Studies on the association between gastric cancer (GC) and the intake of soup-based dish groups (noodles and dumplings, soups, and stews), which are sodium-contributing foods, in Korea are ...insufficient, and the results of studies on the intake of pickled vegetables such as kimchi are inconsistent. This study aimed to determine the association between the incidence of GC and the daily intake of high-sodium dish groups (noodles and dumplings, soups, stews, and pickled vegetables) and whether these associations differ depending on behavioral risk factors for GC. In this case-control study, subjects aged 20-79 years were recruited from two hospitals between December 2002 and September 2006. A total of 440 cases and 485 controls were recruited, of which 307 pairs were matched and included for the analysis. In our results, a higher intake of noodles and dumplings was associated with a significantly increased incidence of GC. In the participants who consumed past or current alcohol, a higher intake of noodles and dumplings was associated with a significantly increased incidence of GC. Our results suggest that efforts to reduce the daily sodium intake from noodles and dumplings are needed to prevent and reduce the incidence of GC.
Reinforced concrete (RC) structures with non-seismic reinforcement details are vulnerable to earthquakes. This experimental study evaluates the efficiency of three techniques to alleviate the dynamic ...responses of existing structures: glass fiber-reinforced polyurea (GFRPU) reinforcement, a lever-typed tuned mass damper (LTMD) system, and a hybrid system of GFRPU and LTMD reinforcements. The lateral-resisting capacity and ductility of the GFRPU reinforcement specimen were enhanced by the material characteristics, and the dynamic responses were alleviated. The LTMD control specimen controlled the dynamic responses by the passive control system of the tuned mass damper (TMD), and the control forces to sustain its geometric motion were exerted on the specimen. The hybrid system was designed to control the dynamic responses by the GFRPU reinforcement and the LTMD control system. Four specimens, including an unreinforced specimen, were tested under external excitations, including the El Centro earthquake. The vibrations were more controlled in the order of the GFRPU reinforcement specimen, the LTMD control specimen, and the hybrid control specimen. The hybrid system was evaluated as excellent for seismic reinforcement, such as preventing abrupt failure with the lateral-resisting capacity and ductility of GFRPU and improving the dynamic control capacity by LTMD.
The infliximab biosimilar CT-P13 was approved for use in Crohn's disease after clinical comparison with originator infliximab in ankylosing spondylitis and rheumatoid arthritis; however, concerns ...about such indication extrapolation have been expressed. This study investigated whether CT-P13 is non-inferior to infliximab in patients with Crohn's disease who were naive to biological therapy.
In this randomised, multicentre, double-blind, phase 3 non-inferiority study, we enrolled patients with active Crohn's disease who had not responded to, or were intolerant to, non-biological treatments. Patients were randomly assigned (1:1:1:1) to receive CT-P13 then CT-P13, CT-P13 then infliximab, infliximab then infliximab, or infliximab then CT-P13, with switching occurring at week 30. Patients received 5 mg/kg CT-P13 or infliximab at weeks 0, 2, 6, and then every 8 weeks up to week 54. The primary endpoint was the proportion of patients with a decrease of 70 points or more in Crohn's Disease Activity Index (CDAI) from baseline to week 6. A non-inferiority margin of −20% was set (CT-P13 was non-inferior to infliximab if the lower limit of the two-sided 95% CI for the treatment difference was greater than −20). This trial is registered with ClinicalTrials.gov, number NCT02096861, and is completed.
Between Aug 20, 2014, and Feb 15, 2017, 308 patients were assessed for eligibility, and 220 patients were enrolled: 111 were randomly assigned to initiate CT-P13 (56 to the CT-P13–CT-P13 group and 55 to the CT-P13–infliximab group) and 109 to initiate infliximab (54 to the infliximab–infliximab group and 55 to the infliximab–CT-P13 group). CDAI-70 response rates at week 6 were similar for CT-P13 (77 69·4%, 95% CI 59·9 to 77·8 of 111) and infliximab (81 74·3%, 95% CI 65·1 to 82·2 of 109; difference −4·9% 95% CI −16·9 to 7·3), thereby establishing non-inferiority. Over the total study period, 147 (67%) patients experienced at least one treatment-emergent adverse event (36 64% in the CT-P13–CT-P13 group, 34 62% in the CT-P13–infliximab group, 37 69% in the infliximab–infliximab group, and 40 73% in the infliximab–CT-P13 group).
This study showed non-inferiority of CT-P13 to infliximab in patients with active Crohn's disease. Biosimilar CT-P13 could be a new option for the treatment of active Crohn's disease.
Celltrion, Pfizer.
This study was conducted to assess the association of the visceral adiposity index (VAI) with insulin resistance and beta cell function in Korean adults with and without type 2 diabetes mellitus. The ...study was carried out using data from the 2015 Korean National Health and Nutrition Examination Survey (KNHANES VI-3) and included 4,922 adults, aged 20 or older. There were several key findings in the present study. First, in subjects without type 2 diabetes mellitus, homeostasis model assessment of insulin resistance (HOMA-IR) (p < 0.001) and beta cell function (HOMA-B) (p < 0.001), insulin (p < 0.001), fasting blood glucose (FBG) (p < 0.001), and metabolic syndrome (MetS) score (p < 0.001) were positively associated with quartiles of VAI. Second, in subjects with type 2 diabetes mellitus, HOMA-IR (p = 0.038), FBG (p = 0.007), and MetS score (p < 0.001) were positively associated with quartiles of VAI, but associations with HOMA-B (p = 0.879) and insulin (p = 0.104) were not significant. In conclusions, the visceral adiposity index is positively associated with insulin resistance and beta cell function in Korean adults without type 2 diabetes mellitus. The visceral adiposity index is positively associated with insulin resistance but not beta cell function in Korean adults with type 2 diabetes mellitus.
This study was conducted to assess the relationship between vitamin D deficiency and anemia, by gender, in Korean adults. The data of 16,060 adults were analyzed (men, 6,840; premenopausal women, ...4,916; postmenopausal women, 4,340) from the fifth Korean National Health and Nutrition Examination Survey (KNHANES V) (2010–2012). There were several key findings. First, after adjusting for related variables, the odds ratio (OR) of anemia hemoglobin (Hb) <13 g/dl in men or Hb <12 g/dl in women using the vitamin D normal group {25-hydroxyvitamin 25(OH)D ≥15.0 ng/ml} as reference, was significant for the vitamin D deficient group 25(OH)D <15.0 ng/ml in the overall population OR, 1.310; 95% confidence interval (CI), 1.168–1.470. Second, the OR of anemia, using the vitamin D normal group as reference, was significant for the vitamin D deficient group in premenopausal women (OR, 1.293; 95% CI, 1.105–1.513). However, vitamin D deficiency in the vitamin D normal group in men (OR, 1.093; 95% CI, 0.806–1.484) and postmenopausal women (OR, 1.130; 95% CI, 0.906–1.409) was not significant. In conclusion, Vitamin D deficiency is positively associated with anemia in premenopausal women, but not in men and postmenopausal women.
The generation of human induced pluripotent stem cells (iPSCs) from somatic cells using gene transfer opens new areas for precision medicine with personalized cell therapy and encourages the ...discovery of essential platforms for targeted drug development. iPSCs retain the genome of the donor, may regenerate indefinitely, and undergo differentiation into virtually any cell type of interest using a range of published protocols. There has been enormous interest among researchers regarding the application of iPSC technology to regenerative medicine and human disease modeling, in particular, modeling of neurologic diseases using patient-specific iPSCs. For instance, Parkinson's disease, Alzheimer's disease, and spinal cord injuries may be treated with iPSC therapy or replacement tissues obtained from iPSCs. In this review, we discuss the work so far on generation and characterization of iPSCs and focus on recent advances in the use of human iPSCs in clinical setting.
Although balloon-assisted enteroscopy (BAE) enables endoscopic visualization of small bowel (SB) involvement in Crohn's disease (CD), there is no data on the changes in outcomes over time. We ...therefore investigated the changes in BAE use on CD patients over different time periods in terms of its role and clinical outcomes.
We used a multicenter enteroscopy database to identify CD patients with SB involvement who underwent BAE (131 procedures, 116 patients). We compared BAE-related factors and outcomes between the first period (70 procedures, 60 patients) and the second period (61 procedures, 56 patients). The specific cutoff point for dividing the two periods was 2007, when BAE guidelines were introduced.
Initial diagnosis of SB involvement in CD was the most common indication for BAE during each period (50.0% vs 31.1%, p=0.034). The largest change was in the number of BAE uses for stricture evaluation and/or treatment, which increased significantly in the latter period (2.9% vs 21.3%, p=0.002). The diagnostic yield in patients with suspected CD was 90.7% in the first period and 95.0% in the second (p=0.695). More endoscopic interventions were performed in the second period than in the first (5.1% vs 17.6%, p=0.041). Enteroscopic success rates were high throughout (100% in the first period vs 80.0% in the second period, p>0.999). In the first and second periods, therapeutic plans were adjusted in 62.7% and 61.4% of patients, respectively.
The overall clinical indications, outcomes, and effectiveness of BAE were constant over time in CD patients with SB involvement, with the exception that the frequency of enteroscopic intervention increased remarkably.
The use of precision medicine for chemotherapy requires the individualization of the therapeutic regimen for each patient. This approach improves treatment efficacy and reduces the probability of ...administering ineffective drugs. To ensure accurate decision-making in a timely manner, anticancer drug efficacy tests must be performed within a short timeframe using a small number of cancer cells. These requirements can be satisfied via microfluidics-based drug screening platforms, which are composed of complex fluidic channels and closed systems. Owing to their complexity, skilled manipulation is required. In this study, we developed a microfluidic platform, to accurately perform multiple drug efficacy tests using a small number of cells, which can be conducted via simple manipulation. As it is a small, open-chamber system, a minimal number of cells could be loaded through simple pipetting. Furthermore, the extracellular matrix gel inside the chamber provides an in vivo-like environment that enables the localized delivery of the drugs to spontaneously diffuse from the channels underneath the chamber without a pump, thereby efficiently and robustly testing the efficacy and resistance of multiple drugs. We demonstrated that this platform enabled the rapid and facile testing of multiple drugs using a small number of cells (~ 10,000) over a short period of time (~ 2 days). These results provide the possibility of using this powerful platform for selecting therapeutic medication, developing new drugs, and delivering personalized medicine to patients.
Background
Pancreatic ductal adenocarcinoma (PDAC) remains a devastating cancer due to its poor survival rate, early detection, and resectability. This study aimed to determine the peripheral blood ...mononuclear cell (PBMC) immune biomarkers in patients with PDAC and investigate the PDAC-specific peripheral blood biomarker panel and validate its clinical performance.
Methods
In this prospective, blinded, case–control study, a biomarker panel formula was generated using a development cohort—including healthy controls, patients at high risk of PDAC, and patients with benign pancreatic disease, PDAC, or other gastrointestinal malignancies—and its diagnostic performance was verified using a validation cohort, including patients with ≥ 1 lesion suspected as PDAC on computed tomography (CT).
Results
RNA-sequencing of PBMCs from patients with PDAC identified three novel immune cell markers, IL-7R, PLD4, and ID3, as specific markers for PDAC. Regarding the diagnostic performance of the regression formula for the three biomarker panels, the sensitivity, specificity, positive predictive value, negative predictive value, and accuracy were 84.0%, 78.8%, 47.2%, 95.6%, and 79.8%, respectively. Based on the formula scores for the biomarker panel, the false-negative rate (FNR) of the biomarkers was 8% (95% confidence interval CI 3.0–13.0), which was significantly lower than that based on CT in the validation cohort (29.2%, 95% CI 20.8–37.6).
Conclusions
The regression formula constructed using three PBMC biomarkers is an inexpensive, rapid, and convenient method that shows clinically useful performance for the diagnosis of PDAC. It aids diagnoses and differential diagnoses of PDAC from pancreatic disease by lowering the FNR compared to CT.
Clinical trial registration
Clinical Research Information Service, KCT0004614 (08 January 2020).
Background
Neutrophil gelatinase‐associated lipocalin (NGAL) is a urine biomarker related to acute renal injury. Whereas several studies have evaluated NGAL levels in hematological malignancy, using ...peripheral blood (PB). Recently, bone marrow (BM) NGAL level was reported to be higher than PB NGAL level in individuals with hematological malignancy, suggesting that BM NGAL would reflect BM microenvironment better than PB NGAL. We measured BM NGAL levels in patients with hematological malignancy, comparing those with NGAL levels in normal BM. We evaluated the association of BM NGAL with hematological parameters including neutrophil counts.
Methods
BM samples were collected from 107 patients who underwent BM examination. Immunoassays were used to assess NGAL levels. Data on hematological parameters were collected from medical records. Intergroup comparisons were performed using the Kruskal‐Wallis H test and Pearson chi‐square test. Single and multiple regression analyses were performed to analyze the relationships.
Results
The independent factors that affected the BM NGAL level were neutrophil counts and BM band neutrophil%, while neutrophil count was the main influencing factor. The acute myeloid leukemia (n = 18) and myelodysplastic syndrome (n = 25) groups showed statistically lower BM NGAL levels than patients with normal BM. The myeloproliferative neoplasm group (n = 34) showed higher BM NGAL levels than patients with normal BM, but this difference was not statistically significant. Neutrophil counts and BM band neutrophil% showed intergroup patterns similar to those of BM NGAL levels.
Conclusion
BM NGAL was related to neutrophil count and BM band neutrophil%, showing different levels according to hematological malignant disease entities.
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