Are Biologics Safe in the Immediate Postoperative Period? A Single-Center Evaluation of Consecutive Crohn's Surgical Patients.

There is no study to date examining the safety of initiating or restarting biologic therapy after major abdominal surgery for Crohn's disease. The purpose of this study was to determine differences in the rates of 90-day superficial surgical site infections, intra-abdominal sepsis, and overall postoperative infectious complications among patients who were initiated on or restarted a biologic within 90 days postoperatively compared with those who were not. This was a retrospective cohort study. The study was conducted at an IBD referral center. Adult patients with Crohn's disease who received a biologic therapy within 90 days of a major abdominal operation between May 20, 2014, and December 31, 2018, were included. Ninety-day superficial surgical site infection, intra-abdominal sepsis, and overall postoperative infectious complications were measured. A total of 680 patients with Crohn's disease were included: 351 were initiated on biologic therapy within 90 days after surgery and 329 were not. Patients exposed to biologic therapy postoperatively were younger (p < 0.001), had a lower BMI (p = 0.0014), were less often diabetic (p = 0.0011), and were more often exposed preoperatively to biologics (p < 0.0001) and immunomodulators (p < 0.0001) but not corticosteroids (p = 0.8399). Of those exposed postoperatively, nearly all (93.7%) had been on a biologics preoperatively, and most resumed the same biologic (68.0%). The median time to starting biologic therapy postoperatively was 31 days (range, 7-89 d). Postoperative biologic exposure was not associated with an increased risk of superficial surgical site infection (HR = 1.02 (95% CI, 0.95-1.09) per week; p = 0.59), intra-abdominal sepsis (HR = 1.07 (95% CI, 0.99-1.16); p = 0.73), or overall postoperative infectious complications (HR = 1.02 (95% CI, 0.98-1.07); p = 0.338); the overall rates of each at 90 days was 13%, 8%, and 28%. The study was limited by its retrospective design and single-center data. Postoperative initiation or resumption of biologic therapy did not increase 90-day rates of superficial surgical site infection, intra-abdominal sepsis, or total infectious complications after major abdominal surgery for Crohn's disease. See Video Abstract at http://links.lww.com/DCR/B207. ¿SON SEGUROS LOS FÁRMACOS BIOLÓGICOS EN EL POSTOPERATORIO INMEDIATO? UNA EVALUACIÓN DE UN SOLO CENTRO DE PACIENTES QUIRÚRGICOS CONSECUTIVOS CON ENFERMEDAD DE CROHN: No hay ningún estudio hasta la fecha que examine la seguridad de iniciar o reiniciar la terapia biológica después de una cirugía abdominal mayor en enfermedad de Crohn.Determinar las diferencias en las tasas a 90 días de infecciones del sitio quirúrgico superficial, sepsis intraabdominal y complicaciones infecciosas postoperatorias generales entre los pacientes en que se inició o reinició un biológico dentro de los 90 días después de la operación en comparación con aquellos que no lo recibieron.Estudio de cohorte retrospectivo.Centro de referencia de enfermedad inflamatoria intestinal.Pacientes adultos con enfermedad de Crohn que recibieron una terapia biológica dentro de los 90 días de una operación abdominal mayor entre el 20 de mayo de 2014 y el 31 de diciembre de 2018.Infección superficial del sitio quirúrgico, sepsis intraabdominal y complicaciones infecciosas postoperatorias generales a 90 días.Se incluyeron un total de 680 pacientes con enfermedad de Crohn: 351 se iniciaron en terapia biológica dentro de los 90 días posteriores a la cirugía y 329 no. Los pacientes expuestos a terapia biológica después de la operación eran más jóvenes (p <0.001), tenían un índice de masa corporal más bajo (p = 0.0014), eran con menos frecuencia diabéticos (p = 0.0011) y estaban expuestos con mayor frecuencia preoperatoriamente a fármacos biológicos (p <0.0001) e inmunomoduladores (p <0.0001) pero no a corticosteroides (p = 0.8399). De los expuestos postoperatoriamente, casi todos (93.7%) habían estado en terapia biológica en el preoperatorio, y la mayoría reanudó la misma terapia biológica (68%). La mediana de tiempo para comenzar la terapia biológica después de la operación fue de 31 días (rango, 7-89 días). La exposición biológica postoperatoria no se asoció con un mayor riesgo de infección superficial del sitio quirúrgico (HR 1.02 (0.95-1.09) por semana, p = 0.59), sepsis intraabdominal. (HR: 1.07 (0.99-1.16), p = 0.73), o complicaciones infecciosas postoperatorias generales (HR: 1.02, intervalo de confianza del 95% 0.98-1.07, p = 0.338); las tasas generales de cada uno a los 90 días fue del 13%, 8% y 28%.Diseño retrospectivo, y datos de un centro único.El inicio o la reanudación en el postoperatorio de la terapia biológica no aumentaron las tasas a 90 días de infección superficial de sitio quirúrgico, sepsis intraabdominal o complicaciones infecciosas totales después de una cirugía abdominal mayor por enfermedad de Crohn. Consulte el Video Resumen en http://links.lww.com/DCR/B207. (Traducción-Dr Jorge Silva Velazco)

Método de determinação e avaliação da depleção de oxitetraciclina em camarão marinho Method for the determination and evaluation of oxytetracycline depletion in marine shrimp

O objetivo deste trabalho foi validar um método para determinação de resíduos de oxitetraciclina (OTC) em camarões, por meio de cromatografia líquida de alta eficiência, e avaliar, pelo método validado, a depleção de resíduos de OTC em camarões in vivo. Para a validação, foram utilizados camarões isentos de OTC e camarões adicionados de OTC in vitro. Foram estabelecidos: seletividade, tempo de retenção, linearidade (coeficiente de correlação), faixa de trabalho, recuperação relativa, limites de detecção e quantificação do método (LDM e LQM, respectivamente) e repetibilidade. Para o experimento in vivo, rações com 200, 400 e 500 &#956;g g-1 de OTC foram administradas aos camarões durante 14 dias. Foi avaliada a concentração do resíduo desse antibiótico no músculo e na carapaça até 22 dias após a suspensão da droga. O coeficiente de correlação linear foi de 0,9997 para o extrato fortificado da matriz, na faixa de trabalho de 0,02 a 0,4 &#956;g g-1; a recuperação foi de 106±17,1% e os LDM e LQM foram de 0,006 e 0,019 &#956;g g-1, respectivamente. O tempo de residência da droga na carapaça dos animais (de 10 a 13 dias) foi maior em comparação ao tempo de residência no músculo (5 dias).<br>This work aimed at validating a method for the determination of oxytetracycline (OTC) residues in shrimp by means of high performance liquid chromatography (HPLC), and at evaluating the OTC residue depletion in shrimps in vivo using the validated method. The shrimp used for validation were either not submitted or submitted to in vitro OTC addition. Selectivity, retention time, linearity (correlation coefficient), work range, relative recovery, detection and method quantification limits and repeatability were determined. For the in vivo experiment, shrimp were fed with feed medicated with OTC at 200, 400 and 500 &#956;g g-1 for 14 days. Oxytetracycline residue concentration in the animals' muscle and carapace was assessed for up to 22 days after stopping medication. The results obtained were: 0.9997 linear correlation coefficient for the fortified matrix extract within a work range of 0.02-0.4 &#956;g g-1, 106±17.1% recovery and 0.006 and 0.019 &#956;g g-1 detection and quantification limits, respectively. A greater OTC residence time was observed in the carapace (10 to 13 days) when compared to the muscle (5 days)