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Fixed dose

Ke Sun, Yue Zhang, Yue Tian, Xiubo Jiang
BACKGROUND: The association between environmental tobacco smoke (ETS) exposure and habitual snoring (HS) risk in children remains controversial. Therefore, a meta-analysis was carried out to evaluate and compare the effect of ETS by different family members and prenatal smoke exposure on the risk of HS in children. METHODS: Relevant studies published in English were identified by a search of PubMed, Embase and Web of Science up to December 2017. Random effect model and fixed effect model were used to pool the findings...
June 15, 2018: Journal of Epidemiology and Community Health
Rafael Herrera Alvarez, Guilherme Pugliesi, Fabio Luis Nogueira Natal, Cecilia Constantino Rocha, Gilmar Arantes Ataide Júnior, Alfredo José Ferreira Melo, Ivani Posar Otzuk, Claudio Alvarenga de Oliveira, Patrice Humblot
Two experiments were performed to evaluate the reproductive performance of zebu beef cows treated with different doses of eCG at the end of a progesterone (P4)/estrogen based protocol for timed artificial insemination (TAI). In Experiment 1, suckling Bos indicus Nelore cows (n = 261) received, on day 0, a progesterone (P4) intravaginal device (PD) and an injection of 1 mg estradiol benzoate (EB). On day 8, the PD was removed, 500 μg of cloprostenol was injected, and cows were assigned to one of the following groups: Control (no treatment), 300 (300 IU of eCG), 600 (600 IU of eCG), and 900 (900 IU of eCG)...
June 8, 2018: Theriogenology
Jill M Butterfield-Cowper, Thomas P Lodise, Manjunath P Pai
OBJECTIVES: To compare daptomycin exposures and predicted safety outcomes with a simulated weight-based and fixed dose in morbidly-obese and non-obese subjects METHODS: We performed a nonparametric population pharmacokinetic analysis of daptomycin concentration-time data from a prior obese and non-obese kidney function matched cohort of healthy adult volunteers. Monte Carlo simulations were performed to compare the maximum concentrations (Cmax ), minimum concentrations (Cmin ), and area under the curve (AUC) with the standard daptomycin 6-mg/kg/day dose or a 500-mg daily fixed dose in obese and non-obese subjects...
June 15, 2018: Pharmacotherapy
Dimitrios A Savva, Nicole Herrera, Radha Rohatgi
BACKGROUND: The American Society of Clinical Oncology guidelines recommend rasburicase for the treatment of pediatric patients with hyperuricemia at risk of tumor lysis syndrome (TLS) using a weight-based dose of 0.1-0.2 mg/kg once daily for 1-7 days. However, there has been a trend in practice due to recent data showing benefit using a fixed-dose approach. The purpose of this study was to evaluate the efficacy and safety between fixed and weight-based dosing of rasburicase in a pediatric population...
June 15, 2018: Pediatric Blood & Cancer
Nobukazu Hayashi, Ichiro Kurokawa, Obukohwo Siakpere, Akira Endo, Toshiki Hatanaka, Masahiro Yamada, Makoto Kawashima
Adapalene 0.1% (ADA) with clindamycin phosphate 1.2% (CLNP; ADA + CLNP) and the fixed-dose combination containing CLNP and benzoyl peroxide 3% (CLNP/BPO 3%) are strongly recommended for the early treatment of acne vulgaris in Japan. Here, we compare the early efficacy and safety of CLNP/BPO 3% with Japanese standard topical use of ADA + CLNP in the treatment of acne vulgaris. In this phase IV, multicenter study, 351 patients were randomized to receive CLNP/BPO 3% or ADA + CLNP for 12 weeks. The primary end-point was percentage change from baseline in total lesion (TL) counts at week 2...
June 15, 2018: Journal of Dermatology
Yasuyuki Fujii, Kenta Suzuki, Yahiro Hasegawa, Fumio Nanba, Toshiya Toda, Takahiro Adachi, Shu Taira, Naomi Osakabe
We previously confirmed that postprandial alterations in the circulation and metabolism after a single oral dose of flavan 3-ols (mixture of catechin and catechin oligomers) were involved in an increase in sympathetic nervous activity. However, it is well known that, in response to various stresses, activation of the hypothalamic-pituitary-adrenal (HPA) axis occurs together with sympathetic nerve activity, which is associated with activation of the sympathetic-adrenal-medullary (SAM) axis. In this study, we examined whether the HPA axis was activated after a single dose of flavan 3-ols...
June 11, 2018: Neuroscience Letters
Jesús Troya, Rocio Montejano, Pablo Ryan, Cristina Gómez, Mariano Matarranz, Alfonso Cabello, Francisco Vera, María Antonia Sepúlveda, Ignacio Santos, Gloria Samperiz, Pablo Bachiller, Vicente Boix, Pilar Barrufet, Miguel Cervero, José Sanz, Javier Solís, María Yllescas, Eulalia Valencia
BACKGROUND: Long-term combination antiretroviral therapy often results in toxicity/tolerability problems, which are one of the main reasons for switching treatment. Despite the favorable profile of raltegravir (RAL), data on its combination with abacavir/lamivudine (ABC/3TC) are scarce. Based on clinical data, we evaluated this regimen as a switching strategy. DESIGN: Multicenter, non-controlled, retrospective study including all virologically suppressed HIV-1-infected patients who had switched to RAL+ABC/3TC...
2018: PloS One
Andrea Maes, Paolo DePetrillo, Shahid Siddiqui, Colin Reisner, Paul Dorinsky
This randomized, phase 1, single-dose, crossover study (NCT02189304) compared the 12-hour pharmacokinetic (PK) and safety profiles of budesonide/glycopyrronium/formoterol fumarate dihydrate metered dose inhaler (BGF MDI) 320/14.4/10 μg and budesonide/formoterol fumarate dihydrate (BFF) MDI 320/10 μg (both formulated using innovative co-suspension delivery technology) to an active comparator (budesonide/formoterol fumarate dihydrate dry powder inhaler [BUD/FORM DPI] 320/9-μg delivered dose) in healthy adults...
June 14, 2018: Clinical Pharmacology in Drug Development
Emily L Marshall, David Borrego, James C Fudge, Dhanashree Rajderkar, Wesley E Bolch
PURPOSE: To assess various computational phantom alignment techniques within Monte Carlo radiation transport models of pediatric fluoroscopically-guided cardiac interventional studies. METHODS: Logfiles, including all procedure radiation and machine data, were extracted from a Toshiba infinix-I unit in the University of Florida Pediatric Catheterization Laboratory for a cohort of 10 patients. Two different alignment methods were then tested against a ground-truth standard based upon identification of a unique anatomic reference point within images co-registered to specific irradiation events within each procedure...
June 13, 2018: Medical Physics
John Kuruvilla, Cheng-Hwai Tzeng, Seok-Goo Cho, Seok Jin Kim, Jih-Luh Tang, Yaming Su, Jingyang Wu, Rita Vargo, Peter Cheverton
A randomized, multicenter, open-label study explored the effect of a fixed-dose (FD) of plerixafor versus the approved weight-based (WB) dose for the mobilization of hematopoietic stem cells (HSCs) in patients with non-Hodgkin's lymphoma and a body weight of ≤70 kg. After mobilization with granulocyte colony-stimulating factor (G-CSF) 10 μg/kg/day for 4 days, patients were randomized 1:1 to either plerixafor FD 20 mg (n = 30) or WB 0.24 mg/kg (n = 31) on the evening of Day 4. Co-primary endpoints were the proportion of patients achieving ≥5 × 106 CD34+ cells/kg in ≤4 days of apheresis, and total systemic exposure to plerixafor (area under the concentration-time curve from 0 to 10 h [AUC0-10 ])...
June 12, 2018: Bone Marrow Transplantation
Frank Kloprogge, Lesley Workman, Steffen Borrmann, Mamadou Tékété, Gilbert Lefèvre, Kamal Hamed, Patrice Piola, Johan Ursing, Poul Erik Kofoed, Andreas Mårtensson, Billy Ngasala, Anders Björkman, Michael Ashton, Sofia Friberg Hietala, Francesca Aweeka, Sunil Parikh, Leah Mwai, Timothy M E Davis, Harin Karunajeewa, Sam Salman, Francesco Checchi, Carole Fogg, Paul N Newton, Mayfong Mayxay, Philippe Deloron, Jean François Faucher, François Nosten, Elizabeth A Ashley, Rose McGready, Michele van Vugt, Stephane Proux, Ric N Price, Juntra Karbwang, Farkad Ezzet, Rajesh Bakshi, Kasia Stepniewska, Nicholas J White, Philippe J Guerin, Karen I Barnes, Joel Tarning
BACKGROUND: The fixed dose combination of artemether-lumefantrine (AL) is the most widely used treatment for uncomplicated Plasmodium falciparum malaria. Relatively lower cure rates and lumefantrine levels have been reported in young children and in pregnant women during their second and third trimester. The aim of this study was to investigate the pharmacokinetic and pharmacodynamic properties of lumefantrine and the pharmacokinetic properties of its metabolite, desbutyl-lumefantrine, in order to inform optimal dosing regimens in all patient populations...
June 2018: PLoS Medicine
Teun van Dillen, Arjan van Dijk
A new methodology has been developed for the assessment of the annual effective dose resulting from removable and fixed radiological surface contamination. It is entitled SUDOQU (SUrface DOse QUantification) and it can for instance be used to derive criteria for surface contamination related to the import of non-food consumer goods, containers and conveyances, e.g., limiting values and operational screening levels. SUDOQU imposes mass (activity)-balance equations based on radioactive decay, removal and deposition processes in indoor and outdoor environments...
June 12, 2018: Journal of Radiological Protection: Official Journal of the Society for Radiological Protection
Jennifer E Schollée, Marc Bourgin, Urs von Gunten, Christa S McArdell, Juliane Hollender
Ozonation and subsequent post-treatments are increasingly implemented in wastewater treatment plants (WWTPs) for enhanced micropollutant abatement. While this technology is effective, micropollutant oxidation leads to the formation of ozonation transformation products (OTPs). Target and suspect screening provide information about known parent compounds and known OTPs, but for a more comprehensive picture, non-target screening is needed. Here, sampling was conducted at a full-scale WWTP to investigate OTP formation at four ozone doses (2, 3, 4, and 5 mg/L, ranging from 0...
May 25, 2018: Water Research
Amol A Verma, Wayne Khuu, Mina Tadrous, Tara Gomes, Muhammad M Mamdani
BACKGROUND: The majority of people with hypertension require more than one medication to achieve blood pressure control. Many patients are prescribed multipill antihypertensive regimens rather than single-pill fixed-dose combination (FDC) treatment. Although FDC use may improve medication adherence, the impact on patient outcomes is unclear. We compared clinical outcomes and medication adherence with FDC therapy versus multipill combination therapy in a real-world setting using linked clinical and administrative databases...
June 2018: PLoS Medicine
Tianye Niu, Pengfei Yang, Xiaonan Sun, Tingyu Mao, Lei Xu, Ning Jeff Yue, Yu Kuang, Liming Shi, Ke Nie
Tumor angiogenesis is considered as an important prognostic factor. With an increasing emphasis on imaging evaluation of the tumor microenvironment, dynamic contrast enhanced (DCE) CT has evolved as an important functional technique in this setting. Yet many questions remain as how and when these functional measurements should be performed for each agent and tumor type, and what quantitative models should be used in the fitting process. In this study, we evaluated the variations of perfusion measurement on DCE-CT for rectal cancer patients from (1) different tracer kinetic models, (2) different scan acquisition lengths and (3) different scan intervals...
June 11, 2018: Physics in Medicine and Biology
R Hartmann, T Feenstra, L Valentino, M Dockal, F Scheiflinger
BACKGROUND: Investigational non-factor products such as emicizumab offer a treatment option for patients with hemophilia and inhibitors. However, their mechanism of action raises questions regarding safety when combined with treatments for breakthrough bleeding. OBJECTIVES: Evaluate in vitro thrombin generation (TG) and clot formation for combinations of activated prothrombin complex concentrate (aPCC), recombinant activated clotting factor VII (rFVIIa), and a sequence-identical analog of emicizumab (SIA)...
June 11, 2018: Journal of Thrombosis and Haemostasis: JTH
Michael Thoene, Janusz Godlewski, Liliana Rytel, Ewa Dzika, Ewa Bejer-Oleńska, Joanna Wojtkiewicz
INTRODUCTION: Bisphenol A (BPA) is used in the chemical industry for manufacturing plastics which are used as food packaging. Data indicate that BPA is released from such products and is widely present in the environment and the human body. So far, the EFSA and the US FDA have determined "safe" BPA oral exposure levels, and a large amount of data indicates that BPA is harmful even at low-doses. Our previously performed analyses concerning BPA exposure demonstrated the impact of this substance on parasympathetic and peptidergic nerve fibers present within the liver...
June 11, 2018: Folia Histochemica et Cytobiologica
Irina Spacova, Mariya I Petrova, Astrid Fremau, Lore Pollaris, Jeroen Vanoirbeek, Jan L Ceuppens, Sven Seys, Sarah Lebeer
BACKGROUND: There is an increasing interest in targeted application of probiotic bacteria for prevention and treatment of airway diseases, including allergies. Here, we investigated the beneficial effects of preventive intranasal treatment with probiotics Lactobacillus rhamnosus GG and L. rhamnosus GR-1 in a mouse model of allergic asthma. METHODS: L. rhamnosus was administered intranasally eight times on days 1-4 and 8-11 at 5x108 CFU/dose, followed by a two-week asthma induction protocol with birch pollen extract on alternating days...
June 10, 2018: Allergy
Sergio Caravita, Andrea Faini, Claudia Baratto, Grzegorz Bilo, Josè Luis Macarlupu, Morin Lang, Miriam Revera, Carolina Lombardi, Francisco C Villafuerte, Piergiuseppe Agostoni, Gianfranco Parati
BACKGROUND: Acute exposure to high-altitude hypobaric hypoxia induces a blood pressure rise in hypertensive humans, both at rest and during exercise. It is unclear whether this phenomenon reflects specific blood pressure hyperreactivity or rather an upward shift of blood pressure levels. We aimed at evaluating the extent and rate of blood pressure rise during exercise in hypertensive subjects acutely exposed to high altitude, and how these alterations can be counterbalanced by antihypertensive treatment...
June 9, 2018: Journal of the American Heart Association
Árpád Farkas, Alpár Horváth, Attila Kerekes, Attila Nagy, Szilvia Kugler, Lilla Tamási, Gábor Tomisa
Lack of coordination between the beginning of the inhalation and device triggering is one of the most frequent errors reported in connection with the use of pMDI devices. Earlier results suggested a significant loss in lung deposition as a consequence of late actuation. However, most of our knowledge on the effect of poor synchronization is based on earlier works on CFC devices emitting large particles with high initial velocities. The aim of this study was to apply numerical techniques to analyse the effect of late device actuation on the lung dose of a HFA pMDI drug emitting high fraction of extrafine particles used in current asthma and COPD therapy...
June 7, 2018: International Journal of Pharmaceutics
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