[Research Study on the Effects of Disinfectants on Medical Images and Medical Equipment in Infection Control Measures].

In this study, we investigated the effects of various disinfectants used to prevent infectious diseases on medical images and medical equipment. First, we investigated the effect of residual disinfectant on medical images in CT, mammography (MMG), and general imaging systems. Acrylic discs with various disinfectants attached were photographed using each imaging device, and visual evaluation and changes in image signal values were evaluated. We also conducted a questionnaire survey of each manufacturer regarding cleaning methods for medical devices. With CT/MMG, residual disinfectant could be visually confirmed on the image. Although this could not be confirmed with the general imaging system, a significant difference was confirmed in the image signal values of the general imaging system through statistical analysis. This is thought to be largely due to the influence of nonlinearity in the short-time imaging range of general imaging equipment. In addition, from the responses to a questionnaire survey of each medical device manufacturer, we were able to understand detailed cleaning methods that are not covered in medical device instruction manuals.

[Embolization Using a Debranched Left Common Carotid Artery Stump for Gutter Endoleak After Thoracic Endovascular Aortic Repair with the Double-debranching and Chimney Technique].

An 88-year-old male underwent thoracic endovascular aortic repair (TEVAR) with the double-debranching and chimney technique for arch aortic aneurysm. When the aforementioned procedure was performed, the left common carotid artery was closed and transected, and the left subclavian artery was embolized and bypassed, respectively. However, postoperatively, the gutter endoleak persisted, and the aneurysm enlarged;therefore, requiring additional surgery. A skin incision was made on the left side of the neck, and the closed and dissected left common carotid artery stump was detected. A sheath was placed at the stump and an angiographic catheter and guidewire were used to retrograde cannulate the gutter beside the chimney graft, and coil embolization was performed. No endoleak was observed at postoperatively and 6-month follow up computed tomography( CT). We believe that embolization from a deblanched left common carotid artery stump is useful for endoleaks after TEVAR employing the chimney and debranching technique.

Surface CD3-negative monomorphic epitheliotropic intestinal T-cell lymphoma.

Intestinal T/NK-cell lymphomas include enteropathy-associated T-cell lymphoma (EATL), monomorphic epitheliotropic intestinal T-cell lymphoma (MEITL), indolent T-cell lymphoproliferative disorders of the GI tract (ITCLPD), extranodal NK/T-cell lymphoma, nasal type (ENKTL), and intestinal T-cell lymphoma NOS (ITCL-NOS). Here we describe a case of surface CD3-negative MEITL. A 63-year-old Japanese female had a tumor located in the conglomerated ileum, which formed multiple mass lesions. The resected tissue showed a diffuse infiltration of monomorphic medium-sized lymphocytes with epitheliotropism. Flowcytometry using a fresh specimen of the tumor revealed positivity for CD7, CD8, CD38, and CD56, but not surface CD3. On immunohistochemistry, the tumor showed positivity for cytoplasmic CD3, CD8, CD56, TIA-1, Granzyme B, and perforin. EBER with in situ hybridization was negative. Moreover, H3K36me3, which is negative in MEITL with SETD2-mutation, was positive. This is an important case of MEITL due to its oncogenesis.

Acute acalculous cholecystitis caused by gallbladder metastasis due to the peritoneal dissemination of gastric cancer: A case report.

INTRODUCTION AND IMPORTANCE: Acute acalculous cholecystitis (AAC) is associated with a high mortality rate. AAC caused by metastasis to the gallbladder is rare. We report a case of AAC caused by gallbladder metastasis due to the peritoneal dissemination of gastric cancer. CASE PRESENTATION: An 84-year-old male visited our hospital because of epigastric pain. Ultrasonography and computed tomography revealed swelling and thickening of the gallbladder wall, but stones were not observed in the gallbladder. We performed emergency surgery with a diagnosis of acute cholecystitis. Laparoscopy revealed the presence of many nodules around the abdominal cavity including the hepatoduodenal ligament. Inflammation of Calot's triangle was severe, so we performed subtotal cholecystectomy. We also resected one of the peritoneal nodules. Macroscopically, there were no stones in the gallbladder and histopathological examination revealed acute cholecystitis and existence of adenocarcinoma involving the subserosa of the gallbladder wall and the resected peritoneal nodule. After surgery, esophagogastroduodenoscopy revealed Borrmann type II lesions at the antrum and gastric biopsy showed adenocarcinoma. He was diagnosed with advanced gastric cancer with peritoneal dissemination. His postoperative course was good. CLINICAL DISCUSSION: The cases of AAC caused by gallbladder metastasis have been little reported in the literature. This case is advanced gastric cancer with peritoneal dissemination and AAC was thought to be caused by peritoneal dissemination from operative and histopathological findings. We successfully treated this rare case of AAC with laparoscopic surgery. CONCLUSION: Although metastasis to the gallbladder is rare, it is necessary to be aware of this possibility when treating AAC.

Effects of vedolizumab in Japanese patients with Crohn's disease: a prospective, multicenter, randomized, placebo-controlled Phase 3 trial with exploratory analyses.

BACKGROUND: Vedolizumab is a gut-selective humanized antibody that binds the α4ß7 integrin. We evaluated efficacy and safety of vedolizumab in Japanese patients with moderate-to-severe Crohn's disease (CD). METHODS: In this Phase 3, double-blind study (NCT02038920), 157 patients were randomized to receive intravenous vedolizumab 300 mg (n = 79) or placebo (n = 78) at Weeks 0, 2, and 6 (induction phase). Patients with CD activity index (CDAI)-70 response at Week 10 were randomized to receive vedolizumab 300 mg (n = 12) or placebo (n = 12) at Week 14, then every 8 weeks until Week 54 (maintenance phase). Primary endpoints were ≥ 100-point reduction in CDAI (CDAI-100 response) at Week 10 for induction, and clinical remission (CR: CDAI ≤ 150) at Week 60 for maintenance. RESULTS: At Week 10, 26.6% of patients who received vedolizumab and 16.7% who received placebo achieved CDAI-100 response (odds ratio [OR] [95% confidence interval (CI)] 1.80 [0.82-3.96]; p = 0.145). At Week 60, 41.7% of vedolizumab-treated patients and 16.7% of placebo-treated patients achieved CR (OR [95% CI] 3.57 [0.53-23.95]; p = 0.178). The incidence of adverse events was similar in both treatment groups in both induction and maintenance phases. In patients without prior anti-TNFα exposure or with inadequate response to anti-TNFα, vedolizumab showed improved outcomes over placebo in the induction phase. Age might be a possible predictive factor of CR for future research. CONCLUSION: Vedolizumab showed a numerically greater efficacy versus placebo as induction therapy, but the difference was not statistically significant. Vedolizumab also showed a numerically greater efficacy in maintenance therapy, and was well tolerated.

Efficacy and Safety of Vonoprazan in Patients With Nonerosive Gastroesophageal Reflux Disease: A Randomized, Placebo-Controlled, Phase 3 Study.

OBJECTIVES: To assess the efficacy and safety of vonoprazan on heartburn symptoms in patients with nonerosive reflux disease (NERD) (ClinicalTrials.gov: NCT02954848). METHODS: This phase 3, double-blind, placebo-controlled study included Japanese patients aged 20 years and older with grade N/M NERD and recurrent heartburn. Patients received placebo (n = 245) or vonoprazan 10 mg (n = 238) for 4 weeks. The primary efficacy outcome was frequency of heartburn experienced by patients during the treatment period (proportion of days without heartburn). Other outcomes included cumulative improvement rates of heartburn, proportion of patients with complete heartburn resolution in the fourth week of treatment, and safety. RESULTS: Compared with placebo, the proportion of days without heartburn was not significantly higher in the vonoprazan group in the full analysis (primary end point, 72.55% vs 61.50%, vonoprazan vs placebo, P = 0.0643) but was significantly higher in the per-protocol-set sensitivity analysis (P = 0.0341). Early onset of response and significantly greater cumulative improvement rates of heartburn were observed in the vonoprazan group (P = 0.0003). In a post hoc analysis, a greater proportion of patients with complete heartburn resolution in the fourth week of treatment were reported in the vonoprazan group (P = 0.0023). Incidence of treatment-emergent adverse events was similar between treatment groups (23.5% vs 23.3%); most treatment-emergent adverse events were mild in severity. DISCUSSION: Although vonoprazan 10 mg was not superior to placebo with respect to proportion of days without heartburn in Japanese patients with NERD, vonoprazan had a significantly higher cumulative rate of heartburn resolution and was well tolerated.

[Proposal of Information Management Method in Heat Generation of Magnetic Resonance Examination].

The safety management information related to heat generation in magnetic resonance imaging (MRI) examinations includes the specific absorption rate (SAR), the root mean square (RMS) of the MRI effective component of the B1 field (B1+rms), and imaging time, which must be set appropriately before an MRI examination. However, unlike image attributes and data, these three parameters do not require any image storage; therefore, information collection and confirmation post-inspection are difficult. Therefore, in this study, we used Digital Imaging and Communications in Medicine of SAR and imaging time using the overlay function of the picture archiving and communication systems (PACS) to confirm the specific absorption rate B1+rms and imaging time post-inspection. The medicine identification tag information was displayed on the PACS viewer. For some imaging times, the console display during scanning and the PACS viewer display did not match. However, the SAR console display during scanning and the PACS viewer display matched well, thereby rendering it easier to manage safety in MRI examinations.

Correction: Vedolizumab in Japanese patients with ulcerative colitis: A Phase 3, randomized, double-blind, placebo-controlled study.

[This corrects the article DOI: 10.1371/journal.pone.0212989.].

Vedolizumab in Japanese patients with ulcerative colitis: A Phase 3, randomized, double-blind, placebo-controlled study.

BACKGROUND: Vedolizumab safety and efficacy have been established in many populations all over the world, but have never been studied in Japan. We report results from a Phase 3, randomized, double-blind, placebo-controlled study of vedolizumab in Japanese patients with active ulcerative colitis (UC). METHODS: Patients with moderate-to-severe UC were enrolled into Cohort 1 (double-blinded) or Cohort 2 (open-label) in the induction phase. Cohort 1 was randomized 2:1 to receive 300 mg vedolizumab or placebo, while Cohort 2 received vedolizumab 300 mg only, at Weeks 0, 2, and 6. Patients from Cohorts 1 and 2 showing a clinical response to vedolizumab at Week 10 were randomized 1:1 to receive vedolizumab or placebo (double-blinded) at Week 14 and then every 8 weeks up to Week 54 as the maintenance phase. The primary endpoint was clinical response at Week 10, for the induction phase, and clinical remission at Week 60, for the maintenance phase. RESULTS: A total of 292 patients were enrolled into the induction phase (246 in Cohort 1, 46 in Cohort 2); 83 patients achieved response to vedolizumab and were subsequently enrolled into the maintenance phase. Clinical response rates at Week 10 were 39.6% (65/164) and 32.9% (27/82) in the vedolizumab and placebo groups in Cohort 1, respectively (adjusted odds ratio [AOR] = 1.37, 95% CI 0.779-2.399; p = 0.2722). In the maintenance phase, clinical remission rate at Week 60 was significantly higher in the vedolizumab group, at 56.1% (23/41), versus 31.0% (13/42) for placebo (AOR = 2.88, 95% CI 1.168-7.108; p = 0.0210). Most adverse events were mild to moderate in intensity, and no deaths occurred during the study period. CONCLUSIONS: Vedolizumab showed numerically greater efficacy compared with placebo as induction therapy, but the difference was not statistically significant. Vedolizumab was significantly superior to placebo as maintenance therapy in Japanese patients with UC. Vedolizumab has favourable safety and tolerability in these patients. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02039505.

Potato powders prepared by successive cooking-process depending on resistant starch content affect the intestinal fermentation in rats.

The effects of resistant starch (RS) in dry potato powders prepared by various processes on intestinal fermentation in rats were assessed. Rats were fed raw potato powder (RP), blanched potato powder (BP), steamed potato powder (SP), or drum-dried potato powder (DP) for 4 weeks. The cecal RS content was significantly higher in the RP group than in the control diet (CN) group and other dry potato powder groups. Cecum pH was significantly lower in the RP group compared to the CN group, and was also significantly lower than that in the SP, BP, and DP groups. Lactic acid bacteria levels in the RP group were significantly higher than those in the CN group, and levels in the SP group also increased relative to the control group. Lactobacillus levels in the RP group were higher than in the CN and other dry potato powder groups. Cecal short-chain fatty acid (SCFA) concentrations in the RP group followed by the SP group exhibited significantly higher levels relative to the control levels. Dry potato powders containing RS produced during the cooking process may represent a useful food material that increases intestinal concentrations of SCFA and enhances the growth of certain lactic acid bacteria.

Comparison of the effect of two types of whole mushroom (Agaricus bisporus) powders on intestinal fermentation in rats.

The effects of two types of mushroom (Agaricus bisporus; white, WM; brown, BM) powders on intestinal fermentation in rats were investigated in terms of the physical characteristics of animals and by bacterial and HPLC analyses of cecal contents. Short-chain fatty acid levels were found to be significantly higher in the WM group than in the BM and the control (CN) groups; coliform bacteria levels in the BM group were significantly lower than those in the CN group, with the WM group inducing an apparent but insignificant decrease in coliforms. Anaerobe levels in the WM group were significantly higher than those in the CN group and, compared with the CN group, the BM and WM groups exhibited significantly increased feces weight and cecum weight, respectively. These results indicate that the mushroom powders, and in particular the WM powder, have beneficial effects on the intestinal environment in rats.

Ordered microporous layered lanthanide 1,3,5-benzenetriphosphonates pillared with cationic organic molecules.

Novel isomorphous pillared-layer-type crystalline lanthanide 1,3,5-benzenetriphosphonates were prepared with bpy and dbo as organic pillars (LnBP-bpy and LnBP-dbo; Ln: Ce, Pr, and Nd). Ab initio crystal structure solution using synchrotron X-ray powder diffraction data revealed that the organic pillars do not exist as neutral coordinating ligands but as cationic molecules. Especially the LnBP-dbo phases have ordered interlayer space filled with water molecules between the dbo pillars, and the interlayer water is successfully removed by heating under vacuum with slightly distorted but basically retained pillared layer structures. Microporosity of the materials is confirmed by adsorption of nitrogen, carbon dioxide, and hydrogen gases. Such microporous layered metal phosphonates pillared with cationic molecules should be unprecedented and should offer new strategies to design ordered microporous materials.

Randomized, double-blind, dose-ranging study of TAK-875, a novel GPR40 agonist, in Japanese patients with inadequately controlled type 2 diabetes.

OBJECTIVE: Assessment of the efficacy and safety of TAK-875 (a novel GPR40 agonist) in Japanese patients with type 2 diabetes inadequately controlled by diet/exercise. RESEARCH DESIGN AND METHODS: This was a phase II, multicenter, randomized, double-blind, parallel-group, placebo-controlled, 12-week dose-ranging evaluation of TAK-875 (6.25-200 mg once daily) with the primary end point of change in A1C at week 12. A nonblinded group received 1 mg glimepiride once daily as an active control. RESULTS: A total of 396 patients were randomized to receive TAK-875 (n = 299), placebo (n = 48), or glimepiride (n = 49). The least square mean changes in A1C at week 12 from baseline were as follows: 0.09% in the placebo group; -0.54, -0.67, -0.88, -1.27, -1.29, and -1.40% in the 6.25-, 12.5-, 25-, 50-, 100-, and 200-mg TAK-875 groups, respectively; and -1.32% in the 1-mg glimepiride group. All TAK-875 groups had statistically significant reductions in A1C compared with placebo (P < 0.0001), and those receiving ≥50 mg TAK-875 achieved reductions in A1C equivalent to those with glimepiride. Results for other glycemic parameters, including improvements during a meal tolerance test, mirrored these positive findings with TAK-875. There were no significant differences in incidence of adverse events among the groups and no dose-dependent changes in tolerability. Hypoglycemic episodes were reported in 0.7% of patients in the TAK-875 groups and in 4.1% of the glimepiride group. CONCLUSIONS: TAK-875 produced clinically and statistically significant improvements in glycemic control in patients with type 2 diabetes inadequately controlled by diet and exercise, and it was well tolerated with a lower propensity to cause hypoglycemia.

The first lanthanide organophosphonate nanosheet by exfoliation of layered compounds.

Lanthanum 1,3,5-benzenetriphosphonate (LBP-II) with layered structure was obtained by a hydrothermal synthesis. LBP-II was successfully exfoliated to give nanosheets as confirmed by AFM observation. Europium or terbium-doped LBP-II as well as their dispersion solutions show photoluminescence.

Glimepiride increases high-density lipoprotein cholesterol via increasing adiponectin levels in type 2 diabetes mellitus.

The aims of the present study are to investigate the effect of glimepiride 1 mg/d on plasma adiponectin and to assess the contribution of adiponectin in changing high-density lipoprotein cholesterol (HDL-c) levels after glimepiride treatment. Forty patients with type 2 diabetes mellitus were included. Plasma adiponectin, fasting plasma glucose, insulin, hemoglobin A(1c), and cholesterol were measured at study entry and after 3 months of treatment with glimepiride. Both plasma adiponectin level (7.5 +/- 4.5 vs 8.3 +/- 4.5 microg/mL, P = .040) and HDL-c level increased significantly (50 +/- 11 vs 53 +/- 10 mg/dL, P = .041) in the all-subjects group. In the low-adiponectin group (initial plasma adiponectin level <6 microg/mL), both plasma adiponectin level (4.5 +/- 0.9 vs 5.9 +/- 2.0 microg/mL, P = .004) and HDL-c level increased significantly (44 +/- 8 vs 49 +/- 9 mg/dL, P = .011). There was no significant change in the high-adiponectin group (initial plasma adiponectin level >or=6 microg/mL). Change in plasma adiponectin level was an independent factor for change in HDL-c level after adjustment for other factors (beta = .574, P = .009, R(2) = 0.524, P = .036). In conclusion, glimepiride improved plasma adiponectin level, especially in the subjects with type 2 diabetes mellitus with low adiponectin level before treatment, and may directly contribute to improving HDL-c level.

Koshikamide B, a cytotoxic peptide lactone from a marine sponge Theonella sp.

Koshikamide B (1) has been isolated from two separate collections of the marine sponge Theonella sp. as the major cytotoxic constituent. Koshikamide B is a 17-residue peptide lactone composed of six proteinogenic amino acids, two D-isomers of proteinogenic amino acids, seven N-methylated amino acids, and two unusual amino acid residues. The unusual amino acids are N(delta)-carbamoylasparagine and 2-(3-amino-2-hydroxy-5-oxopyrrolidin-2-yl)propionic acid (AHPP); the former is first found as the constituent of peptides, whereas the latter is a new amino acid residue. The N-terminus of koshikamide B is blocked by a methoxyacetyl group. The structure of koshikamide B (1) has been determined by interpretation of spectral data and analysis of chemical degradation products. Koshikamide B (1) exhibits cytotoxicity against P388 murine leukemia cells and the human colon tumor (HCT-116) cell line with an IC50 value of 0.45 and 7.5 microg/mL, respectively.

Effects of pioglitazone on serum fetuin-A levels in patients with type 2 diabetes mellitus.

Fetuin-A (alpha2-Heremans-Schmid glycoprotein), a circulating glycoprotein, can inhibit insulin signaling both in vivo and in vitro. Recently, we and another independent group have shown that fetuin-A is positively associated with insulin resistance in humans. Furthermore, it has been reported that higher fetuin-A levels are associated with metabolic syndrome and atherogenic lipid profiles. These data suggest that fetuin-A might be a regulator of insulin resistance and/or metabolic syndrome. However, it is not clear how fetuin-A levels are regulated. To address this, we investigated the effects of representative insulin-sensitizing therapies such as pioglitazone, metformin, and aerobic exercise on fetuin-A levels. Twenty-seven patients with type 2 diabetes mellitus were divided into pioglitazone-treated (Pio), metformin-treated (Met), and exercise-treated (Ex) groups. Ten patients in the Pio group and 9 patients in the Met group took 15 or 30 mg/d pioglitazone or 500 or 750 mg/d metformin, respectively, for 6 months. Eight patients in the Ex group underwent a 3-month aerobic exercise program. Serum fetuin-A levels were measured before and after each intervention. Intervention significantly decreased hemoglobin A(1c) in all groups. After treatment, serum fetuin-A levels significantly decreased in the Pio group (291.2 +/- 57.7 to 253.1 +/- 43.9 microg/mL, P = .006), whereas there were no changes in serum fetuin-A after intervention in either the Met or the Ex groups. We hypothesize that pioglitazone could partially ameliorate insulin resistance via modulating fetuin-A levels.

Clinical impact of metabolic syndrome by modified NCEP-ATPIII criteria on carotid atherosclerosis in Japanese adults.

AIM: The present study aimed to clarify the clinical impact of modified NCEP-ATP III criteria for metabolic syndrome (MS) and Framingham Risk Score (FRS) on carotid atherosclerosis in 615 Japanese adults (319 men and 296 women) including 307 with type 2 diabetes. METHODS: Waist circumference was the only component from the original NCEP-ATP III criteria based on Japanese criteria. The intima-medial thickness (IMT) and stiffness parameter beta of the carotid artery were measured by ultrasound. RESULTS: Both IMT and stiffness parameter beta were significantly increased with the number of coexisting components of MS, and higher in subjects with MS than in those without MS (all Ps < 0.0001). In a logistic regression analysis with each component of MS as independent factors, hyperglycemia and hypertension had the highest odds ratio for progressors of IMT and stiffness parameter beta , respectively. Univariate odds ratios of MS for both IMT and stiffness parameter beta were comparable with that of an increase of 10% in 10-year coronary heart disease (CHD) risk by FRS (CHD risk/ 10%) but inferior to CHD risk by FRS >/= 20%. CONCLUSION: The modified NCEP-ATP III criteria for MS revealed an additive predictive impact on carotid atherosclerosis but no superiority to FRS.

Association of serum fetuin-A with carotid arterial stiffness.

OBJECTIVE: Fetuin-A is a circulating glycoprotein which is well characterized as an inhibitor of ectopic calcification. Vascular calcification commonly found in chronic kidney disease (CKD) patients is a predictor of cardiovascular death. Recently, several groups have demonstrated that low fetuin-A levels are associated with mortality in uraemic patients, possibly through regulation of vascular calcification. However, the physiological significance of fetuin-A in atherosclerosis remains unknown, except in specific conditions, such as vascular calcification in CKD patients. The objective of this study was to investigate the association between serum fetuin-A levels and arterial stiffness, a functional property of atherosclerosis, in healthy subjects. PATIENTS AND MEASUREMENTS: The study subjects comprised 141 healthy subjects. We measured serum fetuin-A levels and stiffness parameter beta for the common carotid artery, which was assessed by ultrasound using a phase-locked echo-tracking system. RESULTS: Simple regression analyses indicated that serum fetuin-A levels were significantly correlated with stiffness parameter beta (r = 0.200, P = 0.018). Multiple regression analyses showed that, besides age, fetuin-A (beta = 0.166, P = 0.033) independently contribute to the stiffness parameter beta (R(2) = 0.310, P < 0.0001). CONCLUSIONS: Serum fetuin-A level is associated with carotid arterial stiffness, independent of known atherogenic factors in healthy subjects.

Effect of adiponectin on carotid arterial stiffness in type 2 diabetic patients treated with pioglitazone and metformin.

Adiponectin, an adipocyte-specific plasma protein, has been reported to exhibit protective effects against atherosclerosis as well as an insulin-sensitizing effect. This study was designed to investigate the effect of adiponectin on carotid arterial stiffness in type 2 diabetic patients treated with pioglitazone and metformin. Twenty type 2 diabetic patients were enrolled and divided into 2 groups, a pioglitazone-treated group (n = 10) and a metformin-treated group (n = 10). Before and after intervention, plasma adiponectin levels were measured by enzyme-linked immunosorbent assay and carotid arterial stiffness was evaluated by the stiffness parameter beta, measured by ultrasound equipped with a phase-locked echo-tracking system. In the pioglitazone group, plasma adiponectin level significantly increased and stiffness parameter beta significantly decreased, whereas in the metformin group neither of these parameters changed significantly. The changes in stiffness parameter beta were significantly and inversely correlated with change in plasma adiponectin level after treatment with pioglitazone or metformin in the group of all subjects (r = -0.472, P = .036). In conclusion, the present study is the first to demonstrate that increase in adiponectin level after treatment with the insulin sensitizers pioglitazone and metformin may improve arterial stiffness in patients with type 2 diabetes mellitus.