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Weeks Post-treatment (week + post-treatment)
Selected AbstractsSertraline, a selective serotonin reuptake inhibitor, affects thirst, salt appetite and plasma levels of oxytocin and vasopressin in ratsEXPERIMENTAL PHYSIOLOGY, Issue 5 2007Ana Paula De Magalhães-Nunes We investigated the effects of chronic administration of sertraline (SERT; ,20 mg kg,1 day,1 in drinking water), a selective serotonin reuptake inhibitor, on water and sodium intake and on plasma levels of oxytocin (OT) and vasopressin (AVP) in basal and stimulated conditions. Basal water intake was reduced in SERT-treated rats. After 24 h of water deprivation, rats treated with SERT for 21 days ingested less water than the control rats (9.7 ± 0.5 versus 20.0 ± 0.9 ml, respectively, at 300 min after water presentation, P < 0.0001). Subcutaneous injection of 2 m NaCl or isoproterenol evoked a lower dipsogenic response in rats treated with SERT for 21 days. Fluid and food deprivation also induced a weaker dipsogenic response in SERT-treated rats (1.6 ± 0.5 versus 10.2 ± 1.2 ml, at 300 min, P < 0.0001) but had no effect on saline intake. Sodium depletion induced a higher natriorexigenic response in the SERT group (5.6 ± 1.3 versus 1.2 ± 0.3 ml, at 300 min, P < 0.0002). Higher urinary density and lower plasma sodium levels were observed after SERT treatment. Sertraline also increased plasma levels of vasopressin and oxytocin (AVP, 2.65 ± 0.36 versus 1.31 ± 0.16 pg ml,1, P < 0.005; OT, 17.16 ± 1.06 versus 11.3 ± 1.03 pg ml,1, P < 0.0009, at the third week post-treatment). These data constitute the first evidence that chronic SERT treatment affects water and sodium intake in rats. These effects seem to be related to the hyponatraemia caused by the higher plasma levels of AVP and OT. [source] Treatment of chronic hepatitis C in patients with haemophilia: a review of the literatureHAEMOPHILIA, Issue 5 2006D. POSTHOUWER Summary., Chronic hepatitis C is a major cause of morbidity and mortality in haemophilia patients. In contrast to studies in the general population, the studies of antiviral therapy in haemophilia patients are limited and often include small numbers of patients. A review of the literature was performed to assess the efficacy of interferon (IFN)-based therapy for patients with haemophilia chronically infected with hepatitis C virus (HCV). Studies were identified by electronic searches (Medline, Embase) and hand searches in references of key articles. Data of the included studies were pooled, and responses to therapy were stratified according to treatment regimen, HIV co-infection status, and treatment history. The main outcome was a sustained virological response (SVR) defined as absence of HCV RNA both at the end of treatment and 24-week post-treatment. Thirty-five studies were identified that included 1151 patients. After pooling the data of included patients, the SVR in HIV-negative treatment naïve patients was 22% for IFN monotherapy, 43% for IFN and ribavirin, and 57% for pegylated IFN and ribavirin, respectively. Re-treatment with IFN and ribavirin of those who failed to respond to previous IFN monotherapy was successful in 33%. In HCV/HIV-coinfected patients, response to IFN monotherapy was 8% and to IFN combined with ribavirin 39%. Responses to IFN-based therapy in patients with haemophilia have been improved over time and are nowadays approximately 50,60%. However, data on haemophilic HCV/HIV-coinfected patients and in patients who failed to respond to previous therapy are limited and future studies in these specific patient population are necessary. [source] Evaluation of Side Effects and Patients' Perceptions during Tooth BleachingJOURNAL OF ESTHETIC AND RESTORATIVE DENTISTRY, Issue 6 2007RALPH H. LEONARD JR. DDS ABSTRACT Objective:, The objective of this nightguard vital bleaching (NGVB) study was to compare tooth sensitivity (TS), gingival irritation (GIr), and other side effects, as well as patients' perceptions during tooth bleaching, from treatment with experimental 5 and 7% hydrogen peroxide (HP) bleaching solutions with those of a commercially available 10% carbamide peroxide (CP) product. Materials and Methods:, Sixty-one participants completed the study wearing a scalloped maxillary treatment tray without reservoirs with the different concentrations of bleaching gels for 30 minutes twice a day for 7 days. Parameters evaluated were changes in gingival index (GI), nonmarginal gingival index, nongingival oral mucosal index, and tooth vitality. Participants were seen pretreatment, after 7 treatment days, and 1 week post-treatment. A daily log form to record TS and GIr was completed by each participant as well as a sensitivity questionnaire at each appointment. Additionally, at 10 months post-treatment, a questionnaire was sent to the participants concerning TS and GIr relative to the treatment process. Results:, Data from end-of-treatment questionnaires, daily log forms, and clinical examination revealed a statistical difference (p, 0.05) in the patients' ranking of and days of TS and GIr between group S (7% HP) and group T (10% CP, control group) at the end of active treatment. There also existed a statistical clinical change in the GI levels for groups R and S compared with the control group T. There was no statistical difference (p > 0.05) in any of the parameters evaluated among the three products at 7 days or 10 months post-treatment. Conclusions:, Participants in group S reported significantly more TS, GIr, and days of each compared with the control. There also existed a significant clinical change in the GI levels for groups R and S compared with the control group T. There was no significant difference among the three products at 7 days post-treatment. After ending treatment, TS/GIr was resolved in 2 to 3 days and did not recur during the 10 months post-treatment. CLINICAL SIGNIFICANCE The experimental HP bleaching solutions, as described in this study, can be used in NGVB with no long-term side effects as evaluated in this study for up to 10 months post-treatment. (J Esthet Restor Dent 19:355,366, 2007) [source] Evaluation of a treatment programme for alcohol-related aggressionCRIMINAL BEHAVIOUR AND MENTAL HEALTH, Issue 4 2008Anna McCulloch Background,The development of effective treatments for alcohol-related aggression and violence is important in binge drinking cultures, as in parts of the UK. Aim,The aim was to evaluate the progress and experience of 10 participants in Control of Violence for Angry Impulsive Drinkers (COVAID) using a single case methodology. Method,Participants completed 10 individual weekly sessions with trained facilitators following the COVAID manual. Change scores on psychometric questionnaires were examined by calculating clinical significance and reliability of change. Self-reports of alcohol consumption and aggression were examined. Follow-up data on convictions were collected. Participants were asked their opinions about COVAID. Results,Scores on the Alcohol-Related Aggression Questionnaire (ARAQ) improved for nine participants; change was both clinically significant and reliable in five cases. Nine participants improved on the Controlled Drinking Self-Efficacy Scale (CDSES), with seven showing clinically significant improvement. Six participants reported a reduction in alcohol consumption from the first to the second half of the programme. At a mean of 29 weeks post-treatment, none of the participants had been reconvicted for a violent offence. Participants reported finding COVAID useful and interesting. Conclusion,Overall, our findings support the possibility that COVAID may assist in reducing alcohol-related violence and violent offending. Copyright © 2008 John Wiley & Sons, Ltd. [source] A cost-effectiveness analysis of modafinil therapy for psychostimulant dependenceDRUG AND ALCOHOL REVIEW, Issue 3 2010JAMES SHEARER Abstract Introduction and Aims. To examine the cost-effectiveness of modafinil (200 mg daily) plus counselling compared with placebo for the treatment of psychostimulant dependence. Design and Methods. Cost and outcome data were collected alongside two randomised controlled trials of modafinil 200 mg daily over 10 weeks for methamphetamine (n = 74) and cocaine dependence (n = 8), respectively. Incremental cost-effectiveness ratios representing the additional costs to achieve a given outcome were calculated for both the change in the number of stimulant-free days and quality-adjusted life years 12 weeks post-treatment. Results. The incremental cost-effectiveness ratio indicated that it would cost an additional $AUD79 to achieve an extra stimulant-free day with modafinil compared with placebo. This result was not statistically significant, but appeared to be a robust estimate after sensitivity analysis. Counselling, whether received within program or from other services, improved the cost-effectiveness of modafinil relative to placebo. Discussion and Conclusions. Strategies to improve the uptake of counselling are recommended as cost-effective.[Shearer J, Shanahan M, Darke S, Rodgers C, van Beek I, McKetin R, Mattick RP. A cost-effectiveness analysis of modafinil therapy for psychostimulant dependence. Drug Alcohol Rev 2010] [source] Effect of triflumuron on brood development and colony survival of free-flying honeybee, Apis mellifera L.JOURNAL OF APPLIED ENTOMOLOGY, Issue 4 2004O. G. Amir Abstract:, The effect of the insect growth regulator (IGR) triflumuron (Alsystin® 25 WP) on honeybee, Apis mellifera L. (Hym., Apidae), was studied in a semi-field test. Free-living colonies were fed one litre per hive of sucrose syrup containing 0, 0.025, 0.25 or 2.5 g of triflumuron. A significant reduction in flight activity was noted 6,10 weeks post-treatment at the two higher doses. These colonies reared less brood than before treatment. While the comb area occupied by uncapped brood was as high as [0.025 and 0.25 g active ingredient (a.i.)] or higher (2.5 g a.i.) than before treatment, there was a significant decline in capped brood at the two higher doses, indicating enhanced larval mortality. No capped brood was reared in the hive treated at the highest dose from 3,9 weeks post-treatment. Yet there was a significant accumulation of pollen and honey in the brood compartment at all doses. All colonies except the one treated at the highest dose survived the following winter. However, at 43 weeks post-treatment, hives treated at intermediate and low doses showed a significant increase in uncapped brood and a significant decrease in capped brood. This study revealed a strong residual toxicity of triflumuron to brood and substantiated its classification as hazardous to honeybee. [source] Macrophage contribution to the response of the rat organ of Corti to amikacinJOURNAL OF NEUROSCIENCE RESEARCH, Issue 9 2007Sabine Ladrech Abstract Transdifferentiation of nonsensory supporting cells into sensory hair cells occurs naturally in the damaged avian inner ear. Such transdifferentiation was achieved experimentally in the cochlea of deaf guinea pigs through Atoh 1 gene transfection. Supporting cells may therefore serve as targets for transdifferentiation therapy. Supporting cells rapidly degenerate after hair cell disappearance, however, limiting the therapeutic window for gene transfer. We studied the time course of ultrastructural and phenotypical changes occurring in Deiters cells (hair cell supporting cells) after ototoxic treatment in the rat. The presence of macrophages in the cochlea was also investigated, to study any deleterious effects they may have on pathologic tissues. One week after treatment most hair cells had disappeared. Deiters cells no longer expressed the glial marker vimentin but instead displayed typical hair cell markers, the calcium binding proteins calbindin and parvalbumin. This suggests that a process of transdifferentiation of Deiters cells into hair cells was activated. By 3 weeks post-treatment, however, the Deiters cells began to degenerate and by 10 weeks post-treatment the organ of Corti was degraded fully. Interestingly, a marked increase in macrophage density was seen after the end of amikacin treatment to 10 weeks post-treatment. This suggests chronic inflammation is involved in epithelium degeneration. Consequently, early treatments with anti-inflammatory factors might promote supporting cell survival, thus improving the efficacy of more specific strategies aimed to regenerate hair cells from nonsensory cells. © 2007 Wiley-Liss, Inc. [source] Clinical trial: the safety and short-term efficacy of recombinant cholera toxin B subunit in the treatment of active Crohn's diseaseALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 3 2010P. STÅL Aliment Pharmacol Ther,31, 387,395 Summary Background, The cholera toxin B subunit ameliorates experimentally induced colitis in mice. In humans, cholera toxin B subunit has never been tested in the treatment of Crohn's disease (CD). Aim, To evaluate the safety and efficacy of treatment with recombinant cholera toxin B subunit of patients with CD. Methods, An open-label, multicentre, nonrandomized trial including 15 patients with mild/moderate CD. Patients received an oral solution of 5 mg recombinant cholera toxin B subunit three times weekly for 2 weeks. Reduction in CD Activity Index (CDAI) with >100 between baseline and days 15, 29, 42 and 70 defined clinical response. Patients with CDAI score ,150 were defined as being in remission. Results, A significant decrease in CDAI score was observed. Response rates were 40% in the full analysis set and 42% in the per protocol analysis. Two patients receiving adjuvant treatment after day 29 were excluded, after which 40% were in remission at 4 weeks and 30% at 8 weeks post-treatment. Mild side effects (arthralgia, headache and pruritus) were seen in 33% of patients. Conclusions, Treatment with recombinant cholera toxin B subunit was safe. Approximately 40% of patients with active CD responded to treatment. Randomized studies are needed to establish the clinical efficacy of recombinant cholera toxin B subunit. [source] Interferon and ribavirin therapy does not select for resistance mutations in hepatitis C virus polymeraseJOURNAL OF VIRAL HEPATITIS, Issue 8 2008C. L. Ward Summary., Ribavirin has a minor and transient effect on hepatitis C virus (HCV) replication and has been suggested to select a novel mutation, F415Y, in the RNA-dependent RNA polymerase of subtype 1a viruses. Twenty-nine patients with chronic hepatitis C (subtyped by INNO LiPA as 1a, 17; 1b, 11; 1a/1b, 1) who were nonresponders to interferon-based therapies were identified retrospectively and screened at Baseline, week 24 of treatment, and 24 weeks post-treatment. Selection of resistance mutations, including at amino acid position 415 of the polymerase, was investigated. Using clonal sequencing and pyrosequencing of the NS5B gene, we screened for the F415Y resistance mutation among patients who received combination therapy with ribavirin and interferon ,. Of the 15 subtype 1a patients treated with interferon plus ribavirin, only one had the F415Y change at week 24, and an F/Y mixture was still present 24 weeks after therapy. Four additional patients in this group had the F415Y change 24 weeks post-therapy. The NS5B genes were sequenced in order to identify amino acid changes associated with ribavirin therapy, but no evidence was found that ribavirin selects for particular amino acids in the RNA-dependent RNA polymerase. Ribavirin, a weak inhibitor of HCV replication, does not select for resistance mutations in the sequence of the HCV RNA polymerase. [source] Non-invasive cryolipolysisÔ for subcutaneous fat reduction does not affect serum lipid levels or liver function tests,LASERS IN SURGERY AND MEDICINE, Issue 10 2009Kenneth B. Klein MD Abstract Background and Objective Cryolipolysis provides a method of non-invasive fat reduction that significantly reduces subcutaneous fat without injury to adjacent tissues. Preliminary animal and human data have suggested that cryolipolysis has no effect on serum lipid profiles or liver tests. This study was intended to more fully document any effect of this procedure on lipid and liver-related blood tests. Study Design/Materials and Methods Forty subjects with fat bulges on their flanks ("love handles") were treated bilaterally with a non-invasive device (Zeltiq Aesthetics, Pleasanton, CA) that precisely cools tissue to achieve a reduction in the fat layer. Serum lipid levels and liver tests were measured prior to treatment, and at 1 day and 1, 4, 8, and 12 weeks post-treatment. Results No meaningful changes in mean values were observed for any blood lipid level or liver test at any point over the 12-week follow-up period. Conclusion Cryolipolysis, when used for reduction of subcutaneous flank fat, is not associated with changes in serum lipids or liver test results. Lasers Surg. Med. 41:785,790, 2009. © 2009 Wiley-Liss, Inc. [source] Usefulness and pharmacokinetic study of oral terbinafine for hyperkeratotic type tinea pedisMYCOSES, Issue 1 2008Izumi Kikuchi Summary To study and establish an optimal administration method of oral antifungal, terbinafine (TBF), for hyperkeratotic type tinea pedis, from the pharmacokinetic point of view, 20 patients with hyperkeratotic type tinea pedis were given TBF 125 mg once daily for 4 weeks and observed over time for improvement in dermatological symptoms and mycological efficacy. Targeting five of the patients, TBF concentration in the stratum corneum was measured using the liquid chromatography/tandem mass spectrometry (LC-MS/MS) method. TBF was detected in the stratum corneum of the sole 1 week after beginning the treatment in some cases and reached its peak 1 week after the completion of the treatment with a concentration of 247.8 ng g,1, which was approximately more than 50 times higher than its minimal inhibitory concentration against dermatophytes. TBF was not detected at 8 weeks post-treatment, although its concentration was 50.73 ng g,1 at 6 weeks post-treatment. Its effectiveness rate (effective + markedly effective) was 95% (19/20) with no adverse reactions, including abnormal changes in the laboratory test values, in any patient. These results suggest that TBF is a useful drug to treat hyperkeratotic tinea pedis from the pharmacokinetic point of view. [source] Response of vulval lichen sclerosus and squamous hyperplasia to photodynamic treatment using sustained topical delivery of aminolevulinic acid from a novel bioadhesive patch systemPHOTODERMATOLOGY, PHOTOIMMUNOLOGY & PHOTOMEDICINE, Issue 2 2009Agnieszka A. Zawislak This study evaluated the clinical and histopathological responses of vulval lichen sclerosus (LS) and squamous hyperplasia (SH) to photodynamic therapy (PDT). A novel bioadhesive patch containing aminolevulinic acid (ALA) at a dose of (38 mg/cm2) was used to treat 10 patients before irradiation with light of 630 nm. Clinical, histopathological and pathological responses to treatment were assessed at 6 weeks post-treatment. After 17 cycles of PDT, six patients reported significant symptomatic relief and no cutaneous photosensitivity. Histopathological differences were not demonstrated, but statistically significant induction of apoptosis was seen. It can be concluded that ALA-PDT patch-based formulation is pragmatic and primarily offers symptomatic management of vulval LS and SH. [source] Restricted transgene persistence after lentiviral vector-mediated fetal gene transfer in the pregnant rabbit modelTHE JOURNAL OF GENE MEDICINE, Issue 9 2008Rafael Moreno Abstract Background Prenatal gene transfer may enable early causal intervention for the treatment or prevention of many devastating diseases. Nevertheless, permanent correction of most inherited disorders requires a sustained level of expression from the therapeutic transgene, which could theoretically be achieved with integrating vectors. Methods Rabbit fetuses received 8.5 × 106 HIV-based recombinant lentivirus particles containing the enhanced green fluorescent protein (EGFP) transgene by intrahepatic, intra-amniotic or intraperitoneal injection at 22 days of gestation. Provirus presence and transgene expression in rabbit tissues were evaluated at both 1.5 and 16 weeks post- in utero intervention by polymerase chain reaction (PCR) and reverse transcriptase-PCR, respectively. Moreover, we assessed persistence of EGFP by immunohistochemistry. Enzyme-linked immunosorbent assays confirmed the development of antibodies specific against both the viral vector and the reporter protein. Results Regardless of the route of administration employed, lentiviral vector-based in utero gene transfer was safe and reached 85% of the intervened fetuses at birth. However, the integrated provirus frequency was significantly reduced to 50% of that in young rabbits at 16 weeks post-treatment. In these animals, EGFP expression was evident in many tissues, including cytokeratin 5-rich basal cells from stratified and pseudostratified epithelia, suggesting that the lentiviral vector might have reached progenitor cells. Conversely, we identified the presence of immune-inflammatory infiltrates in several EGFP-expressing tissues. Moreover, almost 70% of the lentiviral vector-treated rabbits elicited a humoral immune response against the viral envelope and/or the EGFP. Conclusions At two-thirds gestational age, the adaptive immune system of the rabbit appears a relevant factor limiting transgene persistence and expression following lentiviral vector-mediated in utero gene transfer. Copyright © 2008 John Wiley & Sons, Ltd. [source] Effect of dosing frequency on the safety and efficacy of imiquimod 5% cream for treatment of actinic keratosis on the forearms and hands: a phase II, randomized placebo-controlled trialBRITISH JOURNAL OF DERMATOLOGY, Issue 4 2009K. Gebauer Summary Background, Clinical studies in cutaneous conditions other than actinic keratosis (AK) have revealed that the safety and efficacy profile of imiquimod is influenced by dosing frequency. Objectives, To evaluate dosing frequency response of imiquimod 5% for treatment of AK. Methods, This was a phase II, multicentre, randomized, double-blind, placebo-controlled study. Adults with , 10 but , 50 clinical AKs, one of which was histologically confirmed, were randomized (4 : 1) to 2,6 packets of imiquimod or placebo cream applied to the dorsum of the forearms and hands once daily 2, 3, 5 or 7 times per week for 8 weeks. The primary endpoint was complete clearance of AKs in the treatment area at 8 weeks post-treatment. Results, One hundred and forty-nine (94 men and 54 women) white subjects, with a mean ± SD age of 71 ± 10·2 years, were enrolled. Twenty-eight subjects (18·8%) discontinued from study: 0%, 3·1%, 6·9%, 30·0% and 33·3% withdrew for local skin reactions or adverse events in the combined placebo, and in the imiquimod 2, 3, 5 or 7 times per week groups, respectively. Seven serious adverse events occurred; none was related to the study drug. Median baseline lesions ranged from 38 to 40 for the treatment groups. Complete clearance was achieved in 0%, 3·2%, 6·9%, 3·3% and 6·7% of subjects, and partial clearance (, 75% lesion reduction) in 0%, 22·6%, 24·1%, 20·0% and 36·7% of subjects for the placebo and imiquimod 2, 3, 5 or 7 times per week regimens, respectively. Conclusions, Imiquimod 5% applied more frequently than 3 times per week to AKs was not well tolerated. Complete clearance rates were low; however, partial clearance rates increased with increased dosing frequency (P = 0·002). [source] Glucocorticoids increase CD4+CD25high cell percentage and Foxp3 expression in patients with multiple sclerosisACTA NEUROLOGICA SCANDINAVICA, Issue 4 2009M. Braitch Objectives,,, To determine whether percentages of CD4+CD25high T cells (a group of regulatory T cells, Treg) differ in patients with multiple sclerosis (MS) in relapse vs remission after glucocorticoid treatment and whether treatment for relapses changes Treg population and the expression of Foxp3, a key Treg-associated molecule. Materials and methods,,, Peripheral blood mononuclear cells (PBMC) were obtained from 20 patients with MS during relapse, just before and 2 days after starting steroid treatment (i.v. methylprednisolone 1 g/day for 3 days) and then 6 weeks after treatment. CD4+CD25hi cells were analysed by using flow cytometry. Cytokines were measured by using an ELISA and Foxp3, CD3 and CD25 expression by using quantitative real-time PCR. Results,,, The percentage of CD4+CD25hi cells, plasma IL-10 and Foxp3/CD3 ratio increased 48 h after methylprednisolone initiation and returned to baseline values by 6 weeks post-treatment. Conclusions,,, Results suggest that glucocorticoids increase Treg cell functional molecules and percentages. This may be a mechanism whereby steroids expedite recovery from MS relapses. [source] Use of A-type CpG oligodeoxynucleotides as an adjuvant in allergen-specific immunotherapy in humans: a phase I/IIa clinical trialCLINICAL & EXPERIMENTAL ALLERGY, Issue 4 2009G. Senti Summary Background B-type CpG oligodeoxynucleotides (ODN) is currently used in clinical trials because of its prolonged half,life, which is due to its phosphorothioate backbone. A-type CpG ODN is a stronger inducer of IFN but has an unstable phosphodiester backbone that has so far prohibited its clinical use. However, upon association with virus-like particles (VLP) consisting of the bacteriophage Q, coat protein, A-type CpG ODN can be stabilized and can become an efficient adjuvant in mice. Therefore, the phase I/IIa study presented represents the first test of A-type CpGs in humans. Objective To test the safety, tolerability and clinical efficacy of QbG10 as an adjuvant for subcutaneous immunotherapy with a house dust mite (HDM) allergen extract in allergic patients. Methods A single centre, open-label phase I/IIa study evaluated the safety, tolerability and clinical efficacy of QbG10 as an adjuvant to immunotherapy with a subcutaneous HMD allergen extract in 20 patients suffering from HDM allergy. Twenty-one patients were enrolled between March and July 2005. Individual immunotherapy lasted 10 weeks. Clinical end-points included questionnaires, conjunctival provocation, skin prick tests and the measurement of allergen-specific IgG and IgE. Results QbG10 was well tolerated. Almost complete tolerance to the allergen was observed in conjunctival provocation testing after treatment with QbG10, and symptoms of rhinitis and allergic asthma were significantly reduced. Within 10 weeks of therapy, patients were nearly symptom-free and this amelioration lasted for at least 38 weeks post-treatment. Following injections of QbG10 and HDM allergen extract, allergen-specific IgG increased, while there was a transient increase in allergen-specific IgE titres. Skin reactivity to HDM was reduced. Conclusion The subcutaneous application of HDM allergen, together with A-type CpG ODN packaged into VLP, was safe. All patients achieved practically complete alleviation of allergy symptoms after 10 weeks of immunotherapy. This promising clinical outcome calls for larger placebo-controlled phase II studies. [source] | ||||||||||||||||||||||||||||