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1.
Phys Med ; 64: 261-272, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31515029

RESUMO

PURPOSE: The lack of inter-method agreement can produce inconsistent results in neuroimaging studies. We evaluated the intra-method repeatability and the inter-method reproducibility of two widely-used automatic segmentation methods for brain MRI: the FreeSurfer (FS) and the Statistical Parametric Mapping (SPM) software packages. METHODS: We segmented the gray matter (GM), the white matter (WM) and subcortical structures in test-retest MRI data of healthy volunteers from Kirby-21 and OASIS datasets. We used Pearson's correlation (r), Bland-Altman plot and Dice index to study intra-method repeatability and inter-method reproducibility. In order to test whether different processing methods affect the results of a neuroimaging-based group study, we carried out a statistical comparison between male and female volume measures. RESULTS: A high correlation was found between test-retest volume measures for both SPM (r in the 0.98-0.99 range) and FS (r in the 0.95-0.99 range). A non-null bias between test-retest FS volumes was detected for GM and WM in the OASIS dataset. The inter-method reproducibility analysis measured volume correlation values in the 0.72-0.98 range and the overlap between the segmented structures assessed by the Dice index was in the 0.76-0.83 range. SPM systematically provided significantly greater GM volumes and lower WM and subcortical volumes with respect to FS. In the male vs. female brain volume comparisons, inconsistencies arose for the OASIS dataset, where the gender-related differences appear subtler with respect to the Kirby dataset. CONCLUSIONS: The inter-method reproducibility should be evaluated before interpreting the results of neuroimaging studies.


Assuntos
Encéfalo/diagnóstico por imagem , Processamento de Imagem Assistida por Computador/métodos , Imageamento por Ressonância Magnética , Software , Feminino , Humanos , Masculino
2.
Ann Oncol ; 28(8): 1836-1841, 2017 Aug 01.
Artigo em Inglês | MEDLINE | ID: mdl-28520849

RESUMO

BACKGROUND: Recent retrospective studies suggest that beta-adrenergic blocking drugs (BB) are associated with improved outcomes in patients with a range of cancers. Although limited and discordant data suggest that BB may increase overall survival (OS) in localized breast cancer (BC), there is no information on the effects of BB in women with advanced BC. PATIENTS AND METHODS: To explore the association between BB use and BC outcomes, we retrospectively reviewed ROSE/TRIO-012, a double-blinded, multinational phase III trial that randomized 1144 patients with HER2-negative advanced BC to first-line docetaxel in combination with ramucirumab or placebo. We compared progression-free survival (PFS), OS, overall response rate, and clinical benefit rate in patients who received BB to those who did not. RESULTS: 153/1144 (13%) patients received BB; 62% prior to enrolment and 38% began after enrolment. Median PFS in BB treated patients was longer than in patients who did not receive them (10.3 versus 8.3 months; HR 0.81; 95% CI 0.66-0.99; P = 0.038). Patients treated with BB only after enrolment had even higher median PFS (15.5 versus 8.3 months, P < 0.001). In the TNBC subset, median PFS was 13.0 months with BB, compared to 5.2 months without BB (HR 0.52; 95% CI 0.34-0.79; P = 0.002). The benefit of BB intake in PFS was independent of treatment-emergent hypertension (P = 0.476) but associated with treatment arm (P = 0.037). The test for interactions between BB and treatment arm was not significant (P = 0.276). No differences were seen in OS, overall response rate, or clinical benefit rate. A validation dataset analysis had consistent but less substantial improved outcomes for women with node positive operable breast cancer receiving BB in the BCIRG-005 trial. CONCLUSIONS: In this exploratory analysis, BB intake was associated with significant improvement in PFS, particularly in patients with TNBC and patients not previously exposed to BB. CLINICAL TRIAL NUMBER: NCT00703326.


Assuntos
Antagonistas Adrenérgicos beta/uso terapêutico , Anticorpos Monoclonais/uso terapêutico , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Neoplasias da Mama/tratamento farmacológico , Taxoides/administração & dosagem , Anticorpos Monoclonais Humanizados , Neoplasias da Mama/patologia , Intervalo Livre de Doença , Docetaxel , Método Duplo-Cego , Feminino , Humanos , Placebos , Receptor ErbB-2/metabolismo , Estudos Retrospectivos , Análise de Sobrevida , Taxoides/uso terapêutico , Ramucirumab
3.
Int J Impot Res ; 23(1): 17-23, 2011.
Artigo em Inglês | MEDLINE | ID: mdl-21270821

RESUMO

Premature ejaculation (PE) is considered to be the most common male sexual dysfunction. The realization that PE may co-exist with ED prompted the use of PDE5-i's alone or in combination with selective serotonin reuptake inhibitors (SSRIs) for treating ejaculatory disorders. Until recently, there was little evidence that PDE5-i's alone may have a role in the treatment of PE in the absence of ED, and current available treatments include only on-demand dapoxetine. However, available data indicate that there is clinical, anatomical, physiological, pharmacological and genetic evidence to explain the efficacy of PDE5-i's. Nine manuscripts that examined the efficacy of PDE5-i's in the treatment of PE, alone or in combination with SSRIs, were retrieved. All studies reported some significant changes in the intravaginal ejaculatory latency time and sexual satisfaction scores, although not all were clinically meaningful. Well-designed multicenter studies are urgently required to further elucidate the efficacy and safety, as well as the mechanisms of action of PDE5-i's in the treatment of PE. The aim of this review is to discuss basic rationale and to show clinical evidence sustaining the possibility to use off-label PDE5-i's to treat PE.


Assuntos
Ejaculação/efeitos dos fármacos , Inibidores de Fosfodiesterase/uso terapêutico , Disfunções Sexuais Fisiológicas/tratamento farmacológico , Disfunções Sexuais Psicogênicas/tratamento farmacológico , Ensaios Clínicos como Assunto , Ejaculação/fisiologia , Humanos , Masculino , Disfunções Sexuais Fisiológicas/fisiopatologia , Disfunções Sexuais Psicogênicas/fisiopatologia
4.
Andrologia ; 43(1): 9-15, 2011 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-21219376

RESUMO

The application of digital pulse amplitude by fingertip peripheral arterial tonometry (PAT) device in patients with erectile dysfunction (ED) has never been performed. We investigated the diagnostic value of reactive hyperaemia (RH) and augmentation index (AI) as evaluated using PAT in men with ED of any origin. A total of 40 patients underwent diagnostic investigation for ED, including dynamic penile duplex ultrasound (PDU) and PAT device. Moreover, 30 patients without ED served as controls. According to PDU cutoff at 35 cm/sec, patients were divided into vascular (n = 30) and nonvascular (n = 10) ED aetiology. Moreover, controls with (n = 10) or without (n = 20) vascular risk factors (VRFs) were studied in a separate analysis. Average RH-PAT was not different in men with or without ED (P = 0.56) independently of VRFs. The AI was higher in men with ED compared with the controls (P < 0.0001) as well as when controlled for the presence or absence of VRFs (P < 0.0001). An inverse relationship between AI and PSV was also found (r² = -0.72, P < 0.0001). In conclusion, an increased AI but not an impaired RH-PAT is present in men with vascular ED independently of VRFs and may represent an early detection of vascular impairment that may precede endothelial dysfunction in populations at low risk for developing vascular ED.


Assuntos
Endotélio Vascular/fisiopatologia , Disfunção Erétil/fisiopatologia , Manometria/métodos , Pênis/irrigação sanguínea , Doenças Vasculares/diagnóstico , Adulto , Idoso , Artérias/fisiopatologia , Pressão Sanguínea/fisiologia , Estudos de Casos e Controles , Elasticidade/fisiologia , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Fatores de Risco , Sensibilidade e Especificidade , Doenças Vasculares/epidemiologia , Doenças Vasculares/fisiopatologia
5.
Eat Weight Disord ; 15(1-2 Suppl): 1-31, 2010.
Artigo em Italiano | MEDLINE | ID: mdl-20975326

RESUMO

This paper is an Italian Expert Consensus Document on multidimensional treatment of obesity and eating disorders. The Document is based on a wide survey of expert opinion. It presents, in particular, considerations regarding how clinicians go about choosing the most appropriate site of treatment for a given patient suffering from obesity and/or eating disorders: outpatient, partial hospitalization, residential rehabilitation centre, inpatient hospitalization. In a majority of instances obesity and eating disorders are long-term diseases and require a multiprofessional team-approach. In determining an initial level of care or a change to a different level of care, it is essential to consider together the overall physical condition, medical complications, disabilities, psychiatric comorbidity, psychology, behaviour, family, social resources, environment, and available services. We first created a review manuscript, a skeleton algorithm and two rating scales, based on the published guidelines and the existing research literature. As the second point we highlighted a number of clinical questions that had to be addressed in the specific context of our National Health Service and available specialized care units. Then we submitted eleven progressive revisions of the Document to the experts up to the final synthesis that was approved by the group. Of course, from point to point, some of the individual experts would differ with the consensus view. The document can be viewed as an expert consultation and the clinical judgement must always be tailored to the particular needs of each clinical situation. We will continue to revise the Document periodically based on new research information and on reassessment of expert opinion to keep it up-to-date. The Document was not financially sponsored.


Assuntos
Assistência Ambulatorial , Prova Pericial , Transtornos da Alimentação e da Ingestão de Alimentos/diagnóstico , Transtornos da Alimentação e da Ingestão de Alimentos/terapia , Hospitalização , Obesidade/diagnóstico , Obesidade/terapia , Equipe de Assistência ao Paciente , Tratamento Domiciliar , Algoritmos , Assistência Ambulatorial/normas , Anorexia Nervosa/diagnóstico , Anorexia Nervosa/terapia , Transtorno da Compulsão Alimentar/diagnóstico , Transtorno da Compulsão Alimentar/terapia , Bulimia Nervosa/diagnóstico , Bulimia Nervosa/terapia , Comorbidade , Consenso , Hospital Dia , Avaliação da Deficiência , Transtornos da Alimentação e da Ingestão de Alimentos/fisiopatologia , Transtornos da Alimentação e da Ingestão de Alimentos/psicologia , Transtornos da Alimentação e da Ingestão de Alimentos/reabilitação , Fidelidade a Diretrizes , Humanos , Itália , Atividade Motora , Programas Nacionais de Saúde , Estado Nutricional , Obesidade/fisiopatologia , Obesidade/psicologia , Obesidade/reabilitação , Guias de Prática Clínica como Assunto , Tratamento Domiciliar/normas , Fatores de Risco , Meio Social , Caminhada
6.
Int J Clin Pract ; 64(6): 817-20, 2010 May.
Artigo em Inglês | MEDLINE | ID: mdl-20518955

RESUMO

BACKGROUND: Obese individuals often present comorbidities while they appear protected against the development of osteoporosis. However, few and contradictory data are now available on skeletal modifications in obese patients. The aim of this study was to characterise bone mineral density (BMD) in overweight (BMI > 25 < 29.9) and obese (BMI > 30) patients. METHODS: We selected 398 patients (291 women, 107 men, age 44.1 + 14.2 years, BMI 35.8 + 5.9 kg/m(2)) who underwent clinical examination, blood tests and examination of body composition. Subjects with chronic conditions or taking medications interfering with bone metabolism, hormonal and nutritional status and recent weight loss were excluded. RESULTS: Interestingly, 37% (n = 146) of this population showed a significantly lower than expected lumbar BMD: 33% (n = 98) of women showed a T-score -1.84 +/- 0.71, and 45% (n = 48) of men showed a T-score -1.88 +/- 0.64. When the population was divided into subgroups based on different BMI, it was noted that overweight (BMI > 25 < 29.9) was neutral or protective for BMD, whereas obesity (BMI > 30) was associated with a low bone mass, compatible with a diagnosis of osteoporosis. No differences were observed in hormones and lipid profiles among subgroups. CONCLUSIONS: Our results indicate that a subpopulation of obese patients has a significant low lumbar BMD than expected for age. Thus, a careful characterisation of skeletal metabolism might be useful in all obese individuals to avoid fragility fractures later in life.


Assuntos
Índice de Massa Corporal , Densidade Óssea/fisiologia , Obesidade/fisiopatologia , Osteoporose/fisiopatologia , Adulto , Estudos de Coortes , Feminino , Humanos , Vértebras Lombares/fisiologia , Masculino , Pessoa de Meia-Idade , Obesidade/complicações , Osteoporose/complicações
7.
Int J Obes (Lond) ; 34(9): 1404-14, 2010 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-20404828

RESUMO

BACKGROUND: Obesity is an increasing health problem and surgery seems to be the only treatment effective in achieving weight loss without relapse. Among bariatric techniques, many differences exist in terms of weight loss and resolution of comorbidities. Up to now, there are no prospective studies comparing long-term effects of malabsorptive vs restrictive techniques. OBJECTIVE: In this study, cardiometabolic risk factors and body composition changes after malabsorptive biliointestinal bypass (BIBP) and restrictive laparoscopic adjustable gastric banding (LAGB) were compared during a 4-year follow-up. DESIGN: Prospective, case-control and cohort study. PATIENTS: In all, 80 obese subjects, matched for weight and age. Altogether, 40 patients underwent BIBP and 40 underwent LAGB. MEASUREMENTS: Weight, body composition, fasting and post-loading plasma glucose and insulin, homeostatic model assessment index (HOMA-I), lipid profile, blood pressure (BP), erythrocyte sedimentation rate and fibrinogen were monitored at baseline, 12 and 48 months. RESULTS: At 12 months after surgery, a significant reduction in body mass index, total fat mass (FM), trunk FM (trFM), trFM/legs FM (lFM) ratio (trFM/lFM), triglycerides, BP and inflammation markers was observed in both groups. BIBP patients showed a significant reduction in total cholesterol (Tot-C), low-density lipoprotein cholesterol (LDL-C) and high-density lipoprotein cholesterol (HDL-C), whereas the LAGB group showed a significant increase of HDL-C. A further improvement of all the parameters evaluated was seen in the BIBP group at 48 months after surgery. CONCLUSIONS: Both bariatric procedures exerted positive effects on cardiometabolic risk factors and on weight loss in the population studied, but on the long-term period, HOMA-I, Tot-C/HDL-C ratio and body composition improvements were more evident after BIBP. We conclude that malabsorptive BIBP seems to be more effective than LAGB in treating visceral obesity and its metabolic complications.


Assuntos
Cirurgia Bariátrica/métodos , Composição Corporal/fisiologia , Obesidade/cirurgia , Redução de Peso/fisiologia , Adulto , Cirurgia Bariátrica/efeitos adversos , Índice de Massa Corporal , Estudos de Casos e Controles , Feminino , Gastroplastia/efeitos adversos , Gastroplastia/métodos , Humanos , Masculino , Obesidade/sangue , Obesidade/complicações , Estudos Prospectivos , Tempo
8.
J Endocrinol Invest ; 33(11): 776-83, 2010 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-20220293

RESUMO

AIM: To investigate efficacy and safety of two different preparations of testosterone undecanoate (TU) in 52 hypogonadal men [mean age 57 yr and mean testosterone (T) < 320 ng/dl] with metabolic syndrome (MS). SUBJECTS AND METHODS: Randomized, double-blind, double-dummy study with three parallel treatment arms [oral TU; transdermal placebo gel (P); im TU] administration for 12 months (mo). Each subject was randomized (1:1:3) to receive either oral TU (2 capsules of 40 mg/twice per day at breakfast and dinner, equalling a total dose of 160 mg/day; no.=10) for 6 mo and continued with im TU for further 6 mo, or P (3-4 g/day; no.=10) and im TU (1000 mg/12 weeks from week 6; no.=32) for 12 mo. RESULTS: After 6 mo, im TU increased T and free- T levels (p<0.0001), and improved metabolic parameters [reduction in Homeostasis Model Assessment (HOMA) index, p<0.0001; waist circumference and fat mass, p<0.001, respectively], in International Index of Erectile Function-5 and Aging Males' Symptoms scores (p<0.01, respectively). After 12 months, im TU produced further increases in T and free- T levels (p<0.0001) and metabolic parameters (reduction in HOMA-index, p<0.0001; waist circumference p<0.0001; fat mass, p<0.001). No major adverse event due to T treatment occurred. CONCLUSIONS: Clinical efficacy of T replacement therapy in hypogonadal men with MS is reached when its plasmatic levels approach into the medium-high range of normality (>5 ng/ml), although subjective threshold values may be different. Administration of im TU was more effective than oral TU to reach the target for T levels and to improve MS parameters. TU was safe over 12 months and discontinuation rates were similar to placebo.


Assuntos
Hipogonadismo/tratamento farmacológico , Testosterona/análogos & derivados , Administração Oral , Composição Corporal/efeitos dos fármacos , Humanos , Hipogonadismo/sangue , Injeções Intramusculares/economia , Seguro de Serviços Farmacêuticos , Itália , Masculino , Síndrome Metabólica/tratamento farmacológico , Síndrome Metabólica/fisiopatologia , Pessoa de Meia-Idade , Ereção Peniana/efeitos dos fármacos , Testosterona/administração & dosagem , Testosterona/sangue , Testosterona/economia
9.
Int J Impot Res ; 21(4): 221-7, 2009.
Artigo em Inglês | MEDLINE | ID: mdl-19474796

RESUMO

Premature ejaculation (PE) is thought to be the most common male sexual dysfunction; however, the prevalence of lifelong (LL)-PE is relatively low. The aim of this study was to investigate the effects of on-demand vardenafil (10 mg) to modify the intravaginal ejaculatory latency time (IELT) in men with LL-PE without erectile dysfunction. Forty-two men (18-35 years) were enrolled in a 16-week, double-blind, placebo-controlled, cross-over study. Primary end point was the modification from baseline of IELT assessed by stopwatch technique; secondary end points were post-ejaculatory refractory time (PERT) and variations of scores at the Index of Premature Ejaculation questionnaire. The changes in geometric mean IELT were superior after taking vardenafil (0.6+/-0.3 vs 4.5+/-1.1 min, P<0.01), compared with placebo (0.7+/-0.3 vs 0.9+/-1.0 min, ns). PERT dropped significantly after vardenafil (16.7+/-2.0 vs 4.3+/-0.9 min, P<0.001), compared with placebo (15.3+/-2.2 vs 15.8+/-2.3 min). Patients who took vardenafil (vs placebo) reported significantly (P<0.01) increased ejaculatory control (6+/-2 vs 16+/-2), improved overall sexual satisfaction (7+/-2 vs 15+/-1) and distress (4+/-1 vs 8+/-1) scores, respectively. Multiple regression analysis (r(2)=0.86) for IELT by the number of attempts at sexual intercourse showed significant differences between the slopes of lines for placebo and vardenafil (P<0.0001). The most common adverse events for vardenafil (vs placebo) were headache (10 vs 3%), flushing (12 vs 0%) and dyspepsia (10 vs 0%), which tended to disappear over the time. In conclusion, in our study, vardenafil increased IELT and reduced PERT in men with LL-PE. Besides, improvements in confidence, perception of ejaculatory control and overall sexual satisfaction were reported.


Assuntos
Ejaculação/efeitos dos fármacos , Imidazóis/uso terapêutico , Inibidores de Fosfodiesterase/uso terapêutico , Piperazinas/uso terapêutico , Disfunções Sexuais Fisiológicas/tratamento farmacológico , Adolescente , Adulto , Coito/fisiologia , Coito/psicologia , Estudos Cross-Over , Método Duplo-Cego , Feminino , Humanos , Imidazóis/administração & dosagem , Imidazóis/efeitos adversos , Masculino , Inibidores de Fosfodiesterase/efeitos adversos , Piperazinas/administração & dosagem , Piperazinas/efeitos adversos , Estudos Prospectivos , Disfunções Sexuais Fisiológicas/psicologia , Sulfonas/administração & dosagem , Sulfonas/efeitos adversos , Sulfonas/uso terapêutico , Inquéritos e Questionários , Triazinas/administração & dosagem , Triazinas/efeitos adversos , Triazinas/uso terapêutico , Dicloridrato de Vardenafila , Adulto Jovem
10.
J Biol Regul Homeost Agents ; 23(1): 23-9, 2009.
Artigo em Inglês | MEDLINE | ID: mdl-19321043

RESUMO

The aim of our study is to evaluate in Systemic Sclerosis (SSc) male patients the tadalafil effects on Raynaud's phenomenon and on AM and ET-1 plasma levels. In an open-label study 20 consecutive male patients with SSc were enrolled and received 10 mg of tadalafil daily for 12 weeks. The primary endpoint was the subjective reduction of frequency and duration of Raynaud's attacks measured with a 10-point Raynaud's Condition Score; the secondary aim was to modify Adrenomedullin (AM) and Endothelin-1 (ET-1) plasma levels. After the treatment Raynaud's phenomenon was improved by once-daily tadalafil (decrease of mean number of Raynaud's attacks and of Raynaud's Condition Score) and plasma AM and ET-1 levels decreased. The results of our study lead us to postulate the beneficial effect of adding long term inhibition of Phosphodiesterase type 5 to Systemic Sclerosis' therapy.


Assuntos
Adrenomedulina/sangue , Carbolinas/administração & dosagem , Carbolinas/uso terapêutico , Endotelina-1/sangue , Doença de Raynaud/complicações , Doença de Raynaud/tratamento farmacológico , Escleroderma Sistêmico/complicações , Adulto , Esquema de Medicação , Feminino , Humanos , Masculino , Inibidores de Fosfodiesterase/administração & dosagem , Inibidores de Fosfodiesterase/uso terapêutico , Doença de Raynaud/sangue , Escleroderma Sistêmico/sangue , Escleroderma Sistêmico/tratamento farmacológico , Tadalafila
11.
Int J Impot Res ; 20(6): 566-73, 2008.
Artigo em Inglês | MEDLINE | ID: mdl-18997809

RESUMO

Aim of the study was to evaluate whether endothelial dysfunction is a marker of erectile dysfunction (ED) in recreational drug abuse. Sixty-four non-consecutive men complaining of ED from at least 3 months were included. All patients underwent detailed history about recreational drug abuse and were then submitted to dynamic penile duplex ultrasound (PDU). According to pharmaco-stimulated peak systolic velocity (PSV) cutoff at 35 cm s(-1), patients were divided into two groups: organic (O; n=30) and non-organic (NO; n=34) ED. All subjects and 7 healthy age-matched subjects as controls, underwent veno-occlusive plethysmography (VOP) for the evaluation of endothelium-dependent dilatation of brachial arteries. Blood pressure, total and free testosterone, prolactin, estradiol, low-density lipoprotein and high-density lipoprotein cholesterol were also evaluated; patients were classified with regard to insulin resistance through the HOMA-IR index. Cannabis smoking was more frequent in O-ED vs NO-ED (78% vs 3%, P<0.001) in the absence of any concomitant risk factor or comorbidity for ED. VOP studies revealed impaired endothelium-dependent vasodilatation in O-ED but not in NO-ED and controls (12+/-6 vs 32+/-4 and 34+/-5 ml min(-1), respectively; P=0.003). Overall patients showed a direct relationship between HOMA-IR and PSV (r(2)=0.47, P<0.0001), which was maintained in men with organic ED (r(2)=0.62, P<0.0001). In cannabis consumers, a direct relationship between HOMA-IR and VOP was also found (r(2)=0.74, P<0.0001). Receiver-operating characteristic (ROC) curve analysis revealed that VOP values below 17.22 ml min(-1) were suggestive for vasculogenic ED. We conclude that early endothelial damage may be induced by chronic cannabis use (and endocannabinoid system activation); insulin resistance may be the hallmark of early endothelial dysfunction and may concur to determine vascular ED in the absence of obesity. Further studies are warranted to establish a direct relationship between cannabis abuse, onset of insulin resistance and development of vascular ED.


Assuntos
Endotélio Vascular/fisiopatologia , Disfunção Erétil/diagnóstico , Disfunção Erétil/etiologia , Abuso de Maconha/complicações , Adulto , Disfunção Erétil/sangue , Humanos , Masculino , Fluxo Sanguíneo Regional/efeitos dos fármacos , Estudos Retrospectivos , Fatores de Tempo
12.
Diabet Med ; 25(2): 138-46, 2008 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-18290855

RESUMO

AIMS: Erectile dysfunction (ED) is a common comorbidity in men with diabetes mellitus. Tadalafil 10 or 20 mg taken on demand is efficacious and safe for men with diabetes and ED. Recently, continuous treatment with tadalafil has been proposed, addressing ED management as any other chronic condition. This study examined whether once-daily tadalafil 2.5 and 5 mg is efficacious for men with diabetes and ED. METHODS: This randomized, double-blind, placebo-controlled, multicentre, 12-week study enrolled 298 men with diabetes and ED to once-daily treatment with placebo, tadalafil 2.5 mg or tadalafil 5 mg. Primary efficacy measures were International Index of Erectile Function Erectile Function (IIEF EF) Domain score, and patient success rates for vaginal penetration and completion of intercourse. Patient satisfaction, endothelial function biomarkers, and safety were also assessed. RESULTS: Patients receiving either dose of tadalafil had clinically and statistically significant improvements in IIEF EF and statistically significant improvements in mean success rates for vaginal penetration, completion of intercourse, and overall treatment satisfaction (P < or = 0.005 tadalafil vs. placebo, all measures). Endothelial dysfunction biomarkers were unchanged. The most common adverse events were headache, back pain and dyspepsia. CONCLUSIONS: In this first study of men with diabetes and ED, once-daily tadalafil 2.5 and 5 mg was efficacious and well tolerated, suggesting this may be an alternative to on-demand treatment for some men, eliminating the need to plan sex within a limited timeframe.


Assuntos
Carbolinas/administração & dosagem , Diabetes Mellitus Tipo 1/complicações , Diabetes Mellitus Tipo 2/complicações , Disfunção Erétil/tratamento farmacológico , Inibidores de Fosfodiesterase/administração & dosagem , Adulto , Idoso , Coito/psicologia , Humanos , Masculino , Pessoa de Meia-Idade , Satisfação do Paciente , Índice de Gravidade de Doença , Tadalafila , Resultado do Tratamento
13.
Diabet Med ; 25(1): 37-44, 2008 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-18199130

RESUMO

OBJECTIVE: Diabetic patients have a reduced endothelial response to phosphodiesterase-5 inhibitors. The aim of this study was to determine the effects of chronic therapy with sildenafil on endothelial function in patients with Type 2 diabetes mellitus (DM2). METHODS: In a double-blind, placebo-controlled parallel design, 20 patients without erectile dysfunction randomly received a loading dose of sildenafil (100 mg) for 3 days, followed by either sildenafil 25 mg three times a day (t.d.s.) for 4 weeks or sildenafil 25 mg t.d.s. for 4 days followed by placebo t.d.s. for 3 weeks. RESULTS: After 1 week, flow-mediated dilatation (FMD) improved significantly (> 50% compared with baseline) in patients allocated to both sildenafil arms (62 and 64%, respectively). In patients allocated to chronic sildenafil, a progressive increase in percentage of patients with FMD improvement was noted (78, 86 and 94% at 2, 3 and 4 weeks, respectively) while a progressive decrease in the placebo group occurred (45, 18 and 6% at 2, 3 and 4 weeks, respectively). At the end of the study, a significant improvement in FMD compared with baseline was noted after chronic sildenafil (FMD from 6.8 +/- 0.5 to 12.5 +/- 0.7%, P = 0.01 vs. baseline). A decrease in endothelin-1 levels and an increase in nitrite/nitrate levels were found after chronic sildenafil; significant changes from baseline in C-reactive protein, interleukin 6, intercellular adhesion molecule and vascular adhesion molecule levels were also found. CONCLUSIONS: In DM2 patients, daily sildenafil administration improves endothelial function and reduces markers of vascular inflammation, suggesting that the diabetes-induced impairment of endothelial function may be improved by prolonged phosphodiesterase-5 inhibition.


Assuntos
Diabetes Mellitus Tipo 2/tratamento farmacológico , Angiopatias Diabéticas/tratamento farmacológico , Endotélio Vascular/efeitos dos fármacos , Inibidores de Fosfodiesterase/administração & dosagem , Piperazinas/administração & dosagem , Sulfonas/administração & dosagem , Vasodilatadores/administração & dosagem , Adulto , Idoso , Biomarcadores/metabolismo , Artéria Braquial/fisiopatologia , Proteína C-Reativa/metabolismo , Moléculas de Adesão Celular/metabolismo , Diabetes Mellitus Tipo 2/sangue , Diabetes Mellitus Tipo 2/fisiopatologia , Angiopatias Diabéticas/sangue , Angiopatias Diabéticas/fisiopatologia , Relação Dose-Resposta a Droga , Método Duplo-Cego , Humanos , Interleucina-6/metabolismo , Masculino , Pessoa de Meia-Idade , Purinas/administração & dosagem , Citrato de Sildenafila , Resultado do Tratamento , Vasodilatação/efeitos dos fármacos
14.
Commun Agric Appl Biol Sci ; 73(2): 169-78, 2008.
Artigo em Inglês | MEDLINE | ID: mdl-19226754

RESUMO

Few active substances with fungicide activity can be used in organic farming, above all copper and sulphur. The copper is the only substance that can be used against downy mildew; however, since it causes problems of environmental impact, incompatible with organic farming's objective of environmentally friendly farming, the Commission of the European Communities has fixed a ceiling on use expressed in terms of kilograms of copper per hectare per year (Regulation EC n. 473/2002). In order to identify natural products that are able to carry out an anti-downy mildew activity, and to evaluate the effectiveness of low rate copper formulations that can reduce the quantities of copper compound, four-year experimental trials were carried out in organic vineyards. The trials have been carried out according to the Guidelines EPPO/OEPP PP 1/31 (3). Among the low rate copper formulations, copper hydroxide and copper sulphate have been tested. Among the natural substances alternative to copper formulations we have tested: phytostimulant, homeopathic products, acid clay-based products (bentotamnio), resistance promoters (chitosan and lignosulfonate), plant extracts (orange extract, propolis and equisetum) and potassium bicarbonate. All natural substances, with the exception of plant extracts and potassium bicarbonate, were tested in association with low rate copper formulations. In the trials it has been possible to test the effectiveness of different formulations in condition of high, medium and low pressure of Plasmopara viticola (Berk. et Curt.) Berl. et De Toni. Both the copper compounds and the natural products were able to guarantee a satisfactory protection in condition of low and medium pressure of downy mildew. The trial carried out in 2004 was characterized by high pressure of P. viticola; under this condition only the copper formulations produced a satisfactory protection against downy mildew. However, in 2004, we tested only two products alternative to copper compounds. Further studies are needed to verify if the formulations alternative to copper, that gave good results in condition of low and medium pressure of P. viticola, are able to guarantee a satisfactory protection even in condition of high pressure of downy mildew. We would like to highlight that in the four-years of trials the copper formulations tested always guaranteed a metallic copper quantity under 6 kg/ha that is the maximum limit of use/year imposed by Regulation EC n. 473/2002.


Assuntos
Agricultura/métodos , Cobre/farmacologia , Oomicetos/efeitos dos fármacos , Controle Biológico de Vetores/métodos , Vitis/microbiologia , Cobre/efeitos adversos , Cobre/análise , Relação Dose-Resposta a Droga , Fungicidas Industriais/farmacologia , Oomicetos/crescimento & desenvolvimento , Poluentes do Solo/análise
15.
Commun Agric Appl Biol Sci ; 73(2): 159-68, 2008.
Artigo em Inglês | MEDLINE | ID: mdl-19226753

RESUMO

Plant protection in conventional farming, and even more so in organic farming, requires careful and prudent action agro-environmental monitoring and epidemic risk assessment. Often, however, the plant protection products are distributed in a non-targeted way, even when reduced incidence of pests do not require any treatment. In order to optimize the treatments against downy mildew, multi-annual field trials, both in conventional and organic vineyards, have been carried out. In all farms were considered 3 thesis: 1 untreated control thesis (Test), in order to follow the coarse of infection, 1 standard farm reference thesis (St), where the treatments were carried out according to the usual farm procedures and 1 experimental thesis (X). Guideline EPPO/OEPP PP 1/31 (3) have been carried out. We monitored different environmental parameters capable to influence Plasmopora viticola (Berk. and Curt.) Berl. and De Toni development. In fact by a network of RTUs (Remote Terminal Units) distributed all over the vineyards transmitting every 15 minutes via radio or via GPRS to a centralized Data Base 12 environmental parameters: time, data, precipitation, soil temperature, solar radiation, wind direction, wind speed, atmospheric relative humidity, atmospheric temperature, leaf wetness, soil humidity to cm 20 and soil humidity to cm 40. In different phenological growth stages we carried out careful disease assessments on leaves and bunches to evaluate the onset and development of P. viticola. We have studied the downy mildew infections through monitoring the environmental parameters, knowledge of P. viticola biological cycle, the evaluation of cultivar sensibility, the agricultural production method and the area characteristics, to try to optimize the anti- downy mildew treatments. The achieved results have underlined the possibility to obtain a satisfactory protection against P. viticola by correct placing of treatments. In experimental thesis (X) the number of treatments was generally lower than the number made on the thesis standard (ST), with efficacy comparable if not better. This result is most evident in conventional farms where surveillance is less accurate because is can also use plant protection products with a curative action. The trial showed the possibility of obtaining real cost containment management and a lower environmental impact associated with reduced fungicidal treatments.


Assuntos
Agricultura/métodos , Oomicetos/efeitos dos fármacos , Controle Biológico de Vetores/métodos , Controle de Pragas/métodos , Vitis/microbiologia , Monitoramento Ambiental/métodos , Fungicidas Industriais/farmacologia , Oomicetos/crescimento & desenvolvimento
16.
Eat Weight Disord ; 12(2): 70-82, 2007 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-17615491

RESUMO

OBJECTIVE: To investigate the psychometric properties of the Body Uneasiness Test (BUT) in a large sample of subjects with obesity seeking treatment. BUT is a 71-item self-report questionnaire in two parts: BUT-A which measures weight phobia, body image concerns, avoidance, compulsive self-monitoring, detachment and estrangement feelings towards one's own body (depersonalization); and BUT-B, which looks at specific worries about particular body parts or functions. METHODS: We recruited a clinical sample of 1,812 adult subjects (age range 18-65 years, females 1,411, males 401) with obesity (Body Mass Index, BMI > or = 30 kg/m2) and a normal weight (BMI value between 18.5 and 25 kg/m2) non-clinical sample of 457 adult subjects (females 248, males 209) with an Eating Attitudes Test-26 (EAT-26) score under the cut-off point 20 (scores > or = 20 indicate possible cases of eating disorders). RESULTS: The exploratory and confirmatory analyses confirmed a structural five-factor model for BUT-A and an eight-factor model for BUT-B. Internal consistency was satisfactory. Concurrent validity with Binge Eating Scale (BES) and Three-Factor Eating Questionnaire (TFEQ) was evaluated. The authors calculated mean values for BUT scores in adult (18-65 years) patients with obesity, and evaluated the influence of gender, age and BMI. Females obtained statistically significant higher scores than males in all age groups and in all classes of obesity; patients with obesity, compared with normal weight subjects, generally obtained statistically significant higher scores, but few differences could be attributed to the influence of BMI. CONCLUSION: The BUT can be a valuable multidimensional tool for the clinical assessment of body uneasiness in obesity; the scores of its sub-scales do not show a linear correlation with BMI values.


Assuntos
Imagem Corporal , Obesidade/psicologia , Psicometria , Inquéritos e Questionários , Adolescente , Adulto , Fatores Etários , Idoso , Índice de Massa Corporal , Estudos de Casos e Controles , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Valores de Referência , Reprodutibilidade dos Testes , Fatores Sexuais
17.
Int J Impot Res ; 19(2): 200-7, 2007.
Artigo em Inglês | MEDLINE | ID: mdl-16943794

RESUMO

Men with erectile dysfunction (ED) frequently have a disproportionate burden of comorbid vascular disorders including atherosclerotic disease. We investigated whether scheduled tadalafil is better than on-demand (OD) in improving endothelium-dependent vasodilatation of cavernous arteries in men with ED and whether this effect is also exerted on markers of endothelial function. We did an open-label, randomized, crossover study including 20 male outclinic patients aged 18 years or older (mean age 54 years) who had at least a 3-month history of ED of any severity or etiology. Tadalafil (20 mg) on alternate days (ADs) or OD was administered for 4 weeks. Primary end points were variations of basal inflow (peak systolic velocity (PSV)) and flow-mediated dilatation (FMD) of cavernous arteries compared with baseline at penile Duplex ultrasound. Secondary end points were variations of Q13-SIEDY scores regarding morning erections and of markers of endothelial function, that is, vascular cell adhesion molecule (VCAM), intercellular cell adhesion molecule, endothelin-1 (ET-1), insulin and C-reactive protein (CRP). PSVs and FMD were higher after AD treatment when compared with OD and baseline, respectively (P=0.0001), and improvements were maintained from 2 weeks after discontinuation (P<0.005). Patients receiving tadalafil AD experienced a significant improvement of morning erections as compared to AD treatment (P<0.0001); ET1, VCAM and CRP showed a robust decrease after chronic vs OD regimes (P<0.05), with concomitant increase in insulin levels (P<0.05), without any variation in blood pressure and other laboratory parameters. Chronic but not OD tadalafil improves endothelial function with sustained effects from its discontinuation. Chronic treatment also produces a dramatic increase in morning erections, which determines better oxygenation to the penis, thus providing a rationale for vascular rehabilitation.


Assuntos
Carbolinas/administração & dosagem , Endotélio Vascular/efeitos dos fármacos , Disfunção Erétil/tratamento farmacológico , Inibidores de Fosfodiesterase/administração & dosagem , Biomarcadores/metabolismo , Proteína C-Reativa/metabolismo , Carbolinas/uso terapêutico , Artérias Carótidas/anatomia & histologia , Artérias Carótidas/efeitos dos fármacos , Estudos Cross-Over , Endotelina-1/metabolismo , Endotélio Vascular/fisiologia , Humanos , Insulina/sangue , Molécula 1 de Adesão Intercelular/metabolismo , Masculino , Pessoa de Meia-Idade , Pênis/irrigação sanguínea , Pênis/efeitos dos fármacos , Inibidores de Fosfodiesterase/uso terapêutico , Projetos Piloto , Tadalafila , Resultado do Tratamento , Molécula 1 de Adesão de Célula Vascular/metabolismo , Vasodilatação
18.
Commun Agric Appl Biol Sci ; 72(2): 315-9, 2007.
Artigo em Inglês | MEDLINE | ID: mdl-18399458

RESUMO

The powdery mildew represents one of the diseases which affect the grape, it is diffused in all agricultural regions with variable intensity and epidemic course in operation of many microclimatic factors. The powdery mildew of grape is caused from Uncinala necator (Schw.) Burr. (nowadays named Erysiphe necator Schwein.); it is controlled with systemic therapy and contact chemicaL products. In some vineyards located in Latium (central Italy), different field trials have been carried out purposely to rationalize the treatments against E. necator. We have studied the powdery mildew infections through monitoring a set of environmental parameters, the evaluation of cultivar sensibility, the agricultural production method and the area characteristics. We have analysed the following environmental parameters monitoring every 15 minutes: precipitation, soil temperature, solar radiation, wind direction, wind speed, atmospheric relative humidity, atmospheric temperature, leaf wetness, soil humidity to cm 20 and soil humidity to cm 40. Besides, we have used Artificial Intelligence analysis techniques to try to forecast U. necator infections. Guideline EPPO/OEPP PP 1/4 (4) has been used. The trials were conducted in conventional and organic farms. In 2 conventional farms and in organic farm we have considered 1 untreated control thesis, in order to follow the course of infection, 1 standard farm reference thesis (standard), where the treatments were carried out according to the usual farm procedures and 1 thesis where the treatments were carried out according to examining the environmental data. In another conventional vineyard, we have considered only 1 untreated control thesis and 1 standard farm reference thesis (standard) to study disease trend. The achieved results have underlined the possibility (through the knowledge of data pedoclimatic and cultural) to position the treatments against the powdery mildew so that to reduce their number. The lower number of treatments that could follow as a result of environmental data to analyse could bring a series of evident economic and ecologic advantages for the farms.


Assuntos
Agricultura/métodos , Ascomicetos/efeitos dos fármacos , Fungicidas Industriais/farmacologia , Controle de Pragas/métodos , Vitis/microbiologia , Controle Biológico de Vetores , Vinho
19.
Commun Agric Appl Biol Sci ; 72(2): 321-5, 2007.
Artigo em Inglês | MEDLINE | ID: mdl-18399459

RESUMO

This paper describes the further results of the study that has been described in session 5 of the 58th International Symposium on Crop Protection (Ghent 2006). Since then our attention has been focused on verifying the previous communication results working on a two years basis data set belonging to a specific farm. The choice of using data from a single farm derives from the considerations that have been explained in the previous study in which it was clear that an efficient forecasting Artificial Neural Network (ANN) model can be created only in restricted (or at least comparable) pedoclimatic areas. On the basis of the matured experience, at the moment we have realized an ANN which, being trained on 2005 year data, elaborating the following year data is capable of correctly predicting the real Plasmopara viticola (Berk. et Curt.) Berl. et De Toni outbreak, never giving false negative signals (no alarm in presence of infection on the field) and, finally, giving few other alarms which are totally comparable with the ones given by the most common statistical instrument used in this field trials. We confirm the advantages of this approach in terms of: (a) Management and optimization improvement of agricultural activities. (b) Reduction of plant protection products use. (c) Quality improvement of the final product for a real lowering of plant protection products use. (d) Reduction of environmental impact. (e) A more efficient management of the climate changes.


Assuntos
Agricultura/métodos , Modelos Biológicos , Redes Neurais de Computação , Oomicetos/crescimento & desenvolvimento , Vitis/microbiologia , Clima , Previsões , Modelos Teóricos , Controle de Pragas/métodos , Fatores de Tempo
20.
G Ital Med Lav Ergon ; 29(3 Suppl): 700-1, 2007.
Artigo em Italiano | MEDLINE | ID: mdl-18409912

RESUMO

Aim of our study was to assess the stress risk at work in a group of nurses. 197 workers (nurses, auxiliary, physiotherapists, midwives and technicians of laboratory) were enrolled divided in two sets respectively of 100 people (subset A) with daily and nightly shifts and 97 (subset B) only daily workers. The mean age was 43.29 years (DS +/- 8.13) in subset A and 46.85 years (DS +/- 7.48) in subset B. For the survey S-90, a questionnaire composed by 90 items faces to frame some of the possible factors of risk has been used and the relative effects on health's state induced by the occupational stress were analyzed. The results show a possible greater risk of daily sleepiness in workers with nightly job. The majority of hypertension workers in subgroup B could depend more on the elevated mean age of this sample. Although a greater perception of the psychological load has been found, statistically meaningful association between the insurgence of gastrointestinal symptoms and shift was not showed.


Assuntos
Setor de Assistência à Saúde , Doenças Profissionais/epidemiologia , Estresse Psicológico/epidemiologia , Adulto , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Fatores de Risco
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