[Non-IgE-mediated food allergy]. / Alergia alimentaria no mediada por IgE.

Food allergy is an immune response to proteins in food. It usually affects 8% of children and 2% of adults in Western countries. Non-IgE-mediated food allergy mainly affects the gastrointestinal tract. Gastrointestinal food allergies are classified, by their underlying pathogenesis, as: IgE-mediated, non-IgE-mediated, or mixed. The symptoms of patients with food protein-induced allergic proctocolitis originate from local inflammation of the distal colon, which causes hematochezia in neonates. It can affect the entire gastrointestinal tract and cause symptoms of intractable emesis, with subsequent metabolic disorders and hypovolemic shock. Food protein-induced enterocolitis syndrome is a non-IgE-mediated allergy that usually appears in childhood, with prolonged repetitive vomiting, starting 1 to 4 hours after ingestion of food. The manifestation in adults is usually triggered by the consumption of shellfish. Atopic diseases affect 40-60% of patients with food protein- induced enterocolitis syndrome, including 40-50% of those with food protein-induced enteropathy and proctocolitis. Probiotics (Lactobacillus GG) can alleviate the symptoms of allergic proctocolitis induced by food proteins, by altering the composition of the intestinal microbiota. Fecal microbiota transplantation (FMT) can change intestinal microecology efficiently compared to food or probiotics.

La alergia alimentaria es una respuesta inmunitaria a las proteínas de los alimentos. Suele afectar al 8% de los niños y al 2% de los adultos en países occidentales. La alergia alimentaria no mediada por IgE afecta, principalmente, el aparato gastrointestinal. Las alergias alimentarias gastrointestinales se clasifican, por su patogenia subyacente, en: mediadas por IgE, no mediadas por IgE, o mixtas. Los síntomas de pacientes con proctocolitis alérgica inducida por proteínas alimentarias se originan por la inflamación local del colon distal, que causa hematoquecia en neonatos. Puede afectar todo el conducto gastrointestinal y provocar síntomas de emesis intratable, con subsiguientes trastornos metabólicos y choque hipovolémico. El síndrome de enterocolitis inducida por proteínas alimentarias es una alergia no mediada por IgE que suele aparecer en la infancia, con vómito prolongado repetitivo, que inicia entre 1 a 4 horas después de la ingestión de alimentos. La manifestación en adultos suele desencadenarse por el consumo de mariscos. Las enfermedades atópicas afectan del 40-60% de los pacientes con síndrome de enterocolitis inducida por proteínas alimentarias, incluso al 40-50% de quienes padecen enteropatía y proctocolitis inducidas por proteínas alimentarias. Los probióticos (Lactobacillus GG) pueden aliviar los síntomas de proctocolitis alérgica inducida por proteínas alimentarias, al alterar la composición de la microbiota intestinal. El trasplante de microbiota fecal (TMF) puede cambiar la microecología intestinal de manera eficiente comparada con los alimentos o probióticos.

Non-IgE-Mediated Gastrointestinal Food Allergies in Children: An Update.

Non-immunoglobulin E-mediated gastrointestinal food allergic disorders (non-IgE-GI-FA) include food protein-induced enterocolitis syndrome (FPIES), food protein-induced enteropathy (FPE) and food protein-induced allergic proctocolitis (FPIAP), which present with symptoms of variable severity, affecting the gastrointestinal tract in response to specific dietary antigens. The diagnosis of non-IgE-GI-FA is made clinically, and relies on a constellation of typical symptoms that improve upon removal of the culprit food. When possible, food reintroduction should be attempted, with the documentation of symptoms relapse to establish a conclusive diagnosis. Management includes dietary avoidance, nutritional counselling, and supportive measures in the case of accidental exposure. The prognosis is generally favorable, with the majority of cases resolved before school age. Serial follow-up to establish whether the acquisition of tolerance has occurred is therefore essential in order to avoid unnecessary food restriction and potential consequent nutritional deficiencies. The purpose of this review is to delineate the distinctive clinical features of non-IgE-mediated food allergies presenting with gastrointestinal symptomatology, to summarize our current understanding of the pathogenesis driving these diseases, to discuss recent findings, and to address currents gaps in the knowledge, to guide future management opportunities.

ALLERGIC PROCTOCOLITIS IN INFANTS: analysis of the evolution of the nutritional status / Proctocolite alérgica em lactentes: análise da evolução do estado nutricional

ABSTRACT Background Allergic proctocolitis is a disease that affects infants in the first months. The change in feed is the primary factor for clinical improvement and maintenance of the nutritional status of the infant. Objective Study the anthropometric evolution of infants with allergic proctocolitis at diagnosis and 1 to 6 months after nutritional intervention. Methods A retrospective cohort of infants with allergic proctocolitis diagnosis followed at the Pediatric Gastroenterology Institute of São Paulo (IGASTROPED), Brazil. The database with clinical, therapeutic and anthropometric data was obtained from medical records of outpatient infants. The therapeutic intervention was characterized by 1) exclusive breastfeeding with maternal exclusion diet of the six allergens (EBF-MED) or 2) no breastfeeding and use of hypoallergenic formulas. Results Of the 44 infants diagnosed with allergic proctocolitis, 23 were female. The median age of the infants was 3.5 months at the time of admission and 6 months after the intervention. The main clinical complaint was hematochezia with or without other symptoms of allergic proctocolitis. No difference was shown in the infants anthropometric evaluation between the two diets. Conclusion The duration of the allergic proctocolitis did not induce worsening of the infants nutritional status. Importantly, both nutritional interventions were able to keep the infants within the growth channel and resulted in the total clinical symptoms remission. Considering the fundamental mother-child link promoted by breastfeeding, the present data highlights the beneficial role of EBF-MED on the nutritional status of infants diagnosed with allergic proctocolitis in addition to the lower cost that breastfeeding brings compared the use of hypoallergenic formulas.

RESUMO Contexto Proctocolite alérgica é uma enfermidade que afeta lactentes nos primeiros meses. A modificação na alimentação é o fator primordial para melhora do quadro e manutenção do estado nutricional do lactente. Objetivo Avaliar a evolução antropométrica de lactentes com proctocolite alérgica no momento do diagnóstico e 1 a 6 meses após a intervenção nutricional. Métodos Coorte retrospectiva de lactentes com diagnóstico de proctocolite alérgica acompanhados no Instituto de Gastroenterologia Pediátrica de São Paulo (IGASTROPED), Brasil. Os dados foram obtidos a partir dos prontuários de lactentes atendidos ambulatorialmente, coletando-se informações acerca do diagnóstico clínico, conduta terapêutica e dados antropométricos. A intervenção terapêutica foi caracterizada 1) aleitamento materno exclusivo com dieta de exclusão materna de seis alérgenos (AME-DEM) 2) fórmulas hipoalergênicas. Resultados Dos 44 lactentes diagnosticados com proctocolite alérgica, 23 eram do sexo feminino. A mediana de idade dos lactentes foi de 3,5 meses no momento da admissão e de 6 meses após a intervenção. A queixa clínica principal foi hematoquezia associada ou não a outros sintomas da proctocolite alérgica. Não houve diferença estatística na avaliação antropométrica dos lactentes em ambas as dietas. Conclusão A vigência da proctocolite alérgica não provocou agravo do estado nutricional dos lactentes e apesar de diferentes intervenções nutricionais, os lactentes se mantiveram dentro do canal de crescimento e ocasionou o desaparecimento total dos sintomas clínicos. A despeito destes resultados, destaca-se o papel benéfico do AME-DEM no processo de manutenção do estado nutricional do lactente e do vínculo mãe e filho, além do menor custo que o aleitamento materno traz comparado a utilização de fórmulas hipoalergênicas.

ALLERGIC PROCTOCOLITIS IN INFANTS: analysis of the evolution of the nutritional status.

BACKGROUND: Allergic proctocolitis is a disease that affects infants in the first months. The change in feed is the primary factor for clinical improvement and maintenance of the nutritional status of the infant. OBJECTIVE: Study the anthropometric evolution of infants with allergic proctocolitis at diagnosis and 1 to 6 months after nutritional intervention. METHODS: A retrospective cohort of infants with allergic proctocolitis diagnosis followed at the Pediatric Gastroenterology Institute of São Paulo (IGASTROPED), Brazil. The database with clinical, therapeutic and anthropometric data was obtained from medical records of outpatient infants. The therapeutic intervention was characterized by 1) exclusive breastfeeding with maternal exclusion diet of the six allergens (EBF-MED) or 2) no breastfeeding and use of hypoallergenic formulas. RESULTS: Of the 44 infants diagnosed with allergic proctocolitis, 23 were female. The median age of the infants was 3.5 months at the time of admission and 6 months after the intervention. The main clinical complaint was hematochezia with or without other symptoms of allergic proctocolitis. No difference was shown in the infants anthropometric evaluation between the two diets. CONCLUSION: The duration of the allergic proctocolitis did not induce worsening of the infants nutritional status. Importantly, both nutritional interventions were able to keep the infants within the growth channel and resulted in the total clinical symptoms remission. Considering the fundamental mother-child link promoted by breastfeeding, the present data highlights the beneficial role of EBF-MED on the nutritional status of infants diagnosed with allergic proctocolitis in addition to the lower cost that breastfeeding brings compared the use of hypoallergenic formulas.

Presumed Allergic Proctocolitis Resolves with Probiotic Monotherapy: A Report of 4 Cases.

BACKGROUND The prevalence of allergic diseases has been dramatically rising in the United States and other developed nations over recent decades. Growing evidence suggests a partial role for the microbiome in the development of these allergic diseases. Food protein-induced allergic proctocolitis (AP) (also referred to as cow's milk protein intolerance or allergy) is among the earliest and most common food allergic diseases of infancy, yet its pathophysiology is not well understood. The currently accepted clinical practice is to restrict the diet until 12 months of age. CASE REPORT We present 4 cases of clinically diagnosed AP whose symptoms quickly and completely resolved with probiotic Lactobacillus rhamnosus GG (LGG) monotherapy. All 4 infants avoided any dietary restrictions. The range of time from probiotic initiation to symptom resolution was 7-28 days. CONCLUSIONS These cases suggest an important role for the infant intestinal microbiome in the development of gastrointestinal mucosal food allergies such as AP. Prospective investigation of the intestinal microbiome in infants with AP may further our understanding of this disease's pathogenesis. The potential use of probiotic monotherapy in the treatment of AP also warrants further investigation.

Transient hypertransaminasemia related to cow's milk protein antigen induced proctocolitis in infants

No disponible

Improvement of Refractory Ulcerative Proctitis With Sacral Nerve Stimulation.

BACKGROUND AND AIMS: Sacral nerve stimulation (SNS) is recognized for its efficiency and safety for anal incontinence, preventing high morbidity. Evidence from the literature suggests extending SNS to diseases associated with problems of intestinal barrier permeability. The aim of this study was to highlight clinical evidence of the beneficial impact of SNS in a refractory proctitis case report. MATERIALS AND METHODS: A permanent SNS was performed successfully in a patient with proctitis after implantation of the neuromodulator. Despite immunosuppressive drugs, the patient was experiencing mucus and blood discharge, pain, and fecal incontinence. To relieve fecal incontinence, SNS was tested without modification of medications. Disease activity, endoscopic and histologic score, ex vivo barrier permeability, expression of inflammatory cytokines (transforming growth factor-ß, tumor necrosis factor α, Interleukin-6, Interleukin-8), and junctional proteins (ZO-1, claudin-1, occludin) were assessed before and after SNS to observe the impact of SNS other than for incontinence. RESULTS: After a 3-week period of temporary stimulation, the patient experienced significant improvement with a decrease in fecal incontinence and disease activity scores. Both endoscopic and histologic scores showed improvement. The rectal barrier permeability decreased with SNS, whereas junctional protein mRNA expression transiently increased. Clinical and histologic improvement was sustained over time. After 18 months of permanent stimulation, the patient remained improved by SNS. CONCLUSION: This work demonstrates the relevance to explore further indications of SNS beyond fecal incontinence.

Food protein-induced enterocolitis syndrome and allergic proctocolitis.

Non-IgE-mediated food allergic disorders account for up to 40% of milk protein allergy in infants and young children. We aim to review the recent literature and to provide an update on diagnosis and management of food protein-induced enterocolitis syndrome (FPIES) and food protein-induced allergic proctocolitis (FPIAP). The peer-reviewed articles indexed in PubMed have been reviewed. FPIES manifests in infants as profuse, repetitive vomiting and lethargy, often with diarrhea, leading to acute dehydration, or weight loss and failure to thrive, in chronic form. FPIES is caused most commonly by cow's milk (CM) and soy proteins; rice, oat, and other solid foods may also trigger FPIES. FPIES rarely occurs in the exclusively breastfed infants. FPIES is underrecognized; children are often mismanaged as having acute viral gastrointestinal illness, sepsis, or surgical disease, delaying diagnosis of FPIES for many months. Approximately 25% of children with FPIES develop food-specific IgE antibodies and some transition to immediate food allergy; IgE positivity is associated with a more protracted course. FPIES is a self-limiting condition, with most cases resolving by age three to five years. Ondansetron may be helpful in managing acute FPIES. FPIAP is a benign condition of bloody stools in a well-appearing infant, with usual onset between one and four weeks of age. Up to 60% of cases occur in exclusively breastfed infants and resolve with maternal elimination of CM and soy proteins. The majority of cases resolve by age 12 months. FPIES may transition to IgE-mediated food allergy in some patients; IgE positivity to the FPIES food is a marker of a more persistent disease. FPIAP is benign and resolves by age 12 months in most patients.

Effect of zinc supplementation on superoxide dismutase activity in patients with ulcerative rectocolitis / Efecto de la suplementación de zinc sobre la actividad de la enzima superóxido dismutasa (SOD) en pacientes con colitis ulcerosa

Introduction: Ulcerative rectocolitis is characterized by diffuse mucosal inflammation and oxidative stress. Thus, the organism activates the antioxidant defence system in an attempt to reduce the excessive production of reactive oxygen species or neutralize them. Objective: This study evaluated the effect of zinc supplementation on the activity of the enzyme superoxide dismutase (SOD) in patients with ulcerative rectocolitis. Methods: The study included 24 patients, aged between 20 and 59 years and diagnosed with ulcerative rectocolitis, in the remission stage of the disease, who were divided into two groups: experimental - deficient in zinc (n=12) and control - normal or high zinc (n=12). Only the first group underwent supplement intervention, in the form of zinc gluconate (30 mg Zn/day), taken daily in the morning, fasted for 60 days. Plasma and erythrocyte zinc concentrations were determined by flame atomic absorption spectrophotometer. The erythrocyte SOD activity was determined in vitro according to the methodology recommended by the manufacturer Randox. Results and Discussion: Zinc supplementation caused a significant increase in the plasma concentrations of the mineral, and showed a significant reduction in erythrocyte zinc, remaining within normal limits. The SOD activity was high in patients of both the experimental and control groups, with no difference after supplementation. Conclusion: This study demonstrates that zinc supplementation improves the homeostatic condition of the mineral, with no change in SOD activity, as a marker of oxidative stress in patients with ulcerative rectocolitis (AU)

Introducción: La colitis ulcerosa se caracteriza por la inflamación difusa de la mucosa y el estrés oxidativo. De esta forma, el cuerpo activa el sistema de defensa antioxidante en un intento de reducir la producción excesiva de especies reactivas de oxígeno, así como poder neutralizarlos. Objetivo: Este estudio evaluó el efecto de la suplementación de zinc sobre la actividad de la enzima superóxido dismutasa en pacientes con colitis ulcerosa. Métodos: El estudio incluyó 24 pacientes, con edades comprendidas entre 20 y 59 años y con diagnóstico de colitis ulcerosa en fase de remisión de la enfermedad. Los pacientes fueron divididos en dos grupos: experimental - deficiencia de zinc (n = 12) y control - normales o con altos contenido de zinc (n = 12). El grupo experimental se sometió a tratamiento con suplemento de drogas, en forma de gluconato de zinc (30 mg Zn / día), administrada diariamente por la mañana en ayunas durante 60 días. Las concentraciones en plasma y los eritrocitos de zinc se determinaron por espectrofotometría de absorción atómica de llama. La actividad de la superóxido dismutasa (SOD) se determinó por el método de eritrocitos in vitro utilizando el kit de Randox. Resultados y Discusión: La suplementación de zinc causó un aumento significativo en las concentraciones plasmáticas de mineral y mostró una reducción significativa en los eritrocitos, permaneciendo dentro de los límites normales. La actividad de SOD fue mayor en los pacientes de los grupos experimentales y de control, sin diferencias después de la suplementación. Conclusión: El estudio evidenció que la administración de suplementos de zinc mejora la condición homeostática del mineral, sin ningún cambio en la actividad de SOD, como un marcador de estrés oxidativo en pacientes con colitis ulcerosa (AU)

[Clinical characteristics of infants with allergic proctocolitis: a retrospective study of 96 cases].

OBJECTIVE: To study the clinical characteristics of hospitalized infants with allergic proctocolitis, and to provide a scientific basis for early diagnosis and effective treatment of allergic proctocolitis. METHODS: The clinical data of 96 infants with allergic proctocolitis between September 2011 and March 2013 were reviewed retrospectively. Descriptive analysis was performed to assess the clinical characteristics of allergic proctocolitis. RESULTS: The most common clinical manifestation was diarrhea in the 96 infants. The electronic colonoscopy results indicated that 40% of the infants had multiple small nodules, 26% showed focal erythema and brittle mucous membranes, 25% showed multiple superficial erosion, and 9% showed ulcers with surface exudates. The affected areas included the sigmoid colon (87%), rectum (24%), descending colon (13%), and transverse colon ascending colon and ileocecal junction (8%). Histopathologic examination showed eosinophilic infiltration of mucosal layers, the condition of which was mild to moderate in 89% and severe and extremely severe in 12% of the infants. To treat the allergic proctocolitis, mothers and infants were suggested to avoid allergenic foods; 43% of them continued breastfeeding, 45% switched to highly hydrolyzed protein formula, and 13% were prescribed amino acid-based elemental formula. All infants were in complete remission at discharge. CONCLUSIONS: As the clinical manifestations of allergic proctocolitis in infants lack specificity, the electronic colonoscopy and mucosal histopathologic examination are helpful for early and differential diagnosis. The best treatment is to avoid allergenic foods. Formula-feeding infants should be prescribed highly hydrolyzed protein formula or amino acid-based elemental formula.

[Highlights in gastroenterology and hepatology 2013]. / Actualités en gastroentérologie et hépatologie.

This review highlights recent advances in gastroenterology and hepatology, including new insights into the diagnosis, pathogenesis and the treatment of ulcerative colitis, of achalasia, of irritable bowel syndrome, of chronic hepatitis B and of eosinophilic esophagitis. These new developments will be summarized and discussed critically, with a particular emphasis on their potential implications for current and future clinical practice. The recent advances on treatment of chronic hepatitis C will be published in another summary this year.

[New therapeutic goals in inflammatory bowel diseases]. / Nouveaux objectifs thérapeutiques dans les maladies inflammatoires chroniques de l'intestin.

Crohn's disease and ulcerative colitis are chronic, progressive, destructive and disabling conditions. So far therapeutic strategies based only on the relief of symptoms did not change the natural history of inflammatory bowel diseases (BD). In Crohn's disease the concept of deep remission, which includes clinical and inflammatory (endoscopic and biologic) remission, is emerging. In ulcerative colitis, evidence accumulates to recommend achieving and maintaining mucosal healing as assessed by proctosigmoidoscopy. Whether histologic remission is the ultimate therapeutic goal in ulcerative colitis will require further investigation. These new therapeutic targets may be the best way to change disease course (hospitalizations, surgery) and to prevent disability in IBD.

[Management of intestinal complications in inflammatory bowel diseases]. / Traitement des complications digestives des maladies inflammatoires chroniques de l'intestin.

The evolution of inflammatory bowel disease (IBD) is characterized by the occurrence of gastrointestinal complications. For Crohn's disease (CD), it is mainly strictures, fistulas and abdominal or pelvic abscess in luminal forms and perianal lesions (ulcers, fissures, fistula/abscess) in the perineal forms. For ulcerative colitis (UC), main complications are severe flare up and dysplasia/cancer. In Crohn's disease, stenosis can be treated medically in first line (steroid-immunosupppresseurs or antiTNF) especially when the inflammatory component is predominant or in extensive lesions. In case of limited lesions (< 4 cm) and low inflammatory component, endoscopic dilatation can be propose before surgery, especially in patients previously operated on. Abdomino-pelvic abscess should be drained if the size is greater than 4-5 cm and treated with antibiotics. If obstructive signs are present after the resolution of the abscess, surgery is usually required. In some cases, an antiTNF therapy can be discussed (ongoing trial with the GETAID). Surgery during the MC should be performed laparoscopically, particularly in uncomplicated forms (first ileocecal resection) but also whenever possible for complicated diseases. Anoperineal abscess must be drained by non-tight setons. Medical treatment also involves antibiotics and antiTNF, usually in combotherapy. Biological glue is especially interesting in simple fistulas. Collagen plugs have not demonstrated efficacy in simple or complex perianal Crohn's disease fistulas and may have a deleterious effect. They are therefore not recommended. Severe UC flare up are still conventionally treated with corticosteroids IV for 3-5 days, followed in case of failure of a 2nd line treatment with infliximab or ciclosporin. The place of emergency colectomy had regressed due to the effectiveness of medical treatments.

Effect of zinc supplementation on superoxide dismutase activity in patients with ulcerative rectocolitis.

INTRODUCTION: Ulcerative rectocolitis is characterized by diffuse mucosal inflammation and oxidative stress. Thus, the organism activates the antioxidant defence system in an attempt to reduce the excessive production of reactive oxygen species or neutralize them. OBJECTIVE: This study evaluated the effect of zinc supplementation on the activity of the enzyme superoxide dismutase (SOD) in patients with ulcerative rectocolitis. METHODS: The study included 24 patients, aged between 20 and 59 years and diagnosed with ulcerative rectocolitis, in the remission stage of the disease, who were divided into two groups: experimental - deficient in zinc (n=12) and control - normal or high zinc (n=12). Only the first group underwent supplement intervention, in the form of zinc gluconate (30 mg Zn/day), taken daily in the morning, fasted for 60 days. Plasma and erythrocyte zinc concentrations were determined by flame atomic absorption spectrophotometer. The erythrocyte SOD activity was determined in vitro according to the methodology recommended by the manufacturer Randox. RESULTS AND DISCUSSION: Zinc supplementation caused a significant increase in the plasma concentrations of the mineral, and showed a significant reduction in erythrocyte zinc, remaining within normal limits. The SOD activity was high in patients of both the experimental and control groups, with no difference after supplementation. CONCLUSION: This study demonstrates that zinc supplementation improves the homeostatic condition of the mineral, with no change in SOD activity, as a marker of oxidative stress in patients with ulcerative rectocolitis.

Introducción: La colitis ulcerosa se caracteriza por la inflamación difusa de la mucosa y el estrés oxidativo. De esta forma, el cuerpo activa el sistema de defensa antioxidante en un intento de reducir la producción excesiva de especies reactivas de oxígeno, así como poder neutralizarlos. Objetivo: Este estudio evaluó el efecto de la suplementación de zinc sobre la actividad de la enzima superóxido dismutasa en pacientes con colitis ulcerosa. Métodos: El estudio incluyó 24 pacientes, con edades comprendidas entre 20 y 59 años y con diagnóstico de colitis ulcerosa en fase de remisión de la enfermedad. Los pacientes fueron divididos en dos grupos: experimental - deficiencia de zinc (n = 12) y control - normales o con altos contenido de zinc (n = 12). El grupo experimental se sometió a tratamiento con suplemento de drogas, en forma de gluconato de zinc (30 mg Zn / día), administrada diariamente por la mañana en ayunas durante 60 días. Las concentraciones en plasma y los eritrocitos de zinc se determinaron por espectrofotometría de absorción atómica de llama. La actividad de la superóxido dismutasa (SOD) se determinó por el método de eritrocitos in vitro utilizando el kit de Randox. Resultados y Discusión: La suplementación de zinc causó un aumento significativo en las concentraciones plasmáticas de mineral y mostró una reducción significativa en los eritrocitos, permaneciendo dentro de los límites normales. La actividad de SOD fue mayor en los pacientes de los grupos experimentales y de control, sin diferencias después de la suplementación. Conclusión: El estudio evidenció que la administración de suplementos de zinc mejora la condición homeostática del mineral, sin ningún cambio en la actividad de SOD, como un marcador de estrés oxidativo en pacientes con colitis ulcerosa.

Mesalazina grânulos (2 gramas sachê ) para o tratamento de retocolite ulcerativa / Mesalazine granules (2 grams sachet) for the treatment of ulcerative colitis

A Colite ulcerativa e a Doença de Crohn são as duas formas principais de doenças inflamatórias intestinais. Apesar de algumas características em comum, elas podem ser diferenciadas por predisposições genéticas, fatores de risco e diferentes aspectos clínicos, endoscópicos e histológicos. A etiologia ainda é desconhecida, no entanto, indivíduos suscetíveis parecem apresentar resposta imunológica alterada à flora comensal na mucosa, resultando em inflamação. Na retocolite ulcerativa a inflamação é restrita à superfície mucosa, inicia-se, geralmente, no reto e estende-se a todo o cólon. O diagnóstico da colite ulcerativa é baseado nos sintomas clínicos e confirmado por achados objetivos na endoscopia e histologia. O tratamento compreende aminossalicilatos orais e por via retal, corticoides e imunossupressores. É feito de maneira a tratar a fase aguda e após, manter a remissão, sendo o maior objetivo reduzir a sintomatologia. A Tecnologia: Tipo: Medicamento; Princípio Ativo: Mesalazina; Nome comercial: Pentasa® Sachê 2g; Fabricante: Laboratório Ferring Ltda. Mesalazina 2 gramas na formulação de grânulos de liberação prolongada, na forma farmacêutica de sachê, em dose única diária para o tratamento da colite ulcerativa é uma nova apresentação do medicamento. Atualmente, o Ministério da Saúde fornece o medicamento (mesalazina em grânulos) na apresentação de 0,5g em comprimidos aos pacientes diagnosticados com Retocolite Ulcerativa na rede pública de saúde. A proponente indica que nova apresentação proporcionaria maior aderência dos pacientes resultando em maior efetividade do tratamento. Análise da evidência apresentada pelo demandante: Demandante: Ferring International Center SA. Somente serão avaliados os estudos que se enquadram nos critérios e stabelecidos na solicitação por incorporação da tecnologia (tecnologia, indicação, comparadores), submetida pelo demandante. Considerações finais: A evidência atualmente disponível sobre eficácia e segurança do mesalazina sachê 2g para tratamento da colite ulcerativa é baseada fundamentalmente no estudo de Dignass 30 (ensaio clínico multicêntrico, randomizado, de não inferioridade). O estudo comparou mesalazina em grânulos, sachê 2g dose única diária à mesma dose diária dividida em duas tomadas. Foram Incluídos 362 pacientes com colite ulcerativa em remissão. O desfecho primário foi taxa de remissão em 1 ano baseado no disease activity index score. Dentre os desfechos secundários, foi avaliada a aderência à medicação entre os grupos, medida pelo número de sachês distribuídos e retornados, questionário auto-administrado, e escala visual analógica. Recomendação da CONITEC: Considerando a falta de evidências científicas mais robustas, o fato de o estudo apresentado ser de não inferioridade com limitações, que há no SUS tratamento disponível com outra forma farmacêutica do mesmo medicamento para a indicação em questão e a magnitude limitada dos benefícios, após discussão, os membros da CONITEC, presentes na 13ª Reunião do plenário, realizada no dia 07/03/2013, deliberaram por não recomendar a incorporação do medicamento mesalazina grânulos (2 gramas sachê) para o tratamento da colite ulcerativa. Deliberação final: Após análise das contribuições da consulta pública e considerando a preocupação do plenário da CONITEC sobre o impacto orçamentário decorrente da possível migração de pacientes que consomem outras apresentações disponíveis no SUS (de 400mg e 800mg de liberação convencional, as quais se apresentam como medicamento genérico), e o fato de que poderá haver desperdício no sachê, os membros do plenário da CONITEC decidiram buscar mais informações de impacto orçamentário do medicamento, considerando doses e migração entre as formas farmacêuticas. Com isso, foram apresentadas informações compiladas pelo Departamento de Assistência Farmacêutica e Insumos Estratégicos (DAF) acerca do impacto orçamentário do uso de mesalazina por via oral (comprimidos) nos pacientes com Retocolite Ulcerativa no Componente Especializado da Assistência Farmacêutica (CEAF), em 2012. Conforme a análise, foram atendidos 26.824 pacientes. Os membros da CONITEC presentes na reunião do plenário do dia 03/07/2013 deliberaram, por unanimidade, por não recomendar a incorporação da mesalazina sachê 2g para o tratamento da retocolite ulcerativa. Portaria nº 43, de 23 de agosto de 2013 - Decisão de não incorporar o medicamento mesalazina sachê 2g para o tratamento da retocolite ulcerativa no Sistema Único de Saúde (SUS).