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Allergic rhinitis is one of the most common clinical conditions in children; however, data regarding the safety of antihistamines in children with seasonal allergic rhinitis are limiting. To evaluate the safety and efficacy of fexofenadine in children with seasonal allergic rhinitis, data were pooled from three, double-blind, randomized, placebo-controlled, parallel-group, 2-week trials in children (6-11 year) with seasonal allergic rhinitis. All studies assessed fexofenadine HCl 30 mg b.i.d.; two studies included fexofenadine HCl at 15 and 60 mg b.i.d. Patients (and investigators) reported any adverse events during the trial. Physical examinations, including measurements of vital signs and laboratory tests, were performed. Efficacy assessments (total symptom score and individual symptom scores) were evaluated. Exposure to fexofenadine HCl 30 mg b.i.d. and to any fexofenadine dose exceeded 10,000 and 17,000 patient days, respectively. Incidences of adverse events, and discontinuations because of adverse events, were low and similar across treatment groups. In the placebo group, 24.4% of subjects reported adverse events compared with 24.1% for fexofenadine HCl 30 mg b.i.d., and 28.4% for all fexofenadine-treated groups. The most common adverse event overall was headache (4.3% placebo; 5.8% fexofenadine HCl 30 mg b.i.d.; and 7.2% any fexofenadine doses). Treatment-related adverse events were similar across treatment groups with no sedative effects. Fexofenadine HCl 30 mg b.i.d. was significantly superior to placebo in reducing the total symptom score and all individual seasonal allergic rhinitis symptoms, including nasal congestion (p < 0.05). Fexofenadine, at doses of up to 60 mg b.i.d., is safe and non-sedating, and fexofenadine HCl 30 mg b.i.d. effectively reduces all seasonal allergic rhinitis symptoms in children aged 6-11 years.
This randomized, double-blind, placebo-controlled, parallel-group, phase III study (trial registration number JapicCTI-142600) evaluated the effect of a 2-week treatment period with bilastine (20 mg once daily), fexofenadine (60 mg twice daily), or a matched placebo (double dummy) in patients with PAR. All patients were instructed to record individual nasal and ocular symptoms in diaries daily. The primary endpoint was the mean change in total nasal symptom scores (TNSS) from baseline to Week 2 (Days 10-13).
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In bronchopulmonary infections antibiotics can be combined with other drugs, called mucoactive drugs, that act to reduce the abnormal viscoelasticity of the mucus enabling a deeper penetration of more antibiotic into the mucus. Seaprose is a protease that interacts with the polymeric fibrillar structure of the bronchial mucus to shorten the long chains of mucoproteins, DNA and other macromolecules, thus reducing the viscosity of the mucus. In order to assess whether the combination of seaprose (60 mg/8 h) plus erythromycin (500 mg/8 h) allows higher antibiotic levels in sputum than erythromycin (500 mg/8 h) plus placebo, the pharmacokinetic behaviour in sputum and in blood of these two treatments was investigated in a double-blind study in two groups of twenty patients each with bronchopulmonary infections. Serum and sputum levels were determined for each patient at the first and seventh day of the two drug regimens. Statistically significant differences for peak, AUC and MRT, were observed for erythromycin between the first and last dose in the group of patients treated with seaprose plus erythromycin; moreover significant differences for these parameters were observed between the two groups. These findings indicate the presence of a pharmacokinetic synergism between seaprose and erythromycin which allows erythromycin to penetrate bronchial secretion more easily and in higher amounts, performing a sterilizing action with therapeutic advantages.
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The simple brake reaction time and CBRT, and the CBRT component of the multiple task, did not show any significant differences between the drugs. In contrast, the LT, both as a single parameter and as a component of the multiple task, showed significant differences between diphenhydramine and the newer-generation antihistamines in a manner that corresponds with subjective sedation.
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Sixteen healthy volunteers (5 males and 11 females; mean age, 21.8 years) participated in a 4-way, placebo-controlled, crossover study. The effects of fexofenadine (360 mg), modafinil (200 mg), methylphenidate (20 mg), and placebo were compared in a critical tracking, divided attention, motor impulsivity, and vigilance task.
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Ciliary beat frequency increased in the acute phase of a mouse model of allergic rhinitis. Physiologic concentrations of histamine had no effect on CBF, and thus, it appears that other mechanisms control CBF in the acute phase of allergic rhinitis.
We investigate lateral differences in the intrinsic fluctuations comprising the default mode network (DMN) for healthy controls (HCs) and patients with schizophrenia (SZ), both during rest and during an auditory oddball (AOD) task. Our motivation for this study comes from multiple prior hypotheses of disturbed hemispheric asymmetry in SZ and more recently observed lateral abnormalities in the DMN for SZ during AOD. We hypothesized that significant lateral differences would be found in HCs during both rest and AOD, and SZ would show differences from HCs due to hemispheric dysfunction. Our study examined 28 HCs and 28 outpatients with schizophrenia. The scans were conducted on a Siemens Allegra 3T dedicated head scanner. There were numerous crossgroup lateral fluctuations that were found in both AOD and rest. During the resting state, within-group results showed the largest functional asymmetries in the inferior parietal lobule for HCs, whereas functional asymmetries were seen in posterior cingulate gyrus for SZ. Comparing asymmetries between groups, in resting state and/or performing AOD, areas showing significant differences between group (HC > SZ) included inferior parietal lobule and posterior cingulate. Our results support the hypothesis that schizophrenia is characterized by abnormal hemispheric asymmetry. Secondly, the number of similarities in crossgroup AOD and rest data suggests that neurological disruptions in SZ that may cause evoked symptoms are also detectable in SZ during resting conditions. Furthermore, the results suggest a reduction in activity in language-related areas for SZ compared to HCs during rest.
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The results of this study indicate that modern antihistamines are generally considered effective and well tolerated by patients. In general, levocetirizine scored significantly higher in terms of perception of efficacy, tolerability and overall satisfaction. In terms of tolerability, three-quarters of patients were 'very satisfied' and a further fifth were moderately satisfied with levocetirizine and almost all (95%) were happy to continue treatment. Overall, the most commonly reported adverse event in this study was somnolence, a well known effect of antihistamines. The rate of somnolence in the levocetirizine group (3.8%) was similar to that for fexofenadine (both doses) and desloratadine, two products which are considered to be nonsedating antihistamines, and significantly less than half the rate for cetirizine.
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The objective was to create a Turkish n-gram CC classifier for the respiratory syndrome and then compare daily volumes between the n-gram CC classifier and a respiratory ICD-10 code grouping on a test set of data.
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MicroRNAs (miRNAs) are short non-coding RNAs involved in the regulation of gene expression. Selected groups of miRNAs are differentially expressed in various types of cancers. Alterations in miRNAs gene expression have been shown in cells from the B-cell malignancy, multiple myeloma (MM). However, although MM is a disease of plasma cells, abnormalities have been detected in the peripheral blood of the patients. The goal of our study was to analyse the entire miRNome in peripheral lymphocytes of MM patients using reverse transcription quantitative polymerase chain reaction. Using in silica analysis, we also evaluated some of the most interesting and significant pathways. Analysis revealed that MM samples had a distinct miRNA profile compared to the controls. This resulted in the identification of 203 miRNAs, 85 of which were over-expressed and 118 under-expressed. Of these, 184 possessed validated or highly predicted mRNA targets. We identified 12 354 mRNA targets of the transcriptome: 36·4% of the related proteins are involved in death processes while the 21% are required for growth and cell proliferation. We have demonstrated that miRNAs are differentially expressed in the peripheral blood of MM patients compared to controls, affecting some pathways involved in the anti-apoptotic process, cell proliferation and maybe anti-angiogenesis.
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Alfentanil apparent oral clearance was inhibited more than 97% by both acute and steady-state ritonavir/indinavir, and systemic clearance was inhibited more than 90% due to diminished hepatic and intestinal extraction. Ritonavir/indinavir increased fexofenadine area under the plasma concentration-time curve four- to five-fold, suggesting significant inhibition of gastrointestinal P-glycoprotein. Ritonavir/indinavir slightly increased methadone N-demethylation, but it had no significant effects on methadone plasma concentrations or on systemic or apparent oral clearance, renal clearance, hepatic extraction or clearance, or bioavailability. Ritonavir/indinavir had no significant effects on methadone plasma concentration-effect relationships.
The rates of pregnant women with functional symptoms of venous insufficiency who accepted or refused to wear therapeutic compression stockings were evaluated and compared in relation to their clinical evolution and their compliance levels.
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1990-2003. Search terms: second-, third-generation antihistamines; sedating, nonsedating antihistamines; in vitro anti-inflammatory activity; cetirizine; ebastine; loratadine; fexofenadine; desloratadine.
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Syndromic surveillance is designed for early detection of disease outbreaks. An important data source for syndromic surveillance is free-text chief complaints (CCs), which are generally recorded in the local language. For automated syndromic surveillance, CCs must be classified into predefined syndromic categories. The n-gram classifier is created by using text fragments to measure associations between chief complaints (CC) and a syndromic grouping of ICD codes.
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Twelve patients with persistent allergic rhinitis (all skin prick positive to house dust mite) were randomized in a double-blind cross-over fashion to receive for 1 week either FEX 180 mg, ML 10 mg, FEX 180 mg + ML 10 mg combination, or PL, with nasal AMP challenge performed 12 h after dosing. There was a 1-week washout period between each randomized treatment. The primary outcome measure was the maximum percentage peak nasal inspiratory flow (PNIF) fall from baseline over a 60-min period after nasal challenge with a single 400 mg ml(-1) dose of AMP. The area under the 60-min time-response curve (AUC) and nasal symptoms were measured as secondary outcomes.
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Intermittent claudication is the primary symptom of chronic obstructive arteriopathies of the lower extremities. Increased walking distance is the aim of all physical or pharmacological treatment of such patients. The study reported aims to assess the increase in distal arterial blood flow in arteriopathic patients achieved by physical treatment using a cuff, generally positioned on the upper third of the thigh to produce pulsed compressions. By tightening for a few milliseconds slightly behind the natural cardiac systole, the cuff reinforces the systolic thrust to increase distal perfusion without making any additional demand, on the cardiac pump. The cuff used is produced by Vascupump Copyright vp-El. The trial was conducted on 36 patients with intermittent claudication divided into 3 groups. Group A included 12 patients given Vascupump Copyright treatment only (20 yen 45 minute sessions); Group B included 12 patients given combined treatment with the Vascupump Copyright and endovenous Pentoxillin (3 fl/per diem for 20 days); Group C included 12 patients given Pentoxyfillin alone (3 n per diem for 20 days). Each patient was examined at the start (D0) and end (D20) of treatment as follows: Treadmill tests at 0 and 12% gradients at a speed of 3 km/h. Doppler arterial tensiometry with calculation of the Winsor Index; photoplethysmography. Group A revealed an increase in relative and absolute walking distance of 230% and 224% respectively on the flat and 357% and 343% respectively uphill. Doppler tensiometry revealed a 40.7% improvement in Group A compared to 29% in Group B and 13.6% in Group C. By contrast the improvement in the plethysmographic reading was higher in Group B (+ 119%) than in Group A (+67.3%). These results suggest that the Vascupump Copyright gives better than expected results on Fontaine Stage B arteriopathies.
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This study suggested that the selective absorption of fexofenadine enantiomers by intestinal epithelial cells might have been due to the selective uptake mediated by OATPs and that the difference in intestinal absorption was enhanced with a racemic mixture.
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Fexofenadine, a nonsedating antihistamine drug, is effective for the treatment of seasonal allergic rhinitis and chronic urticaria. Simultaneous administration of probenecid increases the plasma concentration of fexofenadine due to an inhibition of its renal elimination in healthy volunteers (Clin Pharmacol Ther 77:17-23, 2005). The purpose of the present study is to investigate the possibility that the drug-drug interaction between fexofenadine and probenecid involves the renal basolateral uptake process. The uptake of fexofenadine was determined in HEK293 cells expressing human organic anion transporter 1 (OAT1/SLC22A6), OAT2 (SLC22A7), OAT3 (SLC22A8), and organic cation transporter 2 (OCT2/SLC22A2). Only hOAT3-HEK showed a significantly greater accumulation of fexofenadine than that in vector-HEK, which was saturable with K(m) and V(max) values of 70.2 microM and 120 pmol/min/mg protein, respectively. Inhibition potency of probenecid for the uptake of fexofenadine was compared between hOAT3 and organic anion-transporting peptide 1B3 (hOATP1B3), a transporter responsible for the hepatic uptake of fexofenadine (Drug Metab Dispos 33:1477-1481, 2005). The K(i) values were determined to be 1.30 and 130 microM for hOAT3 and hOATP1B3, respectively, with Hill coefficients of 0.76 and 0.64, respectively. The K(i) value of probenecid for hOAT3, but not for hOATP1B3, was significantly lower than the maximum unbound plasma concentration of probenecid at clinical dosages. These results suggest that the renal drug-drug interaction between fexofenadine and probenecid is probably explained by an inhibition of the renal uptake of fexofenadine via hOAT3, at least in part.
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These data suggest that an H1-receptor antagonist could potentially benefit postexercise syncope in a hot environment.
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This was a multicenter, double-blind, randomized, placebo-controlled, parallel-group study, conducted between February 29, 2000, and June 14, 2001. Participants were randomized to either fexofenadine hydrochloride, 30 mg, or placebo twice daily for a 2-week period. To facilitate dosing, capsule content was mixed with applesauce (approximately 10 mL). Safety assessments depended on date of entry into the study because of an amendment to the protocol. Before the amendment, assessments included physical examination, vital signs reporting (oral temperature, heart rate, and respiratory rate), and adverse event (AE) reporting. After the amendment, safety assessments included laboratory testing (blood chemistry and hematology profiles), physical examination, 12-lead electrocardiography, and vital signs (oral temperature, blood pressure, heart rate, and respiratory rate) and AE reporting.