Background: This study investigates the long-term efficacy and safety of evogliptin add-on therapy in patients with inadequately controlled type 2 diabetes mellitus (T2DM) previously received dapagliflozin and metformin (DAPA/MET) combination. Methods: In this multicenter randomized placebo-controlled phase 3 trial, patients with glycosylated hemoglobin (HbA1c) levels 7.0% to 10.5% (n=283) previously used DAPA 10 mg plus MET (≥1,000 mg) were randomly assigned to the evogliptin 5 mg once daily or placebo group (1:1). The primary endpoint was the difference in the HbA1c level from baseline at week 24, and exploratory endpoints included the efficacy and safety of evogliptin over 52 weeks (trial registration: ClinicalTrials.gov NCT04170998). Results: Evogliptin add-on to DAPA/MET therapy was superior in HbA1c reduction compared to placebo at weeks 24 and 52 (least square [LS] mean difference, –0.65% and –0.55%; 95% confidence interval [CI], –0.79 to –0.51 and –0.71 to –0.39; P<0.0001). The proportion of patients achieving HbA1c <7% was higher in the triple combination group at week 52 (32.14% vs. 8.51% in placebo; odds ratio, 5.62; P<0.0001). Evogliptin significantly reduced the fasting glucose levels and mean daily glucose levels with improvement in homeostatic model assessment of β-cell function (LS mean difference, 9.04; 95% CI, 1.86 to 16.21; P=0.0138). Adverse events were similar between the groups, and no serious adverse drug reactions were reported in the evogliptin group. Conclusion Long-term triple combination with evogliptin added to DAPA/MET showed superior HbA1c reduction and glycemic control compared to placebo at 52 weeks and was well tolerated.

Background/Aims: Previous studies have reported the protective effects of tauroursodeoxycholic acid (TUDCA) on gastric epithelial cells in some animal models, but the precise mechanisms are unclear. This study examined the effects of TUDCA on NF-κB signaling in gastric epithelial cells. Moreover, the protective effects of TUDCA in experimental gastritis models induced by ethanol and NSAID were evaluated and compared with ursodeoxycholic acid (UDCA). Methods: After a pretreatment with TUDCA or UDCA, human gastric epithelial MKN-45 cells were stimulated with tumor necrosis factor (TNF)-α to activate NF-κB signaling. A real-time PCR (RT-PCR) for human interleukin (IL)-1 mRNA was performed. An electrophoretic mobility shift assay (EMSA) and immunoblot analyses were carried out. In murine models, after a pretreatment with TUDCA or UDCA, ethanol and indomethacin were administered via oral gavage. Macroscopic and microscopic assessments were performed to evaluate the preventive effects of TUDCA and UDCA on murine gastritis. Results: A pretreatment with TUDCA downregulated the IL-1α mRNA levels in MKN-45 cells stimulated with TNF-α, as assessed by RT-PCR. As determined using EMSA, a pretreatment with TUDCA reduced the TNF-α-induced NF-κB DNA binding activity. A pretreatment with TUDCA inhibited IκBα phosphorylation induced by TNF-α, as assessed by immunoblot analysis. TUDCA attenuated the ethanol-induced and NSAID-induced gastritis in murine models, as determined macroscopically and microscopically. Conclusions TUDCA inhibited NF-κB signaling in gastric epithelial cells and ameliorated ethanol- and NSAID-induced gastritis in murine models. These results support the potential of TUDCA for the prevention of gastritis in humans.

Background: Recent studies about completely displaced midshaft clavicle fractures have reported that their nonunion/malunion rates were significantly higher in conservatively treated patients compared to surgically treated patients. The purpose of this study was to evaluate the factors associated with treatment decisions for midshaft clavicle fractures and also the factors that affect patient satisfaction with their treatment choice. Methods: We retrospectively reviewed the records of 75 patients who had been diagnosed with a midshaft clavicle fracture and were treated conservatively at a single institution between March 1, 2013, and December 31, 2014. Their medical records were reviewed to investigate the severity of the initial vertical displacement. A telephone survey was carried out to identify the presence of any patient-perceived deformity and determine if the patient eventually underwent surgery and whether the patient would prefer surgery if the injury recurred. Results: Significantly more patients with vertical displacement ≥100% (9/28) eventually underwent surgery compared to patients with vertical displacement <100% (3/32; p=0.028). Patients with vertical displacement ≥100% (13/28) were significantly more likely to prefer surgery compared to patients with vertical displacement <100% (7/32, p=0.044). Among the conservatively treated patients, nine of 32 participants with a patient-perceived deformity and one of 16 without a patient-perceived deformity responded that they would prefer to receive surgery in same situation in the future (p=0.079). Conclusions Patients with a midshaft clavicle fracture with vertical displacement of ≥100% may eventually require surgical treatment. When conservative treatment is carried out, the long-term patient results may be unsatisfactory due to perceived residual deformities.

Background: Recent studies about completely displaced midshaft clavicle fractures have reported that their nonunion/malunion rates were significantly higher in conservatively treated patients compared to surgically treated patients. The purpose of this study was to evaluate the factors associated with treatment decisions for midshaft clavicle fractures and also the factors that affect patient satisfaction with their treatment choice. Methods: We retrospectively reviewed the records of 75 patients who had been diagnosed with a midshaft clavicle fracture and were treated conservatively at a single institution between March 1, 2013, and December 31, 2014. Their medical records were reviewed to investigate the severity of the initial vertical displacement. A telephone survey was carried out to identify the presence of any patient-perceived deformity and determine if the patient eventually underwent surgery and whether the patient would prefer surgery if the injury recurred. Results: Significantly more patients with vertical displacement ≥100% (9/28) eventually underwent surgery compared to patients with vertical displacement <100% (3/32; p=0.028). Patients with vertical displacement ≥100% (13/28) were significantly more likely to prefer surgery compared to patients with vertical displacement <100% (7/32, p=0.044). Among the conservatively treated patients, nine of 32 participants with a patient-perceived deformity and one of 16 without a patient-perceived deformity responded that they would prefer to receive surgery in same situation in the future (p=0.079). Conclusions Patients with a midshaft clavicle fracture with vertical displacement of ≥100% may eventually require surgical treatment. When conservative treatment is carried out, the long-term patient results may be unsatisfactory due to perceived residual deformities.

Background/Aims: Combination of midazolam and opioids is used widely for endoscopic sedation. Compared with meperidine, fentanyl is reportedly associated with rapid recovery, turnover rate of endoscopy room, and quality of endoscopy. We compared fentanyl with meperidine when combined with midazolam for sedative colonoscopy. Methods: A retrospective, cross-sectional, 1:2 matching study was conducted. Induction and recovery time were compared as the primary outcomes. Moreover, cecal intubation time, withdrawal time, total procedure time of colonoscopy, paradoxical reaction, adenoma detection rate, and adverse effect of midazolam or opioids were assessed as the secondary outcomes. Results: A total of 129 subjects (43 fentanyl vs. 86 meperidine) were included in the analysis. The fentanyl group showed significantly more rapid induction time (4.5±2.7 min vs. 7.5±4.7 min, p<0.001), but longer recovery time (59.5±25.6 min vs. 50.3±10.9 min, p=0.030) than the meperidine group. In multivariate analysis, the induction time of the fentanyl group was 3.40 min faster (p<0.001), but the recovery time was 6.38 min longer (p=0.046) than that of the meperidine group. There was no difference in withdrawal time and adenoma detection rate between the two groups. Conclusions The fentanyl group had more rapid sedation induction time but longer recovery time than the meperidine group.

PURPOSE: This study aimed to develop a multi-channel near-infrared spectroscopy (NIRS) and ultrasonography (USG) fusion imaging system for imaging prostate cancer and to verify its diagnostic capability by applying the hybrid imaging system to a prostate cancer phantom. METHODS: A multi-channel NIRS system using the near-infrared 785-nm wavelength with 12 channels and four detectors was developed. After arranging the optical fibers around a USG transducer, we performed NIRS imaging and grayscale USG imaging simultaneously. Fusion imaging was obtained by processing incoming signals and the spatial reconstruction of NIRS, which corresponded with grayscale USG acquired at the same time. The NIRS-USG hybrid system was applied to a silicone-based optical phantom of the prostate gland containing prostate cancer to verify its diagnostic capability qualitatively. RESULTS: The NIRS-USG hybrid imaging system for prostate cancer imaging simultaneously provided anatomical and optical information with 2-dimensional registration. The hybrid imaging system showed more NIR attenuation over the prostate cancer model than over the model of normal prostate tissue. Its diagnostic capability to discriminate a focal area mimicking the optical properties of prostate cancer from the surrounding background mimicking the optical properties of normal prostate tissue was verified by applying the hybrid system to a silicone-based optical phantom of prostate cancer. CONCLUSION: This study successfully demonstrated that the NIRS-USG hybrid system may serve as a new imaging method for improving the diagnostic accuracy of prostate cancer, with potential utility for future clinical applications.
Diagnosis ; Methods ; Optical Fibers ; Prostate ; Prostatic Neoplasms ; Spectroscopy, Near-Infrared ; Transducers ; Ultrasonography

BACKGROUND: Treatment of distal humerus fractures in osteoporotic elderly patients is often challenging. For non-reconstructible fractures with open reduction and internal fixation, total elbow arthroplasty (TEA) is an acceptable alternative. However, the relatively high complication rates and lifelong activity restrictions make TEA less ideal for elderly or low-demand patients. Efforts to identify or develop alternate procedures that benefit relatively young, high-demand patients have resulted in increased interest in hemiarthroplasty. This systematic review reports the clinical outcomes of hemiarthroplasty for distal humeral fractures. METHODS: We systematically reviewed the databases of PubMed, Ovid MEDLINE, and Cochrane Library. All English-language studies published before June 2017 were considered for possible inclusion. Search terms included ‘distal humerus fracture’ and ‘hemiarthroplasty’. Studies reporting outcomes (and a minimum of 1 year clinical follow-up) in human subjects after hemiarthroplasty (Latitude system) for distal humeral fractures were assessed for inclusion. Patient demographics, clinical and radiographic outcomes, and complications were recorded, and homogenous outcome measures were analyzed. RESULTS: Nine studies with a total of 115 patients met the inclusion criteria. Among the included studies, the weighted mean follow-up time was 35.4 months. Furthermore, the weighted mean of the postoperative range of motion (107.6° flexion-extension, 157.5° for pronation-supination) and functional outcomes (Mayo elbow performance scores: 85.8, Disabilities of the Arm, Shoulder and Hand score: 19.6) were within the acceptable range. CONCLUSIONS: Our study indicates that hemiarthroplasty is a viable option for comminuted distal humerus fracture. Satisfactory functional outcomes were observed in most patients.
Aged ; Arm ; Arthroplasty ; Demography ; Elbow ; Follow-Up Studies ; Hand ; Hemiarthroplasty ; Humans ; Humeral Fractures ; Humerus ; Outcome Assessment (Health Care) ; Range of Motion, Articular ; Shoulder ; Tea

BACKGROUND/AIMS: The optimal route for iron administration in anemic patients with inflammatory bowel disease (IBD) has not been determined. The aim of this study was to compare the efficacies of parenteral and oral iron therapy in IBD patients in Korea. METHODS: A retrospective multicenter study was performed. Patients who had been administered parenteral iron were matched to the controls with oral iron at a 1:1 ratio according to age, sex, and type of IBD. RESULTS: Patients that received parenteral iron exhibited increases in hemoglobin levels of ≥20% from the baseline at lower doses and in shorter durations (p=0.034 and p=0.046, respectively). In the multivariate analysis, parenteral iron therapy appeared to be more efficient than oral iron therapy, but this difference was not statistically significant (hazard ratio [HR], 1.552; 95% confidence interval [CI], 0.844 to 2.851; p=0.157). Patients with ulcerative colitis responded better to iron therapy than those with Crohn's disease (HR, 3.415; 95% CI, 1.808 to 6.450; p<0.001). Patients with an initial hemoglobin level of 10 g/dL or higher responded poorly to iron therapy (HR, 0.345; 95% CI, 0.177 to 0.671; p=0.002). CONCLUSIONS: Parenteral iron therapy appears to be more efficient than oral iron therapy. Physicians should focus on the iron deficiency of IBD patients and consider parenteral iron supplements in appropriate patient groups.
Anemia, Iron-Deficiency ; Colitis, Ulcerative ; Crohn Disease ; Humans ; Inflammatory Bowel Diseases* ; Iron* ; Korea* ; Multivariate Analysis ; Retrospective Studies ; Sucrose*

BACKGROUND/AIMS: The aim of this study was to evaluate the prevalence of colorectal neoplasia in subjects with fundic gland polyps (FGPs) and the relationship between FGPs and colorectal neoplasia in Korea. METHODS: We analyzed 128 consecutive patients with FPGs who underwent colonoscopy between January 2009 and December 2013. For each case, age- (±5 years) and sex-matched controls were identified from among patients with hyperplastic polyps, gastric neoplasms, and healthy controls. Clinical characteristics were reviewed from medical records, colonoscopic findings, pathologic findings, and computed tomography images. The outcome was evaluated by comparison of advanced colonic neoplasia detection rates. RESULTS: Of the 128 patients, seven (5.1%) had colon cancers and seven (5.1%) had advanced adenomas. A case-control study revealed that the odds of detecting a colorectal cancer was 3.8 times greater in patients with FGPs than in the age- and sex-matched healthy controls (odds ratio [OR], 3.80; 95% confidence interval [CI], 1.09-13.24; P =0.04) and 4.1 times greater in patients with FGPs than in healthy controls over 50 years of age (OR, 4.10; 95% CI, 1.16-14.45; P =0.04). Among patients with FGPs over 50 years old, male sex (OR, 4.83; 95% CI, 1.23-18.94; P =0.02), and age (OR, 9.90; 95% CI, 1.21-81.08; P =0.03) were associated with an increased prevalence of advanced colorectal neoplasms. CONCLUSIONS: The yield of colonoscopy in colorectal cancer patients with FGPs was substantially higher than that in average-risk subjects. Colonoscopy verification is warranted in patients with FGPs, especially in those 50 years of age or older.
Adenoma ; Case-Control Studies ; Colon ; Colonic Neoplasms ; Colonoscopy* ; Colorectal Neoplasms ; Humans ; Korea ; Male ; Medical Records ; Polyps* ; Prevalence ; Risk Factors ; Stomach Neoplasms

BACKGROUND/AIMS: Helicobacter pylori infection induces aberrant DNA methylation in gastric mucosa. We evaluated the long-term effect of H. pylori eradication on promotor CpG island hypermethylation in gastric carcinogenesis. METHODS: H. pylori-positive patients with gastric adenoma or early gastric cancer who underwent endoscopic resection were enrolled. According to H. pylori eradication after endoscopic resection, the participants were randomly assigned to H. pylori eradication or non-eradication group. H. pylori-negative gastric mucosa from normal participants provided the normal control. CpG island hypermethylation of tumor-related genes (p16, CDH1, and RUNX-3) was evaluated by quantitative MethyLight assay in non-tumorous gastric mucosa. The gene methylation rate and median values of hypermethylation were compared after one year by H. pylori status. RESULTS: In H. pylori-positive patients, hypermethylation of p16 was found in 80.6%, of CDH1 in 80.6%, and of RUNX-3 in 48.4%. This is significantly higher than normal control (p16, 10%; CDH1, 44%; RUNX-3, 16%) (p<0.05). In the H. pylori eradication group, methylation rates of p16 and CDH1 decreased in 58.1% and 61.3% of the patients, and the median values of hypermethylation were significantly lower at one year compared with the non-eradication group. However, RUNX-3 hypermethylation did not differ significantly at one year after H. pylori eradication. The non-eradication group hypermethylation did not change after one year. CONCLUSIONS: H. pylori infection was associated with promotor hypermethylation of genes in gastric carcinogenesis, and H. pylori eradication might reverse p16 and CDH1 hypermethylation.
Adenoma ; Carcinogenesis* ; CpG Islands* ; DNA Methylation ; Gastric Mucosa ; Helicobacter pylori* ; Helicobacter* ; Humans ; Methylation ; Stomach Neoplasms