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BACKGROUND: Pediatric patients with diffuse intrinsic pontine glioma (DIPG) have a poor prognosis, with a median survival of less than 1 year. Oncolytic viral therapy has been evaluated in patients with pediatric gliomas elsewhere in the brain, but data regarding oncolytic viral therapy in patients with DIPG are lacking. METHODS: We conducted a single-center, dose-escalation study of DNX-2401, an oncolytic adenovirus that selectively replicates in tumor cells, in patients with newly diagnosed DIPG. The patients received a single virus infusion through a catheter placed in the cerebellar peduncle, followed by radiotherapy. The primary objective was to assess the safety and adverse-event profile of DNX-2401. The secondary objectives were to evaluate the effect of DNX-2401 on overall survival and quality of life, to determine the percentage of patients who have an objective response, and to collect tumor-biopsy and peripheral-blood samples for correlative studies of the molecular features of DIPG and antitumor immune responses. RESULTS: A total of 12 patients, 3 to 18 years of age, with newly diagnosed DIPG received 1×1010 (the first 4 patients) or 5×1010 (the subsequent 8 patients) viral particles of DNX-2401, and 11 received subsequent radiotherapy. Adverse events among the patients included headache, nausea, vomiting, and fatigue. Hemiparesis and tetraparesis developed in 1 patient each. Over a median follow-up of 17.8 months (range, 5.9 to 33.5), a reduction in tumor size, as assessed on magnetic resonance imaging, was reported in 9 patients, a partial response in 3 patients, and stable disease in 8 patients. The median survival was 17.8 months. Two patients were alive at the time of preparation of the current report, 1 of whom was free of tumor progression at 38 months. Examination of a tumor sample obtained during autopsy from 1 patient and peripheral-blood studies revealed alteration of the tumor microenvironment and T-cell repertoire. CONCLUSIONS: Intratumoral infusion of oncolytic virus DNX-2401 followed by radiotherapy in pediatric patients with DIPG resulted in changes in T-cell activity and a reduction in or stabilization of tumor size in some patients but was associated with adverse events. (Funded by the European Research Council under the European Union's Horizon 2020 Research and Innovation Program and others; EudraCT number, 2016-001577-33; ClinicalTrials.gov number, NCT03178032.).
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Neoplasias del Tronco Encefálico , Glioma Pontino Intrínseco Difuso , Viroterapia Oncolítica , Virus Oncolíticos , Adenoviridae , Adolescente , Astrocitoma/radioterapia , Astrocitoma/terapia , Neoplasias del Tronco Encefálico/mortalidad , Neoplasias del Tronco Encefálico/patología , Neoplasias del Tronco Encefálico/radioterapia , Neoplasias del Tronco Encefálico/terapia , Niño , Preescolar , Glioma Pontino Intrínseco Difuso/mortalidad , Glioma Pontino Intrínseco Difuso/radioterapia , Glioma Pontino Intrínseco Difuso/terapia , Glioma/radioterapia , Glioma/terapia , Humanos , Infusiones Intralesiones , Viroterapia Oncolítica/efectos adversos , Viroterapia Oncolítica/métodos , Calidad de Vida , Microambiente TumoralRESUMEN
OBJECTIVE: Management of endometrial cancer is advancing, with accurate staging crucial for guiding treatment decisions. Understanding sentinel lymph node (SLN) involvement rates across molecular subgroups is essential. To evaluate SLN involvement in early-stage (International Federation of Gynecology and Obstetrics 2009 I-II) endometrial cancer, considering molecular subtypes and new European Society of Gynaecological Oncology (ESGO) risk classification. METHODS: The SENECA study retrospectively reviewed data from 2139 women with stage I-II endometrial cancer across 66 centers in 16 countries. Patients underwent surgery with SLN assessment following ESGO guidelines between January 2021 and December 2022. Molecular analysis was performed on pre-operative biopsies or hysterectomy specimens. RESULTS: Among the 2139 patients, the molecular subgroups were as follows: 272 (12.7%) p53 abnormal (p53abn, 1191 (55.7%) non-specific molecular profile (NSMP), 581 (27.2%) mismatch repair deficient (MMRd), 95 (4.4%) POLE mutated (POLE-mut). Tracer diffusion was detected in, at least one side, in 97.2% of the cases; with a bilateral diffusion observed in 82.7% of the cases. By ultrastaging (90.7% of the cases) or one-step nucleic acid amplification (198 (9.3%) of the cases), 205 patients were identified with affected sentinel lymph nodes, representing 9.6% of the sample. Of these, 139 (67.8%) had low-volume metastases (including micrometastases, 42.9%; and isolated tumor cells, 24.9%) while 66 (32.2%) had macrometastases. Significant differences in SLN involvement were observed between molecular subtypes, with p53abn and MMRd groups having the highest rates (12.50% and 12.40%, respectively) compared with NSMP (7.80%) and POLE-mut (6.30%), (p=0.004); (p53abn, OR=1.69 (95% CI 1.11 to 2.56), p=0.014; MMRd, OR=1.67 (95% CI 1.21 to 2.31), p=0.002). Differences were also noted among ESGO risk groups (2.84% for low-risk patients, 6.62% for intermediate-risk patients, 21.63% for high-intermediate risk patients, and 22.51% for high-risk patients; p<0.001). CONCLUSIONS: Our study reveals significant differences in SLN involvement among patients with early-stage endometrial cancer based on molecular subtypes. This underscores the importance of considering molecular characteristics for accurate staging and optimal management decisions.
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BACKGROUND: Sugammadex has been associated with increases in the bispectral index (BIS). We evaluated the effects of sugammadex administration on quantitative electroencephalographic (EEG) and electromyographic (EMG) measures. METHODS: We performed a prospective observational study of adult male patients undergoing robot-assisted radical prostatectomy. All patients received a sevoflurane-based general anaesthetic and a continuous infusion of rocuronium, which was reversed with 2 mg kg-1 of sugammadex i.v. BIS, EEG, and EMG measures were captured with the BIS Vista™ monitor. RESULTS: Twenty-five patients were included in this study. Compared with baseline, BIS increased at 4-6 min (ß coefficient: 3.63; 95% confidence interval [CI]: 2.22-5.04; P<0.001), spectral edge frequency 95 (SEF95) increased at 2-4 min (ß coefficient: 0.29; 95% CI: 0.05-0.52; P=0.016) and 4-6 min (ß coefficient: 0.71; 95% CI: 0.47-0.94; P<0.001), and EMG increased at 4-6 min (ß coefficient: 1.91; 95% CI: 1.00-2.81; P<0.001) after sugammadex administration. Compared with baseline, increased beta power was observed at 2-4 min (ß coefficient: 93; 95% CI: 1-185; P=0.046) and 4-6 min (ß coefficient: 208; 95% CI: 116-300; P<0.001), and decreased delta power was observed at 4-6 min (ß coefficient: -526.72; 95% CI: -778 to -276; P<0.001) after sugammadex administration. Neither SEF95 nor frequency band data analysis adjusted for EMG showed substantial differences. None of the patients showed clinical signs of awakening. CONCLUSIONS: After neuromuscular block reversal with 2 mg kg-1 sugammadex, BIS, SEF95, EMG, and beta power showed small but statistically significant increases over time, while delta power decreased.
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Bloqueo Neuromuscular , Robótica , Adulto , Humanos , Masculino , Sugammadex/farmacología , Prostatectomía , Electroencefalografía , AndrostanolesRESUMEN
Wrong surgery (wrong-site, wrong-procedure, or wrong-patient surgery) is among the most feared patient safety problems in hospitals. We aimed to evaluate associations between numeric assessment of risk assigned to wrong surgery with that of other healthcare quality and patient safety challenges. This nationwide study collected information from healthcare quality experts in charge of a clinical quality and/or patient safety department in general hospitals of ≥ 150 beds in Spain. Out of the 100 included hospitals, the highest strength of associations were observed with risk priority number (RPN) for hospital-acquired pressure ulcers, RPN for venous thromboembolism in hospitalized patients, RPN for incorrect patient identification, RPN for lack of informed consent for diagnostic or therapeutic procedures, RPN for catheter-related bacteremia, and RPN for adverse events and injuries due to medical devices related to use and/or design. These results are of potential interest for designing combined and coordinated strategies to improve patient safety in hospitals.
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Hospitales Generales , Seguridad del Paciente , Humanos , España , Estudios Transversales , Errores Médicos , Calidad de la Atención de SaludRESUMEN
BACKGROUND: After the LACC trial, the SUCCOR study, and other studies, we know that patients who have undergone minimally invasive surgery for cervical cancer have worse outcomes, but today, we do not know if the surgical approach can be a reason to change the pattern of relapses on these patients. We evaluated the relapse pattern in patients with stage IB1 cervical cancer (FIGO, 2009) who underwent radical hysterectomy with different surgical approaches. METHODS: A systematic review of literature was performed in PubMed, Cochrane Library, Clinicaltrials.gov, and Web of science. Inclusion criteria were prospective or retrospective comparative studies of different surgical approaches that described patterns or locations of relapse in patients with stage IB1 cervical cancer. Heterogeneity was assessed by calculating I2. RESULTS: The research resulted in 782 eligible citations from January 2010 to October 2020. After filtering, nine articles that met all inclusion criteria were analyzed, comprising data from 1663 patients who underwent radical hysterectomy for IB1 cervical cancer, and the incidence of relapse was 10.6%. When we compared the pattern of relapse (local, distant, and both) of each group (open surgery and minimally invasive surgery), we did not see statistically significant differences, (OR 0.963; 95% CI, 0.602-1.541; p = 0.898), (OR 0.788; 95% CI, 0.467-1.330; p = 0.542), and (OR 0.683; 95% CI, 0.331-1.407; p = 0.630), respectively. CONCLUSION: There are no differences in patterns of relapse across surgical approaches in patients with stage IB1 cervical cancer undergoing radical hysterectomy as primary treatment.
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Histerectomía/métodos , Procedimientos Quirúrgicos Mínimamente Invasivos/métodos , Recurrencia Local de Neoplasia/patología , Neoplasias del Cuello Uterino/cirugía , Femenino , Humanos , Laparoscopía , Laparotomía , Estadificación de Neoplasias , Neoplasias del Cuello Uterino/patologíaRESUMEN
OBJECTIVE: To evaluate disease-free survival of cervical conization prior to radical hysterectomy in patients with stage IB1 cervical cancer (International Federation of Gynecology and Obstetrics (FIGO) 2009). METHODS: A multicenter retrospective observational cohort study was conducted including patients from the Surgery in Cervical Cancer Comparing Different Surgical Aproaches in Stage IB1 Cervical Cancer (SUCCOR) database with FIGO 2009 IB1 cervical carcinoma treated with radical hysterectomy between January 1, 2013, and December 31, 2014. We used propensity score matching to minimize the potential allocation biases arising from the retrospective design. Patients who underwent conization but were similar for other measured characteristics were matched 1:1 to patients from the non-cone group using a caliper width ≤0.2 standard deviations of the logit odds of the estimated propensity score. RESULTS: We obtained a weighted cohort of 374 patients (187 patients with prior conization and 187 non-conization patients). We found a 65% reduction in the risk of relapse for patients who had cervical conization prior to radical hysterectomy (hazard ratio (HR) 0.35, 95% confidence interval (CI) 0.16 to 0.75, p=0.007) and a 75% reduction in the risk of death for the same sample (HR 0.25, 95% CI 0.07 to 0.90, p=0.033). In addition, patients who underwent minimally invasive surgery without prior conization had a 5.63 times higher chance of relapse compared with those who had an open approach and previous conization (HR 5.63, 95% CI 1.64 to 19.3, p=0.006). Patients who underwent minimally invasive surgery with prior conization and those who underwent open surgery without prior conization showed no differences in relapse rates compared with those who underwent open surgery with prior cone biopsy (reference) (HR 1.94, 95% CI 0.49 to 7.76, p=0.349 and HR 2.94, 95% CI 0.80 to 10.86, p=0.106 respectively). CONCLUSIONS: In this retrospective study, patients undergoing cervical conization before radical hysterectomy had a significantly lower risk of relapse and death.
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Conización/estadística & datos numéricos , Histerectomía/estadística & datos numéricos , Recurrencia Local de Neoplasia/prevención & control , Neoplasias del Cuello Uterino/cirugía , Adulto , Bases de Datos Factuales , Supervivencia sin Enfermedad , Femenino , Humanos , Persona de Mediana Edad , Procedimientos Quirúrgicos Mínimamente Invasivos , Puntaje de Propensión , Estudios Retrospectivos , Neoplasias del Cuello Uterino/patologíaRESUMEN
Multiple myeloma (MM) is the second most common haematological malignancy and remains incurable despite therapeutic advances. 18F-FDG (FDG) PET/CT is a relevant tool MM for staging and it is the reference imaging technique for treatment evaluation. However, it has limitations, and investigation of other PET tracers is required. Preliminary results with L-methyl-[11C]- methionine (MET), suggest higher sensitivity than 18F-FDG. This study aimed to compare the diagnostic accuracy and prognostic value of 1FDG and MET in MM patients. We prospectively compared FDG and MET PET/CT for assessment of bone disease and extramedullary disease (EMD) in a series of 52 consecutive patients (8 smoldering MM, 18 newly diagnosed MM and 26 relapsed MM patients). Bone marrow (BM) uptake patterns and the detection of focal lesions (FLs) and EMD were compared. Furthermore, FDG PET parameters with known MM prognostic value were explored for both tracers, as well as total lesion MET uptake (TLMU). Median patient age was 61 years (range, 37-83 years), 54% were male, 13% of them were in stage ISS (International Staging System) III, and 31% had high-risk cytogenetics. FDG PET/CT did not detect active disease in 6 patients, while they were shown to be positive by MET PET/CT. Additionally, MET PET/CT identified a higher number of FLs than FDG in more than half of the patients (63%). For prognostication we focussed on the relapsed cohort, due to the low number of progressions in the two other cohorts. Upon using FDG PET/CT in relapsed patients, the presence of more than 3 FLs (HR 4.61, p = 0.056), more than 10 FLs (HR 5.65, p = 0.013), total metabolic tumor volume (TMTV) p50 (HR 4.91, p = 0.049) or TMTV p75 (HR 5.32, p = 0.016) were associated with adverse prognosis. In MET PET/CT analysis, TMTV p50 (HR 4.71, p = 0.056), TMTV p75 (HR 6.27, p = 0.007), TLMU p50 (HR 8.8, p = 0.04) and TLMU p75 (HR 6.3, p = 0.007) adversely affected PFS. This study confirmed the diagnostic and prognostic value of FDG in MM. In addition, it highlights that MET has higher sensitivity than FDG PET/CT for detection of myeloma lesions, including FLs. Moreover, we show, for the first time, the prognostic value of TMTV and TLMU MET PET/CT in the imaging evaluation of MM patients.
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Mieloma Múltiple , Tomografía Computarizada por Tomografía de Emisión de Positrones , Adulto , Anciano , Anciano de 80 o más Años , Femenino , Fluorodesoxiglucosa F18 , Humanos , Masculino , Metionina , Persona de Mediana Edad , Mieloma Múltiple/diagnóstico por imagen , Tomografía Computarizada por Tomografía de Emisión de Positrones/métodos , Pronóstico , Radiofármacos , Estudios RetrospectivosRESUMEN
BACKGROUND: Dexmedetomidine is frequently used for sedation during deep brain stimulator implantation in patients with Parkinson's disease, but its effect on subthalamic nucleus activity is not well known. The aim of this study was to quantify the effect of increasing doses of dexmedetomidine in this population. METHODS: Controlled clinical trial assessing changes in subthalamic activity with increasing doses of dexmedetomidine (from 0.2 to 0.6 µg kg-1 h-1) in a non-operating theatre setting. We recorded local field potentials in 12 patients with Parkinson's disease with bilateral deep brain stimulators (24 nuclei) and compared basal activity in the nuclei of each patient and activity recorded with different doses. Plasma levels of dexmedetomidine were obtained and correlated with the dose administered. RESULTS: With dexmedetomidine infusion, patients became clinically sedated, and at higher doses (0.5-0.6 µg kg-1 h-1) a significant decrease in the characteristic Parkinsonian subthalamic activity was observed (P<0.05 in beta activity). All subjects awoke to external stimulus over a median of 1 (range: 0-9) min, showing full restoration of subthalamic activity. Dexmedetomidine dose administered and plasma levels showed a positive correlation (repeated measures correlation coefficient=0.504; P<0.001). CONCLUSIONS: Patients needing some degree of sedation throughout subthalamic deep brain stimulator implantation for Parkinson's disease can probably receive dexmedetomidine up to 0.6 µg kg-1 h-1 without significant alteration of their characteristic subthalamic activity. If patients achieve a 'sedated' state, subthalamic activity decreases, but they can be easily awakened with a non-pharmacological external stimulus and recover baseline subthalamic activity patterns in less than 10 min. CLINICAL TRIAL REGISTRATION: EudraCT 2016-002680-34; NCT-02982512.
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Estimulación Encefálica Profunda/métodos , Dexmedetomidina/farmacología , Hipnóticos y Sedantes/farmacología , Enfermedad de Parkinson/terapia , Núcleo Subtalámico/efectos de los fármacos , Relación Dosis-Respuesta a Droga , Femenino , Humanos , Masculino , Persona de Mediana Edad , EspañaRESUMEN
AIMS: To identify and prioritize the root causes of adverse drug events (ADEs) in hospitals and to assess the ability of artificial intelligence (AI) capabilities to prevent ADEs. DESIGN: A mixed method design was used. METHODS: A cross-sectional study for hospitals in Spain was carried out between February and April 2019 to identify and prioritize the root causes of ADEs. A nominal group technique was also used to assess the ability of AI capabilities to prevent ADEs. RESULTS: The main root cause of ADEs was a lack of adherence to safety protocols (64.8%), followed by identification errors (57.4%), and fragile and polymedicated patients (44.4%). An analysis of the AI capabilities to prevent the root causes of ADEs showed that identification and reading are two potentially useful capabilities. CONCLUSION: Identification error is one of the main root causes of drug adverse events and AI capabilities could potentially prevent drug adverse events. IMPACT: This study highlights the role of AI capabilities in safely identifying both patients and drugs, which is a crucial part of the medication administration process, and how this can prevent ADEs in hospitals.
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Inteligencia Artificial , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos , Estudios Transversales , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/prevención & control , Hospitales , Humanos , Errores de Medicación/prevención & control , EspañaRESUMEN
Anti-cluster of differentiation 20 (CD20) monoclonal antibodies (mAbs) have shown promise in follicular lymphoma (FL) as post-induction therapy, by enhancing antibody-dependent cellular cytotoxicity (ADCC). However, cytotoxic cells are reduced after this treatment. We hypothesised that ex vivo expanded lymphokine-activated killer (LAK) cells administered to FL-remission patients are safe and improve anti-CD20 efficacy. This open, prospective, phase II, single-arm study assessed safety and efficacy of ex vivo expanded LAK cells in 20 FL-remission patients following rituximab maintenance. Mononuclear cells were obtained in odd rituximab cycles and stimulated with interleukin 2 (IL-2) for 8 weeks, after which >5 × 108 LAK cells were injected. Patients were followed-up for 5 years. At the end of maintenance, peripheral blood cells phenotype had not changed markedly. Natural killer, LAK and ADCC activities of mononuclear cells increased significantly after recombinant human IL-2 (rhIL-2) stimulation in all cycles. Rituximab significantly enhanced cytotoxic activity. No patients discontinued treatment. There were no treatment-related serious adverse events. Three patients had progressed by the end of follow-up. After a median (interquartile range) follow-up of 59.4 (43.8-70.9) months, 85% of patients remained progression free. No deaths occurred. Quality-of-life improved throughout the study. Post-induction LAK cells with rituximab seem safe in the long term. Larger studies are warranted to confirm efficacy.
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Protocolos de Quimioterapia Combinada Antineoplásica/administración & dosificación , Células Asesinas Activadas por Linfocinas/trasplante , Linfoma Folicular/terapia , Quimioterapia de Mantención , Adolescente , Adulto , Anciano , Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Ciclofosfamida/administración & dosificación , Ciclofosfamida/efectos adversos , Doxorrubicina/administración & dosificación , Doxorrubicina/efectos adversos , Femenino , Estudios de Seguimiento , Humanos , Linfoma Folicular/patología , Masculino , Persona de Mediana Edad , Prednisona/administración & dosificación , Prednisona/efectos adversos , Estudios Prospectivos , Rituximab/administración & dosificación , Rituximab/efectos adversos , Vincristina/administración & dosificación , Vincristina/efectos adversosRESUMEN
BACKGROUND AND AIMS: Obesity is associated with impaired glucose tolerance which is a risk factor for cardiovascular risk. However, the oral glucose tolerance test (OGTT) is not usually performed in patients with normal fasting glycaemia, thus offering false reassurance to patients with overweight or obesity who may have post-prandial hyperglycaemia. As an alternative to resource demanding OGTTs, we aimed to examine the predictive value of anthropometric measures of total and central fat distribution for post-prandial hyperglycaemia in patients with overweight and obesity with normal fasting glycaemia enrolled in the DICAMANO study. METHODS: We studied 447 subjects with overweight/obesity with a fasting glucose value ≤ 5.5 mmol l-1 (99 mg dl-1) and BMI ≥ 25 kg/m2 who underwent a 75-g OGTT. Post-prandial hyperglycaemia was defined as a glucose level ≥ 7.8 mmol l-1 (140 mg dl-1) 2-h after the OGTT. The anthropometric measurements included body mass index, body adiposity index, waist circumference, neck circumference, waist-to-hip ratio and waist-to-height ratio. RESULTS: The prevalence of post-prandial hyperglycaemia was 26%. Mean 1-h OGTT glucose levels, insulin resistance and beta cell dysfunction was higher in those subjects in the highest tertile for each anthropometric measurement, irrespective of fasting glucose level. Central fat depot anthropometric measurements were strongly and independently associated with an increased risk of post-prandial hyperglycaemia. After multivariable-adjustment for fasting plasma glucose level, smoking, and physical activity level, the odds ratio (95% confidence intervals) for the presence of post-prandial hyperglycaemia for neck circumference, waist circumference and waist-to-height ratio were 3.3 (1.4, 7.7), 2.4 (1.4, 4.4) and 2.5 (1.4, 4.5), respectively. CONCLUSIONS: In this large and comprehensively phenotyped cohort, one in four subjects had post-prandial hyperglycaemia despite normal fasting glycaemia. Anthropometric indices of central fat distribution were strongly and independently associated with an increased risk of post-prandial hyperglycaemia. These results support the association between central adiposity and glucose derangements and demonstrate the clinical usefulness of anthropometric measurements as screening tools for the selection of patients who are most likely to benefit from an OGTT. Trial registration ClinicalTrials.gov Identifier: NCT03506581. Registered 24 April 2018-Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT03506581.
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Adiposidad , Antropometría , Glucemia/metabolismo , Ayuno/sangre , Hiperglucemia/sangre , Periodo Posprandial , HumanosRESUMEN
AIMS: Abdominal hypopressive technique (AHT) is gaining popularity as an alternative to pelvic floor muscle training (PFMT) during postpartum. Although, there is no solid evidence for its recommendation. METHODS: We conducted a prospective observational cohort study in a university hospital with 105 primiparae who performed a two-month PFMT or AHT program. The aim was to compare the effectiveness of both treatments in terms of morphofunctional changes in 3D transperineal ultrasound, manometry, dynamometry, and differences in urinary incontinence symptoms (ICIQ-IU-SF) and satisfaction. RESULTS: The average change in levator ani muscle was 1.2 mm higher in AHT group vs PFMT (95% confidence interval [CI], -2.2 to -0.2; P = .017). No statistically significant differences were shown in maximal strength changes between groups. After AHT, basal tone change was 63.0 g/cm2 higher than PFMT (95% CI, -129 to 2.9; P = .06). A statistically significant reduction in ICIQ-IU-SF was observed after both treatments [(PFMT, -0.8 points; 95% CI, -1.4 to -0.1; P = .015), (AHT, -0.7 points; 95% CI, -1.3 to -0.1; P = .018]. AHT showed a higher median satisfaction score than PFMT (P = .004). CONCLUSIONS: This preliminary study is the first that analyses the effect of AHT vs PFMT during postpartum. The results suggest a higher improve for AHT in levator muscle thickness and satisfaction compared to PFMT. These must be considered with caution due to the limitations of the study. Further randomized clinical trials about both techniques during postpartum are required.
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Terapia por Ejercicio/métodos , Músculo Esquelético/fisiología , Diafragma Pélvico/fisiología , Periodo Posparto/fisiología , Incontinencia Urinaria/terapia , Adulto , Estudios de Cohortes , Femenino , Humanos , Estudios ProspectivosAsunto(s)
Procedimientos Quirúrgicos Cardíacos , Mortalidad Hospitalaria , Hiperuricemia , Humanos , Estudios Prospectivos , Procedimientos Quirúrgicos Cardíacos/efectos adversos , Procedimientos Quirúrgicos Cardíacos/mortalidad , Hiperuricemia/mortalidad , Masculino , Femenino , Anciano , Factores de Riesgo , Persona de Mediana EdadRESUMEN
OBJECTIVES: To evaluate the relationship between pharmacokinetic descriptors of dexmedetomidine (predicted area under the curve during the procedure, predicted plasma level at the end of the procedure, and duration of procedure) and sedation depth (proportion of time with bispectral index < 85 during the procedure) with recovery time after ambulatory procedures. MATERIALS AND METHODS: Clinical observational study of patients undergoing oral and maxillofacial ambulatory surgery with dexmedetomidine as sole sedative agent. Patients received a loading dose of dexmedetomidine (0.25-1 µg kg-1) followed by a maintenance infusion (0.2-1.4 µg kg-1 h-1) to keep a bispectral index < 85 until 5 min before the end of the procedure, and were transferred to a post-anesthesia care unit until criteria for discharge were met. RESULTS: Data from 75 patients was analyzed. Sedation depth was directly associated with recovery time (Pearson correlation coefficient [r] = 0.26; p = 0.024). Around 7% of the variation in recovery time was explained by the proportion of time with bispectral index < 85. No association with procedure duration (r = 0.01; p = 0.9), predicted area under the curve (r = 0.1; p = 0.4), or predicted plasma level of dexmedetomidine at the end of the procedure (r = 0.12; p = 0.3) with recovery time was observed. CONCLUSIONS: Sedation depth with dexmedetomidine could play a role in increasing recovery time after oral and maxillofacial ambulatory surgery. In our study, the pharmacokinetic descriptors of dexmedetomidine did not seem to influence recovery time. CLINICAL RELEVANCE: Sedation depth with dexmedetomidine could play a role in increasing recovery time after ambulatory procedures.
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Procedimientos Quirúrgicos Ambulatorios , Periodo de Recuperación de la Anestesia , Dexmedetomidina/farmacocinética , Hipnóticos y Sedantes/farmacocinética , Procedimientos Quirúrgicos Orales , Adulto , Dexmedetomidina/administración & dosificación , Femenino , Humanos , Hipnóticos y Sedantes/administración & dosificación , MasculinoRESUMEN
BACKGROUND: Differentiating between immunoglobulin E (IgE)-dependent and IgE-independent hypersensitivity reactions may improve the etiologic orientation and clinical management of patients with allergic reactions in the anesthesia setting. Serum tryptase levels may be useful to discriminate the immune mechanism of allergic reactions, but the diagnostic accuracy and optimal cutpoint remain unclear.We aimed to compare the diagnostic accuracy of tryptase during reaction (TDR) alone and the TDR/basal tryptase (TDR/BT) ratio for discriminating IgE- from non-IgE-mediated allergic reactions, and to estimate the best cut point for these indicators. METHODS: We included 111 patients (45% men; aged 3-99 years) who had experienced an allergic reaction, even though the allergic reaction could be nonanaphylactic. Allergy tests were performed to classify the reaction as an IgE- or non-IgE-mediated one. The area under the curve (AUC) of the receiver operating characteristic analysis was performed to estimate the discriminative ability of TDR and TDR/BT ratio. RESULTS: An IgE-mediated reaction was diagnosed in 49.5% of patients, and 56% of patients met anaphylaxis criteria. The median (quartiles) TDR for the IgE-mediated reactions was 8.0 (4.9-19.6) and 5.1 (3.5-8.1) for the non-IgE-mediated (P = .022). The median (quartiles) TDR/BT ratio was 2.7 (1.7-4.5) in IgE-mediated and 1.1 (1.0-1.6) in non-IgE-mediated reactions (P < .001). The TDR/BT ratio showed the greatest ability to discriminate IgE- from non-IgE-mediated reactions compared to TDR (AUC TDR/BT = 0.79 [95% confidence interval (CI), 0.70-0.88] and AUC TDR = 0.66 [95% CI, 0.56-0.76]; P = .001). The optimal cut point for TDR/BT (maximization of the sum of the sensitivity and specificity) was 1.66 (95% CI, 1.1-2.2). CONCLUSIONS: The TDR/BT ratio showed a significantly better discriminative ability than TDR to discriminate IgE- from non-IgE-mediated allergic reactions. An optimal TDR/BT ratio threshold of approximately 1.66 may be useful in clinical practice to classify allergic reactions as IgE- or non-IgE-mediated.
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Hipersensibilidad/inmunología , Triptasas/análisis , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Anestesia/efectos adversos , Área Bajo la Curva , Niño , Preescolar , Hipersensibilidad a las Drogas/sangre , Femenino , Humanos , Hipersensibilidad/sangre , Inmunoglobulina E/sangre , Masculino , Persona de Mediana Edad , Receptores de IgE/sangre , Reproducibilidad de los Resultados , Estudios Retrospectivos , Sensibilidad y Especificidad , Pruebas Cutáneas , Adulto JovenRESUMEN
BACKGROUND: Deep brain stimulation electrodes can record oscillatory activity from deep brain structures, known as local field potentials. The authors' objective was to evaluate and quantify the effects of dexmedetomidine (0.2 µg·kg·h) on local field potentials in patients with Parkinson disease undergoing deep brain stimulation surgery compared with control recording (primary outcome), as well as the effect of propofol at different estimated peak effect site concentrations (0.5, 1.0, 1.5, 2.0, and 2.5 µg/ml) from control recording. METHODS: A nonrandomized, nonblinded controlled clinical trial was carried out to assess the change in local field potentials activity over time in 10 patients with Parkinson disease who underwent deep brain stimulation placement surgery (18 subthalamic nuclei). The relationship was assessed between the activity in nuclei in the same patient at a given time and repeated measures from the same nucleus over time. RESULTS: No significant difference was observed between the relative beta power of local field potentials in dexmedetomidine and control recordings (-7.7; 95% CI, -18.9 to 7.6). By contrast, there was a significant decline of 12.7% (95% CI, -21.3 to -4.7) in the relative beta power of the local field potentials for each increment in the estimated peak propofol concentrations at the effect site relative to the control recordings. CONCLUSIONS: Dexmedetomidine (0.2 µg·kg·h) did not show effect on local field potentials compared with control recording. A significant deep brain activity decline from control recording was observed with incremental doses of propofol.
Asunto(s)
Ganglios Basales/efectos de los fármacos , Estimulación Encefálica Profunda , Dexmedetomidina/farmacología , Hipnóticos y Sedantes/farmacología , Enfermedad de Parkinson/cirugía , Propofol/farmacología , Potenciales de Acción/efectos de los fármacos , Anciano , Femenino , Humanos , Masculino , Persona de Mediana EdadRESUMEN
BACKGROUND: Laparoscopic organ-sparing pancreatectomy (LOSP) is an ideal therapeutic option in selected cases of pancreatic neuroendocrine tumors (PNETs). Nevertheless, given the low frequency of PNETs, there is scarce evidence regarding short and particularly long-term outcomes of LOSP in this clinical setting. METHODS: All patients with PNETs who underwent surgery (under a LOSP policy) were retrospectively reviewed from a prospective database maintained at our center. Preoperative characteristics, operative data, pathological features and postoperative outcomes were analyzed. RESULTS: Between December 2003 and December 2015, 36 patients with PNETs underwent laparoscopic resections. Ten were functional tumors, 26 non-functional and 16 were "incidental" cases. The following procedures were performed: one enucleation, eight central pancreatectomies (LCP), one resection of the uncinate process and 26 distal pancreatectomies (DP) (15 of them laparoscopic vessels-preserving). There were no conversions to open surgery, and no drains were routinely left. Mean operative time was 288 min (SD 99). Hospital stay was 6 days. Eighteen patients (50%) experienced some complication of which most were mild (Clavien-Dindo I/II). Three postoperative bleedings occurred: two grade B/one grade C; two required laparoscopic reoperation. Thirteen (36.1%) patients developed peripancreatic fluid collections: two were symptomatic and were managed with transgastric drainage (one presented post-puncture abscesification requiring surgical drainage and splenectomy). Four patients (11%)-one DP and three LCP-developed new-onset pancreatogenic diabetes mellitus (NODM) in the long term. According to the European Neuroendocrine Tumor Society, 19 cases were stage I, seven IIA, two IIIA, one IIIB and seven stage IV. Over a mean follow-up of 51 months, two patients died, one due to recurrence of the tumor and another due to cirrhosis. CONCLUSIONS: The existing different surgical options must be individually considered according to the location and particular characteristics of every tumor. Results from this single-center study document the effectiveness of LOSP in selected cases of PNETs.
Asunto(s)
Laparoscopía/métodos , Tumores Neuroendocrinos/cirugía , Tratamientos Conservadores del Órgano/métodos , Pancreatectomía/métodos , Neoplasias Pancreáticas/cirugía , Adulto , Anciano , Bases de Datos Factuales , Femenino , Humanos , Laparoscopía/efectos adversos , Tiempo de Internación/estadística & datos numéricos , Masculino , Persona de Mediana Edad , Recurrencia Local de Neoplasia/cirugía , Tumores Neuroendocrinos/patología , Tempo Operativo , Tratamientos Conservadores del Órgano/efectos adversos , Páncreas/patología , Páncreas/cirugía , Pancreatectomía/efectos adversos , Neoplasias Pancreáticas/patología , Estudios Prospectivos , Estudios Retrospectivos , Esplenectomía/métodos , Resultado del TratamientoRESUMEN
BACKGROUND: Four predictive models for acute kidney injury associated with cardiac surgery were developed by Demirjian in the United States in 2012. However, the usefulness of these models in clinical practice needs to be established in different populations independent of that used to develop the models. OBJECTIVES: Our aim was to evaluate the predictive performance of these models in a Spanish population. DESIGN: A multicentre, prospective observational study. DATA SOURCES: Twenty-three Spanish hospitals in 2012 and 2013. ELIGIBILITY CRITERIA: Of 1067 consecutive cardiac patients recruited for the study, 1014 patients remained suitable for the final analysis. MAIN OUTCOME MEASURES: Dialysis therapy, and a composite outcome of either a doubling of the serum creatinine level or dialysis therapy, in the 2 weeks (or until discharge, if sooner) after cardiac surgery. RESULTS: Of the 1014 patients analysed, 34 (3.4%) required dialysis and 95 (9.4%) had either dialysis or doubled their serum creatinine level. The areas under the receiver operating characteristic curves of the two predictive models for dialysis therapy, which include either presurgical variables only, or combined presurgical and intrasurgical variables, were 0.79 and 0.80, respectively. The model for the composite endpoint that combined presurgical and intrasurgical variables showed better discriminatory ability than the model that included only presurgical variables: the areas under the receiver operating characteristic curves were 0.76 and 0.70, respectively. All four models lacked calibration for their respective outcomes in our Spanish population. CONCLUSION: Overall, the lack of calibration of these models and the difficulty in using the models clinically because of the large number of variables limit their applicability.