Your browser doesn't support javascript.
Mostrar: 20 | 50 | 100
Resultados 1 - 20 de 34
Filtrar
Mais filtros










Base de dados
Intervalo de ano de publicação
1.
Ann Am Thorac Soc ; 15(7): 827-836, 2018 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-29911888

RESUMO

RATIONALE: The extent of the genetic relatedness among Pseudomonas aeruginosa isolates and its impact on clinical outcomes in the cystic fibrosis (CF) population is poorly understood. OBJECTIVES: The objectives of this study were to determine the prevalence of clonal P. aeruginosa infection in Canada and to associate P. aeruginosa genotypes with clinical outcomes. METHODS: This was an observational study of adult and pediatric patients with CF across Canada. Isolates were typed using multilocus sequence typing. A clone was defined as sharing at least six of seven alleles. Genotyping results were associated with clinical outcomes, including forced expiratory volume in 1 second, body mass index, rate of pulmonary exacerbation, and death/transplant. RESULTS: A total of 1,537 P. aeruginosa isolates were genotyped to 403 unique sequence types (STs) in 402 individuals with CF. Although 39% of STs were shared, most were shared only among a small number of subjects, and the majority (79%) of the genetic diversity in P. aeruginosa isolates was observed between patients. There were no significant differences in clinical outcomes according to genotype. However, patients with a dynamic, changing ST infection pattern had both a steeper decline in forced expiratory volume in 1 second (-2.9% predicted change/yr, 95% confidence interval [CI] = -3.8 to -1.9 compared with 0.4, 95% CI = -0.3 to 1.0; P < 0.001) and body mass index (-1.0 percentile change/yr, 95% CI = -1.6 to -0.3 compared with -0.1, 95% CI = -0.7 to 0.5; P = 0.047) than those with a stable infection with the same ST. CONCLUSIONS: There was no widespread sharing of dominant clones in our CF population, and the majority of the genetic diversity in P. aeruginosa was observed between patients. Changing genotypes over time within an individual was associated with worse clinical outcomes.

3.
Artigo em Inglês | MEDLINE | ID: mdl-28194191

RESUMO

BACKGROUND: Peanut sensitization does not necessarily indicate clinical peanut allergy, and uncertainty as to whether or not there is true peanut allergy can lead to increased anxiety and decreased quality of life for patients and their families. The gold standard for diagnosing clinical peanut allergy is the oral food challenge, but this method is time-consuming and can cause severe allergic reactions. It would therefore be beneficial to develop a tool for predicting clinical peanut allergy in peanut-sensitized individuals whose peanut allergy status is unknown so as to better determine who requires an oral food challenge for diagnosis. METHODS: Two separate studies were conducted. In Study 1, we recruited 100 participants from the allergy clinic at McMaster University and community allergy outpatient clinics in the greater Hamilton area. We examined 18 different variables from participants and used univariate and multivariable logistic regression analysis to determine how well these variables, singly and in combination, were able to predict clinical peanut allergy status. In Study 2, we conducted a retrospective chart review of a second cohort of 194 participants to investigate the reproducibility of our findings. This was a matched case-control study where 97 peanut-allergic participants were gender- and age-matched to 97 non-allergic control participants. RESULTS: Peanut skin prick test wheal size was the best predictor of clinical peanut allergy in both study cohorts. For every 1 mm increase in wheal size, the odds ratio of an individual having clinical peanut allergy was 2.36 in our first cohort and 4.85 in our second cohort. No other variable approached the predictive power of wheal size. CONCLUSIONS: Peanut skin prick test wheal size is a robust predictor of clinical peanut reactivity. The findings of this study may be useful in guiding clinician decision-making regarding peanut allergy diagnostics.

4.
Res Pract Thromb Haemost ; 1(1): 103-111, 2017 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-30046678

RESUMO

Background: Platelet transfusions are commonly used to treat critically ill patients with thrombocytopenia. Whether platelet transfusions are associated with a reduction in the risk of major bleeding is unknown. Patients/Methods: Observational cohort study nested in a previous multicenter, randomized thromboprophylaxis trial in the intensive care unit (ICU). The objective was to evaluate the association between platelet transfusions and adjudicated major bleeding events. Platelet transfusion episodes were reviewed for timing of administration, product type, and dose. Major bleeding with and without platelet transfusions was adjusted for severity of thrombocytopenia, use of anti-platelet agents, surgery and other covariates. Secondary outcomes were thrombosis, death in ICU and platelet count increment. Results: Among 2,256 patients, 71 (3.1%) received 190 platelet transfusions. Of those, 121 (63.7%) were administered to 54 non-bleeding, thrombocytopenic patients. Adjusted rates of major bleeding were not statistically different with or without the administration of platelet transfusions (hazard ratio for transfused patients 0.85; 95% confidence interval, 0.42-1.72). We did not find a significant association between platelet transfusion use and thrombosis or death in ICU in adjusted analyses. Thrombocytopenia, anemia, major or minor bleeding and use of anticoagulants were associated with platelet transfusion administration. The median post-transfusion platelet count increment was 20×109/L at 3.5 hours post-transfusion. Conclusions: Rates of major bleeding were not different for patients who did and did not receive platelet transfusions. Inferences were limited by the small number of transfused patients. Clinical trials are needed to better investigate the potential hemostatic benefit and potential harms of platelet transfusions for this high-risk population.

7.
Respir Res ; 17(1): 80, 2016 07 11.
Artigo em Inglês | MEDLINE | ID: mdl-27401184

RESUMO

BACKGROUND: Despite the high mortality in patients with pneumonia admitted to an ICU, data on risk factors for death remain limited. METHODS: In this secondary analysis of PROTECT (Prophylaxis for Thromboembolism in Critical Care Trial), we focused on the patients admitted to ICU with a primary diagnosis of pneumonia. The primary outcome for this study was 90-day hospital mortality and the secondary outcome was 90-day ICU mortality. Cox regression model was conducted to examine the relationship between baseline and time-dependent variables and hospital and ICU mortality. RESULTS: Six hundred sixty seven patients admitted with pneumonia (43.8 % females) were included in our analysis, with a mean age of 60.7 years and mean APACHE II score of 21.3. During follow-up, 111 patients (16.6 %) died in ICU and in total, 149 (22.3 %) died in hospital. Multivariable analysis demonstrated significant independent risk factors for hospital mortality including male sex (hazard ratio (HR) = 1.5, 95 % confidence interval (CI): 1.1 - 2.2, p-value = 0.021), higher APACHE II score (HR = 1.2, 95 % CI: 1.1 - 1.4, p-value < 0.001 for per-5 point increase), chronic heart failure (HR = 2.9, 95 % CI: 1.6 - 5.4, p-value = 0.001), and dialysis (time-dependent effect: HR = 2.7, 95 % CI: 1.3 - 5.7, p-value = 0.008). Higher APACHE II score (HR = 1.2, 95 % CI: 1.1 - 1.4, p-value = 0.002 for per-5 point increase) and chronic heart failure (HR = 2.6, 95 % CI: 1.3 - 5.0, p-value = 0.004) were significantly related to risk of death in the ICU. CONCLUSION: In this study using data from a multicenter thromboprophylaxis trial, we found that male sex, higher APACHE II score on admission, chronic heart failure, and dialysis were independently associated with risk of hospital mortality in patients admitted to ICU with pneumonia. While high illness severity score, presence of a serious comorbidity (heart failure) and need for an advanced life support (dialysis) are not unexpected risk factors of mortality, male sex might necessitate further exploration. More studies are warranted to clarify the effect of these risk factors on survival in critically ill patients admitted to ICU with pneumonia. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT00182143 .


Assuntos
Mortalidade Hospitalar , Unidades de Terapia Intensiva , Admissão do Paciente , Pneumonia/mortalidade , APACHE , Idoso , Idoso de 80 Anos ou mais , Distribuição de Qui-Quadrado , Bases de Dados Factuais , Feminino , Insuficiência Cardíaca/mortalidade , Humanos , Estimativa de Kaplan-Meier , Nefropatias/mortalidade , Nefropatias/terapia , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Pneumonia/diagnóstico , Pneumonia/terapia , Modelos de Riscos Proporcionais , Diálise Renal/mortalidade , Fatores de Risco , Fatores Sexuais , Fatores de Tempo
8.
Ann Intensive Care ; 6(1): 18, 2016 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-26921148

RESUMO

BACKGROUND: Previous studies have suggested that prediction models for mortality should be adjusted for additional risk factors beyond the Acute Physiology and Chronic Health Evaluation (APACHE) score. Our objective was to identify risk factors independent of APACHE II score and construct a prediction model to improve the predictive accuracy for hospital and intensive care unit (ICU) mortality. METHODS: We used data from a multicenter randomized controlled trial (PROTECT, Prophylaxis for Thromboembolism in Critical Care Trial) to build a new prediction model for hospital and ICU mortality. Our primary outcome was all-cause 60-day hospital mortality, and the secondary outcome was all-cause 60-day ICU mortality. RESULTS: We included 3746 critically ill non-trauma medical-surgical patients receiving heparin thromboprophylaxis (43.3 % females) in this study. The new model predicting 60-day hospital mortality incorporated APACHE II score (main effect: hazard ratio (HR) = 0.97 for per-point increase), body mass index (BMI) (main effect: HR = 0.92 for per-point increase), medical admission versus surgical (HR = 1.67), use of inotropes or vasopressors (HR = 1.34), acetylsalicylic acid or clopidogrel (HR = 1.27) and the interaction term between APACHE II score and BMI (HR = 1.002 for per-point increase). This model had a good fit to the data and was well calibrated and internally validated. However, the discriminative ability of the prediction model was unsatisfactory (C index < 0.65). Sensitivity analyses supported the robustness of these findings. Similar results were observed in the new prediction model for 60-day ICU mortality which included APACHE II score, BMI, medical admission and invasive mechanical ventilation. CONCLUSION: Compared with the APACHE II score alone, the new prediction model increases data collection, is more complex but does not substantially improve discriminative ability. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT00182143.

10.
Wien Klin Wochenschr ; 127(9-10): 323-9, 2015 May.
Artigo em Inglês | MEDLINE | ID: mdl-25931135

RESUMO

BACKGROUND: Austria has the highest number of medical graduates of all Organisation for Economic Co-operation and Development (OECD) countries in relation to its population size, but over 30% choose not to pursue a career as physicians in the country. OBJECTIVE AND RESEARCH DESIGN: This article describes under- and postgraduate medical education in Austria and analyses reasons for the exodus of physicians. MEDICAL EDUCATION: In Austria, medicine is a 5- or 6-year degree offered at four public and two private medical schools. Medical graduates have to complete training in general medicine or a speciality to attain a licence to practice. While not compulsory for speciality training, board certification in general medicine has often been regarded as a prerequisite for access to speciality training posts. ANALYSIS: Unstructured postgraduate training curricula, large amounts of administrative tasks, low basic salaries and long working hours present for incentives for medical graduates to move abroad or to work in a non-clinical setting. The scope of current reforms, such as the establishment of a new medical faculty and the implementation of a common trunk, is possibly insufficient in addressing the issue. CONCLUSION: Extensive reforms regarding occupational conditions and the structure of postgraduate medical education are necessary to avoid a further exodus of junior doctors.


Assuntos
Atitude do Pessoal de Saúde , Escolha da Profissão , Educação de Pós-Graduação em Medicina , Emigração e Imigração , Medicina Geral/educação , Reforma dos Serviços de Saúde , Satisfação no Emprego , Medicina , Programas Nacionais de Saúde , Papel do Médico/psicologia , Estudantes de Medicina/psicologia , Áustria , Currículo , Docentes de Medicina , Humanos , Licenciamento em Medicina , Conselhos de Especialidade Profissional
13.
Implement Sci ; 10: 17, 2015 Feb 07.
Artigo em Inglês | MEDLINE | ID: mdl-25757139

RESUMO

BACKGROUND: The decision to have lung transplantation as treatment for end-stage lung disease from cystic fibrosis (CF) has benefits and serious risks. Although patient decision aids are effective interventions for helping patients reach a quality decision, little is known about implementing them in clinical practice. Our study evaluated a sustainable approach for implementing a patient decision aid for adults with CF considering referral for lung transplantation. METHODS: A prospective pragmatic observational study was guided by the Knowledge-to-Action Framework. Healthcare professionals in all 23 Canadian CF clinics were eligible. We surveyed participants regarding perceived barriers and facilitators to patient decision aid use. Interventions tailored to address modifiable identified barriers included training, access to decision aids, and conference calls. The primary outcome was >80% use of the decision aid in year 2. RESULTS: Of 23 adult CF clinics, 18 participated (78.2%) and 13 had healthcare professionals attend training. Baseline barriers were healthcare professionals' inadequate knowledge for supporting patients making decisions (55%), clarifying patients' values for outcomes of options (58%), and helping patients handle conflicting views of others (71%). Other barriers were lack of time (52%) and needing to change how transplantation is discussed (42%). Baseline facilitators were healthcare professionals feeling comfortable discussing bad transplantation outcomes (74%), agreeing the decision aid would be easy to experiment with (71%) and use in the CF clinic (87%), and agreeing that using the decision aid would not require reorganization of the CF clinic (90%). After implementing the decision aid with interventions tailored to the barriers, decision aid use increased from 29% at baseline to 85% during year 1 and 92% in year 2 (p < 0.001). Compared to baseline, more healthcare professionals at the end of the study were confident in supporting decision-making (p = 0.03) but continued to feel inadequate ability with supporting patients to handle conflicting views (p = 0.01). CONCLUSION: Most Canadian CF clinics agreed to participate in the study. Interventions were used to target identified modifiable barriers to using the patient decision aid in routine CF clinical practice. CF clinics reported using it with almost all patients in the second year.


Assuntos
Atitude do Pessoal de Saúde , Fibrose Cística/cirurgia , Técnicas de Apoio para a Decisão , Transplante de Pulmão/métodos , Participação do Paciente/métodos , Adulto , Idoso , Canadá , Tomada de Decisões , Feminino , Humanos , Capacitação em Serviço , Masculino , Pessoa de Meia-Idade , Enfermeiras e Enfermeiros , Farmacêuticos , Médicos , Estudos Prospectivos , Fatores de Tempo
14.
J Cyst Fibros ; 14(6): 755-62, 2015 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-25690407

RESUMO

BACKGROUND: Pulmonary exacerbations are associated with significant lung function decline from baseline in cystic fibrosis (CF) and it is not well understood why some patients do not respond to antibiotic therapy. The objective of this study was to identify factors associated with lung function response to antibiotic treatment of pulmonary exacerbations. METHODS: As a secondary analysis of a randomized, controlled trial of intravenous antibiotic treatment for pulmonary exacerbations in CF patients, we investigated whether baseline factors and changes in sputum bacterial density, serum or sputum inflammatory markers were associated with recovery of lung function and risk of subsequent exacerbation. RESULTS: In 36 of the 70 exacerbations (51%), patients' lung function returned to >100% of their baseline at day 14 of antibiotic treatment; 34 exacerbations were classified as non-responders. Baseline characteristics were not significantly different between responders and non-responders. Less of a drop in FEV1 from baseline to exacerbation (OR 1.09, 95% CI 1.0, 1.18, p=0.04) as well as a greater decrease in sputum neutrophil elastase (OR 2.94, 95% CI 1.07, 8.06, p=0.04) were associated with response to antibiotic treatment at day 14. In addition, higher CRP (HR 1.35 (95% CI: 1.01, 1.78), p=0.04) and sputum neutrophil elastase (HR 1.71 (95% CI: 1.02, 2.88), p=0.04) at day 14 of antibiotic therapy were associated with an increased risk of subsequent exacerbation. CONCLUSIONS: Inadequate reduction of inflammation during an exacerbation is associated with failure to recover lung function and increased risk of subsequent re-exacerbation in CF patients.


Assuntos
Fibrose Cística/complicações , Pneumopatias/tratamento farmacológico , Pneumopatias/etiologia , Adolescente , Adulto , Criança , Progressão da Doença , Método Duplo-Cego , Feminino , Humanos , Masculino , Adulto Jovem
15.
Br J Sports Med ; 49(8): 511-9, 2015 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-25564004

RESUMO

A systematic review of rugby union and league injuries among players under the age of 21 years was carried out to calculate probabilities of match injury for a player over a season and a pooled estimate of match injury incidence where studies were sufficiently similar. The probability of a player being injured over a season ranged from 6% to 90% for rugby union and 68% to 96% for rugby league. The pooled injury incidence estimate for rugby union was 26.7/1000 player-hours for injuries irrespective of need for medical attention or time-loss and 10.3/1000 player-hours for injuries requiring at least 7 days absence from games; equivalent to a 28.4% and 12.1% risk of being injured over a season. Study heterogeneity contributed to a wide variation in injury incidence. Public injury surveillance and prevention systems have been successful in reducing injury rates in other countries. No such system exists in the UK.


Assuntos
Futebol Americano/lesões , Absenteísmo , Adolescente , Traumatismos em Atletas/epidemiologia , Concussão Encefálica/epidemiologia , Criança , Contusões/epidemiologia , Traumatismos Craniocerebrais/epidemiologia , Extremidades/lesões , Feminino , Hematoma/epidemiologia , Humanos , Incidência , Luxações Articulares/epidemiologia , Lacerações/epidemiologia , Masculino , Lesões do Pescoço/epidemiologia , Medição de Risco , Entorses e Distensões/epidemiologia , Tronco/lesões , Adulto Jovem
16.
J Cyst Fibros ; 14(2): 262-6, 2015 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-25453872

RESUMO

This study aimed to determine whether antimicrobial susceptibility testing of Pseudomonas aeruginosa grown as a biofilm, rather than planktonically, improves efficacy of antibiotic treatment for pulmonary exacerbations. This was a multicenter randomized, double-blind controlled trial of 14 days of intravenous antibiotic treatment for pulmonary exacerbations chosen based on conventional vs. biofilm antimicrobial susceptibility results in CF patients with chronic P. aeruginosa infection. There were 74 exacerbations in 39 patients. A total of 46% (12/26) exacerbations in the conventional group compared to 40% (19/48) exacerbations in the biofilm group achieved a ≥3 log drop in P. aeruginosa sputum density (difference -0.03, 95% CI -0.5 to 0.4, p=0.9). Lung function improvements were similar in both groups. Biofilm antimicrobial susceptibility testing did not lead to improved microbiological or clinical outcomes compared to conventional methods in the treatment of pulmonary exacerbations in CF patients with chronic P. aeruginosa.


Assuntos
Antibacterianos , Biofilmes , Fibrose Cística , Testes de Sensibilidade Microbiana , Infecções por Pseudomonas , Pseudomonas aeruginosa , Antibacterianos/classificação , Antibacterianos/uso terapêutico , Biofilmes/efeitos dos fármacos , Biofilmes/crescimento & desenvolvimento , Canadá , Criança , Fibrose Cística/complicações , Fibrose Cística/microbiologia , Método Duplo-Cego , Feminino , Humanos , Masculino , Testes de Sensibilidade Microbiana/métodos , Testes de Sensibilidade Microbiana/estatística & dados numéricos , Infecções por Pseudomonas/diagnóstico , Infecções por Pseudomonas/tratamento farmacológico , Infecções por Pseudomonas/etiologia , Pseudomonas aeruginosa/efeitos dos fármacos , Pseudomonas aeruginosa/fisiologia , Reprodutibilidade dos Testes , Testes de Função Respiratória/métodos , Escarro/efeitos dos fármacos , Escarro/microbiologia , Resultado do Tratamento
18.
Chest ; 144(4): 1207-1215, 2013 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-23788287

RESUMO

BACKGROUND: Thrombocytopenia is the most common hemostatic disorder in critically ill patients. The objective of this study was to describe the incidence, risk factors, and outcomes of thrombocytopenia in patients admitted to medical-surgical ICUs. METHODS: Three thousand seven hundred forty-six patients in 67 centers were enrolled in a randomized trial in which unfractionated heparin was compared with low-molecular-weight heparin (LMWH) for thromboprophylaxis. Patients who had baseline platelet counts < 75 × 10(9)/L or severe coagulopathy at screening were excluded. We analyzed the risk of developing mild (100-149 × 10(9)/L), moderate (50-99 × 10(9)/L), and severe (< 50 × 109/L) thrombocytopenia during an ICU stay. We also assessed independent and time-varying predictors of thrombocytopenia and the effect of thrombocytopenia on major bleeding, transfusions, and death. RESULTS: The incidences of mild, moderate, and severe thrombocytopenia were 15.3%, 5.1%, and 1.6%, respectively. The predictors of each category of thrombocytopenia were APACHE (Acute Physiology and Chronic Health Evaluation) II score, use of inotropes or vasopressors, and renal replacement therapy. The risk of moderate thrombocytopenia was lower in patients who received LMWH thromboprophylaxis but higher in surgical patients and in patients who had liver disease. Each category of thrombocytopenia was associated with subsequent bleeding and transfusions. Moderate and severe thrombocytopenia were associated with increased ICU and hospital mortality. CONCLUSION: A high severity of illness, prior surgery, use of inotropes or vasopressors, renal replacement therapy, and liver dysfunction are associated with a higher risk of thrombocytopenia developing in the ICU, whereas LMWH thromboprophylaxis is associated with a lower risk. Patients who develop thrombocytopenia in the ICU are more likely to bleed, receive transfusions, and die.


Assuntos
Anticoagulantes/uso terapêutico , Heparina de Baixo Peso Molecular/uso terapêutico , Heparina/uso terapêutico , Trombocitopenia/epidemiologia , Estado Terminal , Feminino , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Fatores de Risco , Método Simples-Cego , Resultado do Tratamento
19.
Respir Care ; 57(11): 1842-9, 2012 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-22613634

RESUMO

BACKGROUND: There are limited data on the safety and efficacy of recruitment maneuvers (RMs) in acute lung injury (ALI) patients. OBJECTIVE: To evaluate the frequency, timing, and risk factors for complications from RMs in adult ALI patients. METHODS: Secondary analysis of data from a randomized controlled trial of a lung open ventilation strategy that included sustained inflation RMs. RESULTS: Respiratory (eg, desaturation) and cardiovascular (eg, hypotension) complications from recruitment maneuvers were common (22% of all patients receiving RMs), and the majority occurred within 7 days of enrollment. New air leak through an existing chest tube was uncommon (< 5%). As compared to patients receiving 1 or fewer RMs, the number of RMs received was associated with increased risk in both younger (age ≤ 56 y) and older patients (age > 56 y): 2 RMs odds ratio [OR] 6.92 (95% CI 1.70-28.2), ≥ 3 RMs OR 15.4 (95% CI 4.77-49.6), and 2 RMs OR 5.43 (95% CI 1.76-16.8), ≥ 3 RMs OR 4.93 (95% CI 1.78-13.7), respectively. Patients with extrapulmonary ALI had decreased odds of developing complications (OR 0.42, 95% CI 0.22-0.80). CONCLUSIONS: Complications in adult ALI patients receiving RMs were common, but serious complications (eg, new air leak through an existing chest tube) were infrequent. There is a significant association between the number of RMs received and complications, even after controlling for illness severity and duration. Given their uncertain benefit in ALI patients, and the potential for complications with repeated application, the routine use of sustained inflation RMs is not justified.


Assuntos
Lesão Pulmonar Aguda/terapia , Respiração Artificial/efeitos adversos , Terapia Respiratória/efeitos adversos , Lesão Pulmonar Aguda/fisiopatologia , Adulto , Idoso , Interpretação Estatística de Dados , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Ensaios Clínicos Controlados Aleatórios como Assunto , Testes de Função Respiratória , Fatores de Risco
20.
PLoS One ; 7(4): e36077, 2012.
Artigo em Inglês | MEDLINE | ID: mdl-22563440

RESUMO

BACKGROUND: Many patients with cystic fibrosis develop persistent airway infection/colonization with Aspergillus fumigatus, however the impact of A. fumigatus on clinical outcomes remains unclear. The objective of this study was to determine whether treatment directed against Aspergillus fumigatus improves pulmonary function and clinical outcomes in patients with cystic fibrosis (CF). METHODS: We performed a double-blind randomized placebo-controlled pilot clinical trial involving 35 patients with CF whose sputum cultures were chronically positive for A. fumigatus. Participants were centrally randomized to receive either oral itraconazole 5 mg/kg/d (N = 18) or placebo (N = 17) for 24 weeks. The primary outcome was the proportion of patients who experienced a respiratory exacerbation requiring intravenous antibiotics over the 24 week treatment period. Secondary outcomes included changes in FEV(1) and quality of life. RESULTS: Over the 24 week treatment period, 4 of 18 (22%) patients randomized to itraconazole experienced a respiratory exacerbation requiring intravenous antibiotics, compared to 5 of 16 (31%) placebo treated patients, P = 0.70. FEV(1) declined by 4.62% over 24 weeks in the patients randomized to itraconazole, compared to a 0.32% improvement in the placebo group (between group difference = -4.94%, 95% CI: -15.33 to 5.45, P = 0.34). Quality of life did not differ between the 2 treatment groups throughout the study. Therapeutic itraconazole blood levels were not achieved in 43% of patients randomized to itraconazole. CONCLUSION: We did not identify clinical benefit from itraconazole treatment for CF patients whose sputum was chronically colonized with A. fumigatus. Limitations of this pilot study were its small sample size, and failure to achieve therapeutic levels of itraconazole in many patients. TRIAL REGISTRATION: ClinicalTrials.gov NCT00528190.


Assuntos
Aspergillus fumigatus/patogenicidade , Fibrose Cística/tratamento farmacológico , Administração Oral , Adolescente , Adulto , Antifúngicos/uso terapêutico , Aspergilose/complicações , Aspergilose/tratamento farmacológico , Criança , Fibrose Cística/complicações , Fibrose Cística/fisiopatologia , Método Duplo-Cego , Feminino , Volume Expiratório Forçado , Hospitalização , Humanos , Injeções Intravenosas , Itraconazol/uso terapêutico , Pulmão/fisiopatologia , Masculino , Projetos Piloto , Efeito Placebo , Qualidade de Vida , Testes de Função Respiratória , Escarro/microbiologia , Fatores de Tempo , Adulto Jovem
SELEÇÃO DE REFERÊNCIAS
DETALHE DA PESQUISA