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BACKGROUND: Part 1 of the RUBY trial (NCT03981796) evaluated dostarlimab plus carboplatin-paclitaxel compared with placebo plus carboplatin-paclitaxel in patients with primary advanced or recurrent endometrial cancer (EC). At the first interim analysis, the trial met one of its dual primary endpoints with statistically significant progression-free survival benefits in the mismatch repair-deficient/microsatellite instability-high (dMMR/MSI-H) and overall populations. Overall survival (OS) results are reported from the second interim analysis. PATIENTS AND METHODS: RUBY is a phase III, global, double-blind, randomized, placebo-controlled trial. Part 1 of RUBY enrolled eligible patients with primary advanced stage III or IV or first recurrent EC who were randomly assigned (1 : 1) to receive either dostarlimab (500 mg) or placebo, plus carboplatin-paclitaxel every 3 weeks for 6 cycles followed by dostarlimab (1000 mg) or placebo every 6 weeks for up to 3 years. OS was a dual primary endpoint. RESULTS: A total of 494 patients were randomized (245 in the dostarlimab arm; 249 in the placebo arm). In the overall population, with 51% maturity, RUBY met the dual primary endpoint for OS at this second interim analysis, with a statistically significant reduction in the risk of death [hazard ratio (HR) = 0.69, 95% confidence interval (CI) 0.54-0.89, P = 0.0020] in patients treated with dostarlimab plus carboplatin-paclitaxel versus carboplatin-paclitaxel alone. The risk of death was lower in the dMMR/MSI-H population (HR = 0.32, 95% CI 0.17-0.63, nominal P = 0.0002) and a trend in favor of dostarlimab was seen in the mismatch repair-proficient/microsatellite stable population (HR = 0.79, 95% CI 0.60-1.04, nominal P = 0.0493). The safety profile for dostarlimab plus carboplatin-paclitaxel was consistent with the first interim analysis. CONCLUSIONS: Dostarlimab in combination with carboplatin-paclitaxel demonstrated a statistically significant and clinically meaningful OS benefit in the overall population of patients with primary advanced or recurrent EC while demonstrating an acceptable safety profile.
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Protocolos de Quimioterapia Combinada Antineoplásica , Carboplatina , Neoplasias do Endométrio , Paclitaxel , Humanos , Feminino , Carboplatina/administração & dosagem , Neoplasias do Endométrio/tratamento farmacológico , Neoplasias do Endométrio/mortalidade , Neoplasias do Endométrio/patologia , Paclitaxel/administração & dosagem , Paclitaxel/efeitos adversos , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Método Duplo-Cego , Pessoa de Meia-Idade , Idoso , Adulto , Idoso de 80 Anos ou mais , Recidiva Local de Neoplasia/tratamento farmacológico , Recidiva Local de Neoplasia/patologia , Recidiva Local de Neoplasia/mortalidade , Intervalo Livre de Progressão , Anticorpos Monoclonais HumanizadosRESUMO
OBJECTIVES: Investigate readmission rates, diagnoses associated with readmission, and associations with mortality through 90-days post-operatively after elective endovascular thoracic and thoracoabdominal aortic repair overall and by extent of coverage. METHODS: A cohort of index elective non-traumatic endovascular thoracic and thoracoabdominal aortic cases from 2010-2018 was derived from the Vascular Implant Surveillance and Interventional Outcomes Network. Cohort readmissions within 90-days postoperative were examined both overall and by Crawford extent (CE) of aortic coverage. Postoperative mortality was examined by reason for readmission and CE. RESULTS: The cohort consisted of 2,093 patients who underwent endovascular thoracic and thoracoabdominal aortic repair (1,541 CE 0A/0B; 240 CE 1-3; 312 CE 4-5). Cumulative risk for 90-day readmission was 34.3% in CE 0A/0B repairs, 33.4% in CE4-5 repairs and 47.4% in CE 1-3 repairs. Compared to CE 0A/B, patients with CE 1-3 repairs experienced an increased risk of readmission within 90 days postoperatively after adjusting for preoperative factors (aHR 1.27(1.00,1.61) while the readmission risk for CE 4-5 repairs did not differ significantly (aHR 0.83 (0.64,1.06). Significant risk factors for 90-day readmission included COPD, dialysis dependence, limited ambulation, visceral/spinal ischemia, and in-hospital stroke. Discharge to home was protective against readmission (HR 0.65, CI 0.54-0.79). Patients with a readmission within 90-days had a 7.89-fold increase in 90-day mortality (HR 7.84; 5.17, 11.9) compared to those not readmitted. CONCLUSIONS: Increasing extent of endovascular thoracic and thoracoabdominal aortic repair was associated with higher 90-day readmission rates. Readmission for all CE was associated with near 8-fold increased risk of mortality. Risk factors associated with increased risk for readmission included pulmonary insufficiency, renal disease, and poor functional status. These findings can inform stakeholders about investment of resources to improve processes of care that both target prevention and mitigate risk of readmission after elective endovascular thoracic and thoracoabdominal aortic repair.
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PURPOSE: A retrospective study, based on a prospectively built database, presents the results of long-term follow-up care of pediatric vagus nerve stimulation (VNS) patients in terms of seizure outcome, surgical aspects, the potential impact of maturation, and medication changes. METHODS: From a prospectively built database, 16 VNS patients (median age 12.0 years, range 6.0 to 16.0 years; median seizure duration 6.5 years, range 2.0 to 15.5 years) followed for at least 10 years were graded as non-responder - NR (seizure frequency reduction < 50%), responder - R (reduction ≥ 50% and < 80%), and 80% responder - 80R (reduction ≥ 80%). Data about surgical aspects (battery replacement, system complications), seizure dynamics, and medication changes were taken from the database. RESULTS: The early percentages of good results (80R + R) were 43.8% (year 1), 50.0% (year 2), and 43.8% (year 3). These percentages remained stable between years 10 and 12 (50% year 10; 46.7% year 11; 50% year 12) and increased in years 16 (60%) and 17 (75%). Depleted batteries were replaced in ten patients, six of whom were either R or 80R. In the four NR, the indication for replacement was improved quality of life. Three patients had VNS explanted or switched off-one had repeated asystolia and two were NR. The effect of hormonal changes in menarche on seizure was not proven. During the study, antiseizure medication was changed in all patients. CONCLUSIONS: The study proved the efficacy and safety of VNS in pediatric patients over an exceptionally long follow-up period. The demand for battery replacements indicates a positive treatment effect.
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Epilepsia , Estimulação do Nervo Vago , Feminino , Criança , Humanos , Adolescente , Seguimentos , Estimulação do Nervo Vago/métodos , Estudos Retrospectivos , Qualidade de Vida , Resultado do Tratamento , Epilepsia/tratamento farmacológico , ConvulsõesRESUMO
INTRODUCTION: Early postoperative mental changes are the most frequent problem after bilateral subthalamic electrode implantation. The study aims to find an association between them and factors related to patient, disease and surgery, including the size of the third ventricle as brain atrophy marker. MATERIAL AND METHODS: The study included 80 patients with bilateral subthalamic electrodes implanted for motor complications of Parkinson's disease (PD). Patients' age, disease and motor complications duration, medication, neuropsychological tests, surgical reports, third ventricle length (intercommissural distance) and width (intermammillary distance) were analysed. RESULTS: Early mental alterations requiring treatment were observed in 25.0% of patients with higher age being significant predictor. The duration of PD motor complications, L DOPA equivalent dose, DSR Mattis, third ventricle length and width were not statistically significant predictors. The incidence of postoperative mental alteration with intermammillary distance > 8 mm was 60%. The percentage of left sided electrodes implanted in anterior trajectory is significantly higher in patients with early mental changes. CONCLUSIONS: Higher age is a risk factor for early postoperative mental changes, but not disease, late motor complications duration and parameters describing third ventricular size except the excessive intermammillary distance. Left sided electrode implanted in anterior position is a risk factor.
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Transtornos Mentais/etiologia , Transtornos Mentais/psicologia , Complicações Pós-Operatórias/psicologia , Núcleo Subtalâmico , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Antiparkinsonianos/administração & dosagem , Antiparkinsonianos/uso terapêutico , Estimulação Encefálica Profunda/efeitos adversos , Eletrodos Implantados , Feminino , Humanos , Levodopa/administração & dosagem , Levodopa/uso terapêutico , Imageamento por Ressonância Magnética , Masculino , Pessoa de Meia-Idade , Testes Neuropsicológicos , Doença de Parkinson/diagnóstico por imagem , Doença de Parkinson/cirurgia , Fatores de Risco , Núcleo Subtalâmico/diagnóstico por imagem , Terceiro VentrículoRESUMO
Backround: Because of the dismal prognosis of untreated brain lymphoma early histological verification using stereobiopsy is decisive for patient with this disease. The study analysed the diagnostic yield of stereobiopsy in brain lymphoma patients with respect to prebiopsy corticosteroid administration. PATIENTS AND METHODS: Patients with brain lymphomas were identified in a group of 162 stereotactic biopsies (108 frame-based and 54 frameless) of patients harboring suspected brain tumor. Non conclusive biopsies were reevaluated to exclude the possibility of missed lymphoma. RESULTS: Total 9 patients (8.3%) and 4 patients (7.4%) had lymphomas in the frame-based and frameless stereobiopsy groups, resp. In 10 patients, corticosteroid treatment of perifocal brain oedema was conducted continually up until biopsy (including one patient with corticotherapy for pulmonary disease). Lesion regression was observed in 6 of these patients. Transient lesion remission was observed during corticotherapy in one patient with lesion recurrence after steroid discontinuation. In 2 patients, corticosteroids were not administered before biopsy. The results of stereobiopsy were inconclusive in 8 patients (4.9%). Before biopsy, the possibility of brain lymphoma was considered in 3 patients, but the final diagnoses were autoimmune vasculitis, histological changes after embolic events from the thrombosed pulmonary veins in pulmonary malformation and local inflammation. CONCLUSION: Although the extent of brain lymphoma decreased after corticosteroid administration, corticotherapy does not exclude valid diagnostic biopsy.Key words: brain lymphoma - stereotaxic techniques - frameless stereotaxy - stereotactic biopsy - corticosreroids Part of the message was presented on XLI. Brno Oncological Days within the Glio Meeting and published in the form of a short abstract. The authors declare they have no potential conflicts of interest concerning drugs, products, or services used in the study. The Editorial Board declares that the manuscript met the ICMJE recommendation for biomedical papers.Submitted: 27. 5. 2017Accepted: 2. 7. 2017.
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Corticosteroides/uso terapêutico , Neoplasias Encefálicas/diagnóstico , Neoplasias Encefálicas/tratamento farmacológico , Linfoma/diagnóstico , Linfoma/tratamento farmacológico , Biópsia , Humanos , Técnicas EstereotáxicasRESUMO
OBJECTIVE: To use data from routine sources to compare rates of obstetric intervention in Europe both overall and for subgroups at higher risk of intervention. DESIGN: Retrospective analysis of aggregated routine data. SETTING: Thirty-one European countries or regions contributing data on mode of delivery to the Euro-Peristat project. POPULATION: Births in participating countries in 2010. METHODS: Countries provided aggregated data about overall rates of obstetric intervention and about caesarean section rates for specified subgroups. MAIN OUTCOME MEASURES: Mode of delivery. RESULTS: Rates of caesarean section ranged from 14.8% to 52.2% of all births and rates of instrumental vaginal delivery ranged from 0.5% to 16.4%. Overall, there was no association between rates of instrumental vaginal delivery and rates of caesarean section, but similarities were observed between some countries that are geographically close and may share common traditions of practice. Associations were observed between caesarean section rates for women with breech and vertex births and with singleton and multiple births but patterns of association for women who had and had not had previous caesarean sections were more complex. CONCLUSIONS: The persisting wide variations in caesarean section and instrumental vaginal delivery rates point to a lack of consensus about practice and raise questions for further investigation. Further research is needed to explore the impact of differences in clinical guidelines, healthcare systems and their financing and parents' and professionals' attitudes to care at delivery.
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Apresentação Pélvica/epidemiologia , Cesárea/estatística & dados numéricos , Parto Obstétrico/estatística & dados numéricos , União Europeia , Padrões de Prática Médica/estatística & dados numéricos , Análise de Variância , Atitude do Pessoal de Saúde , Apresentação Pélvica/terapia , Coleta de Dados , Europa (Continente)/epidemiologia , União Europeia/estatística & dados numéricos , Feminino , Humanos , Guias de Prática Clínica como Assunto , Gravidez , Sistema de Registros , Estudos RetrospectivosRESUMO
Great progress has been made in the diagnostics and treatment of childhood acute lymphoblastic leukemia (ALL) over the past decades. The vast majority of children are cured, however, there is need for further improvement, especially in specific patient subgroups. Our aim was to retrospectively evaluate disease characteristics and treatment outcomes of children with ALL enrolled in a single center into consecutive treatment protocols (ALL-BFM 90, ALL-BFM 95 and ALL IC-BFM 2002) between years 1990 and 2007 and comprehensively summarize diagnostic and therapeutic advances between protocols. In total, 97 patients aged 0 to 18 years were treated for ALL at University Hospital Olomouc in the Czech Republic and steadily high relapse-free survival (RFS), event-free survival (EFS) and overall survival (OS) were observed during the evaluated time period without significant difference between the protocols (RFS 80-86%, EFS 75-83% and OS 84-92%). In conclusion, our center has demonstrated survival rates comparable to leading international study groups for childhood ALL over a substantial period of time. This has been achieved namely due to advances in diagnostics, excellent collaboration on regional, national and international level, quality assurance and high overall standard of care. The acquired experience has been crucial for current participation in the best performing Berlin-Frankfurt-Münster (BFM)-based international trials for childhood ALL.
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Leucemia-Linfoma Linfoblástico de Células Precursoras/terapia , Adolescente , Criança , Pré-Escolar , República Tcheca/epidemiologia , Feminino , Humanos , Lactente , Recém-Nascido , Masculino , Leucemia-Linfoma Linfoblástico de Células Precursoras/genética , Leucemia-Linfoma Linfoblástico de Células Precursoras/mortalidade , Prognóstico , Intervalo Livre de Progressão , Ensaios Clínicos Controlados Aleatórios como Assunto , Estudos RetrospectivosRESUMO
UNLABELLED: Posttraumatic hydrocephalus caused by cerebrospinal fluid circulation disturbances frequently complicates the clinical course and treatment after craniocerebral injury. Hydrocephalus complicating spinal cord injury is only exceptionally reported. The paper presents two cases of complete cervical spinal cord injury with subsequent development of hydrocephalus. The analysis of both cases and literature data confirmed the dominant role of non-spinal factors in the development of hydrocephalus after spinal cord injury. Despite the exceptional occurrence of hydrocephalus after spinal cord injury, this diagnosis should be considered in cases of delayed deterioration of a patient with cervical spinal cord injury, particularly if cerebrospinal fluid space abnormalities and posttraumatic subarachnoid haemorrhage are present. KEY WORDS: spinal cord injury hydrocephalus subarachnoid hemorrhage Blakes pouch cyst neuroendoscopy.
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Hidrocefalia/etiologia , Traumatismos da Medula Espinal/complicações , Hemorragia Subaracnóidea/complicações , Adulto , Vértebras Cervicais/lesões , Feminino , Humanos , Hidrocefalia/diagnóstico por imagem , Hidrocefalia/cirurgia , Imageamento por Ressonância Magnética , Masculino , Fraturas da Coluna Vertebral , Hemorragia Subaracnóidea/diagnóstico por imagem , Ventriculostomia , Adulto JovemRESUMO
BACKGROUND: A high rate of congenital cytomegalovirus (CMV) has been documented in human immunodeficiency virus (HIV)-exposed infants in industrialized settings, both in the pre- and post-highly active antiretroviral therapy (HAART) era. Only limited data on the birth prevalence of congenital CMV among infants of HIV-infected women on prenatal antiretroviral (ARV) prophylaxis are available from sub-Saharan Africa, despite a high prevalence of both infections. We evaluated the prevalence of congenital CMV in HIV-exposed infants in the Western Cape, South Africa. METHODS: HIV-infected mothers were recruited in the immediate postnatal period at a referral maternity hospital between April and October 2012. Maternal and infant clinical data and newborn saliva swabs were collected. Saliva swabs were assayed by real-time polymerase chain reaction for CMV. Data were analyzed using univariate and multivariate logistic regression analyses to determine specific demographic, maternal, and newborn characteristics associated with congenital CMV. RESULTS: CMV was detected in 22 of 748 newborn saliva swabs (2.9%; 95% confidence interval [CI], 1.9%-4.4%). Overall, 96% of mothers used prenatal ARV prophylaxis (prenatal zidovudine, 43.9%; HAART, 52.1%). Maternal age, gestational age, prematurity (<37 weeks' gestation), type of ARV prophylaxis, length of ARV prophylaxis, birth weight, small for gestational age, and infant feeding choice were not significantly different between CMV-infected and -uninfected infants. Maternal CD4 count <200 cells/µL during pregnancy was independently associated with congenital CMV (adjusted odds ratio, 2.9; 95% CI, 1.2-7.3). A negative correlation between CMV load in saliva and maternal CD4 count was observed (r = -0.495, n = 22, P = .019). CONCLUSIONS: The birth prevalence of congenital CMV was high despite prenatal ARV prophylaxis, and was associated with advanced maternal immunosuppression.
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Fármacos Anti-HIV/uso terapêutico , Infecções por Citomegalovirus/congênito , Infecções por Citomegalovirus/epidemiologia , Infecções por HIV/tratamento farmacológico , Complicações Infecciosas na Gravidez/tratamento farmacológico , Infecções Oportunistas Relacionadas com a AIDS , Adulto , Terapia Antirretroviral de Alta Atividade , Citomegalovirus/isolamento & purificação , Infecções por Citomegalovirus/transmissão , Infecções por Citomegalovirus/virologia , Feminino , Infecções por HIV/prevenção & controle , Humanos , Lactente , Recém-Nascido , Transmissão Vertical de Doenças Infecciosas , Nevirapina/uso terapêutico , Gravidez , Prevalência , África do Sul/epidemiologia , Carga Viral , Zidovudina/uso terapêuticoRESUMO
PURPOSE OF THE STUDY: A retrospective analysis of the effect of anticoagulation and anti-aggregation treatments on the post-injury clinical status, frequency of necessary surgical interventions including re-operations, course of intracranial haemorrhage dynamics and treatment outcome in patients with acute traumatic intracranial haematoma. MATERIAL AND METHODS: The group consisted of 328 patients with acute post-traumatic intracranial haemorrhage treated at the author's institution from 2008 to 2012. Fifteen patients with anticoagulation therapy (warfarin; 8 females, 7 males; median age, 72.0 years) and 46 patients with anti-aggregation treatment (21 females, 25 males; median age, 75.5 years ; 37 with acetylsalicylic acid, 5 with thienopyridines, 2 with new antithrombotics and 2 taking dual anti-aggregation therapy), all older than 55 years, were included in statistical analysis. The post-injury clinical condition (Glasgow Coma Scale), incidence of haemorrhagic contusions, intracranial haematoma progression, particularly when surgery was indicated, incidence of re-operations and treatment outcome (Glasgow Outcome Scale - GOS) were the study parameters. The control group included 77 patients with post-traumatic intracranial haematoma with normal coagulation who were older than 55 years (27 females, 50 males; median age, 67 years). Patients younger than 55 years and those with normal coagulation were not included in the statistical analysis. The treatment of all patients with anti-aggregation or anticoagulation therapy was consulted with the haematology specialist. RESULTS: The median age and initial status evaluated by the Glasgow Coma Scale were similar in the groups of anti-aggregated and anticoagulated patients and the control group. The number of good treatment outcomes, as evaluated by the GOS, was significantly higher in the anti-aggregated patients than in those on warfarin. A comparison of anti-aggregated, anticoagulated and normal coagulation patients did not show any statistically significant differences in the incidence of patients operated on, in the incidence of haemorrhagic contusions requiring surgery as a marker of the severity of brain parenchyma injury, intracranial haemorrhage progression with time, particularly when requiring surgery, and the rate of re-operations. However, when comparing the group of anti-aggregated patients with the control group, the higher incidence of haemorrhagic contusions and the lower number of patients requiring surgery were found to be close to the level of statistical significance. DISCUSSION: The positive effect of anti-aggregation and anticoagulation treatment on the morbidity and mortality from cardiovascular diseases should be regarded in relation to a higher risk of haemorrhagic complications. If a bleeding complication occurs, the possibility of neutralising this treatment should be considered, but this is particularly difficult in new agents. The relationship between anti-aggregation or anticoagulation treatment and the treatment results in the patients with head injury is particularly important from the neurosurgical point of view, because the relevant literature data are ambiguous. CONCLUSIONS: The results did not confirm any statistically significant adverse effects of anticoagulation or anti-aggregation treatment on the severity of post-injury status and risk of intracranial bleeding progression. The incidence of poor outcomes is higher in anticoagulated patients than in anti-aggregated patients. Although not reaching the level of statistical significance, the results also indicate higher risk of significant haemorrhagic brain contusions in anti-aggregated patients.
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Anticoagulantes , Doenças Cardiovasculares , Traumatismos Craniocerebrais/complicações , Hemorragia Intracraniana Traumática , Procedimentos Neurocirúrgicos , Inibidores da Agregação Plaquetária , Complicações Pós-Operatórias , Idoso , Anticoagulantes/classificação , Anticoagulantes/farmacologia , Doenças Cardiovasculares/complicações , Doenças Cardiovasculares/tratamento farmacológico , Progressão da Doença , Feminino , Escala de Coma de Glasgow , Humanos , Hemorragia Intracraniana Traumática/diagnóstico , Hemorragia Intracraniana Traumática/etiologia , Hemorragia Intracraniana Traumática/fisiopatologia , Hemorragia Intracraniana Traumática/cirurgia , Masculino , Pessoa de Meia-Idade , Exame Neurológico/métodos , Procedimentos Neurocirúrgicos/efeitos adversos , Procedimentos Neurocirúrgicos/métodos , Inibidores da Agregação Plaquetária/classificação , Inibidores da Agregação Plaquetária/farmacologia , Complicações Pós-Operatórias/diagnóstico , Complicações Pós-Operatórias/etiologia , Complicações Pós-Operatórias/cirurgia , Prognóstico , Reoperação , Estudos Retrospectivos , Resultado do TratamentoRESUMO
INTRODUCTION: Chronic subdural haematoma is a potentially threatening disease, affecting mainly advanced age patients often with frequent serious complicating diseases and extensive concomitant medication including antiaggregation and anticoagulation treatment. Surgery is indicated in symptomatic patients, with haematoma evacuation and subdural drainage via simple skull trephination in the majority of cases. The study aims to analyse the influence of presurgical anticoagulation and antiaggregation treatment on the severity of pre-surgical clinical status and final surgical outcome including the incidence of complications and haematoma recurrence. MATERIAL AND METHODS: The paper retrospectively analyses a group of 132 patients operated on from 2008 to 2013 for chronic subdural haematoma. The following parameters characterising pre-surgical clinical condition were studied: age, anticoagulation and antiaggregation treatment administered, other haemocoagulation problems, interval between the probable injury and surgery, duration of symptoms, the patients pre-surgical clinical condition (Glasgow Coma Scale) and the presence of a speech disorder or at least moderate limb paresis. In the postoperative period and subsequent follow- up, the type of surgery, haematoma recurrence, reoperation technique, postoperative complications and final outcome (Glasgow Outcome Scale) were analysed. RESULTS: 64 patients (42 males, 22 females) without antiaggregation and anticoagulation treatment or other medication potentially altering haemocoagulation with normal coagulation parameters (control group), 20 patients (13 males, 7 females) on anticoagulation and 37 patients (30 males, 7 females) on antiaggregation met study inclusion criteria. Anticoagulated patients and patients on antiaggregation were significantly older than the control group patients. Statistical analysis also proved a shorter duration of clinical symptoms and worse clinical condition (GCS) in anticoagulated patients than in the control group. Skull trephination with drainage was the primary surgery indicated in all but one patient, in patients with anticoagulation or antiaggregation after adequate haematological treatment. Although the incidence of reoperation due to haematoma recurrence and postoperative complications was the highest in anticoagulated patients, this difference from the control group did not reach the level of statistical significance. The analysis of clinical outcome (>2 months after surgery) shows a similar proportion of patients with good outcome (Glasgow Outcome Scale 4.5) in all studied groups - control group 82.8%, anticoagulation treatment 80%, antiaggregation treatment 83.8%. CONCLUSION: Study results did not confirm statistically a significant negative effect of antiaggregation or anticoagulation treatment after adequate pre-surgical preparation on surgical outcomes in chronic subdural haematoma patients (Glasgow Outcome Scale). The highest incidence of complications and haematoma recurrencies was found in anticoagulated patients, although the difference does not reach the level of statistical significance.
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Anticoagulantes/uso terapêutico , Drenagem/métodos , Hematoma Subdural Crônico/tratamento farmacológico , Inibidores da Agregação Plaquetária/uso terapêutico , Feminino , Hematoma Subdural Crônico/cirurgia , Humanos , Masculino , Período Pré-Operatório , Estudos RetrospectivosRESUMO
OBJECTIVES: The aim of the study was to evaluate the long-term efficacy and hospitalization rates in children with refractory focal epilepsy treated by vagus nerve stimulation. MATERIALS AND METHODS: We retrospectively analyzed 15 children with intractable focal epilepsy treated by vagus nerve stimulation (mean age of 14.6 ± 2.5 years at the time of implantation). We analyzed the treatment effectiveness at 1, 2, and 5 year follow-up visits. We counted the average number of urgent hospitalizations and number of days of urgent hospitalization per year for each patient before and after the VNS implantation. RESULTS: The mean seizure reduction was 42.5% at 1 year, 54.9% at 2 years, and 58.3% at 5 years. The number of responders was 7 (46.7%) at 1 year and 9 (60%) at both 2 and 5 years. The mean number of urgent hospitalizations per patient was 1.0 ± 0.6 per year preoperatively and 0.3 ± 0.5 per year post-operatively (P < 0.0001). The mean number of days of urgent hospitalization per patient was 9.3 ± 6.1 per year preoperatively and 1.3 ± 1.8 per year post-operatively ( < 0.0001). CONCLUSIONS: Vagus nerve stimulation is an effective method of treating children with refractory focal epilepsy. It leads to a substantial decrease in the number and duration of urgent hospitalizations.
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Epilepsias Parciais/terapia , Estimulação do Nervo Vago , Adolescente , Anticonvulsivantes/uso terapêutico , Criança , Tosse/etiologia , Transtornos de Deglutição/etiologia , Emergências/epidemiologia , Epilepsias Parciais/tratamento farmacológico , Epilepsia Tônico-Clônica/tratamento farmacológico , Epilepsia Tônico-Clônica/terapia , Feminino , Seguimentos , Parada Cardíaca/etiologia , Hospitalização/estatística & dados numéricos , Humanos , Incidência , Masculino , Recidiva , Estudos Retrospectivos , Resultado do Tratamento , Estimulação do Nervo Vago/efeitos adversosRESUMO
OBJECTIVE: The aim of the paper was to describe the relationship of the anatomical and electrophysiological target for the subthalamic electrode implantation in Parkinson's disease patients defined as the best electrophysiological recordings from multiple paralel electrodes tracts with a target discrepancy explanation. BACKGROUND: Although microrecording is the standard in subthalamic stimulation, microelectrode monitoring prolongs surgical time and may increase the risk of haemorrhagic complications. The main purpose for the electrophysiological mapping is to overcome the discrepancy between the anatomical and electrophysiological targets. METHODS: Subthalamic electrodes were stereotactically implanted in 58 patients using microrecording by means of parallel electrodes at defined distances. The relationship of the final electrode to the anatomical trajectory, the subthalamic nucleus electrical activity length, and the relationship of right and left electrodes were analysed. RESULTS: The final electrode placement matched the anatomical trajectory in 53.4 % of patients on the right side, and 43.1 % of patients on the left side. The electrode position was symmetrical in 38.3 % of patients. The analysis of left and right electrode positions did not prove brain shift as the sole factor responsible for anatomy-functional discrepancy. Further, neither age, Parkinson's disease duration, or L-DOPA adverse effects were confirmed as responsible factors. CONCLUSIONS: The difference between the anatomical trajectory and the final electrode placement underlined the need for functional microelectrode monitoring. Brain shift is not the only causative factor for the difference (Tab. 7, Ref. 27).
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Estimulação Encefálica Profunda/instrumentação , Doença de Parkinson/terapia , Adulto , Idoso , Desenho de Equipamento , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Monitorização Fisiológica , TálamoRESUMO
INTRODUCTION: Advanced age is reported to be an important negative prognostic factor for the final functional outcome in patients after craniocerebral injury. Worse prognosis can also be expected in the presence of significant brain contusion, requiring surgical treatment because of expansive behaviour. Definite adverse influence of alcohol intoxication at the time of injury has not been proven by current literature data. The aim of the study is to analyse the importance of the above mentioned factors for the treatment outcome in patients operated on for craniocerebral injury. MATERIAL AND METHODS: In the group of 246 patients with craniocerebral injury operated on between 2007 and 2011, the authors focused on the influence of age (145 patients < 60 years, 101 patients > 60 years), alcohol intoxication at the moment of injury (blood alcohol level over 0.1% based mainly on serum osmolarity plus clinical signs of alcohol intoxication) and the presence of brain contusion requiring surgical decompression on the final clinical outcome (using the Glasgow Outcome Scale). RESULTS: 54.1% of patients under 60 years of age were alcohol-intoxicated at the moment of injury. The incidence of alcohol intoxication in patients older than 60 years was 35.7%. The incidence of expansive brain contusions requiring surgical decompression was higher in patients older than 60 years and patients with alcohol intoxication. Statistical analysis of prognosis as related to age has shown significantly worse prognosis in patients older than 60 years. The difference was also significant in the subgroup of non-intoxicated patients. Statistical analysis did not show worse prognosis in alcohol-intoxicated patients. The presence of significant contusions influenced the injury prognosis only in patients younger than 60 years. CONCLUSION: The impact of age on the final treatment outcome in patients with craniocerebral injury was proven. The study did not show significant deleterious effect of alcohol intoxication at the time of injury on the final outcome.
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Intoxicação Alcoólica/complicações , Lesões Encefálicas/cirurgia , Traumatismos Craniocerebrais/cirurgia , Adulto , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Lesões Encefálicas/complicações , Lesões Encefálicas/patologia , Traumatismos Craniocerebrais/complicações , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Prognóstico , Adulto JovemRESUMO
BACKGROUND: Allergic rhinoconjunctivitis and chronic urticaria are common histamine-driven diseases, exerting detrimental effects on cognitive functions, sleep, daily activities, and quality of life. Non-sedating second-generation H1-antihistamines are the first-line treatment of choice. Aim of the study was to define the role of bilastine among second-generation H1-antihistamines in the treatment of allergic rhinoconjunctivitis and urticaria in patients of different ages. METHODS: An international Delphi study was carried out to assess consensus among experts from 17 European and extra-European countries on three main topics: 1) Burden of disease; 2) Current treatment options; 3) Specific characteristics of bilastine among second-generation antihistamines. RESULTS: Here, we present the results obtained for a selection of 15 out of 27 consensus statements, focused on disease burden, role of second-generation antihistamines and bilastine profile. The rate of concordance was ≥98% for 4 statements, ≥ 96% for 6, ≥ 94% for 3, and ≥90% for 2. CONCLUSIONS: The high degree of agreement obtained suggests a wide awareness of the burden of allergic rhinoconjunctivitis and chronic urticaria among experts from all over the world and reflects a broad consensus on the role of second-generation antihistamines in general and of bilastine in particular for their management.
Assuntos
Urticária Crônica , Antagonistas não Sedativos dos Receptores H1 da Histamina , Urticária , Humanos , Qualidade de Vida , Técnica Delphi , Antagonistas não Sedativos dos Receptores H1 da Histamina/uso terapêutico , Antagonistas dos Receptores Histamínicos/uso terapêuticoRESUMO
INTRODUCTION: Posttraumatic epilepsy is one of the possible serious consequencies of both closed and open head injury with clinical manifestation months or years after surgery. In pharmacoresistant patients, surgical therapy should be considered. MATERIAL AND METHODS: The study summarises the results of surgical treatment of pharmacoresistant posttraumatic epilepsy in a group of 13 patients (11 males and 2 females). Average age at the time of injury was 9.6 years in males and 8.8 years in females. The average number of seizures was 10.7-17 seizures/month preoperatively. Invasive EEG monitoring was required in 5 patients in whom non invasive or semiinvasive investigations failed to localize the epileptogenic zone adequately. Temporal lobe resections were performed in 4 patients, 4 patients underwent extratemporal resections and vagus nerve stimulation system was implanted in 5 patients. RESULTS: Three patients (75%) after temporal resections became seizure free (Engel I) and in the remaining patient significant reduction of seizures was achieved (Engel III). There were 2 seizure free patients after extratemporal resections (50%) and significant reduction of seizure rates was achieved (Engel III) in the remaining two. One patient after vagus nerve stimulation met the criteria for > 90% response and there was a 50-90% seizure rate reduction in the remaining 4 patients (vagus nerve stimulation responder). CONCLUSIONS: Although in limited group of patients the study confirms good results of surgical treatment of selected posttraumatic epilepsy patients--mainly temporal epilepsy patients and patients after vagus nerve stimulation. Meticulous presurgical evaluation including invasive encephalography in indicated patients is a precondition for surgical success.
Assuntos
Traumatismos Craniocerebrais/complicações , Epilepsia Pós-Traumática/cirurgia , Criança , Epilepsia Pós-Traumática/tratamento farmacológico , Epilepsia Pós-Traumática/etiologia , Feminino , Humanos , MasculinoRESUMO
BACKGROUNDS: Neuroendoscopic biopsy is one of the techniques that can be used for histological verification of a suspected brain tumor. The use of neuroendoscopy is particularly useful for cystic tumors and para- and intraventricular brain tumors that are risky for stereotactic biopsy. The technique of navigated neuroendoscopy enables biopsy sampling under visual control, haemostasis of biopsy site and treatment of cerebrospinal fluid pathways obstruction. PATIENTS AND METHODS: Neuroendoscopic technique was used for biopsy in one patient with a solid brain tumor. 23 patients (12 males, mean age 49.7 years, range 21-75 years and 11 females, mean age 59.1 years, range 22-76 years) with a suspected cystic brain tumor underwent neuroendoscopic biopsy. Suspected intra- or paraventricular brain tumor presented indication for neuroendoscopic biopsy in 36 patients (20 males, mean age 43.9 years, range 6-80 years and 16 females, mean age 46.2 years, range 11-78 years). RESULTS: High grade glioma was most frequently diagnosed in patients with cystic brain tumors, followed by low grade gliomas and metastatic tumors. Diagnostic sample was obtained from all patients. Tumor resection was performed in 7 patients with a cystic tumor after neuroendoscopic biopsy and histological findings were identical in 70.1% of them. Similarly, high grade glioma was most frequently diagnosed in patients with intra or paraventricular tumors, followed by tumors originating from pineal region tissues. Diagnostic sample was obtained from 94.3% of patients. Tumor resection was performed in 5 patients after neuroendoscopic biopsy and histological findings of the resected tissue was identical with neuroendoscopic biopsy in 4 of them (80%). CONCLUSIONS: Neuroendoscopy is a safe biopsy technique for a subset of patients who are high risk for the use of stereotactic biopsy, with comparable results. Neuroendoscopy also provides for cerebrospinal fluid circulation obstruction treatment. The use of neuronavigation or stereotactic planning is particularly useful for the planning of an optimal surgical approach, helps to maintain anatomical orientation in distorted anatomy and facilitates haemostasis in case of intraoperative bleeding.
Assuntos
Biópsia , Neoplasias Encefálicas/patologia , Neuroendoscopia , Adulto , Idoso , Idoso de 80 Anos ou mais , Neoplasias Encefálicas/diagnóstico , Neoplasias Encefálicas/cirurgia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Adulto JovemRESUMO
BACKGROUNDS: An opportunistic infection is an infection caused by pathogens, such as Toxoplasma gondii, that usually are not pathogenic in a healthy host but may cause an infection in immunocompromised patients. Although the most frequent cause of an opportunistic infection is immunodeficiency due to HIV infection, the immunodeficiency induced by anticancer treatment cannot be ignored. DESIGN: A 56-year old female patient after a comprehensive treatment of breast cancer underwent a stereotactic biopsy of MR-verified multiple brain lesions suspected to be of metastatic aetiology. The histology report unexpectedly concluded that the lesion was brain toxoplasmosis confirmed by detection of IgM specific antibody in cerebrospinal fluid. Immunology examination has proven a deficit of cell-mediated immunity. The symptoms (cephalea, cerebellar symptomatology with vertigo) and MR findings disappeared following 6-month treatment with a combination of pyrimethamin, sulfadiazin and leucovorin. CONCLUSION: Since neoplastic duplicities and brain lesions of non-neoplastic aetiology are found in about 11% of oncology patients, histological verification of aetiology of intracranial lesions is essential for targeted therapy of these patients. Our case of brain toxoplasmosis documents the role of opportunistic infections in differential diagnosis of brain lesions in patients who underwent anticancer treatment.
Assuntos
Neoplasias da Mama/terapia , Infecções Oportunistas/complicações , Toxoplasmose Cerebral/complicações , Neoplasias da Mama/complicações , Neoplasias da Mama/imunologia , Feminino , Humanos , Hospedeiro Imunocomprometido , Pessoa de Meia-Idade , Toxoplasmose Cerebral/imunologiaRESUMO
Postoperative haemorrhage is a threatening complication of both brain tumor resection and stereotactic biopsy. The paper describes rare case report of distant wounded glioma syndrome after stereotactic biopsy of glioblastoma, when small distant bleeding was proven in the tumor nodule distant from the original site of biopsy.
Assuntos
Biópsia por Agulha/efeitos adversos , Neoplasias Encefálicas/patologia , Hemorragia Cerebral/etiologia , Glioblastoma/patologia , Técnicas Estereotáxicas , Idoso de 80 Anos ou mais , Humanos , Masculino , Radiografia Intervencionista , Tomografia Computadorizada por Raios XRESUMO
BACKGROUND: The management of cervical cancer patients with intraoperative detection of lymph node involvement remains controversial. Since all these patients are referred for (chemo)radiation after the surgery, the key decision is whether radical hysterectomy should be completed as originally planned, taking into account an additional morbidity associated with extensive surgical dissection prior to adjuvant treatment. The ABRAX study investigated whether completing a radical uterine procedure is associated with an improved oncological outcome of such patients. PATIENTS AND METHODS: We performed retrospective analyses of 515 cervical cancer patients (51 institutions, 19 countries) who were referred for primary curative surgery between 2005 and 2015 (stage IA-IIB, common tumour types) in whom lymph node involvement was detected intraoperatively. Patients were stratified according to whether the planned uterine surgery was completed (COMPL group, N = 361) or abandoned (ABAND group, N = 154) to compare progression-free survival. Definitive chemoradiation was given to 92.9% patients in the ABAND group and adjuvant (chemo)radiation or chemotherapy to 91.4% of patients in the COMPL group. RESULTS: The risks of recurrence (hazard ratio [HR] 1.154, 95% confidence intervals [CI] 0.799-1.666, P = 0.45), pelvic recurrence (HR 0.836, 95% CI 0.458-1.523, P = 0.56), or death (HR 1.064, 95% CI 0.690-1.641, P = 0.78) were not significantly different between the two groups. No subgroup showed a survival benefit from completing radical hysterectomy. Disease-free survival reached 74% (381/515), with a median follow-up of 58 months. Prognostic factors were balanced between the two groups. FIGO stage and number of pelvic lymph nodes involved were significant prognostic factors in the whole study cohort. CONCLUSION: We showed that the completion of radical hysterectomy does not improve survival in patients with intraoperatively detected lymph node involvement, regardless of tumour size or histological type. If lymph node involvement is confirmed intraoperatively, abandoning uterine radical procedure should be considered, and the patient should be referred for definitive chemoradiation. CLINICAL TRIALS IDENTIFIER: NCT04037124.