RESUMO
INTRODUCTION AND AIMS: The patency capsule is an effective diagnostic method for preventing video capsule retention in the small bowel during capsule endoscopy. The most frequently associated complication when using the patency capsule is symptomatic retention. The aim of the present study was to evaluate the effectiveness and safety of patency capsules administered to patients at a tertiary care hospital center. MATERIALS AND METHODS: A retrospective observational study was conducted that included all the patients with confirmed Crohn's disease that were administered a patency capsule, within the time frame of January 2019 and December 2020. PC diagnostic yield, sensitivity, specificity, positive predictive value, and negative predictive value were evaluated, in relation to capsule endoscopy and double-balloon endoscopy findings. Complications associated with the patency capsule were also identified. RESULTS: Thirty patients were included, in whom the patency capsule had 83% sensitivity, 100% specificity, 100% positive predictive value, and 96% negative predictive value, with a diagnostic yield of 96.7%. There was one complication (3.3%) and it resolved spontaneously. CONCLUSIONS: The patency capsule is a safe and effective method for reducing video capsule retention during capsule endoscopy in patients with Crohn's disease.
Assuntos
Endoscopia por Cápsula , Doença de Crohn , Humanos , Doença de Crohn/diagnóstico por imagem , Intestino Delgado/diagnóstico por imagem , Endoscopia por Cápsula/efeitos adversos , Valor Preditivo dos Testes , Estudos RetrospectivosRESUMO
INTRODUCTION: Clostridioides difficile (C. difficile) infection is the main cause of nosocomial diarrhea. First-line treatment is oral vancomycin, but that presentation is not commercially available in Latin America. Our aim was to determine the fecal concentration of the oral administration of the conventional dose of an intravenous vancomycin preparation (VCM), in an experimental model. METHODS: A preclinical trial was conducted on 18 male mice (Balb/c strain), in three batches. The following doses of VCM were administered: 125 mg in batch A; 500 mg in batch B; and VCM-placebo in batch C. After receiving the doses, the mice were placed in metabolic cages, by batch. Feces were collected and the fecal concentration of VCM was analyzed through high pressure liquid chromatography 2, 4 and 6 h after drug administration. RESULTS: The 125 mg dose of VCM reached the minimum inhibitory concentration (MIC) for C. difficile, without reaching the minimum bactericidal concentration (MBC90), at 2, 4, and 6 h (521, 688, and 280 mg/L, respectively). Likewise, the 500 mg dose of VCM reached the MIC at 2 h, increased gradually, and reached MBC90 between 4 and 6 h, in feces (1,062 and 1,779 mg/L, respectively), ANOVA, p = 0.0005. CONCLUSION: The fecal concentration of vancomycin was dependent on the intragastric dose administered. Only the 500 mg dose of VCM reached therapeutic concentration for C. difficile (MIC and MBC90), in the mice. We suggest starting a dose of 500 mg QID for achieving therapeutic concentration against C. difficile, as soon as 4 h after the first dose.
Assuntos
Clostridioides difficile , Infecções por Clostridium , Masculino , Humanos , Animais , Camundongos , Vancomicina/farmacologia , Vancomicina/uso terapêutico , Antibacterianos/uso terapêutico , Fezes , Administração OralRESUMO
The biotechnology-derived medicines known as biosimilars are defined as non-originator treatments that have demonstrated quality, efficacy, and safety comparable to the reference biologic drug. Clinical trials have shown that the infliximab biosimilar, CT-P13, and the candidates for the adalimumab biosimilars, ABP 501 and ZRC 3197, are not significantly different, with respect to efficacy and safety, from the originator drugs in patients with other autoimmune diseases. However, controversy has arisen over the use of biosimilars in inflammatory bowel disease, due to the incipient evidence not only in patients with no previous biotechnology treatment, but also in patients in remission, that could be switched to a biosimilar for non-medical reasons. The present review is the first critical analysis by different specialists in the area of gastroenterology on the use of biosimilars in inflammatory bowel disease, the evidence on interchangeability, the extrapolation of indications, efficacy, safety, immunogenicity, and the clinical impact of the Mexican health regulations. The aim of our review was to make the positioning and recommendations of these new therapeutic options known, given that they have a potential cost-benefit for both patients and healthcare institutions.