RESUMO
La enfermedad metastásica vertebral es frecuente en los pacientes con cáncer avanzado, y conlleva a complicaciones inherentes a su progresión, como lo son la fractura patológica vertebral y la compresión neural metastásica. Se realizó una revisión de los aspectos terapéuticos actuales del manejo de la progresión y de las complicaciones de la enfermedad metastásica vertebral, enfatizando su enfrentamiento sistémico y personalizado. Nuestro objetivo principal es proporcionar información sobre el tratamiento actual de esta afección y la utilidad del manejo sistémico y multidisciplinario.
Metastatic spinal disease is common in patients with advanced cancer, and leads to complications inherent in its progression, such as pathological vertebral fracture and metastatic neural compression. A review of the current therapeutic aspects regarding the progression and complications of metastatic spinal disease was performed, highlighting its systemic, personalized approach. Our aim is to provide information about the current treatment of this condition and the usefulness of its systemic and multidisciplinary management.
Assuntos
Humanos , Neoplasias da Coluna Vertebral/secundário , Neoplasias da Coluna Vertebral/terapia , Radioterapia , Neoplasias da Coluna Vertebral/cirurgiaRESUMO
OBJECTIVES: To evaluate the efficacy of early treatment with prednisone to decrease the progression of COVID-19 pneumonia. TRIAL DESIGN: This is a pragmatic, non-blinded, randomized, two arms, parallel trial. PARTICIPANTS: Patients between 18 and 90 years, with COVID-19 pneumonia, confirmed by RT PCR. The setting for the trial is the Hospital Santiago Oriente which is a secondary level hospital with an emergency room, intensive care, and all basic specialties of medicine. INCLUSION CRITERIA: 18 years or more COVID-19 confirmed by RT-PCR Oxygen requirements up to 35% by venturi mask or 5 liters per minute by nasal cannula (approximately FiO2 40%) Consent form signed Exclusion Criteria: Previous steroid use for more than 48 hours. Pregnancy Chronic respiratory failure Requirements of mechanical ventilation (invasive or no invasive) Chronic liver damage Child Pugh B or C Chronic kidney disease stage IV or V. Immunosuppressed Participation in another trial. INTERVENTION AND COMPARATOR: Experimental arm Prednisone 40 mg days 1 to 4. Then Prednisone 20 mg days 5 to 8. Usual care defined by the attending physician. Control arm No intervention. Usual care defined by the attending physician. MAIN OUTCOMES: Primary outcome Composite Primary End-point: Admission to ICU, Need for Invasive Mechanical Ventilation or All-cause Death by Day 28 Secondary outcomes (followed until day 28). Time to respiratory deterioration Incidence of patients requiring mechanical ventilation: Number of days on mechanical ventilation Special emphasis will be placed on observing the following serious adverse events Deterioration of the glycemic profile that requires the use of insulin Delirium Incidence of hospital infections (pneumonia, urinary tract infection, device associated infections) Cumulative incidence of grade 3 and 4 adverse events (AE). Interruption or temporary suspension of treatment for any reason RANDOMISATION: Randomisation in permuted block. Computer generated random numbers in an allocation rate of 1:1. Stata 14.0 was used. Allocated by the principal investigator (direct communication). BLINDING (MASKING): Patients not blinded. Caregivers not blinded. Participants not blinded. Statistician will not know the allocation. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): 92 patients in each arm. 184 total number of patients. TRIAL STATUS: Protocol version 2.0., approved October 2, 2020. Trial ongoing. Recruitment start: June 23, 2020. Anticipate finish recruiting: November 30, 2020. The protocol has been submitted before the last patient and last visit. The delay in sending to publication is responsibility of the authors. TRIAL REGISTRATION: Early Use of Corticosteroids in Non-critical Patients With COVID-19 Pneumonia (PREDCOVID). Registration number NCT04451174 . Date of trial registration: June 26, 2020. FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.
