PVP solid dispersions containing Poloxamer 407 or TPGS for the improvement of ursolic acid release

Abstract Solid dispersions (SDs) of ursolic acid (UA) were developed using polyvinylpyrrolidone K30 (PVP K30) in combination with non-ionic surfactants, such as D-α-tocopherol polyethylene glycol 1000 succinate (TPGS) or poloxamer 407 (P407) with the aim of enhancing solubility and in vitro release of the UA. SDs were investigated using a 24 full factorial design, subsequently the selected formulations were characterized for water solubility, X-ray diffractometry (XRD), differential scanning calorimetry (DSC), particle diameter, scanning electron microscopy, drug content, physical-chemical stability and in vitro release profile. SDs showed higher UA water-solubility than physical mixtures (PMs), which was attributed by transition of the drug from crystalline to amorphous or molecular state in the SDs, as indicated by XRD and DSC analyses. SD1 (with P407) and SD2 (with TPGS) were chosen for further investigation because they had higher drug load. SD1 proved to be more stable than SD2, revealing that P407 contributed to ensure the stability of the UA. Furthermore, SD1 and SD2 increased UA release by diffusion and swelling-controlled transport, following the Weibull model. Thus, solid dispersions obtained with PVP k-30 and P407 proved to be advantageous to enhance aqueous solubility and stability of UA.

Assessment of tolerance and acceptability between mannitol solution and polyethylene glycol as bowel preparation for colonoscopy: a three-center study / Evaluación de tolerancia y aceptabilidad entre la solución de manitol y el polietilenglicol como preparación intestinal para la colonoscopía: un estudio de tres centros

ABSTRACT Introduction: Adequate bowel preparation is one of the most important factors related to the yield of colonoscopy. Low quality bowel preparation has been associated with lower adenoma detection rates and increased healthcare expenses. Bowel preparation is a major impediment to undergo colonoscopy since it is perceived as an unpleasant experience by patients. Objective: This study was aimed to assess tolerance and acceptability of the bowel preparation using either polyethylene glycol (PEG) or mannitol solution. Materials and methods: We enrolled 140 patients with indications of screening for colorectal cancer or with suspected large bowel diseases. They received either mannitol solution or PEG as bowel preparation. Patients were asked to fill a questionnaire about the bowel preparation experience. Results: Patients perceived more burdensome the preparation with PEG than mannitol for the variables nausea overall experience, post-procedure discomfort, disagreeable flavor, volume ingested and cost (p<0.05). A similar tolerance was reported for abdominal pain, bloating and anal irritation (p>0.05). The acceptability was 82.9% and 71.4% in the Mannitol group and in the PEG group, respectively (p=0.10). Conclusion: Acceptance of the bowel preparation between mannitol solution and PEG was comparable. However, mannitol was better tolerated by the patients in regard to most of the evaluated items.

RESUMEN Introducción: La preparación intestinal adecuada es uno de los factores más importantes relacionados con el rendimiento de la colonoscopía. La preparación intestinal de baja calidad se ha asociado con tasas de detección de adenoma más bajas y mayores gastos de atención sanitaria. La preparación intestinal es un impedimento importante para someterse a una colonoscopía, ya que los pacientes la perciben como una experiencia desagradable. Objetivo: Este estudio tuvo como objetivo evaluar la tolerancia y la aceptabilidad de la preparación intestinal utilizando polietilenglicol (PEG) o solución de manitol. Materiales y métodos: Fueron incluidos 140 pacientes con indicación de pesquisa de cáncer colorrectal o con sospecha de enfermedades del intestino grueso. Los pacientes recibieron solución de manitol o PEG como preparación intestinal. Se pidió a los pacientes que completaran un cuestionario sobre la experiencia de preparación intestinal. Resultados: Los pacientes percibieron más agobiante la preparación con PEG que el manitol para las variables náuseas, experiencia general, molestias posteriores al procedimiento, sabor desagradable, volumen ingerido y costo (p<0,05). Se informó una tolerancia similar para el dolor abdominal, distensión abdominal e irritación anal (p>0,05). La aceptabilidad fue de 82,9% y 71,4% en el grupo de manitol y en el grupo de PEG, respectivamente (p=0,10). Conclusión: La aceptación de la preparación intestinal entre la solución de manitol y el PEG fue comparable. Sin embargo, el manitol fue mejor tolerado por los pacientes con respecto a la mayoría de las variables evaluadas.

Eficacia y tolerabilidad de la reducción del volumen de polietilenglicol para la preparación para colonoscopia / Effectiveness and tolerability of low volume bowel cleansing polyethylene glycol solution for colonoscopy

Background: A successful colonoscopy depends, among other factors, on a proper colon cleansing. This variable also affects the acceptance of the patient to carry out the study. Aim: To analyze the efficacy and tolerability of a low volume polyethylene glycol formulation (2 liters), compared to the conventional presentation of 4 liters. Material and Methods: Patients referred for a colonoscopy were randomly divided to receive either two or four liter of polyethylene glycol as bowel cleansing, which was assessed using the Boston score. Raters of the latter were blinded to the volume of polyethylene glycol that the patients used. Results: Seventy-four patients participated in the study. Subjects who received a 4 liters preparation had an average Boston score of 7.78, versus 8.16 for patients who received a volume of 2 liters (p = 0.267). No significant differences in tolerability were observed between both groups. No significant differences in the efficacy and tolerability between a conventional or a reduced volume of polyethylene glycol solution for the preparation of a colonoscopy were observed. These findings may be especially important for subgroups of patients with difficulties for oral administration of fluids.

Avaliação antimicrobiana de hidrogel de PVA e gel de Propilenoglicol incorporado com Nanopartículas de Prata como sanitizantes / Antimicrobial evaluation of PVA hydrogel and propilene glycol incorporated with silver nanoparticles

As Doenças Transmitidas por Alimentos causam diversos problemas de saúde e prejuízos econômicos e tem como principal causa a má manipulação dos alimentos. Portanto, é necessário o uso de estratégias de higiene pessoal e de sanitização das instalações e equipamentos. Pensando nisso, este trabalho apresenta a síntese e análise antimicrobiana por disco-difusão e contagem bacteriana de um gel sanitizante a base de Polietileno Glicol e um hidrogel de PVA com a incorporação de Nanopartículas de Prata (AgNP). Para o primeiro gel, com AgNP, o resultado foi quatro vezes maior que o controle. Para o segundo gel, o aumento na concentração de AgNP garantiu uma maior inibição bacteriana. Os resultados obtidos comprovam a potencialidade deste sanitizante para aplicação industrial, comercial e laboratorial.

First-wave protease inhibitors for hepatitis C genotype 1 treatment: a real-life experience in Brazilian patients

Abstract INTRODUCTION: Licensed for chronic hepatitis C treatment in 2011, the protease inhibitors (PIs) telaprevir (TVR) and boceprevir (BOC), which have high sustained viral responses (SVR), ushered a new era characterized by the development of direct-action drugs against the hepatitis C virus (HCV). The aim of this study was to analyze the effectiveness and safety of BOC and TVR administered with pegylated interferon and ribavirin and to share the experience of a Brazilian reference center. METHODS: A retrospective descriptive study was conducted in patients with HCV genotype 1 infection who started treatment between July 2013 and December 2015. Data were collected using a computerized system. RESULTS: A total of 115 subjects were included, of which 58 (50.4 %) had liver cirrhosis and 103 (89.6 %) used TVR. The overall SVR rate was 61.7 % (62.1 % for TVR and 58.3 % for BOC). The presence of cirrhosis was associated with a lower SVR rate, whereas patients who relapsed after prior therapy had a greater chance of showing SVR than did non-responders. The incidence of adverse drug reactions (ADRs) was high. Almost all patients (~100 %) presented with hematologic events. Furthermore, treatment had to be discontinued in 15 subjects (13 %) due to severe ADRs. CONCLUSIONS: In conclusion, the SVR rates in our study were lower than those reported in pre-marketing studies but were comparable to real-life data. ADRs, particularly hematological ADRs, were more common compared to those in previous studies and resulted in a high rate of treatment discontinuity.

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).

Effectiveness and safety of first-generation protease inhibitors in real-world patients with hepatitis C virus genotype 1 infection in Brazil: a multicenter study

OBJECTIVE: To evaluate the effectiveness and safety of first-generation protease inhibitors for the treatment of genotype 1 hepatitis C virus-infected patients at Brazilian reference centers. METHODS: This multicenter cross-sectional study included hepatitis C virus genotype 1 monoinfected patients treated with Peg-interferon, ribavirin, and either boceprevir (n=158) or telaprevir (n=557) between July 2013 and April 2014 at 15 reference centers in Brazil. Demographic, clinical, virological, and adverse events data were collected during treatment and follow-up. RESULTS: Of the 715 patients, 59% had cirrhosis and 67.1% were treatment-experienced. Based on intention-to-treat analysis, the overall sustained viral response was 56.6%, with similar effectiveness in both groups (51.9% for boceprevir and 58% for telaprevir, p=0.190). Serious adverse events occurred in 44.2% of patients, and six deaths (0.8%) were recorded. Cirrhotic patients had lower sustained viral response rates than non-cirrhotic patients (46.9% vs. 70.6%, p<0.001) and a higher incidence of serious adverse events (50.7% vs. 34.8%, p<0.001). Multivariate analysis revealed that sustained viral response was associated with the absence of cirrhosis, viral recurrence after previous treatment, pretreatment platelet count greater than 100,000/mm3, and achievement of a rapid viral response. Female gender, age>65 years, diagnosis of cirrhosis, and abnormal hemoglobin levels/platelet counts prior to treatment were associated with serious adverse events. CONCLUSION: Although serious adverse events rates were higher in this infected population, sustained viral response rates were similar to those reported for other patient cohorts.

Predictors of early treatment discontinuation and severe anemia in a Brazilian cohort of hepatitis C patients treated with first-generation protease inhibitors

The aim of this study was to determine risk factors for adverse events (AE)-related treatment discontinuation and severe anemia among patients with chronic hepatitis C virus (HCV) genotype 1 infection, treated with first-generation protease inhibitor (PI)-based therapy. We included all patients who initiated treatment with PI-based therapy at a Brazilian university hospital between November 2013 and December 2014. We prospectively collected data from medical records using standardized questionnaires and used Epi Info 6.0 for analysis. Severe anemia was defined as hemoglobin ≤8.5 mg/dL. We included 203 patients: 132 treated with telaprevir (TVR) and 71 treated with boceprevir (BOC). AE-related treatment discontinuation rate was 19.2% and anemia was the main reason (38.5%). Risk factors for treatment discontinuation were higher comorbidity index (OR=1.85, CI=1.05-3.25) for BOC, and higher bilirubin count (OR=1.02, CI=1.01-1.04) and lower BMI (OR=0.98, CI=0.96-0.99) for TVR. Severe anemia occurred in 35 (17.2%) patients. Risk factors for this outcome were lower estimated glomerular filtration rate (eGFR; OR=0.95, CI=0.91-0.98) for patients treated with TVR, and higher comorbidity index (OR=2.21, CI=1.04-4.67) and ribavirin dosage (OR=0.84, CI=0.72-0.99) for those treated with BOC. Fifty-five (57.3%) patients treated with TVR and 15 (27.3%) patients treated with BOC achieved sustained virological response (SVR). Among patients who received TVR and interrupted treatment due to AE (n=19), only 26.3% (n=5) achieved SVR (P=0.003). Higher number of comorbidities, lower eGFR and advanced liver disease are associated with severe anemia and early treatment cessation, which may compromise SVR achievement.

Does Polyethylene Glycol (PEG) Plus Ascorbic Acid Induce More Mucosal Injuries than Split-Dose 4-L PEG during Bowel Preparation?

BACKGROUND/AIMS: The aims of this study were to compare the bowel-cleansing efficacy, patient affinity for the preparation solution, and mucosal injury between a split dose of poly-ethylene glycol (SD-PEG) and low-volume PEG plus ascorbic acid (LV-PEG+Asc) in outpatient scheduled colonoscopies. METHODS: Of the 319 patients, 160 were enrolled for SD-PEG, and 159 for LV-PEG+Asc. The bowel-cleansing efficacy was rated according to the Ottawa bowel preparation scale. Patient affinity for the preparation solution was assessed using a questionnaire. All mucosal injuries observed during colonoscopy were biopsied and histopathologically reviewed. RESULTS: There was no significant difference in bowel cleansing between the groups. The LV-PEG+Asc group reported better patient acceptance and preference. There were no significant differences in the incidence or characteristics of the mucosal injuries between the two groups. CONCLUSIONS: Compared with SD-PEG, LV-PEG+Asc exhibited equivalent bowel-cleansing efficacy and resulted in improved patient acceptance and preference. There was no significant difference in mucosal injury between SD-PEG and LV-PEG+Asc. Thus, the LV-PEG+Asc preparation could be used more effectively and easily for routine colonoscopies without risking significant mucosal injury.

Health-Related Quality of Life in patients with hepatitis C in double and triple therapy / Calidad de vida relacionada con la salud en pacientes con hepatitis c en terapia doble y triple / Qualidade de vida relacionada à saúde em pacientes com hepatite C em terapia dupla e tripla

Abstract OBJECTIVE Comparing Health-Related Quality of Life (HRQoL) scores in patients with chronic hepatitis C undergoing double and triple antiviral therapy and analyzing possible factors related to HRQoL. METHOD HRQoL was assessed using the Short Form 36 and Chronic Liver Disease Questionnaire, which were applied at baseline and at weeks 4, 12 and 16 of treatment to 32 patients divided into two groups: double therapy with pegylated interferon (IFN-PEG) and ribavirin, and triple therapy with PEG-IFN, ribavirin and telaprevir. RESULTS The reduction of HRQoL was greater in patients receiving triple therapy compared to those treated with two drugs, the most critical time is at 12 weeks in both groups. After removal of telaprevir, the triple therapy group significantly improved their HRQoL scores. Anxiety and depression before treatment, employment status and race are significantly related to diminished HRQoL. CONCLUSION Patients undergoing double and triple therapy have diminished HRQoL indexes, but the addition of telaprevir chooses a more significant decrease.

Resumen OBJETIVO Comparar los puntajes de Calidad de Vida Relacionada con la Salud (CVRS) en pacientes con hepatitis C crónica sometidos a la terapia antiviral doble y triple y analizar los posibles factores relacionados con la CVRS. MÉTODO La CVRS fue evaluada utilizando el Short Form 36 y elChronic Liver Disease Questionnaire , que fueron aplicados antes y en las semanas 4, 12 y 16 de tratamiento, en 32 pacientes divididos en 2 grupos: terapia doble con interferón pegilado (IFN-PEG) y ribavirina, y triple con IFN-PEG, ribavirina y telaprevir. RESULTADOS La reducción de la CVRS fue mayor en pacientes en terapia triple cuando comparados con los tratados con dos drogas, siendo el momento más crítico la 12ª semana en ambos grupos. Después de la retirada del telaprevir, el grupo de terapia triple mejoró de modo significativo los puntajes de CVRS. Ansiedad y depresión en el pre tratamiento, situación de empleo y raza se mostraron relacionados con la reducción de la CVRS. CONCLUSIÓN Pacientes sometidos a la terapia doble y triple presentan reducción de los índices de CVRS, pero la adición del telaprevir les proporciona una caída más expresiva.

Resumo OBJETIVO Comparar os escores de Qualidade de Vida Relacionada à Saúde (QVRS) em pacientes com hepatite crônica C submetidos à terapia antiviral dupla e tripla e analisar os possíveis fatores relacionados à QVRS. MÉTODO A QVRS foi avaliada utilizando o Short Form 36 e oChronic Liver Disease Questionnaire , que foram aplicados antes e nas semanas 4, 12 e 16 de tratamento, em 32 pacientes divididos em 2 grupos: terapia dupla com interferon peguilado (IFN-PEG) e ribavirina e tripla com IFN-PEG, ribavirina e telaprevir. RESULTADOS A redução da QVRS foi maior em pacientes em terapia tripla quando comparados àqueles tratados com duas drogas, sendo o momento mais crítico a 12ª semana em ambos os grupos. Após a retirada do telaprevir, o grupo terapia tripla melhorou de modo significativo os escores de QVRS. Ansiedade e depressão no pré-tratamento, status empregatício e raça se mostraram relacionados à redução da QVRS. CONCLUSÃO Pacientes submetidos à terapia dupla e tripla apresentam redução dos índices de QVRS, mas a adição do telaprevir confere uma queda mais expressiva.

BOWEL PREPARATION BEFORE COLONOSCOPY FOR CHILDREN: comparison of efficacy of three different methods

Background - Colonoscopy is an important diagnostic and therapeutic procedure. Adequate bowel preparation is mandatory. Several regimens were discussed in the literature. Among the drugs which has recently used, polyethylene glycol is one of the most popular agents. Objectives - The aim of this study was to compare efficacy of three different methods for 1 day preparation before colonoscopy. Methods - This study included children with the range of ages (2-21) who had an indication of colonoscopy. Exclusion criteria were based on the history of previous surgery, parental disagreement, and patients who did not use preparation protocol. Three methods for bowel preparation were studied: 1- Polyethylene glycol only; 2- Polyethylene glycol and bisacodyl suppositories; 3- Polyethylene glycol plus normal saline enema. Boston Bowel Preparation Score was used for evaluation of preparation. SPSS version 16.0 (Chicago, IL, USA) were used for data analysis. Results - In this study 83 cases completed the bowel preparation completely. Acceptable bowel preparation was seen in 24 (85.71%), 36 (94.73%), and 14 (82.35%) of cases in PEG, PEG + bisacodyl, and PEG + normal saline enema groups respectively. PEG + bisacodyl suppositories was more effective than PEG + normal saline for the preparation of the first segment ( P=0.05). For second and third segment of colon, BPPS score was higher in PEG + bisacodyl suppositories compared to other regimens, but this difference was not statistically significant. Conclusion - There was no significant difference between 1 day colonoscopy regimens in terms of bowel preparation score. Lowest score was seen in PEG + enema group compared to other group.

Contexto - A colonoscopia é um procedimento diagnóstico e terapêutico importante. A preparação intestinal adequada é obrigatória. Vários esquemas são discutidos na literatura. Dentre as drogas que se têm usado recentemente, o polietilenoglicol é um dos agentes mais utilizados. Objetivo - O objetivo deste estudo foi comparar a eficácia de três métodos diferentes para a preparação feita 1 dia antes de colonoscopia. Métodos - Este estudo incluiu crianças com a gama de idades entre 2 e 21 anos, que tinham indicação de colonoscopia. Os critérios de exclusão foram baseados em história da cirurgia anterior, não aprovação dos pais e pacientes que não utilizaram o protocolo de preparação. Três métodos para a preparação do intestino foram estudados: 1-polietilenoglicol; 2 - polietilenoglicol e bisacodil supositórios; 3 - polietilenoglicol e enema de solução salina. O escore de Boston para preparação intestinal foi usado para a avaliação e os dados foram analisados pelo SPSS versão 16.0 (Chicago, Il, USA). Resultados - Um total de 83 pacientes concluiu completamente o preparo intestinal. Houve preparo aceitável em 24 (85,71%), 36 (94,73%) e 14 (82,35%) dos casos, nos grupos PEG, PEG + bisacodil e PEG + enema salino, respectivamente. PEG + bisacodil supositórios foi mais eficaz do que a PEG + solução salina para a preparação do primeiro segmento ( P=0,05). Para segundo e terceiro segmento do cólon, a pontuação de BPPS foi maior no grupo PEG + bisacodil supositórios em comparação com outros regimes, mas essa diferença não foi estatisticamente significativa. Conclusão - Não houve nenhuma diferença significativa entre os regimes de preparo para colonoscopia de um dia em termos de pontuação de preparação do intestino. A nota mais baixa foi vista no grupo PEG + enema em comparação com outros grupos.

Causas no traumáticas de necrosis avascular bilateral de la cabeza femoral: relación hepatitis C-interferón pegilado / Nontraumatic causes of bilateral avascular necrosis of the femoral head: link between hepatitis C and pegylated interferon

Antecedentes: La necrosis avascular de la cabeza femoral es una patología frecuente en pacientes con antecedentes de trauma, encontrándose como causas patologías vasculares, oncológicas, estados hipercoagulantes, tratamientos esteroideos prolongados, asociándose en algunos casos en pacientes con antecedente de hepatitis C con manejo con interferón pegilado + ribavirin. Seef, Foster y Poynard encontraron al estudiar el comportamiento del virus de la hepatitis, un estado de hipercoagulabilidad, que crea interrupción del flujo vascular retinacular en la cabeza femoral, sin incrementar la incidencia de osteonecrosis en este grupo de pacientes. Lauer expone que dichas infecciones virales llevan un proceso autoinmune, las cuales podrían producir vasculitis transitorias. Giampaolo en 2005 reporta la relación entre el uso de interferón en mieloma múltiple y otros padecimientos oncológicos relacionándose con necrosis avascular femoral. Material y métodos: Se valoraron los casos de diagnóstico de osteonecrosis bilateral de la cabeza femoral bilateral. Resultados: Se revisaron 5 pacientes, 4 mujeres y 1 hombre, con el diagnóstico de osteonecrosis bilateral de la cabeza femoral bilateral. Todos con antecedentes de hepatitis C con manejo con interferón pegilado, corroborándose diagnóstico definitivo por patología posterior a artroplastías, realizándose revisión bibliográfica de la relación de esta patología con el uso de interferón en pacientes con hepatitis C. Conclusiones: Al conocer la relación que existe en enfermedades virales como la hepatitis B y C con la presencia de estados de hipercoagulabilidad, procesos autoinmunes que conllevan a vasculitis transitorias y el uso de interferón pegilado 2B, relacionándose a necrosis avascular de las cabezas femorales, conoceremos nuevas causas asociadas no traumáticas a este padecimiento.

Background: Avascular necrosis of the femoral head is a frequent condition in patients with a history of trauma. The major pathologic causes include vascular diseases, malignancies, hypercoagulability states, long-term steroid treatment, and some patients have a history of hepatitis C infection treated with pegylated interferon and ribavirin. Upon studying the behavior of the hepatitis C virus, Seef, Foster and Poynard found a hypercoagulability state that causes interruption of retinacular blood flow to the femoral head, without an increased incidence of osteonecrosis in this patient group. Lauer states that such viral infections involve an autoimmune process and may result in transient vasculitides. Giampaolo, in 2005, reported the relationship between interferon use for multiple myeloma and other cancers and femoral avascular necrosis. Material and methods: Cases with a diagnosis of bilateral osteonecrosis of the femoral head were assessed. Results: Five patients were included, 4 females and one male, with a diagnosis of bilateral osteonecrosis of the femoral head. All of them had history of hepatitis C infection treated with pegylated interferon. The final diagnosis was proven by pathology after arthroplasty. A literature review was made of articles on the relationship between this condition and interferon use in patients with hepatitis C infection. Conclusions: Finding out the relationship between viral diseases such as hepatitis B and C infection and hypercoagulability states, autoimmune processes leading to transient vasculitides and the use of pegylated interferon 2B, will help us discover new nontraumatic causes associated with this condition.

The clinical effectiveness of pegylated interferon and ribavirin for the treatment of chronic hepatitis C in HIV-infected patients in Brazil: a multicentric study

Introduction: in Brazil, chronic hepatitis C in patients coinfected with the human immunodeficiency virus (HIV) is treated with pegylated interferon (Peg-IFN) and ribavirin (RBV). However, few studies have evaluated the effectiveness of this treatment in this particular population. The identification of the factors that predict sustained virological response (SVR) under current clinical practice would enable clinicians to more accurately estimate the probability of achieving an SVR and therefore utilize the appropriate therapeutics, especially in the era of direct-acting antiviral (DAA) agents. Aims: the primary aim of our study was to determine the SVR rate under current clinical practice. The secondary aims were as follows: (1) to determine the factors before and during treatment that predict SVR; and (2) to identify the causes of treatment interruption. Methods: within a cohort of HIV/hepatitis C virus (HCV)-coinfected patients in Brazil, we performed a retrospective analysis of those individuals treated with Peg-IFN and RBV. Results: among the 382 analyzed patients, SVR was observed in 118 [30.9% (95% confidence interval (CI): 26.3-35.8)], which included 25.9% (75/289) of the patients with genotypes 1 and 4 and 48.2% (41/85) of those with genotypes 2 and 3. After multivariate analyses the independent positive predictors for SVR after treatment for chronic hepatitis C with PegIFN and RBV were: absence of an AIDS-defining illness (p = 0.001), HCV viral load lower than 600,000 IU/mL at the onset of treatment (p = 0.003), higher liver enzyme levels (p = 0.039) at baseline, infection with genotypes 2 or 3 (p = 0.003), and no transient treatment interruption (p = 0.001). The treatment was interrupted in 25.6% (98/382) of the patients because of adverse events (11.3%, 43/382), virologic failure (7.8%, 30/382), and dropout (6.5%, 43/382). The main adverse events were cytopenia and psychiatric disorders. Conclusions: ...

Aceptación y adherencia de una pauta de preparación de colon el mismo díadel examen en población chilena / Patients’ acceptance and adherence to total or partial split dose bowel preparation for colonoscopy in chilean population

Colon preparation is more effective if it is partially or totally administered the same day of the colonoscopy. Objective: To know acceptance of a preparation guideline for the same day of the procedure and adherence to this guideline once it is implemented in a digestive endoscopy center. Methods: First, the importance of a preparation guideline for the same day was explained and adult patients and accompanying persons with preparation in the previous day were asked if they would be willing to prepare for the colonoscopy 4-5 h before the procedure. In the second stage, adult patients were surveyed who received instructions to prepare using polyethylene glycol solution (3 litres) the same day of the procedure. Results: 160 people were surveyed in phase one. 86 percent was willing to get up at 4 am to drink the solution, without statistical correlation with the other variables studied. 42.7 percent would prefer to split the doses and 39 percent would drink all the same day. 102 people were surveyed in phase two. 92 percent drank the preparation totally or partially the same day of the procedure (69 percent and 25 percent, respectively). 82 percent drank at least 80 percent of the dose. 51.5 percent described the preparation process as quite or very unpleasant. 45 percent would prefer colonoscopy preparation in the previous day. Conclusions: In our experience, most patients would accept preparation in the same day of the procedure and adhere to this, however, almost 50 percent would prefer to take it the previous day, in a future procedure.

La preparación de colon es más efectiva si es administrada parcial o totalmente el mismo día de la colonoscopia. Objetivo: Conocer la aceptación a una pauta de preparación al menos en parte el mismo día de la colonoscopia y adherencia a esta una vez implementada en un Centro de Endoscopia Digestiva. Métodos: Primero se explicó la importancia de una pauta de preparación el mismo día y se encuestó a pacientes adultos y acompañantes a estudio endoscópico con preparación exclusiva el día anterior si estarían dispuestos a realizar preparación para colonoscopia 4-5 h antes de la prueba. En la segunda fase se encuestó a pacientes adultos a los que se había indicado preparación con solución de polietilenglicol (3 litros) el mismo día del procedimiento. Resultados: En la fase 1 se encuestó a 160 personas. El 86 por ciento aceptaría levantarse a las 4 AM para tomar la preparación, sin relación estadística con las demás variables estudiadas. El 42,7 porciento preferirían tomar la dosis en forma repartida y 39 por ciento preferían beber todo el mismo día. En la fase 2 se encuestó a 102 personas. El 92 porciento tomó la preparación total o parcialmente el mismo día del examen (69 por ciento y 25 por ciento respectivamente). El 82 porciento tomó al menos 80 por ciento de la cantidad indicada. El 51,5 porciento calificó el proceso de la preparación como bastante o muy desagradable. El 45porciento preferiría en colonoscopias futuras la preparación el día anterior. Conclusiones: En nuestro medio, la mayoría de los pacientes aceptarían la pauta de preparación el mismo día de la prueba y adhieren a esta, aunque casi la mitad preferiría tomarla el día anterior en el futuro.

Sodium Picosulfate with Magnesium Citrate (SPMC) Plus Laxative Is a Good Alternative to Conventional Large Volume Polyethylene Glycol in Bowel Preparation: A Multicenter Randomized Single-Blinded Trial

BACKGROUND/AIMS: We investigated whether sodium picosulfate with magnesium citrate (SPMC) plus bisacodyl compares favorably with conventional polyethylene glycol (PEG) with respect to bowel cleansing adequacy, compliance, and safety. METHODS: We performed a multicenter, prospective, single-blinded study in outpatients undergoing daytime colonoscopies. Patients were randomized into a split preparation SPMC/bisacodyl group and a conventional split PEG group. We compared preparation adequacy using the Boston bowel preparation scale (BBPS), ease of use using a modified Likert scale (LS), compliance/satisfaction level using a visual analogue scale (VAS), and safety by monitoring adverse events during the colonoscopy between the two groups. RESULTS: A total of 365 patients were evaluated by intention to treat (ITT) analysis, and 319 were evaluated by per protocol (PP) population analysis (153 for SPMC/bisacodyl, 166 for PEG). The mean total BBPS score was not different between the two groups in both the ITT and PP analyses (p>0.05). The mean VAS score for satisfaction and LS score for the ease of use were higher in the SPMC/bisacodyl group (p<0.001). The adverse event rate was lower in the SPMC/bisacodyl group than in the PEG group (p<0.05). CONCLUSIONS: The SPMC/bisacodyl treatment was comparable to conventional PEG with respect to bowel preparation adequacy and superior with respect to compliance, satisfaction, and safety.

Peginterferon plus ribavirin and sustained virological response rate in HCV-related advanced fibrosis: a real life study

Background: Tolerance and response to antiviral HCV treatment is poor in advanced fibrosis. The aim of this study was to assess SVR rate and its predictive factors in HCV advanced fibrosis patients treated in real life with full dose PEG-IFN plus RBV and to evaluate the adverse events related to treatment. Methods: A multicentric, retrospective study was conducted at six university hospitals. METAVIR F3 and F4 HCV monoinfected patients who were treated with PEG-IFN and RBV had their data analyzed. A stepwise logistic regression analysis was performed to identify the variables independently related to SVR. Adverse events were recorded during treatment. Results: 308 patients were included, 75% genotype 1 and 23% genotype 3. METAVIR F3 was present in 39% and F4 in 61% of patients. The median Child Pugh score for F4 patients was 5 (5–9). The global SVR rate was 34%, 11% were relapsers and 55% were nonresponders. SVR rates were similar between patients treated with PEG-IFN alfa 2a or alfa 2b (p = 0.24). SVR rates according to Child–Pugh score were 26% (Child A) and 18% (Child B). The independent factors related to SVR in F4 patients were genotype 3, RVR and fewer Child Pugh score points. Treatment interruption occurred in 31% patients and death occurred in 1.9%, all with liver cirrhosis. Conclusion: Treatment of HCV in patients with advanced fibrosis should not be postponed. However, a very careful evaluation of cirrhotic patients must be performed before treatment is indicated and careful monitoring is required during treatment. .

Comparison of the Efficacy and Safety of Sodium Phosphate Tablets and Polyethylene Glycol Solution for Bowel Cleansing in Healthy Korean Adults

PURPOSE: Bowel cleansing is generally regarded as time-consuming and unpleasant among patients. Patients commonly state that bowel preparation provokes more discomfort than the actual colonoscopic examination. The purpose of this study was to compare two regimens of sodium phosphate (NaP) tablets versus polyethylene glycol (PEG) solution for bowel preparation in healthy Korean adults. MATERIALS AND METHODS: This was a single center, prospective, open-label, investigator-blinded, randomized, controlled-pilot study. A total of 62 healthy Korean subjects were randomly assigned to two groups (NaP vs. PEG). Efficacy, safety, and patient-related outcomes, as well as procedural parameters, were evaluated. RESULTS: Although there were no significant differences in total Ottawa bowel quality score, fluid scores and the rate of adequate bowel preparation were significantly better in the NaP group than the PEG group. Additionally, the NaP group showed better results regarding patient tolerance, satisfaction, preference, and rate of adverse events than the PEG group. Significant fluctuations in specific serum electrolytes were common and of a greater magnitude in the NaP group than the PEG group. However, these abnormalities were transient and did not result in serious complications and side effects. CONCLUSION: In this study, NaP tablets were shown to be an effective, well-tolerated, and acceptable regimen for bowel preparation. Also, our study suggests that NaP tablets may be safe and can be used as a bowel cleansing agent in healthy adults undergoing elective colonoscopy. Further multicenter, large scale studies are needed to confirm these findings.

Prediction of a Null Response to Pegylated Interferon alpha-2b Plus Ribavirin in Patients with High Viral Load Genotype 1b Hepatitis C

BACKGROUND/AIMS: The present study aimed to clarify whether virological response within 2 weeks after therapy initiation can predict a null response to pegylated interferon alpha-2b plus ribavirin therapy in patients with high viral load genotype 1b hepatitis C. METHODS: The participants consisted of 72 patients with high viral load genotype 1b. The dynamics of viral load within 2 weeks were measured. RESULTS: Significant differences between null responders and nonnull responders were noted for interleukin (IL)-28B genotype, amino acid 70 substitution, alpha-fetoprotein, low-density lipoprotein cholesterol, hyaluronic acid, and viral response. The area under the curve (AUC) for the receiver operating characteristic curve of the hepatitis C virus (HCV) RNA level decline at 2 weeks (AUC=0.993) was the highest among the factors predicting the null response. When the cutoff value for the HCV RNA level decline at 2 weeks was set at 0.80 log, the sensitivity, specificity, positive predictive value, negative predictive value, and accuracy in predicting a null response were 82%, 96%, 82%, 96%, and 94%, respectively. In comparison, values for the non-TT and mutant type of amino acid 70 substitution were similar to those for HCV RNA level decline at 2 weeks. CONCLUSIONS: Virological response at 2 weeks or the combination of IL-28B and amino acid 70 substitution are accurate predictors of a null response.

Hepatitis C Viral Kinetics as a Determinant of Stopping Pegylated Interferon and Ribavirin in Genotype 1 Infection

No abstract available.