Cohortes de premedicación en endoscopia alta con simeticona, N-acetilcisteína, Hedera helix y validación de la escala visual / Cohorts of premedication for endoscopy of the upper gastrointestinal tract with simethicone, N-acetylcysteine, Hedera helix and visual scale validation

Resumen Los parámetros de calidad para endoscopia digestiva alta han introducido indicadores intraprocedimiento, dentro de los cuales la adecuada visibilidad de la mucosa, libre de saliva, moco o burbujas, puede aumentar la posibilidad de detección de lesiones en fase temprana. Sin embargo, el uso de mucolíticos y antiburbujas ha mostrado gran variabilidad de eficiencia según las soluciones, concentraciones, tiempos de exposición y escala de visibilidad aplicados. Objetivos: determinar la efectividad de diferentes soluciones de premedicación para la limpieza de la mucosa digestiva; validar, mediante una prueba de concordancia interobservador, una nueva escala de adecuada visualización de la mucosa (TVMS) para el esófago, estómago y duodeno; y reportar eventos adversos o complicaciones relacionadas con las soluciones utilizadas y los procedimientos realizados. Material y métodos: estudio de cohortes prospectivas comparativas. Se incluyeron 412 pacientes adultos, ASA I y ASA II, para endoscopia diagnóstica bajo sedación consciente, distribuidos en 6 cohortes similares, divididas en dos grupos: no premedicación, 2 cohortes C1 (ayuno de 6 a 8 horas)y C2 (agua 100 mL); premedicación, 4 cohortes C3 a C6 (C3: agua 100 m L + simeticona 1000 mg; C4: agua 100 mL + simeticona 200 mg + N-acetilcisteína 600 mg; C5: agua 100 mL + simeticona 200 mg + N-acetilcisteína 1000 mg; C6: agua 100 mL + simeticona 200 mg + Hedera helix 70 mg). Se ingirió la solución 15 a 30 minutos antes del paso por cricofaríngeo. Se realizó la prueba de Kappa para medir la concordancia interobservador de la escala TVMS. Resultados: De 412 pacientes, 58% fueron de sexo femenino; 23% (136) fue de cohortes C1 y C2 y 67% (276) fue de cohortes C3 a C6. El tiempo medio de exposición a cada solución fue de 24,4 minutos. El volumen de lavado para lograr una adecuada visualización fue significativamente diferente entre ambos grupos: en los pacientes con premedicación se utilizaron 75,6 mL, mientras que en los pacientes sin premedicación se utilizaron 124 mL (p = 0,000), con una calidad de TVMS excelente de 88,7% frente al 41,4%, respectivamente. La cohorte C4 (agua 100 mL + simeticona 200 mg + N-acetilcisteína 600 mg) mostró ser la más efectiva con una diferencia significativa (p = 0,001) frente a C1 (ayuno) y C2 (placebo con agua 100 mL), y también tuvo una eficiencia superior frente a C3, C5 y C6 en su orden. No se presentaron eventos adversos o complicaciones en relación con la endoscopia, la sedación y los productos usados en la premedicación. Conclusiones: la solución más efectiva como premedicación para lograr una excelente visibilidad de la mucosa digestiva correspondió a la cohorte C4 (SIM 200 + NAC 600 + H2O 100 mL). La escala TVMS propuesta es una herramienta muy completa y fácil de aplicar por más de un observador. La premedicación ingerida, con antiburbuja, mucolítico y agua hasta 100 mL, entre 15 y 30 minutos previos a endoscopia, es segura en las condiciones descritas en este estudio.

Abstract Quality parameters for upper gastrointestinal endoscopy have introduced intraprocedural indicators, including adequate mucosal visualization free of saliva, mucus, or bubbles, which may increase the possibility of early-stage injury detection. The use of mucolytics and anti-foaming agents has shown great efficiency variability depending on the type of solution, concentrations, exposure times and visibility scale applied. Objectives: To determine the effectiveness of different premedication solutions for cleaning the digestive mucosa; to validate, by means of an interobserver concordance test, a new scale for the adequate visualization of the mucosa (TVMS) for the esophagus, stomach, and duodenum; and to report adverse events or complications associated with the solutions used and the procedures performed. Material and methods: Prospective, comparative cohort study. 412 adult patients, ASA I and ASA II, were included for diagnostic endoscopy under conscious sedation. They were distributed in 6 similar cohorts and divided into two groups: non-premedication, 2 in C1 (fasting 6 to 8 hours) and C2 (water 100 mL) cohorts; premedication, 4 C3 to C6 cohorts (C3: water 100 mL + simethicone 1000 mg; C4: water 100 ml + simethicone 200 mg + N-acetylcysteine 600 mg; C5: water 100 ml + simethicone 200 mg + N-acetylcysteine 1000 mg; C6: water 100 ml + simethicone 200 mg + Hedera helix 70 mg). The solution was swallowed 15 to 30 minutes passing through the cricopharyngeus muscle. The Kappa test was performed to measure interobserver concordance of the TVMS scale. Results: Of 412 patients, 58% were female; 23% (136) were included in the C1 and C2 cohorts; and 67% (276) were in the C3 to C6 cohorts. The average exposure time to each solution was 24.4 minutes. The wash volume for proper visualization was significantly different between the two groups. In premedicated patients, 75.6 mL of solution were used, while in patients without premedication, 124 mL were used (p = 0.000), with an excellent quality of TVMS of 88.7% versus 41.4%, respectively. The C4 cohort (water 100 mL + simethicone 200 mg + N-acetylcysteine 600 mg) was the most effective with a significant difference (p= 0.001) compared with the C1 (fasting) and C2 (placebo with water 100 mL) cohorts. It also had better efficiency compared to the C3, C5 and C6 cohorts in that order. There were no adverse events or complications associated with endoscopy, sedation, or premedication products. Conclusions: The most effective solution as a premedication to achieve excellent visibility of the digestive mucosa was that used in the C4 cohort (SIM 200 + NAC 600 + H2OR 100 mL). The proposed TVMS scale is a very complete and easy tool to apply by more than one observer. Premedication ingested, with anti-foam, mucolytic and water up to 100 mL, between 15 and 30 minutes before endoscopy, is safe under the conditions described in this study.

A influência do uso da simeticona nos resultados do exame salivar: estudo preliminar / The influence of simethicone use on salivary examination results: preliminary study

Introdução: o uso da simeticona após coleta salivar é pouco descrito na literatura, sendo indicado para a obtenção de quantitativo maior da amostra. Todavia poucos são os estudos sobre a possível interferência dessa substância nos resultados do exame salivar. Objetivo: Avaliar as propriedades físico-químicas de duas marcas de simeticona e verificar se o fármaco interfere nos resultados do exame salivar. Metodologia: o estudo foi realizado no Laboratório de Bioquímica Oral (ICS/UFBA). Na etapa in vitro, avaliou-se o potencial hidrogeniônico (pH), a acidez titulável total (ATT) e a presença de sólidos solúveis totais (SST) na simeticona das marcas A e B. Na etapa in vivo, foi avaliada a velocidade do fluxo salivar (VFS), pH e a capacidade tampão (CT) na amostra salivar de 23 voluntários, comparando-se os resultados sem e com o uso das medicações (marcas A e B). Resultados: as duas marcas estudadas obtiveram pH menor que o neutro, e os valores de ATT para obtenção do pH 7 foram maiores na marca A. Ambas apresentaram valores elevados de SST. Na etapa in vivo, 78,3% da amostra era de mulheres, com idade média de 21,1 anos e VFS dentro da normalidade. Não houve diferença estatística entre o VFS (p=0,022) e pH (p=0,419) entre os grupos estudados, enquanto os valores da CT relativos ao uso da simeticona da marca A foram diferentes em comparação com os dos dois outros grupos (p=0,005). Conclusão: as propriedades laboratoriais das marcas de simeticona estudadas apresentaram diferenças entre si. O uso da marca A parece ter interferido na CT da saliva coletada.

Introduction: the use of simethicone after salivary collection is controversial in the literature, being indicated to obtain a larger quantity of sample. However, there are few studies on its interference in salivary examination results. Objective: to evaluate the physical and chemical properties of two brands of simethicone. Also, check if the drug interferes with salivary examination results. Methodology: the study was conducted at the Oral Biochemistry Laboratory of ICS / UFBA. In the in vitro stage, the hydrogen potential (pH), the total titratable acidity (TTA) and the presence of total soluble solids (TSS) in the A and B simethicone brands were evaluated. In the in vivo step the salivary flow rate (SFR) was evaluated; also pH and buffer capacity (BC) in the salivary sample of 23 volunteers, comparing the results without and with the use of medications (brands A and B). Results: the two studied brands had lower pH than neutral and the TTA values to obtain pH 7 were higher in brand A. Both presented high values of TSS. In the in vivo stage, 78.3% of the sample was women, with a mean age of 21.1 years and normal SFR. There was no statistical difference between SFR (p = 0.022) and pH (p = 0.419) between the studied groups, while the TCs values for the use of brand A simethicone were different compared to the other two groups (p = 0.005). Conclusion: the laboratory properties of the simethicone brands studied differed from each other. The use of brand A seems to have interfered with the collected saliva BC.

Aplicación de una escala de visualización de la mucosa gástrica, durante la esofagogastroduodenoscopia en pacientes premedicados con N-acetilcisteína más simeticona: experiencia en Ocaña, Norte de Santander / Experience in Ocaña, Norte de Santander, with a Scale for Visualization of the Gastric Mucosa during Esophagogastroduodenoscopy in Patients Medicated with N-acetylcysteine plus Simethicone

Resumen Introducción: la visibilidad de la mucosa gástrica puede verse limitada por el moco adherente y la formación de burbujas durante la endoscopia de vías digestivas altas. Objetivos: conocer los puntajes de visualización de la mucosa gástrica y el número de lavados para aclarar la superficie gástrica de burbujas y espumas, aplicando la escala de Kuo modificada por Chang en pacientes premedicados antes de la esofagogastroduodenoscopia. Materiales y métodos: estudio descriptivo, prospectivo, se incluyeron 120 pacientes entre octubre y diciembre de 2016 a los que se les premedicó con N-acetilcisteína (NAC) al 4%, 400 mg (10 cc) más simeticona (SIM) (dimetilpolisiloxano) 133,3 mg (2 cc) y agua tibia 100 cc, 20 minutos antes del procedimiento; los datos se tabularon en Excel y, ulteriormente, sus frecuencias y porcentajes se analizaron con el paquete estadístico Epi Info CDC (versión 7,2 para Windows, Estados Unidos); se consideró significancia estadística una p <0,05. Resultados: la puntuación total de visibilidad de la mucosa gástrica considerada como óptima con un puntaje de 4 fue 57 (47,50%), con 5 puntos fueron 36 (30%), con 6 y 7 puntos 10 (8,33%), con 8 puntos 6 (5%) y, por último, con 9 puntos 1 (0,83%); no hubo casos en las puntuaciones de 10 a 16. 100 (83,3%) pacientes no necesitaron lavados adicionales con agua para visualizar la mucosa gástrica, contra 13 (10,83%) que requirieron menos de 50 cc y 7 (5,83%) que necesitaron más de 50 cc (p = 0,00). Limitaciones: un solo observador realizó el estudio, lo que pudo generar sesgos de detección; además, la muestra es pequeña. Conclusiones: con la administración de una solución de NAC más SIM diluidas en 100 cc de agua tibia previa a la endoscopia de vías digestivas altas se obtuvo una visualización óptima de la mucosa gástrica en la mayoría de los casos y se observó la necesidad de un menor volumen de agua para aclarar la cavidad gástrica de moco y espuma.

Abstract Introduction: During upper digestive tract endoscopy, visibility of the gastric mucosa can be limited by adherent mucus and bubbles. Objectives: This is a study of visualization of the gastric mucosa and the number of washes needed to clear bubbles and foam from the gastric surface. The modified Kuo scale by Chang was used with patients medicated prior to esophagogastroduodenoscopy. Materials and methods: This is a descriptive and prospective study of 120 patients who were medicated with 400 mg (10cc) of 4% N-acetylcysteine plus 133.3 mg (2cc) of simethicone (Dimethylpolysiloxane) and 100 cc of warm water 20 minutes prior to esophagogastroduodenoscopy from October to December 2016. Data were tabulated in Excel and frequencies and percentages were analyzed using the Epi Info statistical package from the Centers for Disease Control version 7.2 for Windows. Statistical significance was considered to be p <0.05. Results: The optimal score for total visibility of four was achieved 57 patients (47.50%). Thirty-six patients (30%) had scores of five points, ten patients (8.33%) had scores of six or seven points, six patients had scores of eight points (5%), and one patient (0.83%) had a score of nine points. There were no scores from 10 to 16. Hundred patients (83,3%) did not need additional washes with water to visualize the gastric mucosa, thirteen patients (10,83%) required less than 50 cc, and seven (5,83%) required more than 50 cc (p = 0.00). Limitations: This study was done by a single observer which could result in detection biases. Also, the sample is small. Conclusions: Administration of a solution of N-acetylcysteine ​​plus Simethicone diluted in 100 cc of warm water prior to upper digestive tract endoscopy provides for optimal visualization of the gastric mucosa in most cases. A smaller volume of water was needed to clear the gastric cavity of mucus and foam.