.001, respectively). The hospital stay was shorter in the RA group than in the GA group (14.6±5.05 days vs. 18.97±8.92 days, p=0.022). None of the patients experienced a stroke or restenosis during the 27.23±20.3-month follow-up period.CONCLUSION: RA with a reliable awake test reduces shunt use and decreases the clamp and operative times of CEA, eventually resulting in a reduced length of hospital stay.
Anesthesia ; Anesthesia, Conduction ; Anesthesia, General ; Carotid Arteries ; Cervical Plexus Block ; Endarterectomy ; Endarterectomy, Carotid ; Follow-Up Studies ; Humans ; Length of Stay ; Medical Records ; Methods ; Mortality ; Myocardial Infarction ; Operative Time ; Prospective Studies ; Retrospective Studies ; Stroke