Current Issue : April - June Volume : 2019 Issue Number : 2 Articles : 5 Articles
Background: Inhibition of interleukin (IL)-13, a Type 2 inflammatory mediator in asthma, improves lung function\nand reduces exacerbations; however, more effective therapies are needed. A subset of asthma patients also exhibits\nelevated IL-17, which is associated with greater disease severity, neutrophilic inflammation, and steroid resistance.\nBITS7201A is a novel, humanized bispecific antibody that binds and neutralizes both IL-13 and IL-17.\nMethods: Safety, pharmacokinetics, and immunogenicity of BITS7201A were evaluated in a phase 1 study. Part A\nwas a single ascending-dose design with 5 cohorts: 30-, 90-, and 300-mg subcutaneous (SC), and 300- and 750-mg\nintravenous (IV). Part B was a multiple ascending-dose design with 3 cohorts: 150-, 300-, and 600-mg SC every 4\nweeks � 3 doses. Both parts enrolled approximately 8 healthy volunteers into each cohort (6 active: 2 placebo). Part\nB included an additional cohort of patients with mild asthma (600-mg SC).\nResults: Forty-one subjects (31 active, 10 placebo) and 26 subjects (20 active, 6 placebo) were enrolled into Parts A\nand B, respectively. The cohort with mild asthma patients was terminated after enrollment of a single patient. No\ndeaths, serious adverse events, or dose-limiting adverse events occurred. In Part A, 12 active (39%) and 5 placebo\nsubjects (50%), and in Part B, 6 active (30%) and 3 placebo subjects (50%) experienced at least 1 treatmentemergent\nadverse event (TEAE). The most common AEs were fatigue (n = 3) and influenza-like illness (n = 2). One\ninjection-site reaction was reported. Two subjects with elevated blood eosinophil counts at baseline had\ntransient elevations in blood eosinophils����...
Iron deficiency anemia (IDA) occurs in 15â??46% of patients with celiac disease (CD), and in\nsome cases, it may be its only manifestation. Studies in animal models have shown that prebiotics,\nincluding inulin, may help to increase intestinal absorption of iron. The aim of this study was to\nevaluate the effect of a prebiotic, oligofructose-enriched inulin (Synergy 1), on iron homeostasis\nin non-anemic children and adolescents with celiac disease (CD) in association with a gluten-free\ndiet (GFD). Thirty-four CD patients (4â??18 years old) were randomized into two groups receiving\nSynergy 1 (10 g/day) or a placebo (maltodextrin) for three months. Before and after intervention,\nblood samples were collected from all patients for assessment of blood morphology, biochemical\nparameters and serum hepcidin concentration. We found that serum hepcidin concentration after the\nintervention was significantly decreased by 60.9% (p = 0.046) in the Synergy 1 group, whereas no\nsignificant difference was observed in the placebo group. No differences in morphological and\nbiochemical blood parameters (including ferritin, hemoglobin and C-reactive protein (CRP)) were\nobserved after intervention in either group. Given that hepcidin decrease may improve intestinal iron\nabsorption, these results warrant further investigation in a larger cohort and especially in patients\nwith IDA....
Background: Catheter-related infection (CRI) is one of the serious challenges in clinical practice. This preliminary\nclinical study aimed to examine whether next-generation sequencing (NGS) targeting 16S rDNA, which was PCRamplified\ndirectly from the tip of a central venous catheter (CVC), can be used to identify causative pathogens in CRI,\ncompared to the culture method.\nMethods: Hospitalized patients, from whom a CVC had just been removed, were prospectively enrolled and divided\ninto the CRI-suspected and routine removal groups. DNA was extracted from the sonication fluid of CVC specimens\nderived from patients. For analysis of bacterial composition by NGS, the V3â??V4 fragments of bacterial 16S rDNA were\nPCR-amplified, followed by index PCR and paired-end sequencing on an Illumina MiSeq device. Conventional culture\nmethods were also performed in the CRI-suspected group.\nResults: Of CVCs collected from the 156 enrolled patients (114 men; mean age 65.6 years), a total of 14 specimens\n[nine out of 31 patients suspected with CRI and five out of 125 patients without infection symptoms (routine removal\ngroup)] were PCR-positive. In five patients with definite CRI, Staphylococcus was the most frequently detected genus\nby NGS (4/5 specimens), although no pathogens were detected by NGS in the one remaining specimen. The genera\nidentified by NGS were consistent with those from conventional culture tests. There was high agreement between\nNGS and the culture method in the CRI-suspected group, with sensitivity and specificity values of 80.0% and 76.9%,\nrespectively; meanwhile, the false-positive rate of NGS was as low as 4.0% in the routine removal group. Moreover,\nseveral genera, besides the genus identified by culture test, were detected in each patient with definite CRI and surgical\nsite infection (SSI). Additionally, in one patient with SSI, Enterococcaceae were detected not only by NGS but also\nby abdominal abscess drainage culture.\nConclusions: NGS targeting 16S rDNA was able to analyze the bacterial composition of CVC specimens and detect\ncausative pathogens in patients with CRI and was therefore suggested as a promising diagnostic tool for CRI....
Obesity in the postmenopausal period is associated with an increased risk of cardiovascular\ndiseases in women. One of the key drivers of cardiovascular risk is endothelial dysfunction; thus,\nthis is also a crucial point for studies on new therapeutic methods of cardioprotective properties.\nThe aim of the current study was to evaluate the effect of two doses of multispecies probiotic EcologicR\nBarrier supplement on functional (primary endpoint) and biochemical parameters (secondary\nendpoint) of endothelial dysfunction in obese postmenopausal women in a 12-week randomized,\nplacebo-controlled clinical trial. A total of 81 obese Caucasian women participated in the trial.\nThe subjects were randomly assigned to three groups that received a placebo, a low dose (LD)\n(2.5 Ã? 109 colony forming units (CFU) per day), or a high dose (HD) (1 Ã? 1010 CFU per day) of\nlyophilisate powder containing live multispecies probiotic bacteria. The probiotic supplement was\nadministered each day for 12 weeks in two equal portions. A high dose probiotic supplementation for\n12 weeks decreased systolic blood pressure, vascular endothelial growth factor, pulse wave analysis\nsystolic pressure, pulse wave analysis pulse pressure, pulse wave analysis augmentation index,\npulse wave velocity, interleukin-6, tumor necrosis factor alpha, and thrombomodulin. Low doses of\nprobiotic supplementation decreased the systolic blood pressure and interleukin-6 levels. The mean\nchanges in the estimated parameters, compared among the three groups, revealed significant\ndifferences in the vascular endothelial growth factor, the pulse wave analysis systolic pressure,\nthe pulse wave analysis augmentation index, the pulse wave velocity, the tumor necrosis factor\nalpha, and thrombomodulin. The post hoc tests showed significant differences for all parameters\nbetween HD and the placebo group, and HD and LD (besides pulse wave analysis augmentation\nindex). We show for the first time that supplementation with multispecies probiotic EcologicR\nBarrier favorably modifies both functional and biochemical markers of vascular dysfunction in obese\npostmenopausal women....
Background: Pazopanib is indicated in the first-line treatment of metastatic renal cell cancer (mRCC). The aim of\nthis study was to review the efficacy, safety, and pharmacokinetics of pazopanib and see how these aspects are\nlinked to clinical practice.\nMethods: A non-exhaustive systematic review was conducted according to the three topics. No publication\nrestrictions were imposed and the selected languages were Spanish and English. After that, a summary of the\nmain results and findings of the review was presented and discussed during three meetings (one for each\ntopic) with 13 medical oncologists that usually treat mRCC. At these meetings, a questionnaire on the first-line use of\npazopanib in clinical practice was also drawn up. After the meetings, the questionnaire was completed by 60 specialist\nmedical oncologists in renal cancer.\nResults: The efficacy and safety of pazopanib have been demonstrated in several clinical trials, and subsequently\nconfirmed in studies in real-world clinical practice. In addition to its clinical benefit and good safety profile, quality of\nlife results for pazopanib, which compare favorably to sunitinib, make it a good option in the first-line treatment of\npatients. Special populations have been included in studies conducted with pazopanib, and it is safe for use in elderly\npatients, poor functional status, kidney failure, and mild or moderate hepatic impairment, and in patients with\nconcomitant cardiovascular disease. The results of the questionnaire have shown that pazopanib is perceived as an\neffective drug, in which quality of life (QoL) outcomes are valued above all.\nConclusions: This paper offers a comprehensive and critical summary of efficacy, tolerability, and pharmacokinetics of\npazopanib in the treatment of mRCC. Pazopanib is an effective treatment with an acceptable safety profile. Its QoL and\ntolerability results offer certain advantages when compared with other therapeutic alternatives, and its use appears to\nbe safe in different patient profiles....
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