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Neurological complications are frequent during the active course of infective endocarditis (IE), and they are associated with high in-hospital mortality rates. However, limited data exist on the prognostic value of these complications for late outcomes. This study aimed to assess the long-term impact of neurological complications in patients surviving an IE episode. A total of 263 consecutive IE patients admitted to a tertiary care center between 2007 and 2022 were prospectively included. Neurological complications at admission included transient ischemic attack (TIA), ischemic stroke, hemorrhagic stroke, intracerebral abscess, and meningitis. The primary outcome was a composite of overall mortality or heart valve surgery. Of the patients, 34.2% died in the hospital, leaving 173 survivors for long-term follow-up. Over a median of 3.5 years, 29 patients died, and 13 (9%) underwent cardiac surgery, resulting in an overall adverse event rate of 30%. Neurological complications independently predicted long-term adverse outcomes (hazard ratio (HR) 2.237; 95% CI 1.006-4.976), after adjusting for age, chronic kidney disease (CKD), and heart failure (HF) development. In an IE patient cohort, neurological complications at admission, which is a complication directly related to the IE process, were independent predictors of long-term outcomes.
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Abstract Mucopolysaccharidosis type IH (MPS IH) is caused by homozygous IDUA gene pathogenic variants. This results in deficiency of the enzyme α-L-iduronidase (IDUA), which is necessary for the degradation of glycosaminoglycans (GAGs). This study outlines the long-term outcomes in adult Irish patients affected with MPS IH, who were followed up for mean 28 years post Haematopoietic Stem Cell Transplantation. Nineteen adult MPS IH patients underwent HSCT in childhood. The participant cohort represents 6 families. Among the 13 patients with Irish Traveller ethnicity, 6 patients were either siblings or first cousins. All these related patients were homozygous for p. Trp402Ter (W402X). Mean age at the first transplantation was 8 months (range 3-21). Five patients had undergone a second transplantation (n=5, 26%) in childhood, due to graft failure. None of the patients had a cardiac valve surgery at the time of the study. 14/19 patients had mild to moderate aortic or mitral valve insufficiency or stenosis. 3/19 patients used non-invasive ventilation at night. Two patients had tracheostomy in situ. Both sensorineural as well as conductive hearing defects. No corneal clouding post corneal transplantation (n=8) was observed. Six patients attended regular secondary school. Multidisciplinary follow-up is needed to address the disease specific complications in adulthood.
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PURPOSE: The purpose of this study was to evaluate implant survivorship and clinical outcomes following radial head arthroplasty for fracture at long-term follow-ups. METHODS: A retrospective analysis was conducted on adult patients who underwent primary uncemented radial head arthroplasty for radial head or neck fractures between 2012 and 2015. Medical records were reviewed to collect information regarding demographics, injury characteristics, reoperations, and revisions requiring implant removal. A bivariate analysis was conducted to identify potential risk factors for reoperation. A Kaplan-Meier curve was created to determine implant survival rates. Eligible patients were contacted to confirm any reoperations and obtain Quick Disability of the Arm, Shoulder, and Hand scores at long-term follow-ups. RESULTS: A total of 89 patients were eligible for analysis and assessed at a mean of 97 months after surgery (range, 81-128). Reoperation rate was 16% (14 of 89 patients), including 5% of patients requiring implant removal or revision. However, 93% of reoperations occurred within the first 12 months of the index surgery. Fracture dislocations of the elbow had a higher rate of reoperation. A Kaplan-Meier curve demonstrated an implant survival rate of 96% at 10-year follow-up. Of the patients who responded, the mean Quick Disability of the Arm, Shoulder, and Hand score was 8.7 ± 10.3, with none requiring additional reoperations or revisions. There were otherwise similar outcome scores among patients requiring reoperation versus those who did not. CONCLUSIONS: Although radial head arthroplasty for fractures has a high potential for reoperation within the first year, survival rates with uncemented implants remain high at 10 years, and patients report excellent Quick Disability of the Arm, Shoulder, and Hand scores at long-term follow-ups, despite any need for reoperation. Fractures with associated elbow dislocation may be at a higher risk for reoperation, and it is important to provide this prognostic information to patients who are likely to require arthroplasty for more extensive injuries. TYPE OF STUDY/LEVEL OF EVIDENCE: Therapeutic IV.
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OBJECTIVE: To determine the long-term risk of new adverse psychosocial outcomes among adolescents diagnosed with a concussion compared with those not diagnosed. STUDY DESIGN: A retrospective, population-based cohort study was conducted. Adolescents (10-18 years) with a physician-diagnosed concussion between 2000 and 2005 were matched on neighborhood and age with 5 controls without concussion from the general population. New-onset mental health disorders, medication use, social, and justice outcomes were extracted using datasets linked to the population data repository. Adolescents were followed for 11-16 years. Adjusted hazard ratios (95% CIs) were estimated. RESULTS: In total, 2082 adolescents with a concussion were matched to 10â510 without. Adolescents with a concussion had an increased risk of any mental health disorder (HR 1.34; 95% CI 1.25-1.45), mood disorder (HR 1.30; 95% 1.18-1.43), psychosis (HR 1.43; 95% CI 1.18-1.74), substance abuse disorder (HR 1.67; 95% 1.31-2.14), and receiving a psychotropic prescription (HR 1.31; 95% CI 1.20-1.42). Female adolescents had an increased risk of ADHD following concussion (HR 1.89; 95% CI 1.17-3.05). Adolescents with a concussion had an increased risk of being accused (HR 1.22; 95% CI 1.11-1.34), victim (HR 1.29; 95% CI 1.11-1.48), or witness (HR 1.16; 95% CI 1.01-1.32) of a crime, or contact with Child and Family Services (HR 1.33; 95% CI 1.10-1.62). There was no association between concussion and attempting or completing suicide, receiving housing support, or collecting income support. CONCLUSIONS: Concussion was associated with an increased risk for multiple adverse psychosocial outcomes. Future work should focus on early identification of those at risk of these outcomes to help optimize longitudinal medical care and support.
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Concussão Encefálica , Transtornos Mentais , Adolescente , Humanos , Criança , Feminino , Estudos Retrospectivos , Estudos de Coortes , Saúde Mental , Incidência , Transtornos Mentais/epidemiologia , Transtornos Mentais/complicações , Concussão Encefálica/diagnósticoRESUMO
INTRODUCTION: In SERAPHIN, a long-term, event-driven, double-blind randomised controlled trial in pulmonary arterial hypertension (PAH), macitentan 10 mg significantly reduced the risk of morbidity/mortality compared with placebo. Its open-label extension study (SERAPHIN OL) further assessed long-term safety and tolerability of macitentan 10 mg in PAH patients. METHODS: Patients in SERAPHIN who completed the double-blind treatment period or experienced a morbidity event during the study could enter SERAPHIN OL. Patients received macitentan 10 mg once daily, and safety and survival were assessed until end of treatment (+ 28 days). Two overlapping sets were analysed for safety: (1) all patients in SERAPHIN OL (OL safety set); (2) patients randomised to macitentan 10 mg in SERAPHIN (long-term safety/survival set). Survival was evaluated as an exploratory endpoint in the latter set. RESULTS: Of 742 patients randomised in SERAPHIN, 550 (74.1%) entered SERAPHIN OL (OL safety set); 242 patients were randomised to macitentan 10 mg in SERAPHIN (long-term safety/survival set). Median (min, max) exposure to macitentan 10 mg was 40.1 (0.1, 130.5) months (2074.7 patient-years; OL safety set) and 54.7 (0.1, 141.3) months (1151.0 patient-years; long-term safety/survival set). Safety in both analysis sets was comparable to the known safety profile of macitentan. Kaplan-Meier survival estimates (95% CI) at 1, 5, 7 and 9 years were 95.0% (91.3, 97.1), 73.3% (66.6, 78.9), 62.6% (54.6, 69.6) and 52.7% (43.6, 61.0), respectively (long-term safety/survival set; median follow-up: 5.9 years). CONCLUSIONS: This analysis provides the longest follow-up for safety and survival published to date for any PAH therapy. The safety profile of macitentan 10 mg over this extensive treatment period was in line with that observed in SERAPHIN. As the majority of patients were receiving other PAH therapy at macitentan initiation, our study provides additional insight into the long-term safety of macitentan, including as part of combination therapy. TRIAL REGISTRATION: ClinicalTrials.gov Identifiers: NCT00660179 and NCT00667823.
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Hipertensão Arterial Pulmonar , Hipertensão Pulmonar Primária Familiar/tratamento farmacológico , Humanos , Hipertensão Arterial Pulmonar/tratamento farmacológico , Pirimidinas/efeitos adversos , Sulfonamidas/efeitos adversos , Resultado do TratamentoRESUMO
Stem cell transplantation has been investigated as treatment for severe and progressive systemic sclerosis (SSc) for the past 25 years. To date, more than 1000 SSc patients have been transplanted worldwide. Overall and event-free survival have increased over the years, reflecting stricter patient selection criteria and better clinical management strategies. This review addresses long-term outcomes of transplanted SSc patients, considering phase I/II and randomized clinical trials, as well as observational studies and those assessing specific aspects of the disease. Clinical outcomes are discussed comparatively between studies, highlighting advances, drawbacks and controversies in the field. Areas for future development are also discussed.
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After failed conservative management, operative intervention is typically indicated for patients with partial-thickness rotator cuff tears (PTRCTs) with persistent pain and disability symptoms.For PTRCTs involving < 50% of the tendon thickness, debridement with or without acromioplasty resulted in favourable outcomes in most studies.For PTRCTs involving > 50% of the tendon thickness, in situ repair has proven to significantly improve pain and functional outcomes for articular and bursal PTRCTs.The few available comparative studies in the literature showed similar functional and structural outcomes between in situ repair and repair after conversion to full-thickness tear for PTRCTs.Most non-overhead athletes return to sports at the same level as previous to the injury after in situ repair of PTRCTs. However, rates of return to preinjury level of competition for overhead athletes have been generally poor regardless of the utilized technique.During long-term follow-up, arthroscopic in situ repair of articular and bursal PTRCTs produced excellent functional outcomes in most patients, with a low rate of revision. Cite this article: EFORT Open Rev 2020;5:138-144. DOI: 10.1302/2058-5241.5.190010.
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BACKGROUND: Zika virus (ZIKV) infection during pregnancy may cause major congenital defects, including microcephaly, ocular, articular and muscle abnormalities, which are collectively defined as Congenital Zika Syndrome. Here, we performed an in-depth characterization of the effects of congenital ZIKV infection (CZI) in immunocompetent mice. METHODS: Pregnant dams were inoculated with ZIKV on embryonic day 5.5 in the presence or absence of a sub-neutralizing dose of a pan-flavivirus monoclonal antibody (4G2) to evaluate the potential role of antibody-dependent enhancement phenomenon (ADE) during short and long outcomes of CZI. FINDINGS: ZIKV infection induced maternal immune activation (MIA), which was associated with occurrence of foetal abnormalities and death. Therapeutic administration of AH-D antiviral peptide during the early stages of pregnancy prevented ZIKV replication and death of offspring. In the post-natal period, CZI was associated with a decrease in whole brain volume, ophthalmologic abnormalities, changes in testicular morphology, and disruption in bone microarchitecture. Some alterations were enhanced in the presence of 4G2 antibody. INTERPRETATION: Our results reveal that early maternal ZIKV infection causes several birth defects in immunocompetent mice, which can be potentiated by ADE phenomenon and are associated with MIA. Additionally, antiviral treatment with AH-D peptide may be beneficial during early maternal ZIKV infection. FUND: This work was supported by the Brazilian National Science Council (CNPq, Brazil), Minas Gerais Foundation for Science (FAPEMIG), Funding Authority for Studies and Projects (FINEP), Coordination of Superior Level Staff Improvement (CAPES), National Research Foundation of Singapore and Centre for Precision Biology at Nanyang Technological University.
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Anticorpos Facilitadores/imunologia , Interações Hospedeiro-Patógeno/imunologia , Complicações Infecciosas na Gravidez , Infecção por Zika virus/imunologia , Infecção por Zika virus/virologia , Zika virus/fisiologia , Animais , Anticorpos Antivirais/imunologia , Antivirais/farmacologia , Osso e Ossos/diagnóstico por imagem , Osso e Ossos/patologia , Encéfalo/efeitos dos fármacos , Encéfalo/imunologia , Encéfalo/patologia , Encéfalo/virologia , Citocinas/metabolismo , Modelos Animais de Doenças , Feminino , Humanos , Camundongos , Peptídeos/farmacologia , Gravidez , Baço/efeitos dos fármacos , Baço/imunologia , Baço/patologia , Baço/virologia , Síndrome , Resultado do Tratamento , Carga Viral , Infecção por Zika virus/diagnóstico , Infecção por Zika virus/tratamento farmacológicoAssuntos
Displasia Broncopulmonar/tratamento farmacológico , Desenvolvimento de Medicamentos/métodos , Feminino , Humanos , Recém-Nascido de Baixo Peso , Recém-Nascido , Doenças do Recém-Nascido/tratamento farmacológico , Recém-Nascido Prematuro , Inflamação , Masculino , Pediatria/métodos , Pediatria/tendências , Gravidez , Complicações na Gravidez , Fatores de Risco , FumarRESUMO
AIM: To verify whether recurrence-free survival (RFS) surrogates overall survival (OS) in phase III trials for resectable colorectal liver metastases (CRLM). METHODS: MEDLINE, EMBASE, and Scopus databases were consulted. Eligible studies were phase III trials testing any type of systemic therapy (neoadjuvant, adjuvant or perioperative) added to surgery in patients with resectable CRLM. A linear regression model based on hazard ratios (HR) of OS and RFS was performed. RESULTS: Of 3059 studies, 5 phase III trials (1162 patients) were included for analyses. A linear regression weighted by each trial was used to estimate the association between each HR and RFS. The originated formula was: OS HR = (0.93 × RFS HR) + 0.14; with RFS 95%CI (0.48-1.38), with P = 0.007. CONCLUSION: This association suggests that RFS could work as a putative surrogate endpoint of OS in this population, avoiding bigger, longer and more resource-consuming trials. The OS could be assumed based on RFS and our model could be useful to better estimate sample size calculations of phase III trials of CRLM aiming for OS.
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Advances in surgery and chemotherapy regimens have increased the long-term survival of patients with colorectal liver metastases (CRLM). Although liver resection remains an essential part of any curative strategy for resectable CRLM, chemotherapy regimens have also improved the long-term outcomes. However, the optimal timing for chemotherapy regimens remains unclear. Thus, this review addressed key points to aid the decision-making process regarding the timing of chemotherapy and surgery for patients with resectable CRLM. J. Surg. Oncol. 2017;115:213-220. © 2016 Wiley Periodicals, Inc.
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Neoplasias Colorretais/cirurgia , Neoplasias Hepáticas/cirurgia , Seleção de Pacientes , Neoplasias Colorretais/patologia , Hepatectomia , Humanos , Neoplasias Hepáticas/secundárioRESUMO
BACKGROUND: Currently available randomized data on the comparison between percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG) for the treatment of unprotected left main coronary disease (LMD) lacks statistical power due to low numbers of patients enrolled. OBJECTIVES: This study assessed long-term outcomes of PCI and CABG for the treatment of LMD in specific subgroups according to disease anatomic complexity. METHODS: We conducted a pooled analysis of individual patient-level data of the LMD patients included in the PRECOMBAT (Bypass Surgery Versus Angioplasty Using Sirolimus-Eluting Stent in Patients With Left Main Coronary Artery Disease) and SYNTAX (Synergy Between PCI With TAXUS and Cardiac Surgery) trials. Incidences of major adverse cardiac events were assessed at 5 years follow-up. RESULTS: Study population comprised 1,305 patients. The incidence of major adverse cardiac and cerebrovascular events at 5 years was 28.3% in the PCI group and 23.0% in the CABG group (hazard ratio [HR]: 1.23; 95% confidence interval [CI]: 1.01 to 1.55; p = 0.045). This difference is mainly driven by a higher rate of repeat revascularization associated with PCI (HR: 1.85; 95% CI: 1.38 to 2.47; p < 0.001). The 2 strategies showed similar rates of the safety composite endpoint of death, myocardial infarction, or stroke (p = 0.45). In patients with isolated LM or LM + 1-vessel disease, PCI was associated with a 60% reduction in all-cause mortality (HR: 0.40; 95% CI: 0.20 to 0.83; p = 0.029) and 67% reduction in cardiac mortality (HR: 0.33; 95% CI: 0.12 to 0.88; p = 0.025) when compared with CABG. CONCLUSIONS: In patients with unprotected LMD, CABG, and PCI result in similar rates of the safety composite endpoint of death, myocardial infarction, or stroke. In patients with isolated LM or LM + 1-vessel disease, PCI is associated with lower all-cause and cardiac mortality when compared to CABG.
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Ponte de Artéria Coronária , Doença da Artéria Coronariana/cirurgia , Intervenção Coronária Percutânea , Ponte de Artéria Coronária/efeitos adversos , Doença da Artéria Coronariana/patologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Intervenção Coronária Percutânea/efeitos adversos , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/etiologia , Resultado do TratamentoRESUMO
AIM: The aims of this Argentinian study were to describe and analyse the outcomes of a continuous interdisciplinary follow-up programme of patients with gastroschisis. METHODS: This was a prospective, longitudinal study of babies with gastroschisis admitted from 1 November 2003 to 31 October 2014, and this paper presents results at one, three and six years of age. Matched-pairs analyses were carried out when they were one and six. RESULTS: We enrolled 62 babies and assessed 52 at one year of age, 34 at three years and 17 at six years. This showed that 63% had mental health problems and 5% had recurrent wheezing. Normal outcomes at one, three and six years were growth (80%, 85% and 80%), neurology-psychomotor development index (64%, 50% and 82%), audiology (100%, 76% and 76%), vision (98%, 94% and 89%) and language (55%, 62% and 65%). The rehospitalisation rates were 30%, 0.3% and zero, and the surgical re-intervention rates were 9%, 0.3% and 12%. Matched-pairs analysis showed no significant differences between outcomes at the ages of one and six. CONCLUSION: Babies born with gastroschisis were at risk for long-term morbidity and impairments, according to follow-up assessments at the ages of one, three and six years.
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Desenvolvimento Infantil , Gastrosquise , Criança , Pré-Escolar , Humanos , Lactente , Estudos Longitudinais , Estudos ProspectivosRESUMO
PURPOSE: Vascular endothelial growth factor receptor-2 (VEGFR-2), epidermal growth factor receptor-1 (EGFR) and cyclooxygenase-2 (COX-2) stimulate key processes involved in tumour progression and are important targets for cancer therapeutics. (18)F-FDG maximum standardized uptake value (SUVmax) on PET/CT is a marker of tumour metabolic activity. The purpose of this study was to measure percentage reductions in SUVmax (∆SUVmax%), VEGFR-2 (∆VEGFR-2%), EGFR (∆EGFR%) and COX-2 (∆COX-2%) in patients with locally advanced rectal cancer (LARC) after preoperative treatment, and to correlate the changes in these markers of response with pathological response in terms of tumour regression grade (TRG) using Rödel's scale and long-term clinical outcome. METHODS: VEGFR-2, EGFR and COX-2 were measured using a quantitative and qualitative compound immunohistochemistry analysis (immunoreactive score) of the pretreatment endoscopic biopsy and definitive surgical specimens. Composite indexes using ∆SUVmax% and the three molecules were developed to differentiate patients with metabolic and molecular responses from nonresponders. Cox proportional hazards model was used to explore associations between the tumour markers, disease-free survival (DFS) and overall survival (OS). RESULTS: The analysis included 38 patients with a median follow-up of 86 months (range 5 - 113 months). The ∆VEGFR-2%/∆SUVmax% index correctly identified 13 of 19 pathological responders (TRG 3 and 4) and 17 of 19 nonresponders (TRG 0 - 2) (sensitivity 68 %, specificity 89 %, accuracy 79 %, positive predictive value 87 %, negative predictive value 74 %). In multivariate analysis, only the ∆VEGFR-2%/∆SUVmax% index was associated with DFS (HR 0.11, p = 0.001) and OS (HR 0.15, p = 0.02). CONCLUSION: In patients with LARC the ∆VEGFR-2%/∆SUVmax% response index is associated with outcome. Determination of the optimal diagnostic cut-off level for this novel biomarker association should be explored. Evaluation in a clinical trial is required to determine whether selected patients could benefit from treatment with a VEGFR-targeted therapeutic agent.
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Terapia Neoadjuvante , Neoplasias Retais/metabolismo , Neoplasias Retais/terapia , Adulto , Idoso , Ciclo-Oxigenase 2/metabolismo , Intervalo Livre de Doença , Receptores ErbB/metabolismo , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Tomografia por Emissão de Pósitrons combinada à Tomografia Computadorizada , Neoplasias Retais/patologia , Resultado do Tratamento , Receptor 2 de Fatores de Crescimento do Endotélio Vascular/metabolismoRESUMO
BACKGROUND: There is a growing body of research documenting an increased risk of neonatal morbidity for late preterm infants (LPI, 34(0/7) weeks to 36(6/7) weeks) and early term infants (ETI, 37(0/7) weeks to 38(6/7) weeks) compared with term infants (TI, 39(0/7) to 41(6/7) ); however, there has been little research on outcomes beyond the first year of life. In this study, we examined respiratory outcomes of LPI and ETI in early childhood. METHODS: South Carolina Medicaid claims data for maternal delivery and infant birth hospitalisations were linked to vital records data for the years 2000 through 2003. Medicaid claims for all infants were then followed until their fifth birthday or until a break in their eligibility. Infants born between 34(0/7) and 41(6/7) weeks were eligible. Infants with congenital anomaly, birthweight below 500 g or above 6000 g, and multiple births were excluded. We fit Cox proportional hazard models from which adjusted hazard ratio (HR) and 95% confidence interval (CI) were derived. RESULTS: A total of 3476 LPI, 12 398 ETI, and 25 975 term infants were included. Both LPI and ETI were associated with an increased risk for asthma (LPI: HR 1.24, 95% CI 1.10, 1.40; ETI: HR 1.12, 95% CI 1.06, 1.19), and bronchitis (LPI: HR 1.15, 95% CI 1.00, 1.34; ETI: HR 1.13, 95% CI 1.05, 1.2) at 3 to 5 years of age. CONCLUSIONS: Late preterm infants and early term infants are at increased risk for asthma and bronchitis.
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Recém-Nascido Prematuro , Nascimento Prematuro , Transtornos Respiratórios/economia , Transtornos Respiratórios/epidemiologia , Pré-Escolar , Feminino , Humanos , Lactente , Recém-Nascido , Masculino , Medicaid , Gravidez , Modelos de Riscos Proporcionais , Transtornos Respiratórios/etiologia , South Carolina/epidemiologia , Estados Unidos/epidemiologiaRESUMO
BACKGROUND: Gastrointestinal stromal tumours (GISTs) are the most common gastrointestinal sarcomas. This global, prospective registry followed patients with advanced or localised GIST (2007-2011). METHODS: Current and evolving diagnostics, treatments and outcome measures in patients with GIST were assessed. Eligible patients were diagnosed with advanced or localised GIST within 15months of registry entry. No treatment plan was prescribed, and no visit schedule was mandated. Treating physicians recorded patient information, including tumour response, diagnostic methods, medications, surgeries performed, mutation status and adverse events leading to dose/medication changes. Survival outcomes were estimated using the Kaplan-Meier method. Other data were analysed using descriptive statistics. RESULTS: The registry included 1663 patients (advanced GIST, n=1095; localised GIST, n=537). Medications (e.g. tyrosine kinase inhibitor use and dosing), disease progression or recurrence and physician assessment of response to treatment in registry patients were consistent with controlled trials and prevailing clinical recommendations. In advanced GIST, estimated 30-month progression-free survival (PFS) (59.8%) and overall survival (OS) (82.7%) were higher than results from previously reported trials (≈40% and ≈70%, respectively). Consistent with treatment guidelines, the most common initial treatments were imatinib for advanced GIST, and complete surgical resection for localised GIST. Computed tomography scans were the most common imaging technique used at diagnosis and follow-up. Mutation analysis was performed at diagnosis in only 15.3% and 14.5% of patients with advanced and localised GIST, respectively. CONCLUSIONS: In this real-world GIST registry, patients with advanced GIST were treated with imatinib and patients with localised GIST received surgical resection, in accordance with prevailing clinical recommendations.
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Tumores do Estroma Gastrointestinal , Padrões de Prática Médica , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Ásia/epidemiologia , Biomarcadores Tumorais/genética , Canadá/epidemiologia , Análise Mutacional de DNA , Procedimentos Cirúrgicos do Sistema Digestório , Progressão da Doença , Europa (Continente)/epidemiologia , Feminino , Tumores do Estroma Gastrointestinal/genética , Tumores do Estroma Gastrointestinal/mortalidade , Tumores do Estroma Gastrointestinal/patologia , Tumores do Estroma Gastrointestinal/terapia , Humanos , Mesilato de Imatinib/uso terapêutico , Estimativa de Kaplan-Meier , Estudos Longitudinais , Masculino , Pessoa de Meia-Idade , Mutação , Recidiva Local de Neoplasia , Valor Preditivo dos Testes , Estudos Prospectivos , Inibidores de Proteínas Quinases/uso terapêutico , Sistema de Registros , Fatores de Risco , América do Sul/epidemiologia , Fatores de Tempo , Tomografia Computadorizada por Raios X , Resultado do Tratamento , Adulto JovemRESUMO
PURPOSE: To analyze long-term outcomes and prognostic factors in patients with paraaortic lymph-node oligometastases (LNO) from gynecological malignancies treated in a multimodal protocol. METHODS: Patients with a histological diagnosis of LNO gynecological cancer [uterine cervix (n = 14, 40 %), endometrial (n = 18, 51 %), ovarian (n = 3, 9 %)] who underwent surgery with radical intent and intraoperative radiotherapy (IORT), median dose 12.5 Gy) were considered eligible for participation in this study. Additionally, 51 % received external-beam radiotherapy (EBRT). RESULTS: From 1997 to 2012, a total of 35 patients from a single institution were analyzed. With a median follow-up time of 55 months (range 2-148), 5-year loco-regional control (LRC), disease-free survival (DFS) and overall survival (OS) were 79, 44 and 49 %, respectively. On multivariate analysis, no EBRT treatment to the LNO (p = 0.03), and time interval from primary tumor diagnosis to LNO <24 months (p = 0.04) remained significantly associated with locoregional recurrence (LRR). We found on multivariate analysis that only R1 margin status (p = 0.01) was significantly associated with OS. CONCLUSION: From the current series of patients with gynecological LNO, it emerges the fact that EBRT promotes local control. Future prospective studies might be designed according to the predicted risk of LRR focusing on different subgroups.
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Neoplasias dos Genitais Femininos/radioterapia , Metástase Linfática/radioterapia , Radioterapia/métodos , Adulto , Idoso , Quimioterapia Adjuvante , Intervalo Livre de Doença , Feminino , Humanos , Período Intraoperatório , Pessoa de Meia-Idade , Modelos de Riscos Proporcionais , Radioterapia AdjuvanteRESUMO
Background: Long-term outcomes of drug-eluting stents (DES) versus bare-metal stents (BMS) in patients with ST-segment elevation myocardial infarction (STEMI) remain uncertain. Objective: To investigate long-term outcomes of drug-eluting stents (DES) versus bare-metal stents (BMS) in patients with ST-segment elevation myocardial infarction (STEMI). Methods: We performed search of MEDLINE, EMBASE, the Cochrane library, and ISI Web of Science (until February 2013) for randomized trials comparing more than 12-month efficacy or safety of DES with BMS in patients with STEMI. Pooled estimate was presented with risk ratio (RR) and its 95% confidence interval (CI) using random-effects model. Results: Ten trials with 7,592 participants with STEMI were included. The overall results showed that there was no significant difference in the incidence of all-cause death and definite/probable stent thrombosis between DES and BMS at long-term follow-up. Patients receiving DES implantation appeared to have a lower 1-year incidence of recurrent myocardial infarction than those receiving BMS (RR = 0.75, 95% CI 0.56 to 1.00, p= 0.05). Moreover, the risk of target vessel revascularization (TVR) after receiving DES was consistently lowered during long-term observation (all p< 0.01). In subgroup analysis, the use of everolimus-eluting stents (EES) was associated with reduced risk of stent thrombosis in STEMI patients (RR = 0.37, p=0.02). Conclusions: DES did not increase the risk of stent thrombosis in patients with STEMI compared with BMS. Moreover, the use of DES did lower long-term risk of repeat revascularization and might decrease the occurrence of reinfarction. .
Fundamento: Os resultados a longo prazo dos stents farmacológicos (SF) contra stents convencionais (SC) em pacientes com infarto do miocárdio com elevação do segmento ST (IMEST) permanecem incertos. Objetivo: Investigar os resultados a longo prazo dos stents farmacológicos (SF) contra stents convencionais (SC) em pacientes com infarto do miocárdio com elevação do segmento ST (IMEST) . Métodos: Foi realizada pesquisa de dados nas bases de dados MEDLINE, EMBASE, na Cochrane Library, e na ISI Web of Science (até fevereiro de 2013) para estudos clínicos aleatórios que comparam a eficácia durante mais de 12 meses ou a segurança do SF com SC em pacientes com IMEST. Foi apresentada uma estimativa agrupada com risco relativo (RR) e seu intervalo de confiança de 95 % (IC), utilizando modelo de efeitos aleatórios. Resultados: Dez estudos com 7.592 participantes com IMEST foram incluídos. Os resultados gerais mostraram que não houve diferença significativa na incidência de morte por todas as causas e trombose de stent definida/provável entre SF e SC em seguimento de longo prazo. Os pacientes que receberam implante de SF pareciam ter uma incidência de infarto do miocárdio recorrente inferior a1 ano que aqueles que receberam SC (RR = 0,75, 95% CI 0,56-1,00, p = 0,05). Além disso, o risco de revascularização do vaso alvo (RVA) depois de receber o SF diminui consistentemente durante a observação a longo prazo (todos p <0,01). Na análise de subgrupo, o uso de stents com eluição de everolimus (EEE) foi associado a um risco reduzido de trombose de stent em pacientes IMEST (RR = 0,37, p = 0,02). Conclusões: SF não aumentou o risco de trombose de stent em pacientes com IMEST em comparação com SC. Além disso, o uso de SF fez baixar o risco de longo prazo de repetição ...
Assuntos
Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Stents Farmacológicos , Infarto do Miocárdio/terapia , Stents , Trombose Coronária/etiologia , Stents Farmacológicos/efeitos adversos , Metais , Infarto do Miocárdio/fisiopatologia , Razão de Chances , Ensaios Clínicos Controlados Aleatórios como Assunto , Medição de Risco , Fatores de Risco , Stents/efeitos adversos , Fatores de Tempo , Resultado do TratamentoRESUMO
OBJECTIVE: The aim of our study was to evaluate the effects of low doses of clozapine in flexible regime in comparison with haloperidol and chlorpromazine in long term. METHOD: The naturalistic study was prospective, active-controlled with 325 adult outpatients of both genders (140 females), with mean year age of 34.8 (range 21-57), suffering from chronic schizophrenia. The first onset of illness was at the mean of 27.9 years (range 17-38), and subjects had the mean year age of 4.1±0.5 previous relapses. The patients were allocated to receive haloperidol (105 subjects, dose range 2-15 mg), chlorpromazine (n=105, 100-400 mg) or clozapine (n=115, 75-600 mg). The scores of psychometric instruments (GWB, PANSS, CGI) were regularly assessed during 5 year period. RESULTS: The sixty-six responders were included in per-protocol analysis: 12, 10 and 16 with positive and 7, 6 and 15 with negative schizophrenic syndrome in haloperidol, chlorpromazine and clozapine group, respectively. The statistically significant differences in all psychometric scores was found, for both schizophrenic syndromes, favoring clozapine. The distribution of eighteen different types of adverse events, which we noted, were significantly different among treatment groups ( ÷2=315.7, df=34, p<0.001). Clozapine was safer and had fewer adverse effects (average of 0.9 adverse events per patient) than haloperidol (2.7) and chlorpromazine (3.2). CONCLUSIONS: Clozapine, in low doses of flexible regime, in long term (five years) showed better effectiveness in chronic schizophrenics with positive and negative symptoms than typical antipsychotics.
OBJETIVO: O propósito deste estudo foi avaliar os efeitos de baixas doses de clozapina em regime flexível comparando com o uso de haloperidol e clorpromazina por período de 5 anos. MÉTODO: Um estudo prospectivo naturalístico, ativo-controlado foi realizado com 325 pacientes com idade média de 34,8 (variância 21-57). Todos com diagnóstico de esquizofrenia. No primeiro surto da doença os pacientes apresentavam idade média de 27,9 anos (variância 17-38) e os surtos subsequentes apareceram em média 4,1±0,5 anos após. Os pacientes foram orientados a receberem haloperidol (105 pacientes com dose entre 2 e 15 mg), clorpromazina (105 pacientes com dose entre 100 e 400 mg) e clozapina (115 pacientes com dose entre 75 e 600 mg). Os instrumentos psicométricos utilizados (GWB, PANSS e CGI) foram regularmente empregados durante os 5 anos do estudo. RESULTADOS: Os 66 pacientes respondedores ao tratamento foram incluídos no protocolo de análise: 12, 10 e 16 apresentavam síndrome esquizofrênica positiva e 7, 6 e 15 síndrome negativa esquizofrênica com haloperidol, clorpromazina e clozapina, respectivamente. Diferenças estatísticas significantes foram observadas em todas as avaliações psicométricas em ambas síndromes esquizofrênicas favorecendo a clozapina. A distribuição de 18 tipos de efeitos colaterais observados foi diferente de modo significativo entre os 3 grupos estudados. A clozapina foi a droga que apresentou menos efeitos colaterais. CONCLUSÃO: A clozapina administrada por longo termo em pequenas doses em regime flexível apresenta melhor eficácia nas síndromes esquizofrênicas quando comparada a outras drogas antipsicóticas.