Evaluación clínica, bioquímica, endoscópica e histopatológica del tratamiento biológico de colitis ulcerativa: Clinical, biochemical, endoscopic and histopathological evaluation of biological treatment in ulcerative colitis

Background: Biological treatment is currently used as an alternative for the treatment of ulcerative colitis in patient’s refractory to conventional treatment. Objective: To evaluate biological treatment in patients with ulcerative colitis refractory to conventional treatment in a 3rd level care Hospital. Methods: A descriptive, retrospective, longitudinal study was carried out in patients with UC who were refractory to conventional treatment and who received biological treatment. The variables were evaluated in 3 moments: basal state (without biological treatment), at six and twelve months from the start of biological treatment. Descriptive statistics were used to characterize general population, later the 3 states mentioned above were described with their respective variables. Results: Eighteen patients with a mean age of 41.2 years were included. Evaluations at baseline and at 6 and 12 months showed: presence of blood in stools and abdominal pain in 94.4%%, 22.2% and 11.1% respectively; hemoglobin concentration >10.5 g/dl in 50%, 83.3% and 88.9%; serum albumin concentration >3.2 g/dl in 72.2%, 83.3% and 88.9%; the visual Mayo endoscopic scale 38.9%, 33.3% and 16.7% presented Mayo 2 and 61.1%, 16.7% and 1.7% Mayo 3. The histological activity in the baseline evaluation reached a severe level (11.1%), while in evaluations at 6 and 12 months they reached moderate in 55.6% and 27.8% respectively. Conclusions: Biological therapy as a treatment in patients with ulcerative colitis showed improvement in clinical, biochemical, endoscopic and histological manifestations, so far none with deep remission of the disease, no adverse reactions to treatment have been presented.Introducción: El tratamiento biológico es una alternativa para manejar la colitis ulcerativa en pacientes refractarios al tratamiento convencional. Objetivo: Evaluar el tratamiento biológico en pacientes con colitis ulcerativa refractarios al tratamiento convencional en un hospital de 3er nivel de atención. Métodos: Estudio descriptivo, retrospectivo, longitudinal en pacientes con colitis ulcerativa refractarios al tratamiento convencional y que recibieron tratamiento biológico. Las cortes se evaluaron en tres momentos: estado basal (sin terapia biológica), a los seis y doce meses de inicio del tratamiento biológico. Se utilizó estadística descriptiva para la caracterización de la población en general, posteriormente los tres puntos de corte se describieron con sus respectivas variables. Resultados: Se incluyeron 18 pacientes con edad media de 41,2 años. Las evaluaciones, en un estado basal, a los seis y 12 meses; demostraron presencia de sangre en las evacuaciones y dolor abdominal en 94,4%, 22,2% y 11,1% respectivamente, concentración de hemoglobina >10,5 g/dl en 50%, 83,3% y 88,9%; concentración sérica de albúmina >3,2 g/dl en 72,2%, 83,3% y 88,9% y escala visual endoscópica de Mayo 38,9%, 33,3% y 16,7% presentaron Mayo 2 y 61,1%, 16,7% y 1,7% Mayo 3. La actividad histológica en la evaluación basal llego hasta un nivel severo (11,1%), mientras que en evaluaciones a seis y 12 meses llegaron hasta moderada en un 55,6% y 27,8% respectivamente. Conclusiones: La terapia biológica en pacientes con colitis ulcerativa refractaria demostró mejoría en manifestaciones clínicas, bioquímicas, endoscópicas e histológicas. No se registró remisión profunda de la enfermedad, ni reacciones adversas al tratamiento

Understanding the neuroprotective effect of tranexamic acid: an exploratory analysis of the CRASH-3 randomised trial

Background: The CRASH-3 trial hypothesised that timely tranexamic acid (TXA) treatment might reduce deaths from intracranial bleeding after traumatic brain injury (TBI). To explore the mechanism of action of TXA in TBI, we examined the timing of its effect on death. Methods: The CRASH-3 trial randomised 9202 patients within 3 h of injury with a GCS score ≤ 12 or intracranial bleeding on CT scan and no significant extracranial bleeding to receive TXA or placebo. We conducted an exploratory analysis of the effects of TXA on all-cause mortality within 24 h of injury and within 28 days, excluding patients with a GCS score of 3 or bilateral unreactive pupils, stratified by severity and country income. We pool data from the CRASH-2 and CRASH-3 trials in a one-step fixed effects individual patient data meta-analysis. Results: There were 7637 patients for analysis after excluding patients with a GCS score of 3 or bilateral unreactive pupils. Of 1112 deaths, 23.3% were within 24 h of injury (early deaths). The risk of early death was reduced with TXA (112 (2.9%) TXA group vs 147 (3.9%) placebo group; risk ratio [RR] RR 0.74, 95% CI 0.58–0.94). There was no evidence of heterogeneity by severity (p = 0.64) or country income (p = 0.68). The risk of death beyond 24 h of injury was similar in the TXA and placebo groups (432 (11.5%) TXA group vs 421 (11.7%) placebo group; RR 0.98, 95% CI 0.69–1.12). The risk of death at 28 days was 14.0% in the TXA group versus 15.1% in the placebo group (544 vs 568 events; RR 0.93, 95% CI 0.83–1.03). When the CRASH-2 and CRASH-3 trial data were pooled, TXA reduced early death (RR 0.78, 95% CI 0.70–0.87) and death within 28 days (RR 0.88, 95% CI 0.82–0.94). Conclusions: Tranexamic acid reduces early deaths in non-moribund TBI patients regardless of TBI severity or country income. The effect of tranexamic acid in patients with isolated TBI is similar to that in polytrauma. Treatment is safe and even severely injured patients appear to benefit when treated soon after injury. Trial registration: ISRCTN15088122, registered on 19 July 2011; NCT01402882, registered on 26 July 2011

Effect of intravenous corticosteroids on death within 14 days in 10008 adults with clinically significant head injury (MRC CRASH trial): randomised placebo-controlled trial.

BACKGROUND: Corticosteroids have been used to treat head injuries for more than 30 years. In 1997, findings of a systematic review suggested that these drugs reduce risk of death by 1-2%. The CRASH trial--a multicentre international collaboration--aimed to confirm or refute such an effect by recruiting 20000 patients. In May, 2004, the data monitoring committee disclosed the unmasked results to the steering committee, which stopped recruitment. METHODS: 10008 adults with head injury and a Glasgow coma score (GCS) of 14 or less within 8 h of injury were randomly allocated 48 h infusion of corticosteroids (methylprednisolone) or placebo. Primary outcomes were death within 2 weeks of injury and death or disability at 6 months. Prespecified subgroup analyses were based on injury severity (GCS) at randomisation and on time from injury to randomisation. Analysis was by intention to treat. Effects on outcomes within 2 weeks of randomisation are presented in this report. This study is registered as an International Standard Randomised Controlled Trial, number ISRCTN74459797. FINDINGS: Compared with placebo, the risk of death from all causes within 2 weeks was higher in the group allocated corticosteroids (1052 [21.1%] vs 893 [17.9%] deaths; relative risk 1.18 [95% CI 1.09-1.27]; p=0.0001). The relative increase in deaths due to corticosteroids did not differ by injury severity (p=0.22) or time since injury (p=0.05). INTERPRETATION: Our results show there is no reduction in mortality with methylprednisolone in the 2 weeks after head injury. The cause of the rise in risk of death within 2 weeks is unclear