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1.
Respiration ; 2024 May 29.
Artigo em Inglês | MEDLINE | ID: mdl-38810608

RESUMO

Based on the assessment of new evidence, the World Health Organization (WHO) updated its guidelines for the treatment of drug-resistant tuberculosis (TB) in December 2022. The new recommendations and the latest study data made it necessary to update the existing guideline on the treatment of at least rifampicin- (RR-TB) for the German-speaking countries, replacing the respective chapters of the treatment guidelines published 2022. A shortened treatment of proven RR-TB and multidrug-resistant (MDR)-TB for at least 6 months using the fixed and non-modifiable drug combination of bedaquiline, pretomanid, linezolid, and moxifloxacin (BPaLM) is now also recommended for Austria, Germany, and Switzerland under certain conditions considering the existing barriers for the implementation of the new treatment regimen. For the treatment of pre-extensively drug-resistant (pre-XDR)-TB, an individualized treatment for 18 months continues to be the primary recommendation. The non-modifiable drug combination of bedaquiline, pretomanid, and linezolid (BPaL) may be used alternatively in selected pre-XDR-TB cases, provided that all prerequisites are met. The necessary requirements for using BPaLM and BPaL are presented in detail in this amendment to the consensus-based TB treatment guideline for adult patients.

2.
Pneumologie ; 78(1): 35-46, 2024 Jan.
Artigo em Alemão | MEDLINE | ID: mdl-37931778

RESUMO

In December 2022, based on the assessment of new evidence, the World Health Organization (WHO) updated its guidelines for the treatment of drug-resistant tuberculosis (TB). The evaluation of both, these recommendations, and the latest study data, makes it necessary to update the existing guidelines on the treatment of at least rifampicin-resistant tuberculosis for the German-speaking region, hereby replacing the respective chapters. A shortened MDR-TB treatment of at least 6 month using the fixed and non-modifiable drug combination of bedaquiline, pretomanid, linezolid, and moxifloxacin (BPaLM) is now also recommended for Germany, Austria, and Switzerland under certain conditions. This recommendation applies to TB cases with proven rifampicin resistance, including rifampicin monoresistance. For treatment of pre-extensively drug resistant TB (pre-XDR-TB), an individualized treatment for 18 months adjusted to resistance data continues to be the primary recommendation. The non-modifiable drug combination of bedaquiline, pretomanid, and linezolid (BPaL) may be used alternatively in pre-XDR TB if all prerequisites are met. The necessary prerequisites for the use of BPaLM and BPaL are presented in this amendment to the S2k guideline for 'Tuberculosis in adulthood'.


Assuntos
Nitroimidazóis , Tuberculose Resistente a Múltiplos Medicamentos , Tuberculose , Humanos , Rifampina , Antituberculosos/uso terapêutico , Linezolida/uso terapêutico , Áustria , Suíça , Tuberculose Resistente a Múltiplos Medicamentos/tratamento farmacológico , Tuberculose/tratamento farmacológico , Alemanha , Combinação de Medicamentos
3.
Pneumologie ; 76(11): 727-819, 2022 Nov.
Artigo em Alemão | MEDLINE | ID: mdl-36384164

RESUMO

In Germany tuberculosis is a rare disease and usually well treatable. Worldwide it is one of the most common infectious diseases with approximately 10 million new cases every year. Even with low incidences in Germany, tuberculosis is an important differential diagnosis especially due to international developments and migration movements. With a decreasing experience there's a continuous demand on accurate and up-to-date information. This guideline covers all aspects of microbiological diagnostics, basic principles of standard therapy, treatment of extrapulmonary tuberculosis, management of side effects, special features of diagnosis and treatment of resistant tuberculosis, and treatment in TB-HIV coinfection. Also, it explains when treatment in specialized centers is required, aspects of care and legal regulations and the diagnosis and preventive therapy of latent tuberculosis infection. The update of the S2k guideline "Tuberculosis in Adults" is intended to serve as a guideline for prevention, diagnosis, and treatment of tuberculosis for all those involved in tuberculosis care and to help meet the current challenges in dealing with tuberculosis in Germany.


Assuntos
Infecções por HIV , Tuberculose Latente , Tuberculose , Adulto , Humanos , Antituberculosos/uso terapêutico , Tuberculose/diagnóstico , Tuberculose/prevenção & controle , Alemanha
4.
Respiration ; 101(3): 307-320, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-35231915

RESUMO

Assessing the risk for specific patient groups to suffer from severe courses of COVID-19 is of major importance in the current SARS-CoV-2 pandemic. This review focusses on the risk for specific patient groups with chronic respiratory conditions, such as patients with asthma, chronic obstructive pulmonary disease, cystic fibrosis (CF), sarcoidosis, interstitial lung diseases, lung cancer, sleep apnea, tuberculosis, neuromuscular diseases, a history of pulmonary embolism, and patients with lung transplants. Evidence and recommendations are detailed in exemplary cases. While some patient groups with chronic respiratory conditions have an increased risk for severe courses of COVID-19, an increasing number of studies confirm that asthma is not a risk factor for severe COVID-19. However, other risk factors such as higher age, obesity, male gender, diabetes, cardiovascular diseases, chronic kidney or liver disease, cerebrovascular and neurological disease, and various immunodeficiencies or treatments with immunosuppressants need to be taken into account when assessing the risk for severe COVID-19 in patients with chronic respiratory diseases.


Assuntos
COVID-19 , Médicos , Humanos , Masculino , Pandemias , Medição de Risco , SARS-CoV-2
6.
PLoS One ; 12(11): e0187882, 2017.
Artigo em Inglês | MEDLINE | ID: mdl-29125874

RESUMO

BACKGROUND: Blood based Interferon-(IFN)-γ release assays (IGRAs) have a poor predictive value for the development of tuberculosis. This study aimed to investigate the correlation between IGRAs and pulmonary immune responses in tuberculosis contacts in Germany. METHODS: IGRAs were performed on bronchoalveolar lavage (BAL) cells and peripheral blood from close healthy contacts of patients with culturally confirmed tuberculosis. Cellular BAL composition was determined by flow cytometry. BAL cells were co-cultured with three strains of Mycobacterium tuberculosis (Mtb) and Mtb derived antigens including Purified Protein Derivative (PPD), 6 kD Early Secretory Antigenic Target (ESAT-6) and 10 kD Culture Filtrate Protein (CFP-10). Levels of 29 cytokines and chemokines were analyzed in the supernatants by multiplex assay. Associations and effects were examined using linear mixed-effects models. RESULTS: There were wide variations of inter-individual cytokine levels in BAL cell culture supernatants. Mycobacterial infection and stimulation with PPD showed a clear induction of several macrophage and lymphocyte associated cytokines, reflecting activation of these cell types. No robust correlation between cytokine patterns and blood IGRA status of the donor was observed, except for slightly higher Interleukin-2 (IL-2) responses in BAL cells from IGRA-positive donors upon mycobacterial infection compared to cells from IGRA-negative donors. Stronger correlations were observed when cytokine patterns were stratified according to BAL IGRA status. BAL cells from donors with BAL IGRA-positive responses produced significantly more IFN-γ and IL-2 upon PPD stimulation and mycobacterial infection than cells from BAL IGRA-negative individuals. Correlations between BAL composition and basal cytokine release from unstimulated cells were suggestive of pre-activated lymphocytes but impaired macrophage activity in BAL IGRA-positive donors, in contrast to BAL IGRA-negative donors. CONCLUSIONS: In vitro BAL cell cytokine responses to M. tuberculosis antigens or infection do not reflect blood IGRA status but do correlate with stronger cellular responses in BAL IGRA-positive donors. The cytokine patterns observed suggest a pre-activated state of lymphocytes and suppressed macrophage responsiveness in BAL cells from BAL IGRA-positive individuals.


Assuntos
Pulmão/imunologia , Mycobacterium tuberculosis/imunologia , Líquido da Lavagem Broncoalveolar , Alemanha , Humanos
7.
Pneumologie ; 71(6): 325-397, 2017 Jun.
Artigo em Alemão | MEDLINE | ID: mdl-28651293

RESUMO

Since 2015 a significant increase in tuberculosis cases is notified in Germany, mostly due to rising numbers of migrants connected to the recent refugee crisis. Because of the low incidence in previous years, knowledge on tuberculosis is more and more limited to specialized centers. However, lung specialist and healthcare workers of other fields have contact to an increasing number of tuberculosis patients. In this situation, guidance for the management of standard therapy and especially for uncommon situations will be essential. This new guideline on tuberculosis in adults gives recommendations on diagnosis, treatment, prevention and prophylaxis. It provides a comprehensive overview over the current knowledge, adapted to the specific situation in Germany. The German Central Committee against Tuberculosis (DZK e. V.) realized this guideline on behalf of the German Respiratory Society (DGP). A specific guideline for tuberculosis in the pediatrics field will be published separately. Compared to the former recommendations of the year 2012, microbiological diagnostics and therapeutic drug management were given own sections. Chapters about the treatment of drug-resistant tuberculosis, tuberculosis in people living with HIV and pharmacological management were extended. This revised guideline aims to be a useful tool for practitioners and other health care providers to deal with the recent challenges of tuberculosis treatment in Germany.


Assuntos
Antituberculosos/uso terapêutico , Tuberculose Pulmonar/diagnóstico , Infecções Oportunistas Relacionadas com a AIDS/diagnóstico , Infecções Oportunistas Relacionadas com a AIDS/tratamento farmacológico , Infecções Oportunistas Relacionadas com a AIDS/epidemiologia , Infecções Oportunistas Relacionadas com a AIDS/prevenção & controle , Adulto , Antituberculosos/efeitos adversos , Técnicas Bacteriológicas , Estudos Transversais , Emigrantes e Imigrantes/estatística & dados numéricos , Alemanha , Humanos , Refugiados/estatística & dados numéricos , Sociedades Médicas , Tuberculose Resistente a Múltiplos Medicamentos/diagnóstico , Tuberculose Resistente a Múltiplos Medicamentos/tratamento farmacológico , Tuberculose Resistente a Múltiplos Medicamentos/epidemiologia , Tuberculose Resistente a Múltiplos Medicamentos/prevenção & controle , Tuberculose Pulmonar/tratamento farmacológico , Tuberculose Pulmonar/epidemiologia , Tuberculose Pulmonar/prevenção & controle
8.
Infection ; 45(3): 283-290, 2017 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-27866367

RESUMO

PURPOSE: Few individuals that are latently infected with M. tuberculosis latent tuberculosis infection(LTBI) progress to active disease. We investigated risk factors for LTBI and active pulmonary tuberculosis (PTB) in Germany. METHODS: Healthy household contacts (HHCs), health care workers (HCWs) exposed to M. tuberculosis and PTB patients were recruited at 18 German centres. Interferon-γ release assay (IGRA) testing was performed. LTBI risk factors were evaluated by comparing IGRA-positive with IGRA-negative contacts. Risk factors for tuberculosis were evaluated by comparing PTB patients with HHCs. RESULTS: From 2008-2014, 603 HHCs, 295 HCWs and 856 PTBs were recruited. LTBI was found in 34.5% of HHCs and in 38.9% of HCWs. In HCWs, care for coughing patients (p = 0.02) and longstanding nursing occupation (p = 0.04) were associated with LTBI. In HHCs, predictors for LTBI were a diseased partner (odds ratio 4.39), sexual contact to a diseased partner and substance dependency (all p < 0.001). PTB was associated with male sex, low body weight (p < 0.0001), alcoholism (15.0 vs 5.9%; p < 0.0001), glucocorticoid therapy (7.2 vs 2.0%; p = 0.004) and diabetes (7.8 vs. 4.0%; p = 0.04). No contact developed active tuberculosis within 2 years follow-up. CONCLUSIONS: Positive IGRA responses are frequent among exposed HHCs and HCWs in Germany and are poor predictors for the development of active tuberculosis.


Assuntos
Tuberculose Latente/epidemiologia , Tuberculose Pulmonar/epidemiologia , Adulto , Idoso , Feminino , Alemanha/epidemiologia , Pessoal de Saúde/estatística & dados numéricos , Humanos , Testes de Liberação de Interferon-gama , Tuberculose Latente/microbiologia , Masculino , Pessoa de Meia-Idade , Prevalência , Fatores de Risco , Tuberculose Pulmonar/microbiologia , Adulto Jovem
9.
Eur Respir J ; 48(3): 808-17, 2016 09.
Artigo em Inglês | MEDLINE | ID: mdl-27492827

RESUMO

No evidence exists on tuberculosis (TB) and latent TB infection (LTBI) management policies among refugees in European countries.A questionnaire investigating screening and management practices among refugees was sent to 38 national TB programme representatives of low and intermediate TB incidence European countries/territories of the WHO European Region.Out of 36 responding countries, 31 (86.1%) reported screening for active TB, 19 for LTBI, and eight (22.2%) reporting outcomes of LTBI treatment. Screening for TB is based on algorithms including different combinations of symptom-based questionnaires, bacteriology and chest radiography and LTBI screening on different combinations of tuberculin skin test and interferon-γ release assays. In 22 (61.1%) countries, TB and LTBI screening are performed in refugee centres. In 22 (61.1%) countries, TB services are organised in collaboration with the private sector. 27 (75%) countries answered that screening for TB is performed as per national and international guidelines, while 19 (52.7%) gave the same answer with regards to LTBI screening. Infection control measures are inadequate in several of the countries surveyed.There is need for improved coordination of TB screening in Europe to implement the End TB Strategy and achieve TB elimination.


Assuntos
Testes de Liberação de Interferon-gama , Refugiados , Tuberculose/epidemiologia , Tuberculose/terapia , Algoritmos , Controle de Doenças Transmissíveis , Europa (Continente) , Humanos , Incidência , Tuberculose Latente/diagnóstico , Programas de Rastreamento , Guias de Prática Clínica como Assunto , Inquéritos e Questionários , Migrantes , Teste Tuberculínico , Tuberculose/diagnóstico , Organização Mundial da Saúde
10.
Open Forum Infect Dis ; 3(1): ofw011, 2016 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-26973849

RESUMO

Background. Antibiotic-associated diarrhea (AAD) and Clostridium difficile-associated diarrhea (CDAD) are common complications of antibiotic use. Data on the efficacy of probiotics to prevent AAD and CDAD are unclear. We aimed to evaluate the efficacy of Saccharomyces boulardii to prevent AAD and CDAD in hospitalized adult patients. Methods. We conducted a multicenter, phase III, double-masked, randomized, placebo-controlled trial in hospitalized patients who received systemic antibiotic treatment in 15 hospitals in Germany between July 2010 and October 2012. Participants received Perenterol forte 250 mg capsules or matching placebo twice per day within 24 hours of initiating antibiotic treatment, continued treatment for 7 days after antibiotic discontinuation, and were then observed for 6 weeks. Results. Two thousand four hundred forty-four patients were screened. The trial was stopped early for futility after inclusion of 477 participants. Two hundred forty-six patients aged 60.1 ± 16.5 years and 231 patients aged 56.5 ± 17.8 were randomized to the S boulardii group and the placebo group, respectively, with 21 and 19 AADs in the respective groups (P = .87). The hazard ratio of AAD in the S boulardii group compared with the placebo group was 1.02 (95% confidence interval, .55-1.90; P = .94). Clostridium difficile-associated diarrhea occurred in 0.8% of participants (4 of 477). Nine serious adverse events were recorded in the S boulardii group, and 3 serious adverse events were recorded in the placebo group. None were related to study participation. Conclusions. We found no evidence for an effect of S boulardii in preventing AAD or CDAD in a population of hospitalized patients without particular risk factors apart from systemic antibiotic treatment. ClinicalTrials.gov Identifier. NCT01143272.

12.
Dtsch Arztebl Int ; 113(47): 799-807, 2016 Nov 25.
Artigo em Inglês | MEDLINE | ID: mdl-28043323

RESUMO

BACKGROUND: Amantadine, oseltamivir, and zanamivir are currently available in Germany for the prevention and treatment of influenza. We review their efficacy and side-effect profiles. METHODS: This review is based on pertinent randomized and controlled trials (RCTs) and systematic reviews retrieved by a systematic literature search, and on other relevant literature. RESULTS: The efficacy of antiviral drugs for the prevention of symptomatic influenza ranges from 60% to 90% (number needed to treat [NNT], 8-89) depending on the population and type of drug in question. Antiviral drugs shorten the duration of illness by 0.5-1.5 days when given within 48 hours of the onset of symptoms. Neuraminidase inhibitors do not significantly lower the incidence of bronchitis in adults, or of otitis media in children; they do have a positive effect against reported, but not necessarily diagnostically confirmed pneumonia in adults (NNT, 89 [50-232]). The RCTs yielded no information about possible effects on severe cases of influenza, or on mortality, as they included only mildly or moderately ill patients, but observational studies have yielded some evidence of benefit. The most common side effects of oseltamivir (>10%) are headache, nausea, and vomiting; of zanamivir (>1%), a skin rash; and of amantadine (>1%), loss of appetite, nausea, and central nervous effects. CONCLUSION: The benefits of antiviral drugs, particularly neuraminidase inhibitors, outweigh their risks. In deciding whether to use them, physicians should consider the properties of the currently circulating viruses and the patient's individual risk constellation, as directed in clinical treatment recommendations.


Assuntos
Antivirais/uso terapêutico , Influenza Humana/tratamento farmacológico , Pandemias , Alemanha , Humanos , Neuraminidase/antagonistas & inibidores , Ensaios Clínicos Controlados Aleatórios como Assunto , Estações do Ano
13.
Respir Med ; 109(5): 632-41, 2015 May.
Artigo em Inglês | MEDLINE | ID: mdl-25862597

RESUMO

OBJECTIVE: To assess the cost-effectiveness of adding delamanid (Deltyba™) to a background regimen (BR) for treating multidrug-resistant tuberculosis (MDR-TB) in Germany. METHODS: The incremental cost-effectiveness of treating a cohort of MDR-TB patients, 38-years old on average, with Deltyba™ plus BR versus a five drug- BR regimen alone was compared in a Markov model over a period of 10 years. Cost per quality-adjusted life year (QALY) and disability-adjusted life years (DALY) were determined from a societal perspective. Recent data from a German cost calculation on MDR-TB were applied to the 24-month outcome results of patients participating in the placebo-controlled, phase II Otsuka's Trial 204. Costs and effectiveness were discounted at a rate of 3% and subjected to deterministic as well as probabilistic sensitivity analysis in a Monte Carlo simulation. RESULTS: Based on the current market prices the total discounted cost per patient on BR plus Deltyba™ was €142,732 compared to €150,909 for BR alone. The total discounted QALYs per patient were 8.47 for Deltyba™ versus 6.13 for BR alone. Accordingly, the addition of Deltyba™ proved to be dominant over the BR alone-strategy by simultaneously saving €8177 and gaining 2.34 QALYs. Deltyba™ was cost saving in 73% of probabilistic sensitivity analyses compared to BR alone and 100% cost effective at a willingness-to-pay (WTP) threshold of €10,000. CONCLUSIONS: Under conditions prevalent in Germany, Deltyba™ added to a five drug BR regimen is likely to be cost-saving compared to BR alone under a wide range of assumptions. Adding delamanid remained cost-effective when costs due to loss of productivity were excluded as the QALYs gained by lower lethality and a higher proportion of successfully treated patients outweighed the delamanid drug costs. These results strongly support the application of Deltyba™ in treating MDR-TB patients.


Assuntos
Antituberculosos/administração & dosagem , Antituberculosos/economia , Nitroimidazóis/administração & dosagem , Nitroimidazóis/economia , Oxazóis/administração & dosagem , Oxazóis/economia , Tuberculose Resistente a Múltiplos Medicamentos/tratamento farmacológico , Tuberculose Resistente a Múltiplos Medicamentos/economia , Adulto , Análise Custo-Benefício , Custos de Medicamentos , Feminino , Alemanha , Humanos , Masculino , Cadeias de Markov , Anos de Vida Ajustados por Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto , Falha de Tratamento , Resultado do Tratamento
14.
Tuberculosis (Edinb) ; 95(3): 321-7, 2015 May.
Artigo em Inglês | MEDLINE | ID: mdl-25794470

RESUMO

BACKGROUND: Childhood vaccination with Mycobacterium bovis Bacille Calmette-Guérin (BCG) reduces the risk of infection with Mycobacterium tuberculosis and the risk of severe forms of tuberculosis in children. The protection of adults from pulmonary tuberculosis is doubtful. This study evaluated the effect of the vaccination on the growth of M. tuberculosis human bronchoalveolar mononuclear cells (BALMC). METHODS: Healthy, adult healthcare workers who were regularly exposed to M. tuberculosis, household tuberculosis contacts, and cured tuberculosis patients were recruited in a multicentre study conducted in Germany. BALMC were co-cultured with different strains of M. tuberculosis in growth inhibition assays (MGIAs). RESULTS: MGIAs on BALMC were conducted in 90 contact persons (known vaccination status, n = 75) and 62 former tuberculosis patients (known status, n = 22). Growth rates for M. tuberculosis H37Rv in BALMC were independent of the vaccination status, both in healthy contacts and in cured tuberculosis patients. This finding was validated in growth inhibition assays using two different Haarlem M. tuberculosis outbreak strains. Subgroup analyses based on the Interferon-gamma release assay status found no impact of the vaccination on mycobacterial growth. CONCLUSIONS: This study suggests that M. bovis BCG vaccination does not alter the anti-mycobacterial capacity of BALMC as assessed in ex-vivo growth inhibition assays.


Assuntos
Vacina BCG/administração & dosagem , Líquido da Lavagem Broncoalveolar/microbiologia , Pessoal de Saúde , Mycobacterium tuberculosis/crescimento & desenvolvimento , Exposição Ocupacional , Tuberculose Pulmonar/prevenção & controle , Vacinação , Adulto , Fatores Etários , Líquido da Lavagem Broncoalveolar/citologia , Broncoscopia , Células Cultivadas , Criança , Busca de Comunicante , Estudos Transversais , Feminino , Alemanha , Habitação , Humanos , Esquemas de Imunização , Testes de Liberação de Interferon-gama , Masculino , Pessoa de Meia-Idade , Mycobacterium tuberculosis/imunologia , Tuberculose Pulmonar/imunologia , Tuberculose Pulmonar/microbiologia , Tuberculose Pulmonar/transmissão
16.
BMC Infect Dis ; 14: 40, 2014 Jan 22.
Artigo em Inglês | MEDLINE | ID: mdl-24450996

RESUMO

BACKGROUND: Routine annual influenza vaccination is primarily recommended for all persons aged 60 and above and for people with underlying chronic conditions in Germany. Other countries have already adopted additional childhood influenza immunisation programmes. The objective of this study is to determine the potential epidemiological impact of implementing paediatric influenza vaccination using intranasally administered live-attenuated influenza vaccine (LAIV) in Germany. METHODS: A deterministic age-structured model is used to simulate the population-level impact of different vaccination strategies on the transmission dynamics of seasonal influenza in Germany. In our base-case analysis, we estimate the effects of adding a LAIV-based immunisation programme targeting children 2 to 17 years of age to the existing influenza vaccination policy. The data used in the model is based on published evidence complemented by expert opinion. RESULTS: In our model, additional vaccination of children 2 to 17 years of age with LAIV leads to the prevention of 23.9 million influenza infections and nearly 16 million symptomatic influenza cases within 10 years. This reduction in burden of disease is not restricted to children. About one third of all adult cases can indirectly be prevented by LAIV immunisation of children. CONCLUSIONS: Our results demonstrate that vaccinating children 2-17 years of age is likely associated with a significant reduction in the burden of paediatric influenza. Furthermore, annual routine childhood vaccination against seasonal influenza is expected to decrease the incidence of influenza among adults and older people due to indirect effects of herd protection. In summary, our model provides data supporting the introduction of a paediatric influenza immunisation programme in Germany.


Assuntos
Programas de Imunização , Vacinas contra Influenza/administração & dosagem , Influenza Humana/prevenção & controle , Modelos Teóricos , Vacinas Atenuadas/administração & dosagem , Adolescente , Criança , Pré-Escolar , Simulação por Computador , Feminino , Alemanha , Humanos , Lactente , Masculino , Vacinação
17.
Lancet Infect Dis ; 13(2): 123-9, 2013 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-23265995

RESUMO

BACKGROUND: Lower-respiratory-tract infection is one of the most common acute illnesses managed in primary care. Few placebo-controlled studies of antibiotics have been done, and overall effectiveness (particularly in subgroups such as older people) is debated. We aimed to compare the benefits and harms of amoxicillin for acute lower-respiratory-tract infection with those of placebo both overall and in patients aged 60 years or older. METHODS: Patients older than 18 years with acute lower-respiratory-tract infections (cough of ≤28 days' duration) in whom pneumonia was not suspected were randomly assigned (1:1) to either amoxicillin (1 g three times daily for 7 days) or placebo by computer-generated random numbers. Our primary outcome was duration of symptoms rated "moderately bad" or worse. Secondary outcomes were symptom severity in days 2-4 and new or worsening symptoms. Investigators and patients were masked to treatment allocation. This trial is registered with EudraCT (2007-001586-15), UKCRN Portfolio (ID 4175), ISRCTN (52261229), and FWO (G.0274.08N). FINDINGS: 1038 patients were assigned to the amoxicillin group and 1023 to the placebo group. Neither duration of symptoms rated "moderately bad" or worse (hazard ratio 1.06, 95% CI 0.96-1.18; p=0.229) nor mean symptom severity (1.69 with placebo vs 1.62 with amoxicillin; difference -0.07 [95% CI -0.15 to 0.007]; p=0.074) differed significantly between groups. New or worsening symptoms were significantly less common in the amoxicillin group than in the placebo group (162 [15.9%] of 1021 patients vs 194 [19.3%] of 1006; p=0.043; number needed to treat 30). Cases of nausea, rash, or diarrhoea were significantly more common in the amoxicillin group than in the placebo group (number needed to harm 21, 95% CI 11-174; p=0.025), and one case of anaphylaxis was noted with amoxicillin. Two patients in the placebo group and one in the amoxicillin group needed to be admitted to hospital; no study-related deaths were noted. We noted no evidence of selective benefit in patients aged 60 years or older (n=595). INTERPRETATION: When pneumonia is not suspected clinically, amoxicillin provides little benefit for acute lower-respiratory-tract infection in primary care both overall and in patients aged 60 years or more, and causes slight harms. FUNDING: European Commission Framework Programme 6, UK National Institute for Health Research, Barcelona Ciberde Enfermedades Respiratorias, and Research Foundation Flanders.


Assuntos
Amoxicilina/uso terapêutico , Antibacterianos/uso terapêutico , Infecções Respiratórias/tratamento farmacológico , Doença Aguda , Adulto , Idoso , Amoxicilina/efeitos adversos , Antibacterianos/efeitos adversos , Intervalos de Confiança , Diarreia/induzido quimicamente , Método Duplo-Cego , Toxidermias/etiologia , Feminino , Humanos , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Náusea/induzido quimicamente , Atenção Primária à Saúde , Modelos de Riscos Proporcionais , Índice de Gravidade de Doença , Fatores de Tempo
18.
Ann Fam Med ; 10(6): 510-5, 2012.
Artigo em Inglês | MEDLINE | ID: mdl-23149527

RESUMO

PURPOSE: Imaging may produce unexpected or incidental findings with consequences for patients and ordering of future investigations. Chest radiography in patients with acute cough is among the most common reasons for imaging in primary care, but data on associated incidental findings are lacking. We set out to describe the type and prevalence of incidental chest radiography findings in primary care patients with acute cough. METHODS: We report on data from a cross-sectional study in 16 European primary care networks on 3,105 patients with acute cough, all of whom were undergoing chest radiography as part of a research study workup. Apart from assessment for specified signs of pneumonia and acute bronchitis, local radiologists were asked to evaluate any additional finding on the radiographs. For the 2,823 participants with good-quality chest radiographs, these findings were categorized according to clinical relevance based on previous research evidence and analyzed for type and prevalence by network, sex, age, and smoking status. RESULTS: Incidental findings were reported in 19% of all participants, and ranged from 0% to 25% by primary care network, with the network being an independent contributor (P <.001). Of all participants 3% had clinically relevant incidental findings. Suspected nodules and shadows were reported in 1.8%. Incidental findings were more common is older participants and smokers (P <. 001). CONCLUSIONS: Clinically relevant incidental findings on chest radiographs in primary care adult patients with acute cough are uncommon, and prevalence varies by setting.


Assuntos
Tosse/diagnóstico por imagem , Achados Incidentais , Pulmão/diagnóstico por imagem , Doença Aguda , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Estudos Transversais , Europa (Continente) , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Prevalência , Atenção Primária à Saúde , Radiografia Torácica , Adulto Jovem
19.
Ann Fam Med ; 10(6): 523-9, 2012.
Artigo em Inglês | MEDLINE | ID: mdl-23149529

RESUMO

PURPOSE: We sought to determine the prevalence of airway obstruction and bronchodilator responsiveness in adults consulting for acute cough in primary care. METHODS: Family physicians recruited 3,105 adult patients with acute cough (28 days or shorter) attending primary care practices in 12 European countries. After exclusion of patients with preexisting physician-diagnosed asthma or chronic obstructive pulmonary disease (COPD), we undertook complete case analysis of spirometry results (n = 1,947) 28 to 35 days after inclusion. Bronchodilator responsiveness was diagnosed if there were recurrent complaints of wheezing, cough, or dyspnea and an increase of the forced expiratory volume in 1 second (FEV(1)) of 12% or more after bronchodilation. Airway obstruction was diagnosed according to 2 thresholds for the (postbronchodilator) ratio of FEV(1) to forced vital capacity (FEV(1):FVC): less than 0.7 and less than the lower limit of normal. RESULTS: There were 240 participants who showed bronchodilator responsiveness (12%), 193 (10%) had a FEV(1)/FVC ratio of less than 0.7, and 126 (6%) had a ratio of less than the lower limit of normal. Spearman's correlation between the 2 definitions of obstruction was 0.71 (P <.001), with discordance most pronounced among those younger than 30 years and in older participants. CONCLUSIONS: Both bronchodilator responsiveness and persistent airway obstruction are common in adults without established asthma or COPD who consult for acute cough in primary care, which suggests a high risk of undiagnosed asthma and COPD. Different accepted methods to define airway obstruction detected different numbers of patients, especially at the extremes of age. As both conditions benefit from appropriate and timely interventions, clinicians should be aware and responsive to potential underdiagnosis.


Assuntos
Obstrução das Vias Respiratórias/epidemiologia , Asma/diagnóstico , Broncodilatadores/uso terapêutico , Tosse/tratamento farmacológico , Doença Pulmonar Obstrutiva Crônica/diagnóstico , Espirometria/métodos , Doença Aguda , Adulto , Tosse/etiologia , Estudos Transversais , Europa (Continente)/epidemiologia , Humanos , Pessoa de Meia-Idade , Prevalência , Atenção Primária à Saúde , Resultado do Tratamento
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