The paper presents the All-Russian consensus on the diagnosis and treatment of celiac disease in children and adults, which has been elaborated by leading experts, such as gastroenterologists and pediatricians of Russia on the basis of the existing Russian and international guidelines. The consensus approved at the 42nd Annual Scientific Session of the Central Research Institute of Gastroenterology on Principles of Evidence-Based Medicine into Clinical Practice (March 2-3, 2016). The consensus is intended for practitioners engaged in the management and treatment of patients with celiac disease. Evidence for the main provisions of the consensus was sought in electronic databases. In making recommendations, the main source was the publications included in the Cochrane Library, EMBASE, MEDLINE, and PubMed. The search depth was 10 years. Recommendations in the preliminary version were reviewed by independent experts. Voting was done by the Delphic polling system.
Background Tofacitinib is a selective immunosuppressant, the first representative of the Janus kinase family inhibitors, which has a high selectivity against other kinases of the human genome. According to the results of the study, tofacitinib inhibits JAK-1, JAK-2 and in high concentrations-JAK-3 and tyrosine kinase-2. The drug is registered in Russia for the treatment of patients with ulcerative colitis. According to the instructions for medical use, in patients with incomplete response to the induction course, it is possible to conduct an additional 8 weeks of therapy at an induction dose of 10 mg 2 times a day. The objective of the study was to identify the frequency and reasons for the need to prolong the induction course of tofacitinib in patients with ulcerative colitis. Methods 35 patients with ulcerative colitis (UC) who received tofacitinib were observed in the Department of inflammatory bowel diseases. Patients were divided into two groups. Group 1 (n = 10) of patients were bionaive. The second group of patients (n = 25) had previous experience of treatment with one or more anti-TNF-α drugs. The necessity of prolongation up to 16 weeks of induction course of tofacitinib was assessed in patients with an insufficient clinical response at week 8 of therapy (reduction of partial index of Mayo less than 30%) and lack of normalisation of laboratory parameters (CRP, haemoglobin, FCP). The comparative analysis was carried out by the method of four-field tables using nonparametric statistical criteria. Results In the follow-up period among group 1 UC patients (n = 10) who had not previously received anti-TNF-α drugs, the need for a prolonged induction course of tofacitinib was not required in any patient (0%). In the second group of patients (n = 25), previously treated with anti-TNF-α drugs, a prolonged induction course of tofacitinib was required in 9 (36%) patients (x2-4.484; p = 0.028). Conclusion The need for prolongation up to 16 weeks of the induction course of tofacitinib in patients with ulcerative colitis b is significantly higher in patients who have previously received one or more anti-TNF-α drugs.
О р и г и н а л ь н а я с т а т ь я Белоусова Елена Александровна -д-р мед. наук, профессор, руководитель отделения гастроэнтерологии и гепатологии, заведующая кафедрой гастроэнтерологии факультета усовершенствования врачей 1
РезюмеЦель исследования. Сравнить безопасность терапии у больных язвенным колитом (ЯК) и болезнью Крона (БК), получавших комплексную противовоспалительную терапию с применением мезенхимальных стромальных клеток (МСК) костного мозга, и стандартную терапию препаратами 5-аминосалициловой кислоты, глюкокортикостероидами и иммуносупрессорами. Материалы и методы. Неблагоприятные последствия проанализированы у 103 больных (56 с ЯК и 47 с БК) воспалительными заболеваниями кишечника (ВЗК), которым вводили МСК. Полученные результаты сравнили с данными, полученными у 208 пациентов с ЯК и БК, которые находились на стандартной противовоспалительной терапии. Все пациенты сопоставимы по демографическим параметрам, длительности заболевания, протяженности поражения кишечника, характеру течения, форме заболевания, степени тяжести. В анализируемые группы не включали больных, которые получали терапию анти-α-ФНО-препаратами. Безопасность терапии оценивали по наличию осложнений, возникших за время наблюдения. Результаты. Проведя анализ неблагоприятных последствий у 103 больных ВЗК, которым вводили МСК, и сравнив их с результатами лечения 208 больных ЯК и БК, получавших стандартную противовоспалительную терапию, мы не выявили различий в развитии острых посттрансфузионных реакций, инфекционных осложнений, обострений хронических воспалительных заболеваний, тяжелых инфекционных осложнений, злокачественной трансформации и смертельных случаев у больных ЯК и БК, за исключением транзиторной лихорадки. Заключение. Результаты нашего исследования демонстрируют, что инновационный метод клеточной терапии является безопасным для клинического применения.Ключевые слова: безопасность клеточной терапии, мезенхимальные стромальные клетки, болезнь Крона, язвенный колит, воспалительные заболевания кишечника. Aim.To compare the safety of therapy in patients with ulcerative colitis (UC) and Crohn's disease (CD) who have received combination anti-inflammatory therapy using bone marrow mesenchymal stromal cells (MSC) and standard therapy with 5-aminosalicylic acid, glucocorticosteroids, and immunosuppressive agents. Subjects and methods. Unfavorable consequences were analyzed in 103 patients (56 with UC and 47 with CD) with inflammatory bowel disease (IBD) after MSC administration. The findings were compared with data obtained in 208 patients with UC and CD on standard anti-inflammatory therapy. All the patients were similar in demographic parameters, the duration of disease, the extent of intestinal injury, the nature of a course, the type and degree of disease. The analyzed groups did not include patients who had received therapy with anti-TNF-α drugs. The safety of therapy was evaluated from the presence of complications occurring during the follow-up. Results. By analyzing the unfavorable consequences in 103 patients with IBD and comparing them with treatment results in 208 patients with UC and CD on standard anti-inflammatory therapy, the authors revealed no differences in the development of acute posttransfusion reactions, infectious complications, exa...
We analyzed medium-term efficiency and safety of biological therapy of Crohn's disease, in particular transplantation of allogenic mesenchymal stromal bone marrow cells and anticytokine therapy with selective immunosuppressive agents. It was found that both methods of biological therapy of refractory Crohn's disease resulted in clinical and in some cases endoscopic remission. In most cases, clinical remission was maintained without steroid hormone therapy. Thus, both methods produce comparable clinical results. It was concluded that transplantation of mesenchymal stromal bone marrow cells could be considered as a promising method in the therapy of refractory Crohn's disease comparable by its efficiency with infliximab therapy.
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