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1.
Br J Cancer ; 124(11): 1795-1802, 2021 May.
Artigo em Inglês | MEDLINE | ID: mdl-33762716

RESUMO

BACKGROUND: Preoperative chemotherapy containing anthracyclines and taxanes is well established in early-stage breast cancer. Previous studies have suggested that the chemotherapy sequence may matter but definitive evidence is missing. ABCSG trial 34 evaluated the activity of the MUC1 vaccine tecemotide when added to neoadjuvant treatment; the study provided the opportunity for the second randomisation to compare two different anthracycline/taxane sequences. METHODS: HER2-negative early-stage breast cancer patients were recruited to this randomised multicentre Phase 2 study. Patients in the chemotherapy cohort (n = 311) were additionally randomised to a conventional or reversed sequence of epirubicin/cyclophosphamide and docetaxel. Residual cancer burden (RCB) with/without tecemotide was defined as primary study endpoint; RCB in the two chemotherapy groups was a key secondary endpoint. RESULTS: No significant differences in terms of RCB 0/I (40.1% vs. 37.2%; P = 0.61) or pathologic complete response (pCR) rates (24.3% vs. 25%, P = 0.89) were observed between conventional or reverse chemotherapy sequence. No new safety signals were reported, and upfront docetaxel did not result in decreased rates of treatment delay or discontinuation. CONCLUSION: Upfront docetaxel did not improve chemotherapy activity or tolerability; these results suggest that upfront neoadjuvant treatment with anthracyclines remains a valid option.

2.
Integr Cancer Ther ; 19: 1534735420938458, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32735463

RESUMO

Purpose: Cancer and its treatment strategies can have adverse effects on physical functioning and quality of life. Treatment strategies for better quality of life are still an unresolved issue. Physical activity is a promising treatment strategy that still has to be fully investigated. Methods: The ABCSG C07-EXERCISE study evaluated the feasibility of a 1-year exercise training after adjuvant chemotherapy in colorectal cancer patients. The present report presents the patient-reported outcomes during the exercise training. Fourteen patients of one center filled out the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ C30) questionnaire at 5 time points after initiating a 1-year exercise training. Results: At baseline, patients scored social functioning, emotional functioning, financial impact, insomnia, and diarrhea much worse than the German general population. After 1 year of a structured exercise training, a large improvement was reported for social functioning; moderate improvements were reported for pain, diarrhea, financial impact, and taste; and a small change for physical and emotional functioning as well as for global quality of life. Conclusions: The present study observed improvements of social, physical, and emotional functioning as well as global quality of life after 1 year of a structured exercise training in patients with locally advanced colorectal cancer after receiving adjuvant chemotherapy. To enhance compliance, sufficient support and different sport facilities should be offered. The positive effect of exercise on patient-reported outcomes, disease-free survival, and overall survival in cancer survivors have to be further investigated in further randomized clinical trials.


Assuntos
Neoplasias Colorretais , Qualidade de Vida , Quimioterapia Adjuvante , Neoplasias Colorretais/tratamento farmacológico , Exercício Físico , Humanos , Projetos Piloto , Inquéritos e Questionários
3.
Eur J Cancer ; 132: 43-52, 2020 06.
Artigo em Inglês | MEDLINE | ID: mdl-32325419

RESUMO

BACKGROUND: Immune-based strategies represent a promising approach in breast cancer (BC) treatment. The glycoprotein mucin-1 (MUC-1) is overexpressed in more than 90% of BC patients, and is targeted by the cancer vaccine tecemotide. We have investigated the efficacy and safety of tecemotide when added to neoadjuvant standard-of-care (SoC) treatment in early BC patients. PATIENTS AND METHODS: A total of 400 patients with HER2-early BC were recruited into this prospective, multicentre, randomised 2-arm academic phase II trial. Patients received preoperative SoC treatment (chemotherapy or endocrine therapy) with or without tecemotide. Postmenopausal women with oestrogen receptor (ER)+++, or ER++ and Ki67 < 14%, and G1,2 tumours ('luminal A' tumours) received 6 months of letrozole. Postmenopausal patients with triple-negative, ER-/+/++ and Ki67 ≥ 14%, and with G3 tumours, as well as premenopausal patients, received four cycles of epirubicin/cyclophosphamide plus four cycles of docetaxel. Primary end-point was residual cancer burden (RCB; 0/I versus II/III) at surgery. Secondary end-points included pathological complete response (pCR), safety, and quality of life. FINDINGS: We observed no significant difference in RCB 0/I rates between patients with (36.4%) and without (31.9%) tecemotide in the overall study population (p = 0.40) nor in endocrine and chemotherapy-treated subgroups (25.0% versus 13.3%, p = 0.17; 39.6% versus 37.8%, p = 0.75, respectively). The addition of tecemotide did not affect overall pCR rates (22.5% versus 17.4%, p = 0.23), MUC-1 expression, or tumour-infiltrating lymphocytes content. Tecemotide did not increase toxicity when compared to SoC therapy alone. INTERPRETATION: Neoadjuvant tecemotide is safe, but does not improve RCB or pCR rates in patients receiving standard neoadjuvant therapy.


Assuntos
Biomarcadores Tumorais/metabolismo , Neoplasias da Mama/tratamento farmacológico , Vacinas Anticâncer/uso terapêutico , Glicoproteínas de Membrana/uso terapêutico , Adulto , Idoso , Idoso de 80 Anos ou mais , Neoplasias da Mama/metabolismo , Neoplasias da Mama/patologia , Feminino , Seguimentos , Humanos , Pessoa de Meia-Idade , Segurança do Paciente , Prognóstico , Estudos Prospectivos , Receptor ErbB-2/metabolismo , Receptores de Estrogênio/metabolismo , Receptores de Progesterona/metabolismo
5.
Lancet Oncol ; 20(3): 339-351, 2019 03.
Artigo em Inglês | MEDLINE | ID: mdl-30795951

RESUMO

BACKGROUND: In postmenopausal women with hormone receptor-positive, early-stage breast cancer, treatment with adjuvant aromatase inhibitors is the standard of care, but it increases risk for osteoporosis and fractures. Results from the ABCSG-18 trial showed that use of denosumab as an adjuvant to aromatase inhibitor therapy significantly reduced clinical fractures. Disease-free survival outcomes from ABCSG-18 have not yet been reported. METHODS: Postmenopausal patients with early, hormone receptor-positive, non-metastatic adenocarcinoma of the breast, who had completed their initial adjuvant treatment pathway (surgery, radiotherapy, or chemotherapy, or a combination) and were receiving adjuvant aromatase inhibitors, were enrolled at 58 trial centres in Austria and Sweden into this prospective, double-blind, placebo-controlled, phase 3 trial. With permuted block randomisation (block sizes 2 and 4, stratified by previous aromatase inhibitor use, total lumbar spine bone mineral density score at baseline, and type of centre), patients were assigned (1:1) to receive subcutaneous denosumab (60 mg) or matching placebo every 6 months during aromatase inhibitor therapy. The primary endpoint (previously reported) was the time to first clinical fracture after randomisation. The secondary endpoint reported here is disease-free survival (defined as time from randomisation to first evidence of local or distant metastasis, contralateral breast cancer, secondary carcinoma, or death from any cause) in the intention-to-treat population. This study is registered with EudraCT (number 2005-005275-15) and ClinicalTrials.gov (number NCT00556374), and is ongoing for long-term follow-up. FINDINGS: Between Dec 18, 2006, and July 22, 2013, 3425 eligible patients were enrolled and randomly assigned; 1711 to the denosumab group and 1709 to the placebo group (with five others withdrawing consent). After a median follow-up of 73 months (IQR 58-95), 240 (14·0%) patients in the denosumab and 287 (16·8%) in the placebo group had disease-free survival events. Disease-free survival was significantly improved in the denosumab group versus the placebo group (hazard ratio 0·82, 95% CI 0·69-0·98, Cox p=0·0260; descriptive analysis, without controlling for multiplicity). In the denosumab group, disease-free survival was 89·2% (95% CI 87·6-90·8) at 5 years and 80·6% (78·1-83·1) at 8 years of follow-up, compared with 87·3% (85·7-89·0) at 5 years and 77·5% (74·8-80·2) and 8 years in the placebo group. No independently adjudicated cases of osteonecrosis of the jaw or confirmed atypical femoral fractures were recorded. The total number of adverse events was similar in the denosumab group (1367 [including 521 serious] adverse events) and the placebo group (1339 [515 serious]). The most common serious adverse events were osteoarthritis (62 [3·6%] of 1709 in the denosumab group vs 58 [3·4%] of 1690 in the placebo group), meniscus injury (23 [1·3%] vs 24 [1·4%]), and cataract (16 [0·9%] vs 28 [1·7%]). One (<0·1%) treatment-related death (due to pneumonia, septic kidney failure, and cardiac decompensation) occurred in the denosumab group. INTERPRETATION: Denosumab constitutes an effective and safe adjuvant treatment for patients with postmenopausal hormone receptor-positive early breast cancer receiving aromatase inhibitor therapy. FUNDING: Amgen.


Assuntos
Inibidores da Aromatase/administração & dosagem , Neoplasias da Mama/tratamento farmacológico , Denosumab/administração & dosagem , Idoso , Inibidores da Aromatase/efeitos adversos , Densidade Óssea/efeitos dos fármacos , Neoplasias da Mama/genética , Neoplasias da Mama/patologia , Denosumab/efeitos adversos , Intervalo Livre de Doença , Método Duplo-Cego , Feminino , Humanos , Pessoa de Meia-Idade , Pós-Menopausa/efeitos dos fármacos , Modelos de Riscos Proporcionais , Receptor ErbB-2/genética , Receptores de Estrogênio/genética , Receptores de Progesterona/genética
6.
Support Care Cancer ; 26(4): 1345-1352, 2018 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-29168033

RESUMO

INTRODUCTION: Despite advances in adjuvant chemotherapy, 20-30% of patients in stages II-III colorectal cancer will eventually relapse. Observational studies showed a reduction in relapse rate, colon cancer-specific mortality, and overall mortality by physical activity. Results from prospective randomized interventional studies to confirm these observational data are lacking. The aims of this prospective single-arm multicenter pilot study are to evaluate feasibility and safety of exercise training after adjuvant chemotherapy in colorectal cancer patients. PATIENTS AND METHODS: The training was performed three times per week for 1 year and was increased gradually in three phases until reaching 18 metabolic equivalent task hours per week. RESULTS: Overall, 30 patients were included. The planned training intensity could be achieved in all three phases. Patients experienced a performance increase of median 35.5 watt, a weight-loss of a median of 3.0 kg, and a reduction in body fat content of median 1.0% during this exercise training. The analysis showed early study termination due to non-compliance in 10/30 patients (33.3%), disease progression in 4 patients (13.3%), and serious adverse events in 2 patients (6.7%). About half of patients (46.7%) completed the pilot study as planned. Biomarker analysis from 20 patients showed a non-significant reduction in insulin-like growth factor 1 (IGF-1), insulin-like growth factor 2 (IGF-2) and insulin-like growth factor binding protein 3 (IGF-BP3) levels, significant increases in adiponectin and leptin levels, and a non-significant increase in C-peptide levels. CONCLUSION: Exercise training is feasible in patients with colorectal cancer after completion of adjuvant chemotherapy. The main problem encountered during the study was compliance. To improve compliance of exercise training, several measures were adapted for the upcoming prospective randomized ABCSG C08 Exercise II study.


Assuntos
Neoplasias Colorretais/terapia , Terapia por Exercício/métodos , Exercício Físico , Adulto , Idoso , Quimioterapia Adjuvante , Neoplasias Colorretais/tratamento farmacológico , Neoplasias Colorretais/patologia , Estudos de Viabilidade , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Recidiva Local de Neoplasia/tratamento farmacológico , Estadiamento de Neoplasias , Cooperação do Paciente , Projetos Piloto , Estudos Prospectivos
7.
Clin Nutr ; 35(2): 522-527, 2016 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-25912233

RESUMO

BACKGROUND & AIMS: A major problem occurring in cross-sectional studies is sampling bias. Length of hospital stay (LOS) differs strongly between patients and causes a length bias as patients with longer LOS are more likely to be included and are therefore overrepresented in this type of study. To adjust for the length bias higher weights are allocated to patients with shorter LOS. We determined the effect of length-bias adjustment in two independent populations. METHODS: Length-bias correction is applied to the data of the nutritionDay project, a one-day multinational cross-sectional audit capturing data on disease and nutrition of patients admitted to hospital wards with right-censoring after 30 days follow-up. We applied the weighting method for estimating the distribution function of patient baseline variables based on the method of non-parametric maximum likelihood. Results are validated using data from all patients admitted to the General Hospital of Vienna between 2005 and 2009, where the distribution of LOS can be assumed to be known. Additionally, a simplified calculation scheme for estimating the adjusted distribution function of LOS is demonstrated on a small patient example. RESULTS AND CONCLUSION: The crude median (lower quartile; upper quartile) LOS in the cross-sectional sample was 14 (8; 24) and decreased to 7 (4; 12) when adjusted. Hence, adjustment for length bias in cross-sectional studies is essential to get appropriate estimates.


Assuntos
Tempo de Internação , Avaliação Nutricional , Estado Nutricional , Viés de Seleção , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Peso Corporal , Estudos Transversais , Feminino , Seguimentos , Hospitalização , Humanos , Desnutrição/diagnóstico , Desnutrição/prevenção & controle , Pessoa de Meia-Idade , Reprodutibilidade dos Testes , Inquéritos e Questionários , Adulto Jovem
8.
PLoS One ; 10(5): e0127316, 2015.
Artigo em Inglês | MEDLINE | ID: mdl-26000634

RESUMO

OBJECTIVE: To develop a simple scoring system to predict 30 day in-hospital mortality of in-patients excluding those from intensive care units based on easily obtainable demographic, disease and nutrition related patient data. METHODS: Score development with general estimation equation methodology and model selection by P-value thresholding based on a cross-sectional sample of 52 risk indicators with 123 item classes collected with questionnaires and stored in an multilingual online database. SETTING: Worldwide prospective cross-sectional cohort with 30 day in-hospital mortality from the nutritionDay 2006-2009 and an external validation sample from 2012. RESULTS: We included 43894 patients from 2480 units in 32 countries. 1631(3.72%) patients died within 30 days in hospital. The Patient- And Nutrition-Derived Outcome Risk Assessment (PANDORA) score predicts 30-day hospital mortality based on 7 indicators with 31 item classes on a scale from 0 to 75 points. The indicators are age (0 to 17 points), nutrient intake on nutritionDay (0 to 12 points), mobility (0 to 11 points), fluid status (0 to 10 points), BMI (0 to 9 points), cancer (9 points) and main patient group (0 to 7 points). An appropriate model fit has been achieved. The area under the receiver operating characteristic curve for mortality prediction was 0.82 in the development sample and 0.79 in the external validation sample. CONCLUSIONS: The PANDORA score is a simple, robust scoring system for a general population of hospitalised patients to be used for risk stratification and benchmarking.


Assuntos
Mortalidade Hospitalar , Fatores Etários , Humanos , Avaliação de Resultados da Assistência ao Paciente , Valor Preditivo dos Testes , Estudos Prospectivos , Risco , Medição de Risco , Índice de Gravidade de Doença
9.
J Neurotrauma ; 32(1): 23-7, 2015 Jan 01.
Artigo em Inglês | MEDLINE | ID: mdl-25068442

RESUMO

The objective of this study was to determine whether the type of intracranial traumatic lesions, the number of simultaneous traumatic lesions, and the occurrence of skull and facial bone fractures have an influence on S100 calcium binding protein B (S100B) serum levels. Patients with blunt traumatic brain injury were prospectively enrolled into this cohort study over a period of 13 months. Venous blood samples were obtained prior to emergency cranial CT scan in all patients within 3 h after injury. The patients were then assigned into six groups: 1) concussion, 2) epidural hematoma, 3) subdural hematoma, 4) subarachnoid hemorrhage, 5) brain contusions, and 6) brain edema. The study included 1696 head trauma patients with a mean age of 57.7 ± 25.3 years, and 126 patients (8%) had 182 traumatic lesions on CT. Significant differences in S100B serum levels were found between cerebral edema and the other four bleeding groups: epidural p = 0.0002, subdural p < 0.0001, subarachnoid p = 0.0001, brain contusions p = 0.0003, and concussion p < 0.0001. Significant differences in S100B values between patients with one or two intracranial lesions (p = 0.014) or with three (p < 0.0001) simultaneous intracranial lesions were found. In patients with intracranial traumatic lesions, skull fractures, as well as skull and facial bone fractures occurring together, were identified as significant additional factors for the increase in serum S100B levels (p < 0.0001). Older age was also associated with elevated S100B serum levels (p < 0.0001). Our data show that peak S100B serum levels were found in patients with cerebral edema and brain contusions.


Assuntos
Concussão Encefálica/sangue , Edema Encefálico/sangue , Hematoma Epidural Craniano/sangue , Hematoma Subdural/sangue , Subunidade beta da Proteína Ligante de Cálcio S100/sangue , Hemorragia Subaracnóidea/sangue , Adulto , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Concussão Encefálica/diagnóstico por imagem , Edema Encefálico/diagnóstico por imagem , Feminino , Hematoma Epidural Craniano/diagnóstico por imagem , Hematoma Subdural/diagnóstico por imagem , Humanos , Masculino , Pessoa de Meia-Idade , Radiografia , Fraturas Cranianas/sangue , Fraturas Cranianas/diagnóstico por imagem , Hemorragia Subaracnóidea/diagnóstico por imagem
10.
Thromb Res ; 134(4): 918-23, 2014 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-25179518

RESUMO

BACKGROUND: Routine drug monitoring is not required for the two novel direct factor Xa inhibitors apixaban and rivaroxaban. Rapidly available test results might be beneficial in case of bleeding or prior to urgent surgery. OBJECTIVES: The aim of this study was to evaluate the applicability of the two rotational thrombelastometry (ROTEM®) -modifications Low-tissue factor activated ROTEM® (LowTF-ROTEM®) and Prothrombinase induced clotting time - activated ROTEM® (PiCT®-ROTEM®) for determination of apixaban and rivaroxaban in vitro and ex vivo. METHODS: Blood samples from 20 volunteers were spiked with apixaban / rivaroxaban to yield samples with ascending drug concentrations ranging from 50 - 400ng/mL. LowTF - and PiCT® modified ROTEM® tests and determination of the corresponding antifactor Xa activity were performed in duplicate in 280 samples. LowTF-ROTEM® tests were performed in samples from 20 patients on apixaban or rivaroxaban therapy and 20 controls. RESULTS: There was a strong correlation between apixaban / rivaroxaban plasma concentrations and the LowTF-ROTEM® parameters Clotting time (CT; spearman correlation coefficient (SCC) 0.81 and 0.81, respectively) and Time to maximum velocity (t,MaxVel; SCC: 0.81 and 0.80, resp.) and a low to moderate correlation for the PiCT®-ROTEM® parameters CT (SCC: 0.38 and 0.59, resp.) and t,MaxVel. (0.51 and 0.69, resp.) in the in vitro experiments. LowTF-ROTEM CT was significantly prolonged in patients on apxiaban or rivaroxaban therapy compared to controls. CONCLUSIONS: LowTF-ROTEM® could be a valuable diagnostic tool for rapid determination of the effect of apixaban and rivaroxaban at the point of care.


Assuntos
Coagulação Sanguínea/efeitos dos fármacos , Inibidores do Fator Xa/farmacologia , Morfolinas/farmacologia , Pirazóis/farmacologia , Piridonas/farmacologia , Tiofenos/farmacologia , Tromboelastografia/métodos , Inibidores do Fator Xa/sangue , Inibidores do Fator Xa/uso terapêutico , Humanos , Morfolinas/sangue , Morfolinas/uso terapêutico , Sistemas Automatizados de Assistência Junto ao Leito , Pirazóis/sangue , Pirazóis/uso terapêutico , Piridonas/sangue , Piridonas/uso terapêutico , Rivaroxabana , Tiofenos/sangue , Tiofenos/uso terapêutico
11.
Eur J Clin Invest ; 44(9): 813-24, 2014 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-25039263

RESUMO

BACKGROUND: In the general population, poor self-rated health (SRH) is associated with malnutrition; however, these associations have not been studied in hospitalized patients. We aimed to evaluate SRH, indicators of nutrition, nutritional status and their association with in-hospital mortality. MATERIALS AND METHODS: The study is based on data from the nutritionDay, a multinational, multicentre European-wide standardized 1-day cross-sectional survey of nutritional factors, food intake and in-hospital mortality in hospitalized patients. A data set of surveys on SRH in 2010 and 2011 was used in the analysis. RESULTS: Complete sets of data were available for 28 106 patients (64 ± 18 years, 50% men, 7% terminally ill). In relation to body mass index, 7% were undernourished and 16% were obese. Fair/poor SRH was reported by 59% of patients and was associated with low food intake during the previous week or on survey day (P < 0·005). Thirty-day in-hospital mortality was 3%; in adjusted multivariate survival analysis, fair/poor SRH [hazard ratio (HR) 1·53, 95% confidence interval (CI) 1·14-2·05] and reduced food intake [nothing eaten (HR 2·13, 95% CI 1·46-3·11) or not allowed to eat on nutritionDay (HR 2·01, 95% CI 1·30-3·11)] predicted fatal outcome. At particularly high risk were patients who rated their health poor and had reduced food intake on the survey day or within the previous week with relative risks of 7·37 and 8·80, respectively. CONCLUSIONS: We demonstrated high prevalence of poor SRH and insufficient food intake in hospitalized patients. This was associated, particularly in combination, with increased risk of in-hospital mortality.


Assuntos
Ingestão de Alimentos/fisiologia , Desnutrição/mortalidade , Estado Nutricional/fisiologia , Adulto , Distribuição por Idade , Idoso , Idoso de 80 Anos ou mais , Estudos Transversais , Europa (Continente)/epidemiologia , Feminino , Hospitalização/estatística & dados numéricos , Humanos , Masculino , Desnutrição/fisiopatologia , Pessoa de Meia-Idade , Autorrelato , Distribuição por Sexo
12.
Acta Ophthalmol ; 92(7): e540-5, 2014 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-24863099

RESUMO

PURPOSE: The complement factor H (CFH) tyrosine 402 histidine (Y402H, rs1061170) variant is known to be significantly associated with age-related macular degeneration (AMD). Whether this genetic variant may impact retinal blood flow regulation is largely unknown. This study investigated whether flicker-induced vasodilation, an indicator for the coupling between neural activity and blood flow, is altered in subjects carrying the rs1061170 risk allele. METHODS: One hundred healthy subjects (aged between 18 and 45 years) were included in this study. Retinal blood flow regulation was tested by assessing retinal vessel calibres in response to stimulation with diffuse flicker light. Retinal vascular flicker responses were determined with a Dynamic Vessel Analyzer (DVA). In addition, genotyping for rs1061170 was performed. RESULTS: Eighteen subjects were homozygous for the risk allele C, 50 were homozygous for the ancestral allele T, and 31 subjects were heterozygous (CT). One subject had to be excluded from data evaluation, as no genetic analysis could be performed due to technical difficulties. Baseline diameters of retinal arteries (p = 0.39) and veins (p = 0.64) were comparable between the three groups. Flicker-induced vasodilation in both retinal arteries (p = 0.38) and retinal veins (p = 0.62) was also comparable between the three studied groups. CONCLUSIONS: Our data indicate that homozygous healthy young carriers of the C risk allele at rs1061170 do not show abnormal flicker-induced vasodilation in the retina. This suggests that the high-risk genetic variant of CFH polymorphism does not impact neuro-vascular coupling in healthy subjects.


Assuntos
Fusão Flicker/fisiologia , Polimorfismo de Nucleotídeo Único , Vasos Retinianos/fisiologia , Vasodilatação/fisiologia , Adolescente , Adulto , Velocidade do Fluxo Sanguíneo , Pressão Sanguínea/fisiologia , Fator H do Complemento/genética , Feminino , Genótipo , Voluntários Saudáveis , Frequência Cardíaca/fisiologia , Humanos , Pressão Intraocular/fisiologia , Masculino , Pessoa de Meia-Idade , Estimulação Luminosa , Adulto Jovem
13.
Eur J Haematol ; 93(2): 103-11, 2014 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-24617727

RESUMO

OBJECTIVE: There is strong evidence that certain thrombophilic single nucleotide polymorphisms (SNPs) account for an increased risk of thrombosis. The additive impact of inherited thrombotic risk factors to a certain disease- immanent thrombotic risk is vastly unknown. Therefore, we aimed to investigate the influence of three novel, preselected SNPs on the risk of thrombosis in patients diagnosed with myeloproliferative neoplasm (MPN). METHOD: In 167 patients with a diagnosis of essential thrombocythemia (ET) or prefibrotic primary myelofibrosis (PMF) thrombophilic SNPs in the genes of factor VII (F7), nitric oxide synthase 3 (NOS3) and FcɣRIIa (FCGR2A) were determined. Subsequently, the polymorphic variants were correlated with the incidence of major thrombosis after diagnosis. RESULTS: Decanucleotide insertion polymorphism of F7 emerged as an independent, significant risk factor for total thrombosis and arterial thrombosis in particular in the whole group of patients (P = 0.0007) as well as in the separate analysis of patients with ET (P = 0.0002). CONCLUSION: Our results illustrate that the risk of thrombosis in MPN is significantly multiplied by inherited thrombophilic SNPs. This result points to the importance of a combined consideration of the inherited and the acquired hypercoagulable state in patients with MPN. Larger studies are needed to confirm and extend these important findings.


Assuntos
Fator VII/genética , Polimorfismo Genético , Mielofibrose Primária/genética , Trombocitemia Essencial/genética , Trombose/genética , Adulto , Idoso , Feminino , Expressão Gênica , Humanos , Masculino , Pessoa de Meia-Idade , Mutagênese Insercional , Óxido Nítrico Sintase Tipo III/genética , Oligonucleotídeos/genética , Mielofibrose Primária/complicações , Mielofibrose Primária/patologia , Receptores de IgG/genética , Fatores de Risco , Trombocitemia Essencial/complicações , Trombocitemia Essencial/patologia , Trombose/etiologia , Trombose/patologia
14.
Prenat Diagn ; 34(3): 273-8, 2014 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-24446032

RESUMO

OBJECTIVES: Magnetic resonance imaging (MRI) is a powerful, noninvasive tool to study fetal lung volumes after 18 weeks of gestation in vivo. In neonates with congenital heart disease (CHD), proper lung function is essential for postnatal survival. Antenatal detection of abnormal pulmonary development may help to optimize prenatal and perinatal management of at-risk fetuses. We aimed to investigate lung volumes in fetuses with prenatally diagnosed heart disease. METHODS: A cross-sectional, retrospective study of 105 consecutive singleton pregnancies with CHD and a control, non-CHD group (n = 115), that underwent fetal MRI was performed. The heart defects detected were divided into four groups. Lung volumes of fetuses with heart disease were compared with control, non-CHD fetuses. In addition, z-scores of lung volumes were calculated for the CHD group (normal range z-scores from -2-+2). RESULTS: As a group, fetuses with CHD have significantly smaller lung volumes compared with control fetuses when corrected by gestational age (GA) (p = 0.049). Of the 105 CHD fetuses studied, 18 had lung volumes with a z-score < -2. Fetuses with different types of CHD showed similar lung volumes. CONCLUSION: Our data indicate that postpartum pulmonary symptoms and outcome in neonates with congenital heart disease may be attributed to the cardiac disease itself and in part to smaller lung volumes.


Assuntos
Cardiopatias Congênitas/diagnóstico , Pulmão/patologia , Imageamento por Ressonância Magnética , Diagnóstico Pré-Natal , Artéria Pulmonar/patologia , Feminino , Humanos , Tamanho do Órgão , Gravidez , Estudos Retrospectivos
15.
Cephalalgia ; 34(7): 533-9, 2014 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-24326235

RESUMO

BACKGROUND: The objective of this study was to assess the influence of nocturnal headaches (NH) on subjective sleep parameters prospectively in habitual snorers and their bed partners. METHODS: We recruited habitual snorers and their bed partners via newspaper articles. The participants completed a semistructured interview, filled in questionnaires about quality of sleep (PSQI), daytime sleepiness (ESS), depression (SDS) and anxiety (SAS) and they kept a 90-day headache and sleep diary. RESULTS: Seventy-six snorers (25 female) and 41 bed partners (31 female) completed the study recording a total of 6690 and 3497 diary days, respectively. NH were recorded on 222 (3.3%) and 79 (2.2%) days in 32 (42%) snorers and 17 (41%) bed partners, respectively. Snorers with NH showed significantly higher PSQI (5 ± 3 vs. 4 ± 2, p = 0.004), SAS (38 ± 11 vs. 31 ± 10, p = 0.011) and SDS scores (39 ± 12 vs. 34 ± 10, p = 0.048) than snorers without NH. For bed partners with NH we found a significant female predominance (sex ratio f:m = 16:1 vs. 12:12, p = 0.005) and significantly higher SAS scores (38 ± 6 vs. 33 ± 8, p = 0.030) compared with bed partners without NH. The subjective quality of sleep in habitual snorers (p < 0.001) as well as their bed partners (p = 0.017) was negatively influenced by NH, but not total sleep time. DISCUSSION: NH occurred in around 40% of snorers and their bed partners at least once during the 90-day observation period. Our results confirmed a negative impact on the subjective quality of sleep in both groups.


Assuntos
Cefaleia/diagnóstico , Registros Médicos , Transtornos do Sono-Vigília/diagnóstico , Ronco/diagnóstico , Adulto , Ansiedade/diagnóstico , Ansiedade/epidemiologia , Ansiedade/psicologia , Depressão/diagnóstico , Depressão/epidemiologia , Depressão/psicologia , Distúrbios do Sono por Sonolência Excessiva/diagnóstico , Distúrbios do Sono por Sonolência Excessiva/epidemiologia , Distúrbios do Sono por Sonolência Excessiva/psicologia , Feminino , Cefaleia/epidemiologia , Cefaleia/psicologia , Humanos , Entrevista Psicológica , Masculino , Estudos Prospectivos , Qualidade de Vida/psicologia , Transtornos do Sono-Vigília/epidemiologia , Transtornos do Sono-Vigília/psicologia , Ronco/epidemiologia , Ronco/psicologia , Inquéritos e Questionários
16.
J Neurosurg ; 120(2): 447-52, 2014 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-24313609

RESUMO

OBJECT: This study presents newly defined risk factors for detecting clinically important brain injury requiring neurosurgical intervention and intensive care, and compares it with the Canadian CT Head Rule (CCHR). METHODS: This prospective cohort study was conducted in a single Austrian Level-I trauma center and enrolled a consecutive sample of mildly head-injured adults who presented to the emergency department with witnessed loss of consciousness, disorientation, or amnesia, and a Glasgow Coma Scale (GCS) score of 13-15. The studied population consisted of a large number of elderly patients living in Vienna. The aim of the study was to investigate risk factors that help to predict the need for immediate cranial CT in patients with mild head trauma. RESULTS: Among the 12,786 enrolled patients, 1307 received a cranial CT scan. Four hundred eighty-nine patients (37.4%) with a mean age of 63.9 ± 22.8 years had evidence of an acute traumatic intracranial lesion on CT. Three patients (< 0.1%) were admitted to the intensive care unit for neurological observation and received oropharyngeal intubation. Seventeen patients (0.1%) underwent neurosurgical intervention. In 818 patients (62.6%), no evidence of an acute trauma-related lesion was found on CT. Data analysis showed that the presence of at least 1 of the following factors can predict the necessity of cranial CT: amnesia, GCS score, age > 65 years, loss of consciousness, nausea or vomiting, hypocoagulation, dementia or a history of ischemic stroke, anisocoria, skull fracture, and development of a focal neurological deficit. Patients requiring neurosurgical intervention were detected with a sensitivity of 90% and a specificity of 67% by using the authors' analysis. In contrast, the use of the CCHR in these patients detected the need for neurosurgical intervention with a sensitivity of only 80% and a specificity of 72%. CONCLUSIONS: The use of the suggested parameters proved to be superior in the detection of high-risk patients who sustained a mild head trauma compared with the CCHR rules. Further validation of these results in a multicenter setting is needed. Clinical trial registration no.: NCT00451789 ( ClinicalTrials.gov .).


Assuntos
Traumatismos Craniocerebrais/diagnóstico por imagem , Tomografia Computadorizada por Raios X/estatística & dados numéricos , Adulto , Idoso , Idoso de 80 Anos ou mais , Áustria/epidemiologia , Canadá/epidemiologia , Estudos de Coortes , Traumatismos Craniocerebrais/cirurgia , Cuidados Críticos , Feminino , Escala de Coma de Glasgow , Humanos , Masculino , Pessoa de Meia-Idade , Procedimentos Neurocirúrgicos , Valor Preditivo dos Testes , Estudos Prospectivos , Curva ROC , Fatores de Risco , Centros de Traumatologia , Resultado do Tratamento
17.
Resuscitation ; 85(4): 560-6, 2014 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-24215730

RESUMO

BACKGROUND: Efficiently performed basic life support (BLS) after cardiac arrest is proven to be effective. However, cardiopulmonary resuscitation (CPR) is strenuous and rescuers' performance declines rapidly over time. Audio-visual feedback devices reporting CPR quality may prevent this decline. We aimed to investigate the effect of various CPR feedback devices on CPR quality. METHODS: In this open, prospective, randomised, controlled trial we compared three CPR feedback devices (PocketCPR, CPRmeter, iPhone app PocketCPR) with standard BLS without feedback in a simulated scenario. 240 trained medical students performed single rescuer BLS on a manikin for 8min. Effective compression (compressions with correct depth, pressure point and sufficient decompression) as well as compression rate, flow time fraction and ventilation parameters were compared between the four groups. RESULTS: Study participants using the PocketCPR performed 17±19% effective compressions compared to 32±28% with CPRmeter, 25±27% with the iPhone app PocketCPR, and 35±30% applying standard BLS (PocketCPR vs. CPRmeter p=0.007, PocketCPR vs. standard BLS p=0.001, others: ns). PocketCPR and CPRmeter prevented a decline in effective compression over time, but overall performance in the PocketCPR group was considerably inferior to standard BLS. Compression depth and rate were within the range recommended in the guidelines in all groups. CONCLUSION: While we found differences between the investigated CPR feedback devices, overall BLS quality was suboptimal in all groups. Surprisingly, effective compression was not improved by any CPR feedback device compared to standard BLS. All feedback devices caused substantial delay in starting CPR, which may worsen outcome.


Assuntos
Reanimação Cardiopulmonar/instrumentação , Retroalimentação Sensorial , Parada Cardíaca/terapia , Massagem Cardíaca/instrumentação , Cuidados para Prolongar a Vida/instrumentação , Qualidade da Assistência à Saúde , Acelerometria/instrumentação , Adulto , Tamanho Corporal , Feminino , Humanos , Masculino , Manequins , Pressão , Adulto Jovem
18.
J Arthroplasty ; 29(4): 786-91, 2014 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-24290738

RESUMO

In a prospective randomized study of two groups of 65 patients each, we compared the acetabular component position when using the imageless navigation system compared to the freehand conventional technique for cementless total hip arthroplasty. The position of the component was determined postoperatively on computed tomographic scans of the pelvis. There was no significant difference for postoperative mean inclination (P = 0.29), but a significant difference for mean postoperative acetabular component anteversion (P = 0.007), for mean deviation of the postoperative anteversion from the target position of 15° (P = 0.02) and for the outliers regarding inclination (P = 0.02) and anteversion (P < 0.05) between the computer-assisted and the freehand-placement group. Our results demonstrate the importance of imageless navigation for the accurate positioning of the acetabular component.


Assuntos
Acetábulo/diagnóstico por imagem , Artroplastia de Quadril/métodos , Prótese de Quadril , Cirurgia Assistida por Computador , Acetábulo/cirurgia , Adulto , Idoso , Idoso de 80 Anos ou mais , Anteversão Óssea/diagnóstico por imagem , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Tomografia Computadorizada por Raios X
19.
Eur J Anaesthesiol ; 30(11): 695-703, 2013 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-24047727

RESUMO

BACKGROUND: Aortic valve replacement is one of the most common cardiac surgical procedures, especially in elderly patients. Whether or not there is a net life gain over a long period of time is a matter for debate. OBJECTIVE: To compare survival of patients with that of the age, sex, and follow-up year-matched normal population (relative survival). DESIGN: Single-centre, prospectively collected data. SETTING: Tertiary care centre, Vienna, Austria. PATIENTS: We enrolled 1848 patients undergoing elective aortic valve replacement between 1997 and the end of 2008. INTERVENTIONS: None. MAIN OUTCOME MEASUREMENT: Relative survival at the end of 2011 as determined by relative Cox regression analysis. RESULTS: Sixty-nine patients (3.7%) died within the first 30 days. Another 70 patients (3.8%) died within the first year and 429 (23.2%) died during the remaining follow-up period. The longest follow-up period was 14 years (median, 5.8; interquartile range, 3.2 to 8.9). Medical risk indicators for relative survival were diabetes mellitus [hazard ratio 1.69, 95% confidence interval, CI 1.37 to 2.07, P<0.001], pulmonary disease (hazard ratio 1.45, 95% CI 1.16 to 1.81, P=0.001), history of atrial fibrillation (hazard ratio 1.35, 95% CI 1.10 to 1.66, P=.005) and angiotensin-converting enzyme inhibitor medication (hazard ratio 1.21, 95% CI 1.02 to 1.44, P=0.031). Perioperative risk indicators were urgent surgery (hazard ratio 1.40, 95% CI 1.00 to 1.94, P=0.047), resternotomy at 48 h or less (hazard ratio 1.87, 95% CI 1.29 to 2.70, P=0.001), resternotomy at more than 48 h (hazard ratio 1.80, 95% CI 1.32 to 2.45, P<0.001), blood transfusion (hazard ratio 1.06, 95% CI 1.01 to 1.12, P=0.018) and renal replacement therapy (hazard ratio 2.02, 95% CI 1.41 to 2.90, P<0.001). Relative survival was highest in the oldest age quartile (76 to 94 years) and lowest in the youngest (19 to 58 years) (hazard ratio 0.27, 95% CI 0.21 to 0.36; P<0.001). CONCLUSION: Patients who survived the first year after aortic valve replacement had a similar chance of survival as the matched normal population. Relative survival benefit was higher in the oldest age quartile.


Assuntos
Valva Aórtica/cirurgia , Doenças das Valvas Cardíacas/terapia , Implante de Prótese de Valva Cardíaca/métodos , Adulto , Idoso , Feminino , Doenças das Valvas Cardíacas/mortalidade , Próteses Valvulares Cardíacas , Implante de Prótese de Valva Cardíaca/mortalidade , Humanos , Masculino , Pessoa de Meia-Idade , Modelos de Riscos Proporcionais , Estudos Prospectivos , Risco , Resultado do Tratamento , Adulto Jovem
20.
Reprod Biol Endocrinol ; 11: 84, 2013 Aug 31.
Artigo em Inglês | MEDLINE | ID: mdl-24004836

RESUMO

BACKGROUND: Although most pregnancies after IVF result in normal healthy outcomes, an increased risk for a number of obstetric and neonatal complications, compared to naturally conceived pregnancies, has been reported. While there are many studies that compare pregnancies after assisted reproductive techniques with spontaneously conceived pregnancies, fewer data are available that evaluate the differences between IVF and ICSI-conceived pregnancies. The aim of our present study was, therefore, to compare obstetric and perinatal outcomes in pregnancies conceived after in vitro fertilization (IVF) versus intracytoplasmatic sperm injection (ICSI). METHODS: Three-hundred thirty four women who had become pregnant after an IVF or ICSI procedure resulted in a total of 530 children referred between 2003 und 2009 to the Department of Obstetrics and Gynecology of the Medical University of Vienna, a tertiary care center, and were included in this retrospective cohort study. We assessed maternal and fetal parameters in both groups (IVF and ICSI). The main study outcomes were preterm delivery, the need for neonatal intensive care, and congenital malformations. Moreover, we compared the course of pregnancy between both groups and the occurrence of complications that led to maternal hospitalization during pregnancy. RESULTS: There were 80 children conceived via ICSI and 450 children conceived via IVF.Mean gestational age was significantly lower in the ICSI group (p = 0.001). After ICSI, the birth weight (p = 0.008) and the mean APGAR values after 1 minute and after 10 minutes were lower compared to that of the IVF group (p = 0.016 and p = 0.047, respectively). Moreover, ICSI-conceived children had to be hospitalized more often at a neonatal intensive care unit (p = 0.004). There was no difference in pH of the umbilical artery or in major congenital malformations between the two groups. Pregnancy complications (i.e., premature rupture of membranes, cervical insufficiency, and premature uterine contractions) and the need for maternal hospitalization during pregnancy were found significantly more often after IVF (p = 0.0016 and p = 0.0095, respectively), compared to the ICSI group. CONCLUSIONS: When comparing IVF versus ICSI-conceived pregnancies at a tertiary care center, we found the course of pregnancy to be more complicated after IVF, whereas the primary fetal outcome seemed to be better in this group than after ICSI treatment.


Assuntos
Fertilização In Vitro/efeitos adversos , Complicações na Gravidez/epidemiologia , Resultado da Gravidez , Injeções de Esperma Intracitoplásmicas/efeitos adversos , Centros de Atenção Terciária , Adulto , Peso ao Nascer , Anormalidades Congênitas/epidemiologia , Feminino , Idade Gestacional , Humanos , Concentração de Íons de Hidrogênio , Recém-Nascido , Terapia Intensiva Neonatal , Projetos Piloto , Gravidez , Artérias Umbilicais/patologia , Artérias Umbilicais/fisiologia
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