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1.
Respir Res ; 25(1): 236, 2024 Jun 06.
Artigo em Inglês | MEDLINE | ID: mdl-38844921

RESUMO

BACKGROUND: The effect of dual systemic antibiotic therapy against Pseudomonas aeruginosa in patients with pre-existing lung disease is unknown. To assess whether dual systemic antibiotics against P. aeruginosa in outpatients with COPD, non-cystic fibrosis (non-CF) bronchiectasis, or asthma can improve outcomes. METHODS: Multicenter, randomised, open-label trial conducted at seven respiratory outpatient clinics in Denmark. Outpatients with COPD, non-CF bronchiectasis, or asthma with a current P. aeruginosa-positive lower respiratory tract culture (clinical routine samples obtained based on symptoms of exacerbation not requiring hospitalisation), regardless of prior P. aeruginosa-status, no current need for hospitalisation, and at least two moderate or one hospitalisation-requiring exacerbation within the last year were eligible. Patients were assigned 1:1 to 14 days of dual systemic anti-pseudomonal antibiotics or no antibiotic treatment. Primary outcome was time to prednisolone or antibiotic-requiring exacerbation or death from day 20 to day 365. RESULTS: The trial was stopped prematurely based in lack of recruitment during the COVID-19 pandemic, this decision was endorsed by the Data and Safety Monitoring Board. Forty-nine outpatients were included in the study. There was a reduction in risk of the primary outcome in the antibiotic group compared to the control group (HR 0.51 (95%CI 0.27-0.96), p = 0.037). The incidence of admissions with exacerbation within one year was 1.1 (95%CI 0.6-1.7) in the dual antibiotic group vs. 2.9 (95%CI 1.3-4.5) in the control group, p = 0.037. CONCLUSIONS: Use of dual systemic antibiotics for 14 days against P. aeruginosa in outpatients with chronic lung diseases and no judged need for hospitalisation, improved clinical outcomes markedly. The main limitation was the premature closure of the trial. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03262142, registration date 2017-08-25.


Assuntos
Antibacterianos , Pacientes Ambulatoriais , Infecções por Pseudomonas , Pseudomonas aeruginosa , Humanos , Masculino , Feminino , Infecções por Pseudomonas/tratamento farmacológico , Infecções por Pseudomonas/microbiologia , Infecções por Pseudomonas/diagnóstico , Infecções por Pseudomonas/epidemiologia , Antibacterianos/uso terapêutico , Idoso , Pessoa de Meia-Idade , Pseudomonas aeruginosa/efeitos dos fármacos , Pseudomonas aeruginosa/isolamento & purificação , Dinamarca/epidemiologia , Progressão da Doença , Resultado do Tratamento , Hospitalização , Doença Pulmonar Obstrutiva Crônica/tratamento farmacológico , Doença Pulmonar Obstrutiva Crônica/microbiologia , Doença Pulmonar Obstrutiva Crônica/diagnóstico
2.
Eur Clin Respir J ; 10(1): 2257993, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-37746028

RESUMO

Introduction: It remains unclear whether long-term non-invasive ventilation (LT-NIV) for patients with chronic obstructive pulmonary disease (COPD) improves survival and reduces admissions as results from randomized trials are inconsistent. We aim to determine whether LT-NIV initiated after an admission with acute hypercapnic respiratory failure (AHRF) can affect survival and admission rate in COPD patients. Methods: A randomized controlled open-label trial, allocating patients with COPD to LT-NIV or standard of care immediately after an admission with AHRF treated with acute NIV. LT-NIV was aimed to normalize PaCO2 using high-pressure NIV. Results: The study was discontinued before full sample size due to slow recruitment. 28 patients were randomized to LT-NIV and 27 patients to standard of care. 42% of patients had a history of ≥ 2 admissions with AHRF. Median IPAP was 24 cmH2O (IQR 20-28). The primary outcome, time to readmission with AHRF or death within 12 months, did not reach significance, hazard ratio 0.53 (95% CI 0.25-1.12) p = 0.097. In a competing risk analysis, adjusted for history of AHRF, the odds ratio for AHRF within 12 months was 0.30 (95% CI 0.11-0.87) p = 0.024. The LT-NIV group had less exacerbations (median 1 (0-1) vs 2 (1-4) p = 0.021) and readmissions with AHRF (median 0 (0-1) vs 1 (0-1) p = 0.016). Conclusion: The risk of the primary outcome, time to readmission with AHRF or death within 12 months was numerically smaller in the LT-NIV group, however, did not reach significance. Nevertheless, several secondary outcome analyses like risk of AHRF, number of episodes of AHRF and exacerbations were all significantly reduced in favour of high-pressure LT-NIV, especially in patients with frequent AHRF.

3.
Trials ; 23(1): 817, 2022 Sep 27.
Artigo em Inglês | MEDLINE | ID: mdl-36167555

RESUMO

BACKGROUND: Pseudomonas aeruginosa infection is seen in chronic pulmonary disease and is associated with exacerbations and poor long-term prognosis. However, evidence-based guidelines for the management and treatment of P. aeruginosa infection in chronic, non-cystic fibrosis (CF) pulmonary disease are lacking. The aim of this study is to investigate whether targeted antibiotic treatment against P. aeruginosa can reduce exacerbations and mortality in patients with chronic obstructive pulmonary disease (COPD), non-CF bronchiectasis, and asthma. METHODS: This study is an ongoing multicenter, randomized, controlled, open-label trial. A total of 150 patients with COPD, non-CF bronchiectasis or asthma, and P. aeruginosa-positive lower respiratory tract samples will be randomly assigned with a 1:1 ratio to either no antibiotic treatment or anti-pseudomonal antibiotic treatment with intravenous beta-lactam and oral ciprofloxacin for 14 days. The primary outcome, analyzed with two co-primary endpoints, is (i) time to prednisolone and/or antibiotic requiring exacerbation or death, in the primary or secondary health sector, within days 20-365 from study allocation and (ii) days alive and without exacerbation within days 20-365 from the study allocation. DISCUSSION: This trial will determine whether targeted antibiotics can benefit future patients with chronic, non-CF pulmonary disease and P. aeruginosa infection in terms of reduced morbidity and mortality, thus optimizing therapeutic approaches in this large group of chronic patients. TRIAL REGISTRATION: ClinicalTrials.gov NCT03262142 . Registered on August 25, 2017.


Assuntos
Asma , Bronquiectasia , Doença Pulmonar Obstrutiva Crônica , Antibacterianos/efeitos adversos , Asma/complicações , Asma/diagnóstico , Asma/tratamento farmacológico , Bronquiectasia/diagnóstico , Bronquiectasia/tratamento farmacológico , Ciprofloxacina/efeitos adversos , Fibrose , Humanos , Prednisolona/uso terapêutico , Prognóstico , Pseudomonas aeruginosa , Doença Pulmonar Obstrutiva Crônica/tratamento farmacológico , beta-Lactamas
4.
Clin Microbiol Infect ; 28(7): 990-995, 2022 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-35124256

RESUMO

OBJECTIVES: It is unclear whether recurrent sputum culture with Pseudomonas aeruginosa from patients with chronic obstructive pulmonary disease (COPD) is caused by intermittent airway carriage by different P. aeruginosa lineages or persistent carriage by the same lineage, and whether lineages genetically adapt during carriage. METHODS: Whole-genome sequencing was performed for P. aeruginosa isolates sampled longitudinally from sputum cultures in patients with COPD who were enrolled in an ongoing randomized controlled trial (clinicaltrials.gov: NCT03262142). RESULTS: A total of 153 P. aeruginosa isolates were sequenced for 23 patients during 365 days of follow-up. Recurrent presence of P. aeruginosa was seen in 19 patients (83%) and was caused by persistence of the same clonal lineage in all but one patient. We identified 38 genes mutated in parallel in two or more lineages, suggesting positive selection for adaptive mutations. Mutational enrichment analysis revealed genes important in antibiotic resistance and chronic infections to be more frequently mutated. DISCUSSION: Recurrent P. aeruginosa was common and carried for a prolonged time after initial detection in the airways of patients with COPD. Recurrence was caused by persistence of the same clonal lineage and was associated with genetic adaptation. Trial data on possible clinical benefits of attempting antibiotic eradication of P. aeruginosa in COPD are warranted.


Assuntos
Infecções por Pseudomonas , Doença Pulmonar Obstrutiva Crônica , Antibacterianos/farmacologia , Antibacterianos/uso terapêutico , Humanos , Infecções por Pseudomonas/tratamento farmacológico , Pseudomonas aeruginosa/genética , Doença Pulmonar Obstrutiva Crônica/complicações , Doença Pulmonar Obstrutiva Crônica/microbiologia , Sistema Respiratório/microbiologia
5.
ERJ Open Res ; 7(3)2021 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-34345629

RESUMO

BACKGROUND: There are emerging data of long-term effects of coronavirus disease 2019 (COVID-19) comprising a diversity of symptoms. The aim of this study was to systematically describe and measure pulmonary and extra-pulmonary post-COVID-19 complications in relation to acute COVID-19 severity. METHODS: Patients attending a standard of care 3 months post-hospitalisation follow-up visit and those referred by their general practitioner because of persistent post-COVID-19 symptoms were included. Patients underwent symptomatic, quality of life, pulmonary (lung function and high-resolution computed tomography (HRCT)), cardiac (high-resolution ECG), physical (1-min sit and stand test (1-MSTST), handgrip strength, cardiopulmonary exercise testing (CPET)) and cognitive evaluations. RESULTS: All 34 hospitalised and 22 out of 23 non-hospitalised patients had ≥1 complaint or abnormal finding at follow-up. Overall, 67% of patients were symptomatic (Medical Research Council (MRC) ≥2 or COPD assessment test (CAT) ≥10), with no difference between hospitalised versus non-hospitalised patients. Pulmonary function (forced expiratory volume in 1 s (FEV1) or diffusing capacity of the lung for carbon monoxide (D LCO)) <80% of predicted) was impaired in 68% of patients. D LCO was significantly lower in those hospitalised compared to non-hospitalised (70.1±18.0 versus 80.2±11.2% predicted, p=0.02). Overall, 53% had an abnormal HRCT (predominantly ground-glass opacities) with higher composite computed tomography (CT) scores in hospitalised versus non-hospitalised patients (2.3 (0.1-4.8) and 0.0 (0.0-0.3), p<0.001). 1-MSTST was below the 25th percentile in almost half of patients, but no signs of cardiac dysfunction were found. Cognitive impairments were present in 59-66% of hospitalised and 31-44% of non-hospitalised patients (p=0.08). CONCLUSION: Three months after COVID-19 infection, patients were still symptomatic and demonstrated objective respiratory, functional, radiological and cognitive abnormalities, which were more prominent in hospitalised patients. Our study underlines the importance of multidimensional management strategies in these patients.

6.
Respir Res ; 21(1): 263, 2020 Oct 12.
Artigo em Inglês | MEDLINE | ID: mdl-33046053

RESUMO

BACKGROUND: Long-term treatment with corticosteroids causes loss of bone density, but the effects of using short-term high-dose systemic-corticosteroid therapy to treat acute exacerbations of chronic obstructive pulmonary disease (AECOPD) are unclear. Our aim was to determine whether high-dose corticosteroid therapy affected bone turnover markers (BTMs) to a greater extent compared to low-dose corticosteroid therapy. METHODS: The CORTICO-COP trial (NCT02857842) showed that an eosinophil-guided corticosteroid intervention led to approximately 60% lower accumulated corticosteroid dose for hospitalized patients with AECOPD (low-dose group) compared with 5-day standard corticosteroid treatment (high-dose group). We compared the levels of BTMs C-terminal telopeptide of type 1 collagen (CTX) and procollagen type 1 N-terminal propeptide (P1NP) in 318 participants during AECOPD and at 1- and 3-month follow-up visits. RESULTS: CTX decreased and P1NP increased significantly over time in both treatment groups. There were no significant differences between the groups at 1- or 3-months follow-up for P1NP. A significant drop in CTX was seen at 3 months (down Δ24% from the baseline, p = 0.017) for the high dose group. CONCLUSION: Short-term, high-dose systemic corticosteroid treatment caused a rapid suppression of biomarkers of bone resorption. Corticosteroids did not suppress biomarkers of bone formation, regardless of patients receiving low or high doses of corticosteroids. This therapy was, therefore, harmless in terms of bone safety, in our prospective series of COPD patients. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02857842 . Submitted August 2nd, 2016.


Assuntos
Corticosteroides/administração & dosagem , Remodelação Óssea/efeitos dos fármacos , Doença Pulmonar Obstrutiva Crônica/tratamento farmacológico , Doença Pulmonar Obstrutiva Crônica/metabolismo , Idoso , Idoso de 80 Anos ou mais , Biomarcadores/metabolismo , Remodelação Óssea/fisiologia , Esquema de Medicação , Eosinófilos/efeitos dos fármacos , Eosinófilos/metabolismo , Feminino , Seguimentos , Humanos , Masculino , Doença Pulmonar Obstrutiva Crônica/diagnóstico
7.
Respir Med ; 172: 106129, 2020 10.
Artigo em Inglês | MEDLINE | ID: mdl-32905893

RESUMO

Between March 2016 and October 2017, we randomised 134 patients with severe COPD from 8 hospitals in the Capital Region of Denmark to participate in either standardised, outpatient pulmonary rehabilitation (control group) or on-line, supervised and home-based tele-rehabilitation (intervention group). We found no difference between the groups in the primary outcome: six minutes walking distance (6MWD) after completion of the programme. The current study presents results from the 12-month follow-up with assessment of the 6MWD and analyses of hospitalisation and mortality. There were no significant differences between or within the groups in the 6MWD one year after completion of the programme.


Assuntos
Modalidades de Fisioterapia , Doença Pulmonar Obstrutiva Crônica/fisiopatologia , Doença Pulmonar Obstrutiva Crônica/reabilitação , Telerreabilitação/métodos , Idoso , Feminino , Seguimentos , Hospitalização/estatística & dados numéricos , Humanos , Masculino , Doença Pulmonar Obstrutiva Crônica/mortalidade , Índice de Gravidade de Doença , Fatores de Tempo , Resultado do Tratamento , Teste de Caminhada
8.
Lancet Respir Med ; 7(8): 699-709, 2019 08.
Artigo em Inglês | MEDLINE | ID: mdl-31122894

RESUMO

BACKGROUND: Treatment with systemic corticosteroids in patients with acute exacerbations of chronic obstructive pulmonary disease (COPD) is associated with debilitating adverse effects. Therefore, strategies to reduce systemic corticosteroid exposure are urgently required and might be offered by a personalised biomarker-guided approach to treatment. The aim of this study was to determine whether an algorithm based on blood eosinophil counts could safely reduce systemic corticosteroid exposure in patients admitted to hospital with acute exacerbations of COPD. METHODS: We did a multicentre, randomised, controlled, open-label, non-inferiority trial at the respiratory departments of three different university-affiliated hospitals in Denmark. Eligible participants were patients included within 24h of admission to the participating sites, aged at least 40 years, with known airflow limitation (defined as a post-bronchodilator FEV1/forced vital capacity [FVC] ratio ≤0·70) and a specialist-verified diagnosis of COPD, who were designated to start on systemic corticosteroids by the respiratory medicine physician on duty. We randomly assigned patients (1:1) to either eosinophil-guided therapy or standard therapy with systemic corticosteroids. Both investigators and patients were aware of the group assignment. All patients received 80 mg of intravenous methylprednisolone on the first day. The eosinophil-guided group were from the second day given 37·5 mg of prednisolone oral tablet daily (for a maximum of up to 4 days) on days when their blood eosinophil count was at least 0·3 × 109 cells per L. On days when the eosinophil count was lower, prednisolone was not administered. If a patient was discharged during the treatment period, a treatment based on the last measured eosinophil count was prescribed for the remaining days within the 5-day period (last observation carried forward). The control group received 37·5 mg of prednisolone tablets daily from the second day for 4 days. The primary outcome was the number of days alive and out of hospital within 14 days after recruitment, assessed by intention to treat (ITT). Secondary outcomes included treatment failure at day 30 (ie, recurrence of acute exacerbation of COPD resulting in emergency room visits, admission to hospital, or need to intensify pharmacological treatment), number of deaths on day 30, and duration of treatment with systemic corticosteroids. The non-inferiority margin was 1·2 days (SD 3·8). This trial is registered at ClinicalTrials.gov, number NCT02857842, and was completed in January, 2019. FINDINGS: Between Aug 3, 2016, and Sept 30, 2018, 159 patients in the eosinophil-guided group and 159 patients in the control group were included in the ITT analyses. There was no between-group difference for days alive and out of hospital within 14 days after recruitment: mean 8·9 days (95% CI 8·3-9·6) in the eosinophil-guided group versus 9·3 days (8·7-9·9) in the control group (absolute difference -0·4, 95% CI -1·3 to 0·5; p=0·34). Treatment failure at 30 days occurred in 42 (26%) of 159 patients in the eosinophil-guided group and 41 (26%) of 159 in the control group (difference 0·6%, 95% CI -9·0 to 10·3; p=0·90). At 30 days nine patients (6%) of 159 in the eosinophil-guided group and six (4%) of 159 in the control group had died (difference 1·9%, 95% CI -2·8 to 6·5; p=0·43). Median duration of systemic corticosteroid therapy was lower in the eosinophil-guided group: 2 days (IQR 1·0 to 3·0) compared with 5 days (5·0 to 5·0) in the control group, p<0·0001. INTERPRETATION: Eosinophil-guided therapy was non-inferior compared with standard care for the number of days alive and out of hospital, and reduced the duration of systemic corticosteroid exposure, although we could not entirely exclude harm on some secondary outcome measures. Larger studies will help to determine the full safety profile of this strategy and its role in the management of COPD exacerbations. FUNDING: The Danish Regions Medical Fund and the Danish Council for Independent Research.


Assuntos
Eosinófilos/efeitos dos fármacos , Glucocorticoides/uso terapêutico , Metilprednisolona/uso terapêutico , Prednisolona/uso terapêutico , Doença Pulmonar Obstrutiva Crônica/tratamento farmacológico , Administração Oral , Idoso , Idoso de 80 Anos ou mais , Biomarcadores/sangue , Dinamarca , Feminino , Humanos , Masculino , Resultado do Tratamento
9.
Eur Clin Respir J ; 6(1): 1571332, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-30728926

RESUMO

Introduction: Hospital mortality among chronic obstructive pulmonary disease (COPD) patients receiving NIV for acute respiratory failure has shown to be significantly higher in clinical settings than in the randomized trials (RCTs) which clinical guidelines are based on. This may be due to the quality of care of NIV or patient selection. In daily clinical practice, we include patients with terminal pulmonary disease with a do-not-intubate (DNI) or a do-not-resuscitate (DNR) order with a high mortality risk compared to highly selected patients in RCTs. The aim of this study was to determine the role of patient selection for in-hospital mortality among patients receiving NIV for acute respiratory failure of COPD. Methods: We conducted a retrospective study including all patients receiving acute NIV due to acute respiratory failure at the respiratory wards in 2012-2013 at two hospitals in Greater Copenhagen. Results: Overall in-hospital mortality rate was 30%. In patients with a DNI/DNR order, mortality was 59% and in patients with no limitations in treatment 2%. Patients who fulfilled the exclusion criteria of the RCT by Plant et al. had a mortality of 41% compared to 25% in the remaining population. Conclusions: High overall in-hospital mortality reflects that patient selection in clinical practice is very different from RCT. Quality of acute NIV treatment seems acceptable in clinical practice for patients with less severe COPD and no limitations in treatment. Higher mortality in patients with DNI/DNR order may be due to inefficient NIV treatment for these patients with more severe COPD.

10.
BMC Pulm Med ; 17(1): 114, 2017 Aug 15.
Artigo em Inglês | MEDLINE | ID: mdl-28810909

RESUMO

BACKGROUND: The most commonly applied treatment for acute exacerbations of chronic obstructive pulmonary disease (AECOPD) is a 5-day course of high-dose systemic corticosteroids. However, this treatment has not been shown to reduce mortality and can potentially have serious side effects. Recent research has shown that, presumably, only a subgroup of COPD patients identifieable by blood eosinophil count benefit from a rescue course of prednisolone. By applying a biomarker-guided strategy, the aim of this study is to determine whether it is possible to reduce the use of systemic corticosteroids in AECOPD without influencing the outcome. METHODS: This is an ongoing prospective multicenter randomized controlled open label trial comprising 320 patients with AECOPD recruited from four hospitals in Denmark. The patients are randomized 1:1 to either standard care or eosinophil-guided corticosteroid-sparing therapy where prednisolone is not administered if the daily blood sampling reveals an eosinophil level below 0.3 × 109 cells/L. The primary endpoint is length of hospital stay within 14 days after recruitment. The secondary endpoints are treatment failure, 30-day mortality rate, COPD related re-admission rate, change in FEV1, and a number of adverse effect measures obtained within 3 months after the index hospitalisation date related to corticosteroid usage. DISCUSSION: This will be a very large RCT providing knowledge about the effectiveness of individualized biomarker-guided corticosteroid therapy in hospitalised patients with AECOPD. TRIAL REGISTRATION: Clinicaltrials.gov, NCT02857842 , 02-august-2016. Clinicaltrialregister.eu: Classification Code: 10,010,953, 02-marts-2016.


Assuntos
Eosinofilia/sangue , Glucocorticoides/uso terapêutico , Tempo de Internação/estatística & dados numéricos , Prednisolona/uso terapêutico , Doença Pulmonar Obstrutiva Crônica/tratamento farmacológico , Progressão da Doença , Eosinofilia/complicações , Eosinófilos , Hospitalização , Humanos , Contagem de Leucócitos , Mortalidade , Planejamento de Assistência ao Paciente , Readmissão do Paciente , Doença Pulmonar Obstrutiva Crônica/sangue , Doença Pulmonar Obstrutiva Crônica/complicações , Doença Pulmonar Obstrutiva Crônica/mortalidade , Falha de Tratamento , Resultado do Tratamento
11.
COPD ; 14(1): 30-36, 2017 02.
Artigo em Inglês | MEDLINE | ID: mdl-27723369

RESUMO

In severe COPD, patients having survived acute hypercapnic respiratory failure (AHRF) treated with noninvasive ventilation (NIV) have a high mortality and risk of readmissions. The aim was to analyze the prognosis for patients with COPD having survived AHRF and to assess whether previous admissions with NIV predict new ones.We conducted a retrospective follow-up analysis of 201 patients two years after NIV treatment of AHRF. Comparison of time-to-event in patients previously treated with NIV versus patients with no previous NIV treatment. We found a one-year mortality of 33.8% and high risks of: readmission (53.2%), any event (67.7%), and life-threatening events (49.8%). Patients with previous NIV treatments had an increased hazard ratio for life-threatening events: 1.60, p = 0.023 despite having lower in-hospital mortality than patients with no previous NIV treatment (18.9% vs. 33.1%, p = 0.043). We found that having survived one episode of AHRF considerably worsened the prognosis for the affected patients.The prognosis for patients having survived AHRF with NIV treatment is poor: the prognosis worsens with additional episodes of AHRF. Future research and treatment should focus on patients with repeated episodes of AHRF.


Assuntos
Hipercapnia/terapia , Ventilação não Invasiva/estatística & dados numéricos , Readmissão do Paciente/estatística & dados numéricos , Doença Pulmonar Obstrutiva Crônica/mortalidade , Doença Pulmonar Obstrutiva Crônica/terapia , Insuficiência Respiratória/terapia , Idoso , Dinamarca/epidemiologia , Feminino , Seguimentos , Mortalidade Hospitalar , Humanos , Hipercapnia/etiologia , Masculino , Prognóstico , Doença Pulmonar Obstrutiva Crônica/complicações , Recidiva , Insuficiência Respiratória/etiologia , Estudos Retrospectivos
12.
Artigo em Inglês | MEDLINE | ID: mdl-27382274

RESUMO

BACKGROUND: This study was conducted to investigate whether point-of-care (POC) procalcitonin (PCT) measurement can reduce redundant antibiotic treatment in patients hospitalized with acute exacerbation of COPD (AECOPD). METHODS: One-hundred and twenty adult patients admitted with AECOPD were enrolled in this open-label randomized trial. Patients were allocated to either the POC PCT-guided intervention arm (n=62) or the control arm, in which antibiotic therapy followed local guidelines (n=58). RESULTS: The median duration of antibiotic exposure was 3.5 (interquartile range [IQR] 0-10) days in the PCT-arm vs 8.5 (IQR 1-11) days in the control arm (P=0.0169, Wilcoxon) for the intention-to-treat population. The proportion of patients using antibiotics for ≥5 days within the 28-day follow-up was 41.9% (PCT-arm) vs 67.2% (P=0.006, Fisher's exact) in the intention-to-treat population. For the per-protocol population, the proportions were 21.1% (PCT-arm) vs 73.9% (P<0.00001, Fisher's exact). Within 28-day follow-up, one patient died in the PCT-arm and two died in the control arm. A composite harm end point consisting of death, rehospitalization, or intensive care unit admission, all within 28 days, showed no apparent difference. CONCLUSION: Our study shows that the implementation of a POC PCT-guided algorithm can be used to substantially reduce antibiotic exposure in patients hospitalized with AECOPD, with no apparent harm.


Assuntos
Antibacterianos/administração & dosagem , Calcitonina/sangue , Tomada de Decisão Clínica , Hospitalização , Pulmão/efeitos dos fármacos , Sistemas Automatizados de Assistência Junto ao Leito , Testes Imediatos , Doença Pulmonar Obstrutiva Crônica/tratamento farmacológico , Idoso , Idoso de 80 Anos ou mais , Algoritmos , Biomarcadores/sangue , Dinamarca , Progressão da Doença , Esquema de Medicação , Farmacorresistência Bacteriana , Feminino , Fidelidade a Diretrizes , Humanos , Pulmão/fisiopatologia , Masculino , Pessoa de Meia-Idade , Seleção de Pacientes , Guias de Prática Clínica como Assunto , Valor Preditivo dos Testes , Doença Pulmonar Obstrutiva Crônica/sangue , Doença Pulmonar Obstrutiva Crônica/diagnóstico , Doença Pulmonar Obstrutiva Crônica/fisiopatologia , Fatores de Tempo , Resultado do Tratamento , Procedimentos Desnecessários
13.
BMC Pulm Med ; 16: 32, 2016 Feb 12.
Artigo em Inglês | MEDLINE | ID: mdl-26867542

RESUMO

BACKGROUND: In chronic obstructive pulmonary disease, the prognosis for patients who have survived an episode of acute hypercapnic respiratory failure due to an exacerbation is poor. Despite being shown to improve survival and quality-of-life in stable patients with chronic hypercapnic respiratory failure, long-term noninvasive ventilation is controversial in unstable patients with frequent exacerbations, complicated by acute hypercapnic respiratory failure. In an uncontrolled group of patients with previous episodes of acute hypercapnic respiratory failure, treated with noninvasive ventilation, we have been able to reduce mortality and the number of repeat respiratory failure and readmissions by continuing the acute noninvasive ventilatory therapy as a long-term therapy. METHODS: Multi-center open label randomized controlled trial of 150 patients having survived an admission with noninvasive ventilatory treatment of acute hypercapnic respiratory failure due chronic obstructive pulmonary disease. The included patients are randomized to usual care or to continuing the acute noninvasive ventilation as a long-term therapy, both with a one-year follow-up period. The primary endpoint is time to death or repeat acute hypercapnic respiratory failure; secondary endpoints are one-year mortality, number of readmissions and repeat acute hypercapnic respiratory failure, exacerbations, dyspnea, quality of life, sleep quality, lung function, and arterial gases. DISCUSSION: Though previous studies of long-term noninvasive ventilation have shown conflicting results, we believe the treatment can reduce mortality and readmissions when applied in patients with previous need of acute ventilatory support, regardless of persistent hypercapnia. TRIAL REGISTRATION: clinicaltrials.org: NCT01513655 16-Jan-2012.


Assuntos
Serviços de Assistência Domiciliar , Ventilação não Invasiva/métodos , Doença Pulmonar Obstrutiva Crônica/terapia , Estudos de Coortes , Hospitalização , Humanos , Hipercapnia/epidemiologia , Readmissão do Paciente , Insuficiência Respiratória/epidemiologia , Estudos Retrospectivos , Taxa de Sobrevida
14.
Peptides ; 63: 90-5, 2015 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-25445610

RESUMO

Trefoil factors (TFFs) 1, 2 and 3 are small polypeptides that are co-secreted with mucin throughout the body. They are up-regulated in cancer and inflammatory processes in the gastrointestinal system, where they are proposed to be involved in tissue regeneration, proliferation and protection. Our aim was to explore their presence in pulmonary secretions and to investigate whether they are up-regulated in pulmonary diseases characterized by mucin hypersecretion. Bronchioalveolar lavage fluid was obtained from 92 individuals referred to bronchoscopy. The patients were grouped according to diagnosis and pulmonary function. The concentrations of TFF1, TFF2 and TFF3 were measured by ELISA. All three peptides were detected in bronchioalveolar lavage fluid. Patients with chronic obstructive pulmonary disease had concentrations two to three times above the levels in the healthy reference group, and patients with pulmonary malignancies had concentrations of TFF1 and TFF2 three times that of the reference group. The results suggest that TFFs are involved in tissue regeneration, proliferation and protection in lung diseases.


Assuntos
Peptídeos/metabolismo , Doença Pulmonar Obstrutiva Crônica/metabolismo , Adulto , Idoso , Idoso de 80 Anos ou mais , Líquido da Lavagem Broncoalveolar , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Doença Pulmonar Obstrutiva Crônica/patologia , Índice de Gravidade de Doença , Fator Trefoil-2
15.
Artigo em Inglês | MEDLINE | ID: mdl-26557242

RESUMO

BACKGROUND: Chronic obstructive pulmonary disease (COPD) is a major cause of morbidity and mortality. Furthermore, the prevalence of COPD is increasing, and it places an increasing burden on health care systems worldwide. Therefore, there is a growing interest in home telecare solutions that can help patients manage their disease at home and thereby possibly reduce the risk of readmission. PURPOSE: The primary aim of this study is to assess the feasibility of a telehealth care solution when offered in connection with discharges from a pulmonary ward at a university hospital. Secondary aims are to assess the reasons for the exclusion of patients, and the reasons for patients not consenting to participate, as well as to identify the predictors for consenting or not consenting among the subgroup of eligible patients. METHODS: In this study, all data in the screening log were collected over a period of 10 months. RESULTS: A total of 462 patients admitted with an acute exacerbation in COPD (AECOPD) were screened. Almost 70% of the patients were excluded, and 49% of the eligible patients did not consent. Thus, only 15.6% of the screened patients were included. No significant differences were found regarding known risk factors of readmission between the eligible patients, who were included, and those who did not consent. The only significant difference was that more patients in the group that consented are being followed up in our outpatient clinic, notably 84% versus 55.7% (p<0.001), suggesting that this telehealthcare solution is 25 more appealing to those patients who are already being followed up in the outpatient clinic. CONCLUSION: These findings emphasize the importance of designing telecare solutions that allow for the inclusion of the actual population of patients admitted with AECOPD.

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