Aims
The study aimed to evaluate and compare the efficacy and safety of enavogliflozin, a newly developed sodium‐glucose cotransporter 2 inhibitor, with placebo in Korean patients with type 2 ...diabetes mellitus.
Materials and Methods
Patients with glycated haemoglobin (HbA1c) of 7.0‐10.0%, entered a 2‐week placebo run‐in period, and were randomized to receive once‐daily enavogliflozin (0.1, 0.3 or 0.5 mg) or placebo for 12 weeks. The primary efficacy endpoint was the change in HbA1c from baseline at week 12.
Results
Overall, 194 patients were included in the full analysis set placebo, n = 46; enavogliflozin (0.1 mg, n = 49; 0.3 mg, n = 50; 0.5 mg, n = 49). Patients receiving 0.1, 0.3 and 0.5 mg enavogliflozin showed significantly reduced HbA1c compared with those receiving placebo at week 12 (−0.79%, −0.89%, −0.92% and −0.08%, respectively; p < .001 vs. placebo). Mean changes in fasting plasma glucose from baseline at week 12 were −30.5, −31.1, −35.0 and 4.9 mg/dl in patients receiving enavogliflozin doses and placebo, respectively. The proportion of patients achieving HbA1c <7.0% at week 12 was significantly higher in the three enavogliflozin groups than in the placebo group (42.9%, 44.0%, 61.2% and 17.4%, respectively). A higher proportion of patients showed HbA1c reduction by >0.5% after receiving enavogliflozin doses than those receiving placebo (61.2%, 72.0%, 65.3% and 26.1%, respectively). There were no significant differences in incidences of adverse events of hypoglycaemia and genital infection between the groups.
Conclusions
Once‐daily enavogliflozin monotherapy for 12 weeks is an effective, safe, and well‐tolerated treatment for Korean patients with type 2 diabetes mellitus.
Levels of
Escherichia coli
and male-specific bacteriophages (MSBs) were determined in the filter feeders obtained from retail markets, commercial farms, and wild beds in Korea. The accumulation and ...elimination of
E. coli
and MSBs were compared between ascidians and bivalves (oysters and mussels) during relaying and depuration.
E. coli
concentrations in ascidians from retail markets ranged between < 20 and 460 most probable number/100 g while MSBs were not detected.
E. coli
levels in bivalves from commercial farms and wild beds were not significantly different but bacterial levels in ascidians were consistently lower. Ascidians exhibited much lower ability than bivalves to accumulate
E. coli
and MSBs during relaying in a polluted coastal area. This study also shows that an equilibrium was developed between levels of microbes in water and ascidians and shellfish during relaying.
E. coli
and MSBs in ascidians decreased quickly during depuration in a clean seawater tank. However, after 1 day,
E. coli
in bivalves decreased by only 1.1–1.6 logs, and the elimination of MSBs was negligible. Therefore, depuration is an effective means to reduce the health risk of contaminated ascidians.
Vibrio parahaemolyticus is the most prevalent gastroenteritis-causing pathogen in Korea and in some other Asian countries. It is frequently found in oysters and other seafood. This study monitored ...changes in the prevalence of V. parahaemolyticus and environmental parameters in oyster aquaculture environments in Korea. From June to October 2014, we tested oysters (Crassostrea gigas) from shellfish-harvesting areas off the west coast of Korea. These 71 isolates were the sum of 16 (22.5 %), 19 (26.8 %), 23 (32.4 %), and 13 (18.3 %) isolates collected in July, August, September, and October, respectively. These 71 isolates had the following profiles of resistance against 16 antibiotics: all isolates were resistant to ampicillin and vancomycin, and 52.2, 50.7, and 50.7 % of isolates exhibited resistance to cephalothin, rifampin, and streptomycin, respectively. PCR analysis for the presence of the species-specific toxR gene confirmed that 38 (53.5 %) of the total 71 isolated strains were positive for V. parahaemolyticus. In PCR analysis for virulence of V. parahaemolyticus, of the 71 isolates tested in the present study, only 38 (53.5 %) were positive for the trh virulence gene and 71 (100 %) was negative for the tdh virulence gene.
The antimicrobial resistance patterns to 15 antimicrobial agents of Vibrio parahaemolyticus and Vibrio alginolyticus isolated from farmed fishes, including olive flounder (Paralichthys olivaceus), ...black rockfish (Sebastes schlegeli), red sea bream (Pagrus major), and sea bass (Lateolabrax japonicus), were investigated from 2005 through 2007. A total of 218 V. parahaemolyticus isolates and 153 V. alginolyticus isolates were obtained from the 180 fish samples collected from fish farms located along the southern coast of Korea. We found that 65.1% of V. parahaemolyticus and 85.6% of V. alginolyticus isolates showed antimicrobial resistance against more than one antimicrobial agent. The prevalence of resistance in V. parahaemolyticus isolates to ampicillin was highest (57.8%), followed by resistance to rifampin (11.9%), streptomycin (8.7%), and trimethoprim (6.4%). V. alginolyticus isolates were also most resistant to ampicillin (75.2%), followed by tetracycline (15.0%), trimethoprim (12.4%), and rifampin (9.8%). The prevalence of multiresistance to four or more antimicrobials was higher in V. alginolyticus (11.1%) than in V. parahaemolyticus (5%). Antimicrobial resistance rates per isolate of V. parahaemolyticus and V. alginolyticus possessing virulence genes were not different from those of the rest of the isolates.
In this study, several medicinal plant extracts including spices, herb teas, and medical herbs were screened for antiviral activity against feline calicivirus (FCV), a surrogate of norovirus. Among ...them, a methanolic extract of green tea,
Camellia sinensis
, only exhibited a significant antiviral activity against FCV. The methanolic extract was further fractionated with several solvents such as methanol (MeOH),
n
-hexane, chloroform (CHCl
3
), ethyl acetate (EtOAc),
n
-butanol (
n
-BuOH), and water. EtOAc-soluble fraction exhibited the highest antiviral activity against FCV. Moreover, the analysis of the most active fraction using a HPLC led to the identification of 4 known catechins: (-)-epigallocatechin (EGC), (-)-epicatechin (EC), (-)-epigallocatechin gallate (EGCG), and (-)-epicatechin gallate (ECG). Among the catechins tested in this study, EGCG exhibited the most effective antiviral activity (EC
50
, 12 mg/mL) with relatively low cytotoxicity (CC
50
, 320 mg/ mL), resulting relatively high selectivity index value 26.67. To our knowledge, this is the first experimental verification showing antiviral activity of catechins from green tea against FCV.
In this study, we constructed a rapid detection system for a foodborne pathogen, Vibrio parahaemolyticus, by using enzyme-linked immunosorbent assay (ELISA)-on-a-chip (EOC) biosensor technology to ...minimize the risk of infection by the microorganism. The EOC results showed a detection capability of approximately 6.2x10(5) cells per ml, which was significantly higher than that of the conventional rapid test kit. However, this high level of sensitivity required cultivation of the pathogen prior to analysis, which typically exceeded a day. To shorten the test period, we combined the EOC technology with immunomagnetic separation (IMS), which could enhance the sensitivity of the biosensor. IMS was carried out with magnetic particles coated with a monoclonal antibody specific to the microbe. To test the performance of the IMS-EOC method, fish intestine samples were prepared by artificially inoculating less than 1 or 5 CFU/10 g, allowing for enrichment over predetermined times, and analyzing the sample by using the EOC sensor after concentrating the culture 86-fold via IMS. Using this approach, the bacterium was detected after (at most) 9 h, which approximately corresponds to standard working hours. Thus, the IMS-EOC method allowed for the rapid detection of V. parahaemolyticus, which is responsible for foodborne diseases, and this method could be used for early isolation of contaminated foods before distribution.
The bacteriological pollution of water is a serious global environmental issue. The pollution of water by human and animal wastes can be a source of hazardous pathogens, which may pose serious health ...risks. In this study, we evaluated the microbiological water quality in the southern Ganghwado Bay area, South Korea. A total of 30 samples (14 discharge water samples from the drainage area and 16 sea water samples from the adjacent area) were analyzed for the concentrations of total coliforms (TC) and fecal coliforms (FC) in November 2013. The highest concentration of FC (28,000 MPN/100 mL) was found at site L1 (inland). The highest mean concentrations of coliforms were found at sites W9 (sea water) and W11 (sea water), with TC and FC concentrations of 33 MPN/100 mL. In conclusion, site L1 located near W9 and W11 is clearly identified as the main source of pollution at Dongmak Beach.
The present study evaluated the efficacy of a combination of ibandronate and cholecalciferol on the restoration of the levels of 25-hydroxyvitamin D (25OHD) and various bone markers in postmenopausal ...women with osteoporosis.
This was a randomized, double-blind, active-controlled, prospective 16-week clinical trial conducted in 20 different hospitals. A total of 201 postmenopausal women with osteoporosis were assigned randomly to one of two groups: the IBN group, which received a once-monthly pill containing 150 mg ibandronate (n=99), or the IBN+ group, which received a once-monthly pill containing 150 mg ibandronate and 24,000 IU cholecalciferol (n=102). Serum levels of 25(OH)D, parathyroid hormone (PTH), and various bone markers were assessed at baseline and at the end of a 16-week treatment period.
After 16 weeks of treatment, the mean serum levels of 25(OH)D significantly increased from 21.0 to 25.3 ng/mL in the IBN+ group but significantly decreased from 20.6 to 17.4 ng/mL in the IBN group. Additionally, both groups exhibited significant increases in mean serum levels of PTH but significant decreases in serum levels of bone-specific alkaline phosphatase and C-telopeptide of type 1 collagen (CTX) at 16 weeks; no significant differences were observed between the groups. However, in subjects with a vitamin D deficiency, IBN+ treatment resulted in a significant decrease in serum CTX levels compared with IBN treatment.
The present findings demonstrate that a once-monthly pill containing ibandronate and cholecalciferol may be useful for the amelioration of vitamin D deficiency in patients with postmenopausal osteoporosis. Moreover, this treatment combination effectively decreased serum levels of resorption markers, especially in subjects with a vitamin D deficiency, over the 16-week treatment period.
To evaluate bacteriological and toxicological safety, the hygienic indicator bacterium and paralytic and diarrhetic shellfish toxins in the shellfish produced in the Kamakman Area from 2012 to 2016 ...were investigated. Fecal coliforms and E. coli of all 194 oyster samples tested did not exceed 230 MPN/100 g. The geometric mean of the fecal coliform analyzed with the oyster samples of harvesting period was 19.6 MPN/100 g, which was more stable than the non-harvesting period (26.5 MPN/100 g). For the toxicological evaluation of the Kamakman Area, 77 oyster samples and 350 mussel samples as an indicator were analyzed. Paralytic shellfish toxins were detected very low in the range of $40{\sim}46{\mu}g$/100 g in 13 mussel samples during late April and early June, but not in oyster samples. Diarrhetic shellfish toxin was detected in 2 of 180 samples, but it was found to be below the regulation value (0.16 mg OA equ./kg). Based on the bacteriological studies, it was confirmed that the shellfish produced in Kamakman area meets the standard of shellfish hygiene of the Food Sanitation Act and meets the Grade A of the shellfish production area of EU. As the results of the paralytic and diarrhetic shellfish toxin evaluation, it was confirmed that the Kamakman Area is also toxicologically safe for shellfish production. 본 연구는 2012년부터 2016년까지 전남 가막만해역에서 생산되는 패류에 대하여 위생지표세균, 마비성 및 설사성패류독소를 분석하여 세균학적, 독물학적 안전성을 평가하고자 하였다. 총 194점의 굴 시료에서 분변계대장균과 대장균을 분석한 결과 모두 230 MPN/100 g을 초과하지 않았다. 굴 수확시기 동안 분석한 분변계대장균의 기하학적 평균치는 19.6 MPN/100 g으로 비수확시기(26.5 MPN/100 g) 보다 안정적인 것으로 나타났다. 가막만해역의 독물학적 평가를 위해 굴 77개 시료와 패류독소 지표종인 지중해담치 350개 시료에 대한 분석을 실시하였다. 마비성패류독소는 4월말부터 6월초 사이에 지중해담치 13개 시료에서 $40{\sim}46{\mu}g$/100 g 범위로 매우 낮게 검출되었으며, 굴 시료에서는 전혀 검출되지 않았다. 설사성패류독소는 총 180개 시료 중 2개 시료에서 검출되었으나, 기준치에 미치지 못하는 것으로 확인되었다. 따라서 가막만해역에서 생산되는 패류의 세균학적 안전성을 평가한 결과, 식품위생법의 패류 위생기준에 적합하였고, EU의 패류생산해역 A등급 기준에 부합하는 것으로 확인되었다. 또한 마비성 및 설사성패류독소는 기준치보다 매우 낮은 수준으로 검출되어 독물학적 안전성이 확보된 패류생산해역으로 평가되었다.
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