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BACKGROUND: Sleep is a significant dimension of daily life. However, only a few studies have examined the sleep quality of asthmatics in a real-world clinical settings. OBJECTIVE: This study is aimed to estimate the prevalence of sleep impairments among asthmatic patients and examine the relationship between sleep quality, asthma control, rhinitis symptoms, and sociodemographic characteristics. METHODS: The present study adopted the observational cross-sectional research design that has been designed by the Italian Respiratory Society and used valid assessments to measure the study variables. RESULTS: Data from 1150 asthmatic patients (mean age 51.01 years ± 16.03) were subjected to analysis. 58.3% of the patients had impaired sleep quality (Pittsburgh Sleep Quality Index [PSQI] total scores > 5), and their mean PSQI score was 5.68 (SD = 3.4). A significant correlation emerged between sleep quality and asthma control (p = 0.0001) and a significant albeit weak correlation emerged between PSQI total scores and Total 5 Symptoms Score (r = 0.24, p = 0.0001). Sleep quality was significantly associated health-related quality of life [HRQoL]. (r = 0.50, p < 0.001). After exclusion of patients at risk for Obstructive Sleep Apnea Syndrome (OSAS) and Gastro Esophageal Reflux Disease (GERD), the most important determinants of PSQI score were HRQoL, In the entire sample asthma control is the strongest predictor of both sleep quality and HRQoL. CONCLUSIONS: The results of this real-world study highlight the prevalence, impact and predictors of sleep disturbances in asthmatic patients and suggest the need for physicians to detect poor sleep quality.
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Asma/epidemiologia , Qualidade de Vida , Distúrbios do Início e da Manutenção do Sono/epidemiologia , Sono/fisiologia , Adulto , Idoso , Estudos Transversais , Feminino , Refluxo Gastroesofágico/epidemiologia , Humanos , Masculino , Pessoa de Meia-Idade , Prevalência , Rinite/epidemiologia , Apneia Obstrutiva do Sono/epidemiologia , Fatores SocioeconômicosRESUMO
OBJECTIVE: the RhinAsthma Patient Perspective (RAPP) is the only available tool to assess HRQoL in daily practice. The aim of this study is to cross-culturally validate the RAPP in Spanish. METHODS: The RAPP was translated into Spanish. Adult patients receiving usual care for asthma and allergic rhinitis (AR) were recruited consecutively and assessed twice with a four-week interval between visits to test the psychometric properties of the questionnaire. RESULTS: 149 patients (62.8% female) with a mean age of 37.7 years completed the study. Exploratory and confirmatory factor analysis confirmed the uni-dimensional structure of the questionnaire. Internal consistency (0.73 at visit 1; 0.87 at visit 2), convergent and discriminant validity (p<.05 at both visits) were satisfactory. Reliability was confirmed by an ICC of 0.69 and a CCC of 0.74. Responsiveness was supported by a significant association with VAS (r=0.28, p<0.003) and ACT (r=-0.35, p<0.01). The minimal clinical difference (MID) value in the analyzed population was 2. CONCLUSIONS: The Spanish version of RAPP was demonstrated to have satisfactory psychometric properties and is a valid, reliable and responsive tool for the assessment of asthma and AR HRQoL in clinical practice.
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Asma , Psicometria/instrumentação , Qualidade de Vida , Rinite Alérgica , Inquéritos e Questionários , Adulto , Feminino , Humanos , Idioma , Masculino , TraduçãoRESUMO
The aim of this cross-sectional observational study was to explore quality of life and well-being in patients with drug-induced anaphylaxis. Two validated tools were used: the Drug Hypersensitivity Quality-of-Life Questionnaire (DrHy-Q) and the Psychological General Well-Being Index (PGWBI). Sixty-five patients (13 males) underwent data analysis. The mean DrHy-Q score was 62.82 ± 12.1. Mean PGWBI score was 64.03 ± 17.66. DrHy-Q score was significantly correlated with PGWBI total score (r = -0.314; P = 0.011) and with the following domains: Anxiety (r = -0.260; P = 0.036), Depressed mood (r = -0.406; P = 0.001), Positive well-being (r = -0.251; P = 0.004), and General Health (r = -0.352; P = 0.004). Compared with the Italian reference population, patients had a significantly reduced PGWBI total and domain score. Our results highlight for the first time how impaired HRQoL and distress commonly feature in survivors to anaphylactic reactions to drug.
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Anafilaxia/epidemiologia , Hipersensibilidade a Drogas/epidemiologia , Qualidade de Vida , Sobreviventes , Anafilaxia/psicologia , Estudos de Casos e Controles , Estudos Transversais , Hipersensibilidade a Drogas/psicologia , Feminino , Humanos , Masculino , Inquéritos e QuestionáriosRESUMO
Inhaled corticosteroids (ICS) are frequently recommended for the treatment of asthma and COPD, often in combination with long-acting beta2-agonists (LABA), depending on the severity of the disease and/or on the specific phenotype. Several ICS/LABA combinations are currently available that differ in their pharmacokinetic characteristics and dose of both components. Thus, this review assesses differences in the efficacy and the safety profiles of the ICS components in the two more frequently used ICS/LABA combinations (budesonide/formoterol and fluticasone/salmeterol) for the management of COPD. Whereas the basic mechanism of action is similar for all ICS (binding with the intracellular glucocorticoid receptor, which mediates both genomic and non genomic effects), the pharmacokinetic and characteristics of ICS are quite different in terms of receptor affinity, bioavailability, lipophilicity and drug persistence in the airways. Fluticasone persists longer in airway mucus and requires more time to dissolve in the lining fluid and then enter the airway wall, whereas budesonide is cleared more quickly from the airways. Comparative efficacy of the two major ICS/LABA combinations recommended for the treatment of COPD show similar efficacy in terms of reduction of exacerbations, improvement in forced expiratory volume in the first second (FEV1) and quality of life. One retrospective cohort study suggested a greater efficacy for the budesonide/formoterol combination on hospital or emergency department admissions, oral corticosteroid courses, and addition of tiotropium, and an observational real-life study reported a greater reduction of COPD exacerbations with budesonide/formoterol than with fluticasom/salmeterol combination. Among the potential side effects of chronic ICS treatment in patients with COPD, recently the use of fluticasone or fluticasone/salmeterol combination has been associated with a higher prevalence of pneumonia in the major long-term studies. On the other hand, no similar increased risk of pneumonia has been reported in patients with COPD treated with the budesonide/formoterol combination. A recent population-based cohort study from the Quebec database showed that the adjusted odds ratio for having severe pneumonia was higher for fluticasone (2.1) than for budesonide (1.17) or other ICS (1.41). Of the ICS studied, only fluticasone demonstrated a dose-related increase in risk of pneumonia in patients with COPD. This difference between fluticasone and budesonide may be explained by the longer retention of fluticasone in the airways, with potentially greater inhibition of type-1 innate immunity. Therefore, the risk:benefit ratio should be evaluated thoroughly when choosing an ICS/LABA combination for patients with COPD.
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Agonistas de Receptores Adrenérgicos beta 2/uso terapêutico , Glucocorticoides/uso terapêutico , Doença Pulmonar Obstrutiva Crônica/tratamento farmacológico , Administração por Inalação , Agonistas de Receptores Adrenérgicos beta 2/administração & dosagem , Agonistas de Receptores Adrenérgicos beta 2/efeitos adversos , Combinação de Medicamentos , Glucocorticoides/administração & dosagem , Glucocorticoides/efeitos adversos , Humanos , Doença Pulmonar Obstrutiva Crônica/fisiopatologia , Qualidade de VidaRESUMO
Randomized Controlled Trials (RCTs) are the "gold standard" for evaluating treatment outcomes providing information on treatments "efficacy". They are designed to test a therapeutic hypothesis under optimal setting in the absence of confounding factors. For this reason they have high internal validity. The strict and controlled conditions in which they are conducted, leads to low generalizability because they are performed in conditions very different from real life usual care. Conversely, real life studies inform on the "effectiveness" of a treatment, that is, the measure of the extent to which an intervention does what is intended to do in routine circumstances. At variance to RCTs, real life trials have high generalizability, but low internal validity. Recently the number of real life studies has been rapidly growing in different areas of respiratory medicine, particularly in asthma and COPD. The role of such studies is becoming a hot topic in respiratory medicine, attracting research interest and debate. In the first part of this review we discuss some of the advantages and disadvantages of different types of RCTs and analyze the strengths and weaknesses of real life trials, considering the recent examples of some studies conducted in COPD. We then discuss methodological approaches and options to overcome some of the limitations of real life studies. Comparing the conclusions of effectiveness and efficacy trials can provide important pieces of information. Indeed, these approaches can result complementary, and they can guide the interpretation of each other results.
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Doença Pulmonar Obstrutiva Crônica/terapia , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Projetos de Pesquisa , Asma/terapia , Fatores de Confusão Epidemiológicos , HumanosRESUMO
In Europe more than 50% of asthmatic treated patients have a not well-controlled asthma. The present survey aims at investigating how different specialists approach asthmatic patients. A web anonymous questionnaire was randomly administered to 604 General Practitioners (GPs), 241 Pneumologists and 131 Allergists. It concerned: epidemiology, diagnostic workup, follow-up and risk factors, treatment and future risk. A general agreement emerges about asthma diagnostic work-up. All categories are aware of the impact of comorbidities on asthma. LABA/inhaled steroids combination is considered the first choice treatment. Surprisingly, depot steroids and long-acting beta2 agonists (LABA) alone are still prescribed by GPs. Concerning monitoring tools, Allergists rely on inflammation biomarkers, whereas reduction of rescue medication is more relevant for GPs. Asthma Control Test (ACT) is considered time consuming by more than 50% of all physicians and is not known by most of GPs. Adherence is considered a crucial problem in asthma management. All categories seem to have a good knowledge about asthma. The cultural background may account for mild differences in asthma control tools and treatment options. GPs have a pivotal role in discriminating patients who need specific assessment by specialists. It is thus important that GPs and specialists share common tools for recognizing and managing those patients.
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Asma/terapia , Asma/diagnóstico , Seguimentos , Clínicos Gerais , Humanos , Itália , Medicina , Fatores de Risco , Inquéritos e QuestionáriosRESUMO
BACKGROUND: This study was designed to assess if illness perception, mood state and coping strategies differ according to allergic rhinitis (AR) persistence and severity. METHODS: Illness perception, mood profiles, coping behaviors and rhinitis symptoms were assessed by means of validated tools inpatients classified according to the Allergic Rhinitis and Its Impact on Asthma (ARIA) guidelines. RESULTS: Two hundred and thirty-one patients underwent data analysis. No difference in age, sex, socio-economic status, smoking habits was detected comparing patients according to AR severity, duration or 4 ARIA classes. Patients with intermittent AR reported higher scores than those with persistent AR in confusion-bewilderment of Profile of Mood States (POMS); patients with moderate/severe rhinitis had significantly higher scores than those with mild rhinitis in TSSS, Identity and Consequences. No differences were detected in all assessed outcomes in the 4 ARIA classes. CONCLUSIONS: The patient's perspective about AR is independent of persistence and severity of symptoms. This may explain why AR remains under-diagnosed and under-treated, even in its most severe forms. Self-management plans should consider the patient's perspective.
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Alérgenos/imunologia , Asma/imunologia , Rinite Alérgica Sazonal/imunologia , Rinite Alérgica/imunologia , Rinite/imunologia , Alérgenos/química , Asma/fisiopatologia , Estudos Transversais , Humanos , Rinite/fisiopatologia , Rinite Alérgica/fisiopatologia , Índice de Gravidade de DoençaRESUMO
BACKGROUND: The impact of chronic spontaneous urticaria (CSU) on health-related quality of life (HRQoL) is widely held to be mainly influenced by disease activity and comorbidities. OBJECTIVE: To assess the correlation between disease activity and HRQoL impairment by using validated disease-specific instruments. METHODS: The Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL) was translated into Greek and subsequently applied to 110 CSU patients along with the Dermatology Life Quality Index and the Urticaria Activity Score. After the validity and reliability of the Greek CU-Q2oL had been determined, we assessed the relation between disease activity and HRQoL impairment by computing correlations as well as by performing multiple regression analysis. RESULTS: Exploratory factor analysis revealed a six-scale structure of the Greek CU-Q2oL that explained 67.9% of its total variance. The internal consistency was satisfactory with Cronbach's α >0.7. Disease activity was the only predictor of quality of life impairment, but it only moderately correlated with the CU-Q2oL total score (r = 0.40, p < 0.0001). CONCLUSION: Our results suggest that there are additional factors to disease activity that are responsible for the pronounced reduction of HRQoL in CSU, and this supports the recommendation to assess and monitor both disease activity and quality of life in CSU patients.
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Qualidade de Vida/psicologia , Inquéritos e Questionários , Urticária/psicologia , Adulto , Doença Crônica , Ingestão de Alimentos , Emoções , Feminino , Grécia , Humanos , Masculino , Saúde Mental , Pessoa de Meia-Idade , Prurido/etiologia , Prurido/psicologia , Reprodutibilidade dos Testes , Índice de Gravidade de Doença , Sono , Urticária/complicações , Urticária/fisiopatologiaRESUMO
This article is an attempt to analyze and discuss the role and the purported mechanisms of azithromycin (AZM) in non-eosinophilic severe asthma, including antineutrophil activity, an effect on gastroesophageal reflux or antibacterial activity against an underlying chronic infection, such as Chlamydia pneumoniae. Macrolides have an expanding role in the therapy of chronic inflammatory diseases based on their additional anti-inflammatory and immunosuppressive properties. Many studies have been performed in lung transplantation field and maintenance treatment has been proved to be effective in cystic fibrosis, bronchiectasis, diffuse panbronchiolitis, and in bronchiolitis obliterans syndrome and in the prevention of exacerbations in patients with chronic obstructive pulmonary disease. Pathobiological studies of people with severe, refractory asthma focused on its heterogeneity encouraging more targeted and personalized approaches to asthma therapy. In neutrophilic asthma corticosteroids are not very effective, while the immunomodulatory action of macrolides is particularly relevant on neutrophils. Recently, The AZIthromycin in Severe ASThma (AZISAST) study, published on the April number of Thorax, provided evidences on the efficacy and safety of long-term add-on treatment with AZM in severe non-eosinophilic asthma. Despite concerns about an increased proportion of macrolide-resistant organism and about the effects of macrolides on cardiovascular events, there was no evidence of an increased risk of pneumonia or other adverse events. Because the AZISAST study was not able to demonstrate significant improvement in lung function and use of rescue medication, there is still a need for new data confirming the efficacy of AZM in severe non-eosinophilic asthma.
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Understanding whether the ABCD GOLD classification method is informative with respect to the spirometric classification of severity in predicting mortality of patients with chronic obstructive pulmonary disease (COPD) is subject of debate. The results of a study performed on a sample of the Norwegian population (HUNT2) were recently published. Such data showed the inferiority of ABCD classification in predicting mortality compared to the spirometric classification, which was considered the gold standard up to the 2011 version of GOLD guidelines. This result is not in line with the results of other studies that have shown the equivalence of the two classifications. The new GOLD classification seemed to be a step forward for what concerns understanding patient's needs, but it seems clear that the insertion of a single clinical variable to the spirometric data may not be exhaustive in describing all the phenomena related to a heterogeneous disease such as COPD. The publication of the HUNT study provides an opportunity to analyze how the evidence has been produced, which scientific speculations it offers, what considerations could be drawn and what further research would be appropriate.
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OBJECTIVE: Lantigen B, a bacterial lysate, was developed in the 1960s and showed a prophylactic effect in patients with recurrent respiratory tract infections. The objective of this article is to review the literature to update the efficacy and safety profile of Lantigen B in preventing recurrent respiratory tract infections (RRTI). MATERIALS AND METHODS: Articles available from international data banks and producing company archives were used. Only clinical studies providing a control group were considered. The effects of Lantigen B on the number of infectious episodes or comparable parameters were analyzed. RESULTS: 22 randomized clinical trials on 4,571 patients published between 1963 and 2014, with different methodologic accuracy, consistently demonstrated that Lantigen B reduced RRTI vs. placebo (RR -0.47; 95% CI = -0.38 to -0.56). The RR always favored Lantigen B in all the other subsets analyzed in adults with RRTI (RR = -0.48; 95% CI = - 0.33 to -0.62) and children (RR = -0.490; 95% CI = - 0.36 to -0.61). Unfortunately, some studies performed in the past evaluated a small number of patients, and clinical procedures were not always performed according to the more recent good clinical practices. Despite these evident limitations of considered studies, the response frequency has remained almost unchanged since the first articles in the 1960s. CONCLUSIONS: These data confirm the efficacy of Lantigen B alone in the prophylaxis of acute respiratory infections in adults and children but also suggest that Lantigen B, used with novel therapeutic strategies, can further improve clinical outcomes.
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Infecções Respiratórias , Adulto , Criança , Humanos , Infecções Respiratórias/prevenção & controle , Bactérias , Bases de Dados FactuaisRESUMO
BACKGROUND: The present study aimed to develop a short validated patient-completed questionnaire, the RhinAsthma Patient Perspective (RAPP), to assess the health-related quality of life (HRQoL) in patients with asthma and comorbid allergic rhinitis in clinical practice. METHODS: A provisional RAPP questionnaire was formed from candidate items identified through retrospective analysis of 333 RHINASTHMA questionnaires. This was then tested on 150 asthma patients with allergic rhinitis. RESULTS: Psychometric analyses identified eight items fitting a unidimensional model to form RAPP. Internal consistency (Cronbach's alpha coefficient > 0.8) and agreement with RHINASTHMA (r = -0.31, P = 0.0001) were excellent. Criterion, discriminant, and convergent validity were good. Reliability in 47 stable patients was very good (intra-class and concordance correlation coefficients were 0.90 and 0.89, respectively). Responsiveness in 103 patients with health improvement or deterioration was significantly associated with changes in Global Rating Scale (r = -0.4965, P < 0.01), Rhinitis Visual Analogue Scale (r = 0.5722, P < 0.01) and asthma control test (r = -0.6483, P < 0.01). Minimal clinical difference in the analyzed population was 2. CONCLUSION: RhinAsthma Patient Perspective is a simple eight-question questionnaire with good measurement properties and sensitivity to health changes, which will provide a valid, reliable and standardized HRQoL measurement in patients with asthma and comorbid allergic rhinitis in clinical practice.
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Asma/psicologia , Qualidade de Vida , Rinite Alérgica Perene/psicologia , Inquéritos e Questionários , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Psicometria , Rinite AlérgicaRESUMO
Advances in basic research and research and development plans of pharmaceutical companies are radically changing the kind of available drugs and therapeutic targets. We are switching from predominantly chemical molecules, aimed at treating large populations of patients (blockbuster drugs), to a new generation of products, mostly biotech, aimed at modifying a specific pathogenetic mechanism. In other word we are moving fast to targeted therapy, which represents the first step toward personalized therapy, where the right drug at the right dose is administered to the right person, at the right time. Like the patent expiration of chemical products has corresponded to the development of generic drugs, the expiration of new biotech products will witness the appearance of biosimilars. The latter are biologic products that are highly similar but not identical to the reference medical products in terms of quality, safety and efficacy. This implies specific research, clinical monitoring, physicians updating of knowledge for a safe and appropriate use of these products. We are the beginning of a devolution in patient's care and physicians' practice.
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Produtos Biológicos/uso terapêutico , Medicamentos Biossimilares/uso terapêutico , Desenho de Fármacos , Produtos Biológicos/administração & dosagem , Produtos Biológicos/efeitos adversos , Medicamentos Biossimilares/administração & dosagem , Medicamentos Biossimilares/efeitos adversos , Indústria Farmacêutica/métodos , Monitoramento de Medicamentos/métodos , Medicamentos Genéricos/administração & dosagem , Medicamentos Genéricos/uso terapêutico , Humanos , Terapia de Alvo Molecular , Patentes como Assunto , Medicina de Precisão/métodosRESUMO
A role in pulmonary immunity has been ascribed to Natural Killer (NK) cells and several in vitro studies have shown a corticosteroid-induced inhibition of NK cells mediated cytotoxicity. Several clinical trials on chronic obstructive pulmonary disease (COPD) have suggested a relationship between COPD treatment and occurrence of respiratory infections. Aims of our study were to investigate if real life COPD treatment affects peripheral blood NK cells total count and their receptors expression and to assess if different doses of formoterol and budesonide, administered alone or in combination, are able to modulate the surface expression of activating (NKp30, NKp44, NKp46 and NKG2D) and inhibitory (KIR2DL2/L3, KIR3DL1 and NKG2A) receptors on peripheral blood NK cells of COPD patients. Moreover, we evaluated the potential effect of treatment with budesonide and/or formoterol on IFN-γ secretion in vitro. NK cells were isolated from peripheral blood of 7 healthy volunteers, 9 chronic bronchitis (CB) and 11 COPD patients. Total NK cells count and activating and inhibitory receptors expression were evaluated. NK cells were cultured for 20h in 96-well plates with IL-2 (100IU/ml)+IL-12 (2.5ng/ml), with or without budesonide (Bud; 1 and 0.01µM) and formoterol (For; 30 and 0.3nM) alone or in combination. Cells were analyzed by flow cytometry and IFN-γ was measured in cell supernatants by ELISA test. No difference between real life treated COPD, CB and healthy subjects was found concerning NK total count and NK cell receptors expression. When cells were stimulated over night with cytokines and treated with drugs, only NKG2D receptor was modulated. Its expression was significantly downregulated by budesonide alone and in combination with formoterol in COPD patients. IFN-γ production induced by stimulation with IL-2+IL-12 was decreased in a highly significant way (p<0.01) by all treatments in all groups. Even if in vitro experiments with budesonide, alone or in combination with formoterol, showed a modulation of NKG2D receptor expression and IFN-γ production, our ex vivo results show that real life LABA and ICS treatment does not influence peripheral NK cells count and their receptors phenotype.
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Interferon gama/biossíntese , Células Matadoras Naturais/imunologia , Subfamília K de Receptores Semelhantes a Lectina de Células NK/análise , Doença Pulmonar Obstrutiva Crônica/tratamento farmacológico , Doença Pulmonar Obstrutiva Crônica/imunologia , Idoso , Budesonida/uso terapêutico , Etanolaminas/uso terapêutico , Fumarato de Formoterol , Humanos , Interferon gama/metabolismo , Interleucina-2/farmacologia , Células Matadoras Naturais/metabolismoRESUMO
The clinical features of Celiac Disease (CD) are heterogeneous and both severity and extent of villous atrophy do not correlate with clinical presentation. This study aims to evaluate the psychological wellbeing of CD patients with a similar clinical pattern and to explore whether patients with different levels of wellbeing differed in illness perception and coping strategies. CD outpatients with proven diagnosis filled in validated questionnaires to investigate wellbeing (PGWBI), illness perception (IPQ-R) and coping style (COPE). One hundred and four patients underwent data analysis. Compared to Italian reference sample, CD patients reported a significantly reduced PGWBI total score (p<0.001), self-control (p<0.001), general health (p=0.002) and vitality (p<0.001) and increased anxiety (p=0.009). 7.7% of patients reported a positive wellbeing, 40.4% distress absence, 28.8% a moderate distress and 23.1% a severe distress. Patients with distress showed a different illness perception and reported more frequently two dysfunctional strategies: focus on and venting emotions (p= 0.009) and substance abuse (p= 0.01) compared to those having a positive wellbeing. A high percentage of CD patients experience distress and differ from those who reach wellbeing in illness perception and use of coping strategies. Assessing subjective viewpoint with standardized methods can provide useful information for a better management of CD patients.
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Adaptação Psicológica , Doença Celíaca/psicologia , Adulto , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , PercepçãoRESUMO
BACKGROUND: Most health care systems consider continuing medical education a potential tool to improve quality of care and reduce disease management costs. Its efficacy in general practitioners needs to be further explored. OBJECTIVE: This study assesses the effectiveness of a one-year continuing medical education/continuing professional development course for general practitioners, regarding the improvement in knowledge of ARIA and GINA guidelines and compliance with them in asthma management. METHODS: Sixty general practitioners, covering 68,146 inhabitants, were randomly allocated to continuing medical education/continuing professional development (five residential events +four short distance-learning refresher courses over one year) or no training. Participants completed a questionnaire after each continuing medical education event; key questions were repeated at least twice. The Local Health Unit prescription database was used to verify prescription habits (diagnostic investigations and pharmacological therapy) and hospitalizations over one year before and after training. RESULTS: Fourteen general practitioners (46.7%) reached the cut-off of 50% attendance of the training courses. Knowledge improved significantly after training (p < 0.001, correct answers to key questions +13%). Training resulted in pharmaceutical cost containment (trained general practitioners +0.5% vs. controls +18.8%) and greater attention to diagnosis and monitoring (increase in spirometry +63.4%, p < 0.01). CONCLUSION: This study revealed an encouraging impact of educational events on improvement in general practitioner knowledge of guidelines and daily practice behavioral changes. Long-term studies of large populations are required to assess the effectiveness of education on the behavior of physicians in asthma management, and to establish the best format for educational events.
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Educação Médica Continuada , Clínicos Gerais/educação , Fidelidade a Diretrizes , Conhecimentos, Atitudes e Prática em Saúde , Asma/diagnóstico , Asma/terapia , Humanos , Hipersensibilidade/diagnóstico , Hipersensibilidade/terapia , Projetos Piloto , Rinite/diagnóstico , Rinite/terapiaRESUMO
It has been demonstrated that Leukotriene modifiers reduce rhinitis symptoms, but montelukast preventive effect on inflammatory cells pattern in intranasal challenge studies has not been already assessed. This pilot study has been designed to explore the montelukast effects in preventing early/late inflammatory cells response to specific allergen challenge in persistent rhinitis. After a 4 week wash-out period, patients were randomised to receive montelukast/placebo for 4 weeks. Pre-post treatment nasal washing and scraping before and after specific nasal challenge were performed. No difference in baseline inflammatory cells count before and after treatment was shown between groups. Despite at a basal level a decrease of inflammatory cells in active group after treatment was observed, the statistical significance was not reached. The generalised mixed model showed that, after therapeutic interventions, the inflammatory cells increased 30' and 6 hour after challenge but, only in the active group the cells amounting was less for eosinophils (-34%), macrophages (-56%), lymphocytes (-45%) and neutrophils (-46%; p = 0.001). The longitudinal generalised linear model with just one time variable showed a decrease of all inflammatory cellular types although a significant relevance was reached only for macrophages (p = 0.038) and neutrophils (p = 0.001). The modulatory effect on neutrophils and macrophages could lead to montelukast still unexplored effects. Specific trials, sized according to the results of this pilot exploratory study, could add relevant evidences concerning the leukotrienes receptors antagonist treatment of specific rhinitis and asthma phenotypes.
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Acetatos/uso terapêutico , Hipersensibilidade/prevenção & controle , Inflamação/prevenção & controle , Antagonistas de Leucotrienos/uso terapêutico , Quinolinas/uso terapêutico , Rinite Alérgica Perene/prevenção & controle , Adulto , Contagem de Células , Ciclopropanos , Método Duplo-Cego , Eosinófilos/efeitos dos fármacos , Eosinófilos/imunologia , Feminino , Humanos , Hipersensibilidade/imunologia , Inflamação/imunologia , Linfócitos/efeitos dos fármacos , Linfócitos/imunologia , Macrófagos/efeitos dos fármacos , Macrófagos/imunologia , Masculino , Neutrófilos/efeitos dos fármacos , Neutrófilos/imunologia , Projetos Piloto , Rinite Alérgica Perene/imunologia , SulfetosRESUMO
BACKGROUND: Allergic rhinitis, especially when persistent (PER) and associated with asthma heavily impairs patients' quality of life (QoL). OBJECTIVE: This study assessed the effect of mometasone furoate nasal spray (MFNS) on the QoL of patients with PER and asthma, using the Rhinasthma questionnaire (EUDRACT n. 2007-004683-45). METHODS: Patients with moderate/severe PER and intermittent asthma were randomized to MFNS (alcohol-free) 200 µg/day or placebo for 28 days. Rhinasthma was completed at baseline and at weeks 2 and 4. The total five symptom score (T5SS) for rhinitis, the asthma symptom score and the sum of the two [global symptoms score (GSS)] were recorded daily. The primary outcome was the change in the Rhinasthma global summary (GS) at the end of treatment. Secondary end-points were (a) the change from baseline to end of treatment of each Rhinasthma factor: upper airways (UAs), lower airways (LAs) and respiratory allergy impact; (b) the change from baseline to end of treatment of the T5SS and of the GSS and (c) the use of rescue medication. RESULTS: Fifty-two adults were randomized. Compared with placebo, MFNS produced a significant change in the Rhinasthma GS (-10.4 vs. 0.4; P<0.01). MFNS also achieved a significant improvement of the UA (-16.6 vs. 0.1; P<0.001), LA (-10.8 vs. 1.1; P<0.001) and GSS (-6.7 vs. -3.1; P=0.019). The change of the T5SS was greater in the MFNS group but did not reach statistical significance. CONCLUSION: In patients with PER rhinitis and intermittent asthma, MFNS improves the QoL and the burden of respiratory symptoms. Treating rhinitis may affect the asthma-related QoL.