Eficacia de la combinación de polietilenglicol (PEG) en tubos de politetrafluoroetileno (PTFE) como injerto en la regeneración de nervio ciático. Modelo animal / Efficacy of the combination of polyethylene glycol (PEG) in polytetrafluoroethylene (PTFE) tubes as a graft in regeneration of the sciatic nerve. Animal model

Introducción y objetivo: La lesión de nervio periférico, en todos sus mecanismos, es un evento frecuente entre la población en general. Existen distintos métodos de reparación de la misma, sin embargo, no hay suficiente investigación sobre el injerto más eficaz. El objetivo de este estudio es determinar la superioridad de la combinación de polietilenglicol en tubos de politetrafluoroetileno como injerto sobre el uso aislado del mismo y de un autoinjerto. Material y método: Estudio experimental de casos y controles utilizando ratas Wistar a las que se les indujo, bajo sedación, lesión nerviosa mediante extracción de injerto nervioso de nervio ciático y su posterior reparación, divididas en 3 grupos: autoinjerto, injerto de politetrafluoroetileno e injerto de politetrafluoroetileno con polietilenglicol. Resultados: Analizamos 8 variables histopatológicas con conteo total de axones, encontrando mayor número en las muestras de autoinjerto. Entre las variables clínicas, analizamos la deformidad de la extremidad, la atrofia muscular macroscópica y la alteración en la marcha. El grupo de la combinación de materiales mostró una evolución excelente en las 3 categorías. Conclusiones: La recuperación clínica de la extremidad intervenida en el grupo donde se utilizó la combinación de los materiales en estudio fue notablemente superior; observamos además mucha mejor organización axonal, indicando una superioridad de esta combinación respecto a los otros grupos evaluados. (AU)

Background and objective: Peripheral nerve injury, in all its mechanisms, is a frequent event in the general population. There are diferent methods of repairing it, however there is not enough research on the most effective graft. The objective of this study is to determine the superiority of the combination of polyethylene glycol in polytetrafluoroethylene tubes as a graft versus its isolated use and an autograft. Methods: Experimental study of cases and controls using Wistar rats that were induced, under sedation, nerve injury by extracting a nerve graft from the sciatic nerve and its subsequent repair, divided into 3 groups: autograft, polytetrafluoroethylene graft and polytetrafluoroethylene graft with polyethylene glycol. Results: Eight histopathological variables were analyzed and a total axon count was made, finding a greater number in the autograft samples. Among the clinical variables, limb deformity, macroscopic muscular atrophy and walking disturbance were analyzed, showing the group of the combination of materials an excellent evolution in the 3 categories. Conclusions: The clinical recovery of the operated limb in the group where the combination of the studied materials was used was notably superior, in addition to the observation of much better axonal organization, indicating a superiority of this combination with respect to the other groups evaluated. (AU)

Efficacy, safety, and acceptability of polyethylene glycol 3350 without electrolytes vs magnesium hydroxide in functional constipation in children from six months to eighteen years of age: A controlled clinical trial.

INTRODUCTION AND AIMS: There are few studies that compare polyethylene glycol (PEG) 3350 and magnesium hydroxide (MH), as long-term treatment of functional constipation (FC) in children, and they do not include infants as young as 6 months of age. Our aim was to determine the efficacy, safety, and acceptability of PEG vs MH in FC, in the long term, in pediatric patients. METHODS: An open-label, parallel, controlled clinical trial was conducted on patients from 6 months to 18 years of age, diagnosed with FC, that were randomly assigned to receive PEG 3350 or MH for 12 months. Success was defined as: ≥ 3 bowel movements/week, with no fecal incontinence, fecal impaction, abdominal pain, or the need for another laxative. We compared adverse events and acceptability, measured as rejected doses of the laxative during the study, in each group and subgroup. RESULTS: Eighty-three patients with FC were included. There were no differences in success between groups (40/41 PEG vs 40/42 MH, p = 0.616). There were no differences in acceptability between groups, but a statistically significant higher number of patients rejected MH in the subgroups > 4 to 12 years and > 12 to 18 years of age (P = .037 and P = .020, respectively). There were no differences regarding adverse events between the two groups and no severe clinical or biochemical adverse events were registered. CONCLUSIONS: The two laxatives were equally effective and safe for treating FC in children from 0.5 to 18 years of age. Acceptance was better for PEG 3350 than for MH in patients above 4 years of age. MH can be considered first-line treatment for FC in children under 4 years of age.

Macroprolactin: From laboratory to clinical practice.

Prolactin measurement is very common in standard clinical practice. It is indicated not only in the study of pituitary adenomas, but also when there are problems with fertility, decreased libido, or menstrual disorders, among other problems. Inadequate interpretation of prolactin levels without contextualizing the laboratory results with the clinical, pharmacological, and gynecological/urological history of patients leads to erroneous diagnoses and, thus, to poorly based studies and treatments. Macroprolactinemia, defined as hyperprolactinemia due to excess macroprolactin (an isoform of a greater molecular weight than prolactin but with less biological activity), is one of the main causes of such erroneous diagnoses, resulting in poor patient management when not recognized. There is no unanimous agreement as to when macroprolactin screening is required in patients with hyperprolactinemia. At some institutions, macroprolactin testing by polyethylene glycol (PEG) precipitation is routinely performed in all patients with hyperprolactinemia, while others use a clinically based approach. There is also no consensus on how to express the results of prolactin/macroprolactin levels after PEG, which in some cases may lead to an erroneous interpretation of the results. The objectives of this study were: 1. To establish the strategy for macroprolactin screening by serum precipitation with PEG in patients with hyperprolactinemia: universal screening versus a strategy guided by the alert generated by the clinician based on the absence or presence of clinical symptoms or by the laboratory when hyperprolactinemia is detected. 2. To create a consensus document that standardizes the reporting of prolactin results after precipitation with PEG to minimize errors in the interpretation of the results, in line with international standards.

Morphometric study of rat sciatic nerve recovery after three nerve repair techniques: epineural suture, polyethylene glycol hydrogel and fibrin sealant / Estudio morfométrico de la recuperación del nervio ciático de rata después de tres técnicas de reparación nerviosa: sutura epineural, hidrogel de polietilenglicol y sellante de fibrina

SUMMARY: The effectiveness of microsurgical technique has a direct impact on the recovery of the injured peripheral nerve. The aim of our study was to investigate the result of sciatic nerve regeneration in rats after complete neurotomy and after nerve repair techniques including: 1) epineural suture; 2) polyethylene glycol hydrogel (PEG) (DuraSeal); 3) fibrin sealant (Tisseel). The cross-section of distal sciatic nerve was studied at 14th, 30th and 60th days after nerve repair. Morphometry of myelinated nerve fibers in the distal stump of the sciatic nerve was performed. A significant increase in the number of myelinated nerve fibers was found, especially between 14 and 30 days. The density of myelinated nerve fibers in the distal stump at day 60 was significantly higher after using nerve repair technique including PEG and fibrin versus epineural suture (29.2 % and 32.1 % versus 21.5 %, P <0.05), and a higher level of remyelination of nerve fibers observed in the group with PEG. On day 60, complete elimination of PEG and fibrin sealant was not observed, encapsulation was found around the clusters of hydrogel. Thereby, three peripheral nerve repair techniques were equally effective, only with the use of PEG remyelination of nerve fibers was increasing.

RESUMEN: La efectividad de la técnica microquirúrgica tiene un impacto directo en la recuperación del nervio periférico lesionado. El objetivo de nuestro estudio fue investigar el resultado de la regeneración del nervio ciático en ratas después de una neurotomía completa y después de técnicas de reparación nerviosa que incluyeron: 1) sutura epineural; 2) hidrogel de polietilenglicol (PEG) (DuraSeal); 3) sellante de fibrina (Tisseel). La sección transversal del nervio ciático distal se estudió a los 14, 30 y 60 días después de la reparación del nervio. Se realizó la morfometría de fibras nerviosas mielinizadas en el muñón distal del nervio ciático. Se observó un aumento significativo en el número de fibras nerviosas mielinizadas, especialmente entre los 14 y 30 días. La densidad de las fibras nerviosas mielinizadas en el muñón distal en el día 60 fue significativamente mayor después de usar una técnica de reparación nerviosa que incluye PEG y fibrina en comparación con la sutura epineural (29,2 % y 32,1 % versus 21,5 %, P <0,05), y un mayor nivel de remielinización del nervio en fibras observadas en el grupo con PEG. El día 60, no se observó la eliminación completa de PEG y sellador de fibrina, se encontró encapsulación alrededor de los grupos de hidrogel. Por lo tanto, tres técnicas de reparación de nervios periféricos fueron igualmente efectivas, solo que aumentaba la remielinización de fibras nerviosas con PEG.

Macroprolactin: From laboratory to clinical practice. / Macroprolactina: del laboratorio a la práctica clínica. Recomendaciones del grupo de trabajo de laboratorio de la SEEN y de la comisión de hormonas de la SEQCML sobre la medición e informe del resultado de la macroprolactina.

Prolactin measurement is very common in standard clinical practice. It is indicated not only in the study of pituitary adenomas, but also when there are problems with fertility, decreased libido, or menstrual disorders, among other problems. Inadequate interpretation of prolactin levels without contextualizing the laboratory results with the clinical, pharmacological, and gynecological/urological history of patients leads to erroneous diagnoses and, thus, to poorly based studies and treatments. Macroprolactinemia, defined as hyperprolactinemia due to excess macroprolactin (an isoform of a greater molecular weight than prolactin but with less biological activity), is one of the main causes of such erroneous diagnoses, resulting in poor patient management when not recognized. There is no unanimous agreement as to when macroprolactin screening is required in patients with hyperprolactinemia. At some institutions, macroprolactin testing by polyethylene glycol (PEG) precipitation is routinely performed in all patients with hyperprolactinemia, while others use a clinically based approach. There is also no consensus on how to express the results of prolactin/macroprolactin levels after PEG, which in some cases may lead to an erroneous interpretation of the results. The objectives of this study were: 1. To establish the strategy for macroprolactin screening by serum precipitation with PEG in patients with hyperprolactinemia: universal screening versus a strategy guided by the alert generated by the clinician based on the absence or presence of clinical symptoms or by the laboratory when hyperprolactinemia is detected. 2. To create a consensus document that standardizes the reporting of prolactin results after precipitation with PEG to minimize errors in the interpretation of the results, in line with international standards.

Funcionalização do polietilenoglicol metil éter via reação de bromoacetilação: ativação, caracterização por MALDI-TOF e mecanismo de reação / Poly(ethylene glycol) methyl ether functionalization by bromoacetylation reaction: Activation, characterization by MALDI-TOF and reaction mechanism / Funcionalización de polietilenglicol metil éter mediante reacción de bromoacetilación: activación, caracterización por MALDI-TOF y mecanismo de reacción

Resumo A PEGuilação, reação química de conjugação com a molécula de polietilenoglicol (PEG) ou polietilenoglicol metil éter (mPEG), tem sido amplamente aplicada pelas indústrias farmacêuticas como estratégia de melhoria das propriedades farmaco-cinéticas de compostos bioativos. O PEG é um polímero que possui um esqueleto de poliéter quimicamente inerte e que apresenta grupos hidroxilas (-OH) em suas extremidades. Assim, o PEG para tornar-se apto como reagente de conjugação deve ser ativado com um grupo funcional que seja reativo. Nesse sentido, a bromoaceti-lação apresenta-se como uma alternativa para a funcionalização do PEG. Portanto, nesse trabalho objetivamos descrever em detalhes os procedimentos e o mecanismo de reação envolvida na funcionalização do mPEG, através da reação de bromoacetilação. Além do mais, estudamos a aplicação do MALDI-ToF para a caracterização do produto ativado. Após a bromoacetilação, por um procedimento adaptado, obteve-se o bromoacetil-mPEG-éster, com rendimento bruto de 56,78%. Análises posteriores, por espectrometria de massas por MALDI-ToF, possibilitaram identificar e caracterizar o produto bromoacetilado. Entre as condições de reação, o controle de temperatura (-10 °C a 0 °C) mostrou-se eficaz favorecendo a adição nucleofílica essencial à bromoacetilação. Assim, concluímos que o controle da baixa temperatura reacional é um fator chave para o favorecimento da adição nucleofílica à carbonila e, portanto, essencial na obtenção do mPEG funcionalizado via bromoacetilação. Estudos posteriores serão necessários, no entanto, para confirmar se o mPEG esterificado, nessas condições, poderá ser utilizado na conjugação com moléculas de natureza proteica ou peptídica, por meio de substituição nucleofílica bimolecular.

SUMMARY PEGylation, a chemical reaction of conjugation with the polyethylene glycol molecule (PEG), has been widely applied by the pharmaceutical industries as a strategy to improve the pharmacokinetic properties of bioactive compounds. PEG is a polymer that has a chemically inert polyether backbone and hydroxyl groups (-OH) at its ends. Thus, PEG to become fit as a reagent for conjugation must be activated with a functional group that is reactive. In this sense, bromoacetylation presents itself as an alternative for the functionalization of PEG. Therefore, in this study we aim to describe in detail the procedures and reaction mechanism involved in the functionalization of mPEG through the bromoacetylation reaction. In addition, we used the spectrometric technique, by MALDI-ToF, for the characterization of the activated product. After applying an adapted bromoacetylation procedure, bromoacetyl-mPEG-ester was obtained with a yield of 56.78%. Subsequent analyzes of MALDI-ToF mass spectrometry were able to correctly identify and characterize the bromoacety-lated product. Among the reaction conditions, temperature control (from -10 °C to 0 °C) was effective in favoring the essential nucleophilic addition to bromoacetylation. Thus, we conclude that the control of the low reaction temperature is a key factor in favoring the nucleophilic addition to carbonyl and, therefore, obtaining a favorable conversion to functionalized PEG via bromoacetylation. Further studies, however, will be necessary to confirm whether PEG esterified with these conditions can be used in conjunction with molecules of a protein or peptide nature by means of bimolecular nucleophilic substitution.

RESUMEN La PEGilación, una reacción química de conjugación con la molécula de polietilenglicol (PEG), ha sido ampliamente aplicada por las industrias farmacéuticas como una estrategia para mejorar las propiedades farmacocinéticas de los compuestos bioactivos. El PEG es un polímero formado por un esqueleto de poliéter químicamente inerte con grupos hidroxilo (-OH) en sus extremos. Por lo tanto, para usar el PEG como reactivo de conjugación debe activarse con un grupo funcional que sea reactivo. En este sentido, la bromoacetilación es una alternativa para la funcionalización de PEG. De esta manera, en este trabajo nuestro objetivo es describir en detalle los procedimientos y el mecanismo de reacción involucrados en la funcionalización de PEG a través de la reacción de bromoacetilación. Además, estudiamos la aplicación de MALDI-ToF para la caracterización del producto activado. Después de aplicar un procedimiento de bromoacetilación adaptado, se obtuvo bromoacetil-mPEG-éster con un rendimiento bruto de 56,78%. Los análisis posteriores de espectrometría de masas por MALDI-ToF pudieron identificar y caracterizar correctamente el producto bromoacetilado. Entre las condiciones de reacción, el control de la temperatura (desde -10 °C hasta 0 °C) fue eficaz para favorecer la adición nucleofílica esencial a la bromoacetilación. Así, concluimos que el control de la baja temperatura de reacción es un factor clave para favorecer la adición nucleofílica al carbonilo y, por lo tanto, esencial para obtener el mPEG funcionalizado mediante la bromoacetilación. Sin embargo, serán necesarios más estudios para confirmar si el mPEG esterificado en estas condiciones puede usarse junto con moléculas de naturaleza proteica o peptídica por medio de la sustitución nucleófila bimolecular.

Effect of polyethylene glycol versus lactulose on abdominal pain in children occult constipation: a randomized controlled study: un estudio controlado aleatorio / Efecto del polietilenglicol versus lactulosa sobre el dolor abdominal en el estreñimiento oculto en niños

Introduction and aim: Functional abdominal pain (FAP) is one of the major gastrointestinal complaints in childhood. Studies have reported occult constipation (OC) as one of the leading causes of abdominal pain. Recent researches have proposed laxatives as potent therapeutic targets for abdominal pain in patients with OC. However, no study has compared effect of poly ethylene glycol (PEG) and lactulose on occult constipation. Materials and methods: 51 patients aged 4 to 18 years with abdominal pain who had OC (defined as fecal impaction in abdominal X ray) were studied. Demographic and clinical data including age, sex, body weight, height, abdominal pain duration, abdominal pain rate and fecal odor were registered. They were randomly assigned to receive PEG (1gr/kg) or Lactulose (1cc/kg) for at least two weeks. All patients were reevaluated by pain measurement scale after at least two weeks of treatment. Results: It is indicated that the efficacy of PEG for reducing abdominal pain in OC was 48% while it was 37% for Lactulose. This study indicated that this efficacy is not affected significantly by sex and fecal odor, however this efficacy is influenced by age, body weight, abdominal pain duration and abdominal pain rate for both PEG and Lactulose. Conclusion: It could be concluded that PEG is a more efficient drug for treating abdominal pain in occult constipation than Lactulose and its optimum effect can be achieved in elder patients with more severe abdominal pain.

Introducción y objetivo: El dolor abdominal funcional (FAP) es una de las principales molestias gastrointestinales en la infancia. Los estudios han informado que el estreñimiento oculto (OC) es una de las principales causas de dolor abdominal. Investigaciones recientes han propuesto laxantes como objetivos terapéuticos potentes para el dolor abdominal en pacientes con OC. Sin embargo, ningún estudio ha comparado el efecto del polietilenglicol (PEG) y la lactulosa sobre el estreñimiento oculto. Materiales y métodos: Se estudiaron 51 pacientes de 4 a 18 años con dolor abdominal que tenían OC (definida como impactación fecal en rayos X abdominales). Se registraron datos demográficos y clínicos que incluyen edad, sexo, peso corporal, altura, duración del dolor abdominal, tasa de dolor abdominal y olor fecal. Fueron asignados aleatoriamente para recibir PEG (1 gr/kg) o lactulosa (1 cc/kg) durante al menos dos semanas. Todos los pacientes fueron reevaluados por la escala de medición del dolor después de al menos dos semanas de tratamiento. Resultados: Se indica que la eficacia de PEG para reducir el dolor abdominal en OC fue del 48% mientras que fue del 37% para la lactulosa. Este estudio indicó que esta eficacia no se ve afectada significativamente por el sexo y el olor fecal, sin embargo, esta eficacia está influenciada por la edad, el peso corporal, la duración del dolor abdominal y la tasa de dolor abdominal tanto para PEG como para lactulosa. Conclusión: Se podría concluir que el PEG es un fármaco más eficaz para tratar el dolor abdominal en el estreñimiento oculto que la lactulosa y que su efecto óptimo se puede lograr en pacientes mayores con dolor abdominal más severo.Palabras clave: dolor abdominal, estreñimiento oculto, polietilenglicol, lactulosa.

Eficacia y seguridad de tres esquemas para la preparación del colon para colonoscopia (polietilenglicol (PEG) 4 litros (4 L) (dosis única) vs. PEG 4 L dividido (2 L + 2 L) vs. PEG 2 L dividido de volumen bajo (1 L + 1 L): ensayo clínico controlado aleatorizado / A randomized controlled clinical trial of the efficacy and safety of colonoscopy preparation using a single four liter dose of polyethylene glycol (PEG) vs. two 2 liter doses of PEG vs. two low volume (1L + 1L) doses of PEG

Resumen Introducción: la colonoscopia es el examen estándar de oro para evaluar la mucosa del colon. De la limpieza del colon en la preparación intestinal para colonoscopia depende el hallazgo de pólipos, que pueden ser adenomatosos con potencial maligno y con la posibilidad de degenerarse en cáncer de colon. Objetivo: comparar la eficacia y la seguridad de tres tipos de preparaciones para la limpieza del colon: dosis única de polietilenglicol (PEG) 4 litros (4 L) y dosis divididas: PEG 4 L dividido (2 L + 2 L) y PEG 2 L dividido (1 L + 1 L) de volumen bajo. Métodos: en pacientes con una colonoscopia electiva de una clínica universitaria, se realizó un ensayo clínico controlado aleatorizado y ciego (para el médico que evaluó la limpieza del colon). Se asignaron 74 pacientes para cada grupo. El parámetro principal de eficacia fue la preparación integral de calidad adecuada medida con la escala de Boston, y los parámetros secundarios fueron el porcentaje de eventos adversos, la tolerabilidad y la tasa de detección de pólipos. Resultados: la preparación completa de todo el colon fue significativamente de mayor la calidad en la alternativa de 4 L divididos (2 L + 2 L), seguida de la otra alternativa dividida (1 L + 1 L) y menor en la dosis única (79,7 %, 75,7 % y 63,5 %, respectivamente, p = 0,019); también se encontraron diferencias en la detección de pólipos (13,5 %, 24,3 % y 9,5 %, p = 0,037) y sin diferencias en la presentación de al menos un evento adverso (p = 0,254) ni en la tolerabilidad (p = 0,640). Conclusiones: las dos preparaciones de dosis dividida tienen una mayor eficacia en la limpieza del colon en comparación con la dosis única de 4 L y en la detección de pólipos, mientras que no se evidencian diferencias en las preparaciones para la ocurrencia de eventos adversos y la tolerabilidad. La dosis de PEG 2 L dividido puede ser una muy buena opción para las preparaciones de colonoscopia electiva.

Abstract Introduction: Colonoscopy is the gold standard for evaluation of the colonic mucosa. Colon cleansing in preparation for colonoscopy depends on finding of polyps which can be adenomatous with malignant potential and the possibility of degenerating into colon cancer. Objective: This study's objective was to compare the efficacy and safety of three types of preparations for colon cleansing: a single four liter dose of polyethylene glycol (PEG) vs. two 2 liter doses of PEG vs. two low volume (1L + 1L) doses of PEG. Methods: This is a randomized controlled clinical trial of patients who underwent elective colonoscopy at a University clinic. It was blinded for the doctor who evaluated colon cleansing. Seventy four patients 74 patients were randomized into each group. The main parameter of effectiveness was integral preparation of adequate quality measured on the Boston scale. Secondary parameters were the percentage of adverse events, tolerability and detection rate of polyps. Results: Complete preparation of the entire colon was achieved significantly more often with 4 liters divided into two 2 liter doses followed by the other divided alternative (1 L + 1 L). It was achieved least frequently with in the single dose: 79.7%, 75.7% and 63.5%, respectively, p = 0.019. Differences were also found in the detection of polyps (13.5%, 24.3% and 9.5%, respectively, p = 0.037). ) There were no differences in presentation of at least one adverse event (p = 0.254) or in tolerability (p = 0.640). Conclusions: The two divided dose preparations had higher colon cleansing and polyp detection efficacies than did the single 4L dose while there were no differences in occurrence of adverse events and tolerability. The divided PEG 2L dose could be a very good option for elective colonoscopy preparation.

Evaluación comparativa de efectividad y tolerabilidad con polietilenglicol y picosulfato de sodio-citrato de magnesio como agentes de preparación intestinal para colonoscopia / Comparative evaluation of effectiveness and tolerability with polyethylene glycol and sodium picosulfate-magnesium citrate as intestinal preparation agents for colonoscopy

Resumen Introducción La efectividad de la colonoscopia depende de múltiples factores, destacando la calidad de preparación intestinal y la tolerabilidad que tenga el paciente a la preparación administrada. Objetivo Comparar dos agentes de preparación intestinal, el polietilenglicol (PEG) y el picosulfato de sodiocitrato de magnesio (PSCM) en términos de efectividad y tolerabilidad de la preparación. Pacientes y Método Ensayo clínico aleatorizado en pacientes ambulatorios sometidos a colonoscopia en Clínica INDISA. Evaluando efectividad y tolerabilidad con el Boston Bowel Preparation Score (BBPS) y cuestionario de Lawrence [compuesto por escala Likert, dos preguntas cualitativas y escala visual análoga (EVA)], respectivamente. Resultados 189 pacientes, de los cuales 123 se aleatorizaron a PEG y 66 a PSCM. El BBPS en los pacientes que utilizaron PEG, la media fue 7,51 (DS 1,66) y con PSCM fue 7,12 (DS 1,71) (p = 0,111). Al analizar la tolerabilidad con escala Likert, la media con PEG fue 0,94 (DS 0,68) y con PSCM fue 0,63 (DS 0,61) (p = 0,0004). La EVA con PEG tuvo una media de 7,68 (DS 2,4) y con PSCM de 9,04 (DS 1,59) (p < 0,0001). Al preguntar ausentismo laboral, no hubo diferencias significativas en ambos grupos y al preguntar si ocuparía la misma preparación en una futura colonoscopia, hubo significancia estadística a favor del PSCM (p = 0,026). Conclusión No encontramos diferencias en la efectividad de preparación intestinal al comparar PEG y PSCM, sin embargo, el PSCM es mejor tolerado.

Introduction The effectiveness of colonoscopy depends on multiple factors, being two of the most important ones an adequate bowel preparation and the patient's tolerability to the preparation. Objectives Compare effectiveness and tolerability of two bowel preparation agents, polyethylene glycol (PEG) and sodium picosulfate/magnesium citrate (SPMC). Patients and Methods Randomized clinical trial on outpatients that went into colonoscopy in INDISA Clinic. We evaluated effectiveness and tolerability with Boston Bowel Preparation Score (BBPS) and Lawrence questionnaire [composed by Likert scale, two qualitative questions and Visual Analogue Scale (VAS) for pain], respectively. Results 189 patients, 123 were randomized to PEG and 66 to SPMC. BBPS average in patients in the PEG branch was 7.51 (SD 1.66) and for SPMC 7.12 (SD 1.71) (p = 0.111). Likert scale for evaluating tolerability average for PEG was 0.94 (SD 0.68) and for SPMC 0.63 (SD 0.61) (p = 0.0004). VAS scale for PEG had an average of 7.68 (SD 2.4) and for PSCM 9.04 (SD 1.59) (p < 0.0001). When we asked for workplace absenteeism, there were no significant differences between both groups and when we asked about using the same intestinal preparation in a future colonoscopy there was statistical significance in favor to SPMC (p = 0.026). Conclusions No differences were noted on effectiveness between the PEG and SPMC bowel preparations. Nevertheless, SPMC appeared to be better tolerated by patients.

Tolerancia, seguridad y eficacia de la preparación intestinal con un día de PEG3350 + bisacodilo en comparación con 2 días de PEG3350 + bisacodilo en pacientes pediátricos / Tolerance, safety and efficacy of the one-day preparation of PEG3350 + bisacodyl compared to 2 days of PEG3350 + bisacodyl in pediatric patients

Resumen: Introducción: Múltiples preparaciones intestinales se han utilizado en niños sometidos a una colonoscopia, con limitación variable debido a la aceptación, tolerancia y la limpieza adecuada. El objetivo del estudio fue comparar la tolerancia seguridad y eficacia de la preparación intestinal para colonoscopia de 1 día con PEG 3350 (polietilenglicol) (4 g/kg/día) + bisacodilo y el tratamiento con 2 días de preparación con PEG 3350 (2 g/kg/día) + bisacodilo en pacientes pediátricos. Métodos: Se realizó un ensayo clínico, aleatorizado y ciego. Se incluyeron pacientes de 2 a 18 años, que ameritaron colonoscopia en forma programada. Los pacientes se asignaron de manera aleatoria en dos grupos: 1 día de preparación con PEG 3350 4 g/kg/día + bisacodilo y 2 días de preparación con PEG 3350 2 g/kg/día + bisacodilo. Por medio de un cuestionario, exploración física y valoración endoscópica (escala de Boston), se determinó la tolerancia, seguridad y eficacia de las 2 preparaciones a evaluar. Se realizó una prueba t de Student para variables cuantitativas y χ2 para variables cualitativas. Resultados: No hubo diferencias significativas en las tasas de cumplimiento, los efectos adversos y la extensión de la evaluación colonoscópica. Conclusiones: La tolerancia y seguridad entre la preparación intestinal para colonoscopia de 1 día con PEG 3350 (polietilenglicol) (4 g/kg/día) + bisacodilo y la preparación de 2 días con PEG 3350 (2 g/kg/día) + bisacodilo fue semejante. La calidad de la limpieza fue buena en ambos grupos, siendo parcialmente más eficaz en el grupo de 1 día con PEG 3350 (polietilenglicol) (4 g/kg/día).

Abstract: Background: Multiple intestinal preparations have been used in children undergoing colonoscopy, with variable limitation due to acceptance, tolerance, and proper cleaning. The objective of this study was to compare the tolerability, safety and efficacy of the colonoscopy preparation with 1 day with PEG 3350 (poliethylenglycol) (4 g/kg/day) + bisacodyl compared to 2 days of preparation with PEG 3350 (2 g/kg/day) + bisacodyl in pediatric patients. Methods: A clinical, randomized, and blind trial was performed. Patients aged 2 to 18 years scheduled for colonoscopy were included. Patients were randomized into two groups: 1 day of preparation with PEG 3350 4 g/kg/day + bisacodyl and 2 days of preparation with PEG 3350 2 g/kg/day + bisacodyl. Through a questionnaire, physical examination and endoscopic evaluation (Boston scale), the tolerance, safety and efficacy of the 2 preparations to be evaluated were determined. Student's t test was performed for quantitative variables and χ2 for qualitative variables. Results: There were no significant differences in compliance rates, adverse effects, and extent of colonoscopic evaluation. Conclusions: Tolerance and safety between the intestinal preparation for 1-day colonoscopy with PEG 3350 (4 g/kg/day) + bisacodyl and the 2-day preparation with PEG 3350 (2 g/kg/day) + bisacodyl were similar. The quality of cleanliness was good in both groups, being partially more effective in the 1-day group with PEG 3350 (4 g/kg/day).

[Tolerance, safety and efficacy of the one-day preparation of PEG3350 + bisacodyl compared to 2 days of PEG3350 + bisacodyl in pediatric patients]. / Tolerancia, seguridad y eficacia de la preparación intestinal con un día de PEG3350 + bisacodilo en comparación con 2 días de PEG3350 + bisacodilo en pacientes pediátricos.

BACKGROUND: Multiple intestinal preparations have been used in children undergoing colonoscopy, with variable limitation due to acceptance, tolerance, and proper cleaning. The objective of this study was to compare the tolerability, safety and efficacy of the colonoscopy preparation with 1 day with PEG 3350 (poliethylenglycol) (4g/kg/day) + bisacodyl compared to 2 days of preparation with PEG 3350 (2g/kg/day) + bisacodyl in pediatric patients. METHODS: A clinical, randomized, and blind trial was performed. Patients aged 2 to 18 years scheduled for colonoscopy were included. Patients were randomized into two groups: 1 day of preparation with PEG 3350 4g/kg/day + bisacodyl and 2 days of preparation with PEG 3350 2g/kg/day + bisacodyl. Through a questionnaire, physical examination and endoscopic evaluation (Boston scale), the tolerance, safety and efficacy of the 2 preparations to be evaluated were determined. Student's t test was performed for quantitative variables and χ2 for qualitative variables. RESULTS: There were no significant differences in compliance rates, adverse effects, and extent of colonoscopic evaluation. CONCLUSIONS: Tolerance and safety between the intestinal preparation for 1-day colonoscopy with PEG 3350 (4g/kg/day) + bisacodyl and the 2-day preparation with PEG 3350 (2g/kg/day) + bisacodyl were similar. The quality of cleanliness was good in both groups, being partially more effective in the 1-day group with PEG 3350 (4g/kg/day).

[Comparison of the effectiveness and safety of polyethylene glycol with and without electrolytes in the treatment of chronic constipation]. / Comparación sobre la efectividad y seguridad del polietilenglicol con y sin electrolitos en el tratamiento del estreñimiento funcional.

INTRODUCTION: To compare the effectiveness and safety of polyethylene glycol with and without electrolytes (EL) over a 12 week period in treatment of chronic constipation in paediatrics. MATERIAL AND METHODS: This was an observational, prospective, longitudinal, parallel group study, including 62 children with chronic constipation according to ROME III criteria and a history of faecal impaction. The children were divided into groups, one group of 30 received polyethylene glycol without EL (PEG) and 32 PEG with EL (PEG+EL) for at least 12 weeks. The main outcomes were the number of bowel movements at 6 and 12 weeks, and the presence of electrolyte disturbances at 6 weeks. RESULTS: The mean weekly stool frequencies were similar in both groups at 6 and 12 weeks, with 5.4 and 4.6 stools per week in the PEG+EL and PEG groups, respectively at 12 weeks. After 6 weeks of treatment, 83% (25 of 30) of the PEG group had at least one electrolyte disturbance compared with 56% (18 of 32) in the PEG+EL group (P=.02). Hyponatraemia was found in 15% (5 of 32) vs. 36% (11 of 30) of PEG+EL and PEG groups, respectively (P=.05). None of the laboratory abnormalities were clinically relevant. CONCLUSIONS: PEG formulations with or without EL have a quite similar effectiveness, safety and acceptability. PEG without EL produced more electrolyte abnormalities, but none of them were symptomatic.