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1.
Vaccines (Basel) ; 10(9)2022 Sep 01.
Artículo en Inglés | MEDLINE | ID: mdl-36146524

RESUMEN

This review describes key aspects of the development of the rVSVΔG-ZEBOV-GP Ebola vaccine and key activities which are continuing to further expand our knowledge of the product. Extensive partnerships and innovative approaches were used to address the various challenges encountered during this process. The rVSVΔG-ZEBOV-GP Ebola vaccine was initially approved by the European Medicines Agency and prequalified by the World Health Organization in November 2019. It was approved by the United States Food and Drug Administration in December 2019 and approved in five African countries within 90 days of prequalification. The development resulted in the first stockpile of a registered Ebola vaccine that is available to support outbreak response. This also provides insights into how the example of rVSVΔG-ZEBOV-GP can inform the development of vaccines for Sudan ebolavirus, Marburg virus, and other emerging epidemic diseases in terms of the types of approaches and data needed to support product registration, availability, and the use of a filovirus vaccine.

2.
Ann Surg Oncol ; 22(4): 1288-93, 2015 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-25256130

RESUMEN

BACKGROUND: Laparoscopic liver resection (LLR) for large malignant tumors can be technically challenging. Data on this topic are scarce, and many question its feasibility, safety, and oncologic efficiency. This study aimed to assess outcomes of LLR for large (≥ 5 cm) and giant (≥ 10 cm) malignant liver tumors. METHODS: A prospectively collected database of 422 LLRs was reviewed from August 2003 to August 2013. The data for 52 patients undergoing LLR for large malignant tumors were analyzed. A subgroup analysis of giant tumors also is reported. RESULTS: During the period studied, 52 LLRs were performed (males, 53.8 %; mean age, 64.6 years) for large malignant tumors. Colorectal liver metastasis was the most common indication (42.3 %). The 52 LLRs included 32 major (61.5 %) and 20 minor (38.5 %) LLRs for tumors with a mean diameter of 83 mm. The median operative time was 240 min [interquartile range (IQR), 150-330 min], and the blood loss was 500 ml (IQR, 200-1,373 ml). Eight conversions (15.4 %) were performed. Six patients experienced complications (11.5 %). Among the 44 patients with successful LLRs, two patients (4.5 %) had an R1 resection. The median hospital stay was 5 days (range, 1-21 days), and no mortality occurred during a 90-day period. A subgroup analysis of patients with giant tumors showed greater blood loss (p = 0.002) and a longer operative time (p = 0.052) but no difference in terms of conversions (p = 0.64) or complications (p = 0.32). CONCLUSION: The findings showed that LLR is feasible and safe for large malignant tumors and can be performed with acceptable morbidity and oncologic efficiency. When used for giant malignant tumors, LLR is associated with greater blood loss and a longer operative time but no increase in complications.


Asunto(s)
Carcinoma Hepatocelular/cirugía , Neoplasias Colorrectales/cirugía , Hepatectomía , Laparoscopía , Neoplasias Hepáticas/cirugía , Tumores Neuroendocrinos/cirugía , Adulto , Anciano , Anciano de 80 o más Años , Pérdida de Sangre Quirúrgica , Carcinoma Hepatocelular/secundario , Neoplasias Colorrectales/patología , Femenino , Estudios de Seguimiento , Humanos , Neoplasias Hepáticas/secundario , Masculino , Persona de Mediana Edad , Estadificación de Neoplasias , Tumores Neuroendocrinos/secundario , Pronóstico , Estudios Prospectivos , Adulto Joven
4.
World J Surg ; 37(12): 2918-26, 2013 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-24101011

RESUMEN

BACKGROUND: Chyle leak complicates 1.3-10.8 % of pancreatic resections. Universal use of parenteral nutrition following pancreatic resection may reduce the incidence of chyle leak. However, this denies the majority of patients who do not develop chyle leak the benefits of enteral nutrition (EN). The present study aimed to identify risk factors for chyle leak following pancreatic resection within a single institution where EN was used universally. METHODS: All patients who underwent pancreatic resection between January 2007 and December 2010 were identified retrospectively. The patients had been treated according to a common unit protocol of enteral feeding; those developing chyle leak were switched to a medium-chain triglyceride (MCT) regimen. Clinical progress and recovery after surgery was evaluated. Multivariate analysis was performed to identify factors associated with chyle leak. RESULTS: A total of 245 patients underwent major pancreatic resection (231 pancreatoduodenectomy, 14 total pancreatectomy). Chyle leak complicated 40 cases (16.3 %). After multivariate analysis, both extensive lymphadenectomy (P = 0.002) and postoperative portal/mesenteric venous thrombosis (PVT) (P = 0.009) were independently linked with a higher incidence of chyle leak. The development of chyle leak was not associated with poorer survival or prolonged duration of hospital stay. It was associated with a significantly increased duration of abdominal drainage and reduced likelihood of early hospital discharge (P = 0.026). CONCLUSIONS: Universal use of enteral feeding is associated with a high rate of chyle leak following pancreatic resection. Patients undergoing extensive lymphadenectomy or those who develop PVT postoperatively are at increased risk. Development of chyle leak was not associated with additional morbidity or mortality following implementation of an MCT regimen. The implication is that reactive management of chyle leak with conversion to a MCT predominant diet is safe.


Asunto(s)
Quilo , Nutrición Enteral/efectos adversos , Pancreatectomía , Pancreaticoduodenectomía , Cuidados Posoperatorios/efectos adversos , Complicaciones Posoperatorias/etiología , Adulto , Anciano , Anciano de 80 o más Años , Drenaje , Femenino , Estudios de Seguimiento , Humanos , Modelos Logísticos , Masculino , Persona de Mediana Edad , Análisis Multivariante , Nutrición Parenteral Total , Cuidados Posoperatorios/métodos , Complicaciones Posoperatorias/diagnóstico , Complicaciones Posoperatorias/prevención & control , Complicaciones Posoperatorias/terapia , Estudios Retrospectivos , Factores de Riesgo , Resultado del Tratamiento
5.
Pancreatology ; 13(1): 58-62, 2013.
Artículo en Inglés | MEDLINE | ID: mdl-23395571

RESUMEN

INTRODUCTION: Data on enhanced recovery programmes after pancreatoduodenectomy (ERP-PD) is limited. The aim of this pilot study was to evaluate the feasibility, safety and clinical outcomes of ERP-PD when implemented at a high-volume UK university referral centre. METHODS: This was an observational single-surgeon case-control study (before-and-after pathway). A total of 20 consecutive patients were prospectively enrolled for the ERP-PD and compared with 24 consecutive patients previously treated during an equal time frame. RESULTS: Patients in the ERP-PD group had a significant shorter time to remove naso-gastric tube (median of 5 vs. 7 days, p = 0.0001), start liquid diet (median of 2 vs. 5 days, p < 0.0001), start solid food (median of 4 vs. 9 days, p < 0.0001), pass stools (median of 6 vs. 7 days, p = 0.002), and had shorter length of stay (median of 8.5 days vs. 13 days, p = 0.015) compared to the pre-pathway group. Postoperative complications were overall less frequent but not significantly different in the ERP-PD group (p = 0.077). No difference in mortality and readmission rates was found. CONCLUSIONS: Our findings support the feasibility and safety of ERP-PD. Improved patients' outcomes, significant bed day savings and increase National Health Service productivity are anticipated with implementation of ERP-PD on a larger scale.


Asunto(s)
Pancreaticoduodenectomía/rehabilitación , Atención Perioperativa/métodos , Anciano , Estudios de Casos y Controles , Protocolos Clínicos , Femenino , Humanos , Tiempo de Internación , Masculino , Persona de Mediana Edad , Atención Perioperativa/normas , Proyectos Piloto , Complicaciones Posoperatorias
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