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1.
Eur Respir J ; 61(6)2023 06.
Artigo em Inglês | MEDLINE | ID: mdl-37230499

RESUMO

BACKGROUND: Standard of care for interstitial lung disease (ILD) with a nonspecific interstitial pneumonia (NSIP) pattern proposes mycophenolate mofetil (MMF) as one of the first-step therapies while rituximab is used as rescue therapy. METHODS: In a randomised, double-blind, two-parallel group, placebo-controlled trial (NCT02990286), patients with connective tissue disease-associated ILD or idiopathic interstitial pneumonia (with or without autoimmune features) and a NSIP pattern (defined on NSIP pathological pattern or on integration of clinicobiological data and a NSIP-like high-resolution computed tomography pattern) were randomly assigned in a 1:1 ratio to receive rituximab (1000 mg) or placebo on day 1 and day 15 in addition to MMF (2 g daily) for 6 months. The primary end-point was the change in percent predicted forced vital capacity (FVC) from baseline to 6 months analysed by a linear mixed model for repeated measures analysis. Secondary end-points included progression-free survival (PFS) up to 6 months and safety. FINDINGS: Between January 2017 and January 2019, 122 randomised patients received at least one dose of rituximab (n=63) or placebo (n=59). The least-squares mean change from baseline to 6 months in FVC (% predicted) was +1.60 (se 1.13) in the rituximab+MMF group and -2.01 (se 1.17) in the placebo+MMF group (between-group difference 3.60, 95% CI 0.41-6.80; p=0.0273). PFS was better in the rituximab+MMF group (crude hazard ratio 0.47, 95% CI 0.23-0.96; p=0.03). Serious adverse events occurred in 26 (41%) patients of the rituximab+MMF group and in 23 (39%) of the placebo+MMF group. Nine infections were reported in the rituximab+MMF group (five bacterial infections, three viral infections, one other) and four bacterial infections in the placebo+MMF group. INTERPRETATION: Combination of rituximab and MMF was superior to MMF alone in patients with ILD and a NSIP pattern. The use of this combination must take into consideration the risk of viral infection.


Assuntos
Pneumonias Intersticiais Idiopáticas , Doenças Pulmonares Intersticiais , Humanos , Rituximab/uso terapêutico , Rituximab/efeitos adversos , Ácido Micofenólico/uso terapêutico , Imunossupressores/efeitos adversos , Pulmão , Resultado do Tratamento , Doenças Pulmonares Intersticiais/tratamento farmacológico , Pneumonias Intersticiais Idiopáticas/tratamento farmacológico , Método Duplo-Cego
2.
J Clin Microbiol ; 56(9)2018 09.
Artigo em Inglês | MEDLINE | ID: mdl-29976593

RESUMO

No gold standard exists for histopathological diagnosis of a prosthetic joint infection (PJI). The historical criterion considers the presence of neutrophil infiltration upon examination of periprosthetic tissue. Morawietz et al. proposed a classification of periprosthetic membranes (Morawietz et al., Clin Pathol 59:591-597, 2006, https://doi.org/10.1136/jcp.2005.027458) and a more recently described classification with a new cutoff value of 23 neutrophils in 10 high-power fields (Morawietz et al., Histopathology 54:847-853, 2009. https://doi.org/10.1111/j.1365-2559.2009.03313.x). We performed a multicenter prospective study, which compared both methods for the diagnosis of PJI. All suspicions of PJI (n = 264) between December 2010 and March 2012 in seven centers were prospectively included. Five perioperative specimens were collected per patient for cultures, and one was collected for histology. Diagnosis of PJI was made according to the Infectious Diseases Society of America (IDSA) guidelines. Histopathological analysis classified the patients according to the threshold of 23 neutrophils and according to the classification of Morawietz. Performances of both methods were compared by using clinical and/or bacteriological criteria as the gold standard. Among 264 patients with suspected PJI, a diagnosis of infection was confirmed in 215 and unconfirmed in 49 patients. Histopathological analysis was available for 150 confirmed PJI and 40 unconfirmed PJI cases. The sensitivity, specificity, positive predictive value, negative predictive value, and accuracy were 78.7%, 90.0%, 96.7%, 52.9%, and 81.1%, respectively, for the Morawietz classification, and 82.0%, 90.0%, 96.9%, 57.1%, and 83.7%, respectively, for the 23-neutrophil threshold. The new algorithm using a threshold of 23 neutrophils can be proposed as a new gold standard for the histopathological diagnosis of PJI.


Assuntos
Artrite Infecciosa/diagnóstico , Interface Osso-Implante/patologia , Prótese Articular , Neutrófilos/patologia , Infecções Relacionadas à Prótese/diagnóstico , Idoso , Artrite Infecciosa/patologia , Técnicas Bacteriológicas , Feminino , Humanos , Contagem de Leucócitos , Masculino , Estudos Prospectivos , Infecções Relacionadas à Prótese/patologia , Sensibilidade e Especificidade
3.
Am J Respir Crit Care Med ; 195(8): 1022-1032, 2017 Apr 15.
Artigo em Inglês | MEDLINE | ID: mdl-27653798

RESUMO

RATIONALE: Assessment of fluid responsiveness relies on dynamic echocardiographic parameters that have not yet been compared in large cohorts. OBJECTIVES: To determine the diagnostic accuracy of dynamic parameters used to predict fluid responsiveness in ventilated patients with a circulatory failure of any cause. METHODS: In this multicenter prospective study, respiratory variations of superior vena cava diameter (∆SVC) measured using transesophageal echocardiography, of inferior vena cava diameter (∆IVC) measured using transthoracic echocardiography, of the maximal Doppler velocity in left ventricular outflow tract (∆VmaxAo) measured using either approach, and pulse pressure variations (∆PP) were recorded with the patient in the semirecumbent position. In each patient, a passive leg raise was performed and an increase of aortic velocity time integral greater than or equal to 10% defined fluid responsiveness. MEASUREMENTS AND MAIN RESULTS: Among 540 patients (379 men; age, 65 ± 13 yr; Simplified Acute Physiological Score II, 59 ± 18; Sequential Organ Failure Assessment, 10 ± 3), 229 exhibited fluid responsiveness (42%). ∆PP, ∆VmaxAo, ∆SVC, and ∆IVC could be measured in 78.5%, 78.0%, 99.6%, and 78.1% of cases, respectively. ∆SVC greater than or equal to 21%, ∆VmaxAo greater than or equal to 10%, and ∆IVC greater than or equal to 8% had a sensitivity of 61% (95% confidence interval, 57-66%), 79% (75-83%), and 55% (50-59%), respectively, and a specificity of 84% (81-87%), 64% (59-69%), and 70% (66-75%), respectively. The area under the receiver operating characteristic curve of ∆SVC was significantly greater than that of ∆IVC (P = 0.02) and ∆PP (P = 0.01). CONCLUSIONS: ∆VmaxAo had the best sensitivity and ∆SVC the best specificity in predicting fluid responsiveness. ∆SVC had a greater diagnostic accuracy than ∆IVC and ∆PP, but its measurement requires transesophageal echocardiography.


Assuntos
Ecocardiografia/métodos , Hidratação , Respiração Artificial , Veia Cava Inferior/fisiopatologia , Veia Cava Superior/fisiopatologia , Idoso , Ecocardiografia Doppler , Ecocardiografia Transesofagiana , Feminino , Humanos , Masculino , Estudos Prospectivos , Reprodutibilidade dos Testes , Sensibilidade e Especificidade , Veia Cava Inferior/diagnóstico por imagem , Veia Cava Superior/diagnóstico por imagem
4.
Ultraschall Med ; 39(5): 544-558, 2018 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-29232725

RESUMO

PURPOSE: To evaluate changes in tumor vascularization parameters based on contrast-enhanced ultrasound (CEUS) quantification criteria of at least one visible liver metastasis as an early predictor of non-response to chemotherapy, including bevacizumab for colorectal cancer (CRC) liver metastases. MATERIALS AND METHODS: This multicenter prospective study included patients who received first-line bevacizumab-based chemotherapy. Tumor enhancement measured using CEUS within one liver metastasis and in relation to the surrounding healthy liver was quantified within 8 days before the first infusion of bevacizumab (E0), 24 hours after the end of the first infusion of bevacizumab (E1), in the 24 hours before the 2nd and 3 rd infusion of bevacizumab on day 15 (E2) and day 30 (E3), respectively, and after 2 months of treatment (E4). Endpoints were tumor response using RECIST criteria at 2 months, progression-free survival (PFS) and overall survival (OS). RESULTS: Among the 137 patients included in this study, 109 were analyzed. Only CEUS parameters calculated in relation to healthy liver were significant. High wash-in and wash-out rates at baseline were significantly associated with a better tumor response. Increases over time E2-E0 and E3-E0 for peak enhancement were significantly associated with shorter progression-free survival. Increases over time E2-E0 and E3-E0 for peak enhancement and wash-in area under the curve were significantly associated with a shorter overall survival. CONCLUSION: This large study demonstrated that early dynamic changes in the vascularity of liver metastases evaluated by quantified CEUS are associated with outcome in patients receiving first-line bevacizumab-based treatment for metastatic CRC.


Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica , Neoplasias Colorretais , Neoplasias Hepáticas , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Bevacizumab/administração & dosagem , Neoplasias Colorretais/patologia , Humanos , Neoplasias Hepáticas/diagnóstico por imagem , Neoplasias Hepáticas/secundário , Estudos Prospectivos , Resultado do Tratamento
5.
Int J Cancer ; 139(10): 2325-35, 2016 11 15.
Artigo em Inglês | MEDLINE | ID: mdl-27472156

RESUMO

In first-line metastatic colorectal cancer (mCRC), baseline prognostic factors allowing death risk and treatment strategy stratification are lacking. Syndecan-1 (CD138) soluble form was never described as a prognostic biomarker in mCRC. We investigated its additional prognostic value for overall survival (OS). mCRC patients with unresectable disease at diagnosis were treated with bevacizumab-based chemotherapy in two independent prospective clinical trials (development set: n = 126, validation set: n = 51, study NCT00489697 and study NCT00544011, respectively). Serums were collected at baseline for CD138 measurement. OS determinants were assessed and, based on the final multivariate model, a prognostic score was proposed. Two independent OS prognostic factors were identified: Lactate Dehydrogenase (LDH) high level (p = 0.0066) and log-CD138 high level (p = 0.0190). The determination of CD138 binary information (cutoff: 75 ng/mL) allowed the assessment of a biological prognostic score with CD138 and LDH values, identifying three risk groups for death (median OS= 38.9, 30.1 and 19.8 months for the low, intermediate and high risk groups, respectively; p < 0.0001). This score had a good discrimination ability (C-index = 0.63). These results were externally confirmed in the validation set. Our study provides robust evidence in favor of the additional baseline soluble CD138 prognostic value for OS, in mCRC patients. A simple biological scoring system is proposed including LDH and CD138 binary status values.


Assuntos
Neoplasias Colorretais/sangue , Sindecana-1/sangue , Idoso , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Biomarcadores Tumorais/sangue , Ensaios Clínicos Fase II como Assunto , Estudos de Coortes , Neoplasias Colorretais/tratamento farmacológico , Neoplasias Colorretais/patologia , Feminino , Humanos , Estimativa de Kaplan-Meier , Neoplasias Hepáticas/sangue , Neoplasias Hepáticas/secundário , Masculino , Pessoa de Meia-Idade , Metástase Neoplásica , Prognóstico
6.
Eur Respir J ; 48(3): 833-42, 2016 09.
Artigo em Inglês | MEDLINE | ID: mdl-27174889

RESUMO

Gastro-oesophageal reflux has long been suspected of implication in the genesis and progression of idiopathic pulmonary fibrosis (IPF). We hypothesised that hiatal hernia may be more frequent in IPF than in other interstitial lung disease (ILD), and that hiatal hernia may be associated with more severe clinical characteristics in IPF.We retrospectively compared the prevalence of hiatal hernia on computed tomographic (CT) scans in 79 patients with IPF and 103 patients with other ILD (17 scleroderma, 54 other connective tissue diseases and 32 chronic hypersensitivity pneumonitis). In the IPF group, we compared the clinical, biological, functional, CT scan characteristics and mortality of patients with hiatal hernia (n=42) and without hiatal hernia (n=37).The prevalence of hiatal hernia on CT scan at IPF diagnosis was 53%, similar to ILD associated with scleroderma, but significantly higher than in the two other ILD groups. The size of the hiatal hernia was not linked to either fibrosis CT scan scores, or reduction in lung function in any group. Mortality from respiratory causes was significantly higher among IPF patients with hiatal hernia than among those without hiatal hernia (p=0.009).Hiatal hernia might have a specific role in IPF genesis, possibly due to pathological gastro-oesophageal reflux.


Assuntos
Alveolite Alérgica Extrínseca/diagnóstico por imagem , Refluxo Gastroesofágico/diagnóstico por imagem , Hérnia Hiatal/diagnóstico por imagem , Fibrose Pulmonar Idiopática/diagnóstico por imagem , Doenças Pulmonares Intersticiais/diagnóstico por imagem , Adulto , Idoso , Idoso de 80 Anos ou mais , Alveolite Alérgica Extrínseca/complicações , Progressão da Doença , Feminino , Refluxo Gastroesofágico/complicações , Refluxo Gastroesofágico/mortalidade , Hérnia Hiatal/complicações , Humanos , Fibrose Pulmonar Idiopática/complicações , Fibrose Pulmonar Idiopática/mortalidade , Doenças Pulmonares Intersticiais/complicações , Doenças Pulmonares Intersticiais/mortalidade , Masculino , Pessoa de Meia-Idade , Prevalência , Radiografia Torácica , Estudos Retrospectivos , Risco , Escleroderma Sistêmico/complicações , Escleroderma Sistêmico/diagnóstico por imagem , Tomografia Computadorizada por Raios X
7.
J Clin Microbiol ; 54(2): 385-91, 2016 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-26637380

RESUMO

Although numerous perioperative samples and culture media are required to diagnose prosthetic joint infection (PJI), their exact number and types have not yet been definitely determined with a high level of proof. We conducted a prospective multicenter study to determine the minimal number of samples and culture media required for accurate diagnosis of PJI. Over a 2-year period, consecutive patients with clinical signs suggesting PJI were included, with five perioperative samples per patient. The bacteriological and PJI diagnosis criteria were assessed using a random selection of two, three, or four samples and compared with those obtained using the recommended five samples (references guidelines). The results obtained with two or three culture media were then compared with those obtained with five culture media for both criteria. The times-to-positivity of the different culture media were calculated. PJI was confirmed in 215/264 suspected cases, with a bacteriological criterion in 192 (89%). The PJI was monomicrobial (85%) or polymicrobial (15%). Percentages of agreement of 98.1% and 99.7%, respectively, for the bacteriological criterion and confirmed PJI diagnosis were obtained when four perioperative samples were considered. The highest percentages of agreement were obtained with the association of three culture media, a blood culture bottle, a chocolate agar plate, and Schaedler broth, incubated for 5, 7, and 14 days, respectively. This new procedure leads to significant cost saving. Our prospective multicenter study showed that four samples seeded on three culture media are sufficient for diagnosing PJI.


Assuntos
Artrite/diagnóstico , Artrite/microbiologia , Infecções Relacionadas à Prótese/diagnóstico , Infecções Relacionadas à Prótese/microbiologia , Técnicas Bacteriológicas/métodos , Estudos Transversais , Feminino , Custos de Cuidados de Saúde , Humanos , Masculino , Reprodutibilidade dos Testes , Sensibilidade e Especificidade , Fatores de Tempo
8.
J Clin Microbiol ; 52(10): 3583-9, 2014 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-25056331

RESUMO

There is no standard method for the diagnosis of prosthetic joint infection (PJI). The contribution of 16S rRNA gene PCR sequencing on a routine basis remains to be defined. We performed a prospective multicenter study to assess the contributions of 16S rRNA gene assays in PJI diagnosis. Over a 2-year period, all patients suspected to have PJIs and a few uninfected patients undergoing primary arthroplasty (control group) were included. Five perioperative samples per patient were collected for culture and 16S rRNA gene PCR sequencing and one for histological examination. Three multicenter quality control assays were performed with both DNA extracts and crushed samples. The diagnosis of PJI was based on clinical, bacteriological, and histological criteria, according to Infectious Diseases Society of America guidelines. A molecular diagnosis was modeled on the bacteriological criterion (≥ 1 positive sample for strict pathogens and ≥ 2 for commensal skin flora). Molecular data were analyzed according to the diagnosis of PJI. Between December 2010 and March 2012, 264 suspected cases of PJI and 35 control cases were included. PJI was confirmed in 215/264 suspected cases, 192 (89%) with a bacteriological criterion. The PJIs were monomicrobial (163 cases [85%]; staphylococci, n = 108; streptococci, n = 22; Gram-negative bacilli, n = 16; anaerobes, n = 13; others, n = 4) or polymicrobial (29 cases [15%]). The molecular diagnosis was positive in 151/215 confirmed cases of PJI (143 cases with bacteriological PJI documentation and 8 treated cases without bacteriological documentation) and in 2/49 cases without confirmed PJI (sensitivity, 73.3%; specificity, 95.5%). The 16S rRNA gene PCR assay showed a lack of sensitivity in the diagnosis of PJI on a multicenter routine basis.


Assuntos
Infecções Bacterianas/diagnóstico , Técnicas de Diagnóstico Molecular/métodos , Osteoartrite/diagnóstico , Reação em Cadeia da Polimerase/métodos , Infecções Relacionadas à Prótese/diagnóstico , RNA Ribossômico 16S/genética , Adulto , Idoso , DNA Bacteriano/genética , DNA Ribossômico/genética , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Sensibilidade e Especificidade
9.
Cancer Imaging ; 24(1): 77, 2024 Jun 17.
Artigo em Inglês | MEDLINE | ID: mdl-38886836

RESUMO

BACKGROUND: The Response Evaluation Criteria in Solid Tumors (RECIST) are often inadequate for the early assessment of the response to cancer therapy, particularly bevacizumab-based chemotherapy. In a first cohort of patients with colorectal cancer liver metastases (CRLM), we showed that variations of the tumor-to-liver density (TTLD) ratio and modified size-based criteria determined using computed tomography (CT) data at the first restaging were better prognostic criteria than the RECIST. The aims of this study were to confirm the relevance of these radiological biomarkers as early predictors of the long-term clinical outcome and to assess their correlation with contrast-enhanced ultrasound (CEUS) parameters in a new patient cohort. METHODS: In this post-hoc study of the multicenter STIC-AVASTIN trial, we retrospectively reviewed CT data of patients with CRLM treated with bevacizumab-based regimens. We determined the size, density and TTLD ratio of target liver lesions at baseline and at the first restaging and also performed a morphologic evaluation according to the MD Anderson criteria. We assessed the correlation of these parameters with progression-free survival (PFS) and overall survival (OS) using the log-rank test and a Cox proportional hazard model. We also examined the association between TTLD ratio and quantitative CEUS parameters. RESULTS: This analysis concerned 79 of the 137 patients included in the STIC-AVASTIN trial. PFS and OS were significantly longer in patients with tumor size reduction > 15% at first restaging, but were not correlated with TTLD ratio variations. However, PFS was longer in patients with TTLD ratio > 0.6 at baseline and first restaging than in those who did not reach this threshold. In the multivariate analysis, only baseline TTLD ratio > 0.6 was a significant survival predictor. TTLD ratio > 0.6 was associated with improved perfusion parameters. CONCLUSIONS: Although TTLD ratio variations did not correlate with the long-term clinical outcomes, TTLD absolute values remained a good predictor of survival at baseline and first restaging, and may reflect tumor microvascular features that might influence bevacizumab-based treatment efficiency. TRIAL REGISTRATION: NCT00489697, registration number of the STIC-AVASTIN trial.


Assuntos
Bevacizumab , Neoplasias Colorretais , Neoplasias Hepáticas , Adulto , Idoso , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Bevacizumab/uso terapêutico , Neoplasias Colorretais/tratamento farmacológico , Neoplasias Colorretais/patologia , Neoplasias Colorretais/mortalidade , Fígado/diagnóstico por imagem , Fígado/patologia , Neoplasias Hepáticas/secundário , Neoplasias Hepáticas/tratamento farmacológico , Neoplasias Hepáticas/diagnóstico por imagem , Neoplasias Hepáticas/mortalidade , Prognóstico , Estudos Retrospectivos , Tomografia Computadorizada por Raios X/métodos , Ultrassonografia/métodos
10.
Clin Res Hepatol Gastroenterol ; 48(7): 102380, 2024 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-38788975

RESUMO

BACKGROUND: Visceral fat produces angiogenic factors such as vascular endothelial growth factor that promote tumoral growth. However, its influence on outcome for patients with advanced cancer treated with anti-angiogenic agents is controversial. AIMS: The aim of this study was to determine whether visceral fat volume, visceral fat area and body mass index are associated with outcome in patients receiving first-line bevacizumab-based treatment for metastatic colorectal cancer. METHODS: This multicenter prospective study included 103 patients with metastatic colorectal cancer who received first-line bevacizumab-based chemotherapy. Computed tomography was used to measure visceral fat volume and visceral fat area. Endpoints were tumoral response at 2 months, progression free survival and overall survival. RESULTS: Visceral fat volume and visceral fat area, but not body mass index, were significantly associated with better outcome. Using sex-specific median values progression free survival was significantly longer in patients with high visceral fat volume (13.2 versus 9.4 months; p = 0.0043). In the same way, high visceral fat volume and visceral fat area were associated with a significantly better overall survival: 31.3 versus 20.5 months (p = 0.0072) and 29.3 versus 20.5 months (p = 0.0078), respectively. By multivariate analysis, visceral fat volume was associated with longer progression free survival and overall survival. CONCLUSION: This study demonstrates that a high visceral fat volume is associated with better outcome in patients receiving first-line bevacizumab-based chemotherapy for metastatic colorectal cancer.


Assuntos
Bevacizumab , Neoplasias Colorretais , Gordura Intra-Abdominal , Humanos , Bevacizumab/uso terapêutico , Bevacizumab/administração & dosagem , Gordura Intra-Abdominal/diagnóstico por imagem , Neoplasias Colorretais/tratamento farmacológico , Neoplasias Colorretais/patologia , Neoplasias Colorretais/mortalidade , Masculino , Feminino , Pessoa de Meia-Idade , Estudos Prospectivos , Idoso , Resultado do Tratamento , Adulto , Antineoplásicos Imunológicos/uso terapêutico , Índice de Massa Corporal , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Metástase Neoplásica , Intervalo Livre de Progressão , Idoso de 80 Anos ou mais , Taxa de Sobrevida , Fluoruracila/uso terapêutico
11.
Transfusion ; 53(6): 1335-45, 2013 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-22998014

RESUMO

BACKGROUND: The clinical equivalence of plasma treated to reduce pathogen transmission and untreated plasma has not been extensively studied. A clinical trial was conducted in liver transplant recipients to compare the efficacy of three plasmas. STUDY DESIGN AND METHODS: A randomized, equivalence, blinded trial was performed in four French liver transplantation centers. The three studied (fresh-frozen) plasmas were quarantine (Q-FFP), methylene blue (MB-FFP), and solvent/detergent (S/D-FFP) plasmas. The primary outcome was the volume of plasma transfused during transplantation. Secondary outcomes included intraoperative blood loss, hemostasis variables corrections, and adverse events. RESULTS: One-hundred patients were randomly assigned in the MB-FFP, 96 in the S/D-FFP, and 97 in the Q-FFP groups, respectively. The median volumes of plasma transfused were 2254, 1905, and 1798 mL with MB-FFP, S/D-FFP, and Q-FFP, respectively. The three plasmas were not equivalent. MB-FFP was not equivalent to the two other plasmas, but S/D-FFP and Q-FFP were equivalent. The median numbers of transfused plasma units were 10, 10, and 8 units with MB-FFP, S/D-FFP, and Q-FFP, respectively. Adjustment on bleeding risk factors diminished the difference between groups: the excess plasma volume transfused with MB-FFP compared to Q-FFP was reduced from 24% to 14%. Blood loss and coagulation factors corrections were not significantly different between the three arms. CONCLUSION: Compared to both Q-FFP and S/D-FFP, use of MB-FFP was associated with a moderate increase in volume transfused, partly explained by a difference in unit volume and bleeding risk factors. Q-FFP was associated with fewer units transfused than either S/D-FFP or MB-FFP.


Assuntos
Perda Sanguínea Cirúrgica/prevenção & controle , Hemostasia , Transplante de Fígado , Plasma , Complicações Pós-Operatórias/prevenção & controle , Perda Sanguínea Cirúrgica/estatística & dados numéricos , Detergentes , Método Duplo-Cego , Inibidores Enzimáticos , Feminino , Humanos , Modelos Lineares , Hepatopatias/epidemiologia , Hepatopatias/cirurgia , Masculino , Azul de Metileno , Pessoa de Meia-Idade , Complicações Pós-Operatórias/sangue , Complicações Pós-Operatórias/epidemiologia , Quarentena , Fatores de Risco , Solventes , Resultado do Tratamento , Viroses/prevenção & controle
13.
Orthop Traumatol Surg Res ; 109(7): 103661, 2023 11.
Artigo em Inglês | MEDLINE | ID: mdl-37474020

RESUMO

BACKGROUND: Trochanteric fractures are a public health issue due to the aging of the population. Treatment aims to reduce their related morbidity and mortality and to allow an early return to independence. Postoperative anemia is associated with poorer functional recovery and an increased mortality rate. The aim of this study was to assess whether minimally invasive side plate fixation (Minimal Invasive Screw System, MISS™) resulted in reduced perioperative bleeding compared with conventional fixation (Pertrochanteric Hip Screw, PHS™). HYPOTHESIS: We hypothesized that minimally invasive side plate fixation (MISS) would result in reduced perioperative bleeding compared with conventional fixation (PHS). PATIENTS AND METHODS: We conducted an open randomized controlled trial with blinded assessment of the primary outcome. Inclusion criteria were patients aged over 65 years with isolated reducible trochanteric fracture. The 2 surgical implants were of the same shape, the only difference between them being the locking mode of the femoral neck screw on the plate of the MISS device, allowing a percutaneous approach. Primary outcome was perioperative bleeding evaluated with Mercuriali's formula. Secondary outcomes included operating time, scar length, length of hospital stay, radiological criteria such as quality of fracture reduction, implant positioning, bone healing, complications and functional recovery compared between the 2 groups. RESULTS: One hundred and eight patients met the inclusion criteria and were randomized to receive either PHS (n=54) or MISS (n=54). Osteosynthesis with MISS significatively reduced perioperative bleeding (median 243mL, interquartile range [152-410] vs. 334mL [247-430] [p=0.0299]), operating time (65min [57-73] vs. 79min [66-89] [p=0.0002]) and scar length after 45 days (7cm [5-8] vs. 14cm [12-15] [p<0.0001]). There was no statistically significant difference between groups in postoperative complications, revision surgery or serious adverse events. CONCLUSION: Compared with PHS, MISS reduced operating time, perioperative bleeding and scar length with no observed functional difference. LEVEL OF EVIDENCE: I.


Assuntos
Cicatriz , Fraturas do Quadril , Humanos , Idoso , Resultado do Tratamento , Fixação Interna de Fraturas/métodos , Parafusos Ósseos , Fraturas do Quadril/diagnóstico por imagem , Fraturas do Quadril/cirurgia , Hemorragia , Placas Ósseas
14.
J Clin Psychol Med Settings ; 19(3): 320-8, 2012 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-22669411

RESUMO

This longitudinal study analyzed the interactions between the quality of life and the coping strategies of 100 patients treated for breast cancer and their caregivers. Data were collected after diagnosis, at the end of treatment, and 6 months after treatment with the Quality of Life Questionnaire-C30 (QLQ-C30), Duke Health Profile and Ways of Coping Checklist for both patients and caregivers. The theoretical model was tested using a typology of patients and mixed model analyses. The quality of life of patients changed over time and no cluster effect was found. The influence of the sociodemographic characteristics, coping strategies (patients and caregivers) and the quality of life of caregivers on patient's quality of life were different according to the quality of life dimensions considered. To understand the adaptation of patients to their disease, it is therefore essential to look at whether the caregiver is capable of playing a supporting role.


Assuntos
Adaptação Psicológica , Neoplasias da Mama/psicologia , Cuidadores/psicologia , Qualidade de Vida , Apoio Social , Adulto , Idoso , Análise por Conglomerados , Feminino , França , Humanos , Modelos Lineares , Estudos Longitudinais , Masculino , Pessoa de Meia-Idade , Análise Multivariada
15.
BMJ Open ; 12(7): e059464, 2022 07 28.
Artigo em Inglês | MEDLINE | ID: mdl-35902188

RESUMO

OBJECTIVES: The first COVID-19 lockdown led to a significantly reduced access to healthcare, which may have increased decompensations in frail patients with chronic diseases, especially older patients living with a chronic cardiovascular disease (CVD) or a mental health disorder (MHD). The objective of COVIQuest was to evaluate whether a general practitioner (GP)-initiated phone call to patients with CVD and MHD during the COVID-19 lockdown could reduce the number of hospitalisation(s) over a 1-month period. DESIGN: This is a cluster randomised controlled trial. Clusters were GPs from eight French regions. PARTICIPANTS: Patients ≥70 years old with chronic CVD (COVIQuest_CV subtrial) or ≥18 years old with MHD (COVIQuest_MH subtrial). INTERVENTIONS: A standardised GP-initiated phone call aiming to evaluate patients' need for urgent healthcare, with a control group benefiting from usual care (ie, the contact with the GP was by the patient's initiative). MAIN OUTCOME MEASURES: Hospital admission within 1 month after the phone call. RESULTS: In the COVIQuest_CV subtrial, 131 GPs and 1834 patients were included in the intervention group and 136 GPs and 1510 patients were allocated to the control group. Overall, 65 (3.54%) patients were hospitalised in the intervention group vs 69 (4.57%) in the control group (OR 0.82, 95% CI 0.56 to 1.20; risk difference -0.77, 95% CI -2.28 to 0.74). In the COVIQuest_MH subtrial, 136 GPs and 832 patients were included in the intervention group and 131 GPs and 548 patients were allocated to the control group. Overall, 27 (3.25%) patients were hospitalised in the intervention group vs 12 (2.19%) in the control group (OR 1.52, 95% CI 0.82 to 2.81; risk difference 1.38, 95% CI 0.06 to 2.70). CONCLUSION: A GP-initiated phone call may have been associated with more hospitalisations within 1 month for patients with MHD, but results lack robustness and significance depending on the statistical approach used. TRIAL REGISTRATION NUMBER: NCT04359875.


Assuntos
COVID-19 , Doenças Cardiovasculares , Clínicos Gerais , Estudantes de Medicina , Adolescente , Idoso , COVID-19/epidemiologia , COVID-19/prevenção & controle , Doença Crônica , Controle de Doenças Transmissíveis , Humanos , Morbidade , Resultado do Tratamento
16.
Ultrasound Med Biol ; 46(2): 286-296, 2020 02.
Artigo em Inglês | MEDLINE | ID: mdl-31753600

RESUMO

This study evaluated the reproducibility of dynamic contrast-enhanced ultrasound (DCEUS) parameters outlining liver metastases of colorectal cancer in 45 patients, before and after anti-angiogenic-based therapy. Tumor enhancement was quantified by drawing three regions of interest (ROIs): (i) outlining the tumor based on portal phase DCEUS images, (ii) in the hypo-enhanced center of the lesion and (iii) outlining the lesion using parametric imaging. Perfusion parameters were extracted from time-intensity curves. Another ROI was drawn in healthy liver parenchyma for normalization. Intra- and inter-observer reproducibility of these parameters was evaluated using intra-class correlation coefficients (ICCs). For the three ROIs, both intra- and inter-observer reproducibility were excellent (ICCs ≥0.9) for 50.8% absolute parameters and were moderate to good (0.7 ≤ ICC < 0.9) for 26.7% of them. In healthy liver parenchyma and for normalized parameters, reproducibility was moderate to excellent for 59.4% of intensity parameters and was low (ICC <0.7) for almost all temporal parameters. This study indicates that DCEUS is a reproducible tool for evaluating perfusion parameters.


Assuntos
Inibidores da Angiogênese/uso terapêutico , Neoplasias Colorretais/patologia , Neoplasias Hepáticas/irrigação sanguínea , Neoplasias Hepáticas/diagnóstico por imagem , Fluxo Sanguíneo Regional , Idoso , Feminino , Humanos , Neoplasias Hepáticas/tratamento farmacológico , Neoplasias Hepáticas/secundário , Masculino , Pessoa de Meia-Idade , Variações Dependentes do Observador , Estudos Prospectivos , Reprodutibilidade dos Testes , Ultrassonografia
17.
Clin Nutr ; 39(11): 3319-3330, 2020 11.
Artigo em Inglês | MEDLINE | ID: mdl-32164981

RESUMO

BACKGROUND: Changes in skeletal muscle mass (SMM), total adipose tissue mass (TAT) or bone mineral density (BMD) have been described in patients with cancer undergoing various treatments; simultaneous variations of all 3 tissues has not been reported. METHODS: Data were prospectively collected in a clinical study (NCT00489697) including patients with liver metastases of colorectal cancer who received 4 cycles of bevacizumab in combination with cytotoxic chemotherapy. Computerized tomography (CT) at baseline and after chemotherapy was used to quantify skeletal muscle and adipose tissue cross-sectional areas, and mean lumbar spine BMD using validated approaches. RESULTS: After exclusion of patients lacking adequate CT images or missing data, 72 subjects were included. Patients were 63% male, aged 63.2 ± 10.3 years, 100% had liver metastases and 54%, 24% and 22% respectively has 0, 1 and ≥2 extrahepatic metastases. 100% tolerated 4 cycles of treatment and none showed progressive disease at the end of treatment. The scan interval was 70 days (95% CI, 62.3 to 80.5). Thresholds for loss of tissue were defined as loss ≥ measurement error. 10% of patients showed no loss of any tissue and a further 43% lost one tissue (SMM, TAT or BMD); 47% of patients lost 2 tissues (16.5% lost SMM + TAT, 8% lost SMM + BMD, 10% lost TAT + BMD) or all 3 tissues (12.5%). Catabolic behavior (2 or 3 tissue loss vs 0 or 1 tissue loss) associated with disease burden, including unresectable primary tumor (p = 0.010), presence of extrahepatic (EH) metastases (p = 0.039) and number of EH metastases (p = 0.004). No association was found between the number of tissues lost and treatment response, which was uniformly high, or treatment toxicity, which was uniformly low. CONCLUSION: Multiple tissues can be measured in routine CT images and these show considerable inter-individual variation. Substantial losses in some individuals appear to associate with disease burden.


Assuntos
Tecido Adiposo/diagnóstico por imagem , Antineoplásicos/efeitos adversos , Bevacizumab/efeitos adversos , Densidade Óssea/fisiologia , Neoplasias Colorretais/tratamento farmacológico , Músculo Esquelético/diagnóstico por imagem , Tecido Adiposo/efeitos dos fármacos , Tecido Adiposo/patologia , Idoso , Densidade Óssea/efeitos dos fármacos , Neoplasias Colorretais/patologia , Monitoramento de Medicamentos , Feminino , Humanos , Neoplasias Hepáticas/tratamento farmacológico , Neoplasias Hepáticas/secundário , Vértebras Lombares/diagnóstico por imagem , Masculino , Pessoa de Meia-Idade , Músculo Esquelético/efeitos dos fármacos , Músculo Esquelético/patologia , Estudos Prospectivos , Tomografia Computadorizada por Raios X , Resultado do Tratamento , Ultrassonografia
18.
Semin Nephrol ; 29(1): 59-66, 2009 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-19121475

RESUMO

The prevalence of protein-energy malnutrition progressively increases during the evolution of chronic kidney disease (CKD). As a consequence, it has been reported that 40% of patients present with symptoms of undernutrition at the entrance to chronic dialysis treatment. In patients established on maintenance hemodialysis, the prevalence of malnutrition varies from 20% to 60% according to which indicators of nutritional status are used. Protein-energy malnutrition is associated with an increase in overall and cardiovascular death risks both in CKD patients not yet on dialysis and in dialysis patients. Given the impact of protein-energy wasting on the outcome of CKD patients, screening malnutrition and monitoring protein-energy status appear of primary importance. Therefore, scientific and professional societies or foundations have developed guidelines for the assessment of nutritional status as well as for the treatment of malnourished CKD patients. Recently, an expert panel recommended the term protein-energy wasting for loss of body protein mass and fuel reserves. According to these recommendations, protein-energy wasting should be diagnosed if 3 characteristics are present (low serum levels of albumin, transthyretin, or cholesterol), reduced body mass (low or reduced body mass or fat mass or weight loss with reduced intake of protein and energy), and reduced muscle mass (muscle wasting or sarcopenia, reduced mid-arm-muscle circumference). The present article addresses the methods for assessing protein-energy status, their specificities regarding the CKD staging, and the criteria for choosing among these methods when managing the follow-up evaluation of CKD patients. The practical implications of nutritional parameters for the management of CKD patients are illustrated by a case presentation.


Assuntos
Falência Renal Crônica/fisiopatologia , Desnutrição Proteico-Calórica/diagnóstico , Proteínas/metabolismo , Composição Corporal , Humanos , Falência Renal Crônica/terapia , Masculino , Pessoa de Meia-Idade , Terapia Nutricional , Desnutrição Proteico-Calórica/fisiopatologia , Desnutrição Proteico-Calórica/terapia , Diálise Renal
19.
Urol Oncol ; 36(2): 80.e17-80.e24, 2018 02.
Artigo em Inglês | MEDLINE | ID: mdl-29153942

RESUMO

BACKGROUND: Previous studies have suggested a link between metabolic syndrome (MetS) and prostate cancer (PCa). In the present study, we aimed to assess the association between MetS and markers of PCa aggressiveness on radical prostatectomy (RP). METHODS: All patients consecutively treated for PCa by RP in 6 academic institutions between August 2013 and July 2016 were included. MetS was defined as at least 3 of 5 components (obesity, elevated blood pressure, diabetes, low high-density lipoprotein (HDL)-cholesterol, and hypertriglyceridemia). Demographic, biological, and clinical parameters were prospectively collected, including: age, biopsy results, preoperative serum prostate-specific antigen, surgical procedure, and pathological data of RP specimen. Locally advanced disease was defined as a pT-stage ≥3. International Society of Urological Pathology (ISUP) groups were used for pathological grading. Qualitative and quantitative variables were compared using chi-square and Wilcoxon tests; logistic regression analyses assessed the association of MetS and its components with pathological data. Statistical significance was defined as a P<0.05. RESULTS: Among 567 men, 249 (44%) had MetS. In a multivariate model including preoperative prostate-specific antigen, biopsy ISUP-score, clinical T-stage, age, and ethnicity: we found that MetS was an independent risk factor for positive margins, and ISUP group ≥4 on the RP specimen (odds ratio [OR] = 1.5; 95% CI: 1.1-2.3; P = 0.035; OR = 2.0; 95% CI: 1.1-4.0; P = 0.044, respectively). In addition, low HDL-cholesterol level was associated with locally advanced PCa (OR = 1.6; 95% CI: 1.1-2.4; P = 0.024). Risks of adverse pathological features increased with the number of MetS components: having ≥ 4 MetS components was significantly associated with higher risk of ISUP group ≥ 4 and higher risk of positive margins (OR = 1.9; 95% CI: 1.1-3.3; P = 0.017; OR = 1.8; 95% CI: 1.1-2.8; P = 0.007, respectively). CONCLUSION: MetS was an independent predictive factor for higher ISUP group and positive margins at RP. Low HDL-cholesterol alone, and having 4 and more MetS components were also associated with higher risk of adverse pathological features.


Assuntos
HDL-Colesterol/metabolismo , Síndrome Metabólica/metabolismo , Prostatectomia/métodos , Neoplasias da Próstata/cirurgia , Idoso , Distribuição de Qui-Quadrado , Humanos , Modelos Logísticos , Masculino , Síndrome Metabólica/complicações , Pessoa de Meia-Idade , Prognóstico , Estudos Prospectivos , Antígeno Prostático Específico/sangue , Neoplasias da Próstata/sangue , Neoplasias da Próstata/patologia , Fatores de Risco
20.
Lancet Haematol ; 5(2): e82-e94, 2018 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-29275118

RESUMO

BACKGROUND: Most patients with chronic lymphocytic leukaemia relapse after initial therapy combining chemotherapy with rituximab. We assessed the efficacy and safety of rituximab maintenance treatment versus observation for elderly patients in remission after front-line abbreviated induction by fludarabine, cyclophosphamide, and rituximab (FCR). METHODS: This randomised, open-label, multicentre phase 3 trial at 89 centres in France enrolled treatment-naive and fit patients aged 65 years or older with chronic lymphocytic leukaemia without del(17p). Eligible patients had an Eastern Cooperative Oncology Group performance status of 0-1 and adequate renal and hepatic function. Patients in response to complete induction treatment with four monthly courses of full-dose FCR with two interim rituximab doses on day 14 of cycles 1 and 2 (oral fludarabine [40 mg/m2 per day] and oral cyclophosphamide [250 mg/m2 per day] for the first 3 days of each cycle, rituximab at 375 mg/m2 intravenously on day 0 of cycle 1 and subsequently at 500 mg/m2 on day 14 of cycle 1, days 1 and 14 of cycle 2, and day 1 of cycles 3 and 4) were eligible for randomisation. Recovery from FCR toxicity and patient willingness to continue the trial were mandatory. We randomly assigned (1:1) patients to either receive intravenous rituximab (500 mg/m2) every 8 weeks for up to 2 years or undergo observation, with a central computer-generated randomisation list using randomly permuted blocks of variable sizes. Randomisation was stratified by IGHV mutational status, the presence or absence of del(11q), and response level to induction treatment. The primary endpoint was progression-free survival, with the objective to assess the superiority of rituximab maintenance relative to observation. The final analysis was done in the intention-to-treat population. Safety was analysed in all patients who received at least one dose of study drug in the rituximab group and in all patients in the observation group. This trial is closed to accrual whilst continuing patient follow-up. The study is registered with ClinicalTrials.gov, number NCT00645606. FINDINGS: Between Dec 14, 2007, and Feb 18, 2014, 542 patients were enrolled, of whom 525 started FCR induction. Between June 10, 2008, and Aug 14, 2014, 409 (78%) patients were randomly assigned to rituximab maintenance (n=202) or observation (n=207). Four (2%) patients in the rituximab group did not receive the allocated treatment (progressive disease [n=1], adverse events [n=3]). After a median follow-up of 47·7 months (IQR 30·4-65·8), median progression-free survival in the rituximab group (59·3 months, 95% CI 49·6-not estimable) was improved compared with the observation group (49·0 months, 39·9-60·5; hazard ratio 0·55, 95% CI 0·40-0·75; p=0·0002). Neutropenia and grade 3-4 infections were more common with rituximab maintenance (105 [53%] of 198 patients vs 74 [36%] of 207 patients and 38 [19%] vs 21 [10%], respectively) during the study. The most common grade 3-4 infection was lower respiratory tract infection (24 [12%] vs eight [4%]). The incidence of second cancers, except basal cell carcinoma, was similar in both groups (29 [15%] vs 23 [11%]). Deaths were related to adverse events for 23 (11%) patients in the rituximab group and 16 (8%) in the observation group. INTERPRETATION: 2-year maintenance rituximab in selected elderly patients improves progression-free survival and shows an acceptable safety profile. Immunotherapy maintenance strategy is a relevant option in front-line treatment of chronic lymphocytic leukaemia, even in the age of targeted therapy. FUNDING: French National Cancer Institute (INCa), Roche, Chugai.


Assuntos
Leucemia Linfocítica Crônica de Células B/tratamento farmacológico , Rituximab/uso terapêutico , Idoso , Feminino , Humanos , Imunoterapia , Leucemia Linfocítica Crônica de Células B/patologia , Masculino , Rituximab/farmacologia
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