BACKGROUND AND AIMS: Evidence on the safety of newer biologics during pregnancy is limited. We aimed to assess the safety of ustekinumab and vedolizumab treatment during gestation on pregnancy and infant outcome. Furthermore, we evaluated the placental transfer of these agents. METHODS: We performed a prospective, multicentre, observational study in consecutive women with inflammatory bowel disease exposed to ustekinumab or vedolizumab 2 months prior to conception or during pregnancy. Pregnancy, neonatal, and infant outcomes were evaluated and compared with the anti-tumour necrosis factor [TNF]-exposed control group. Drug levels were assessed in maternal and cord blood at delivery. RESULTS: We included 54 and 39 pregnancies exposed to ustekinumab and vedolizumab, respectively. In the ustekinumab group, 43 [79.9%] resulted in live births, and 11 [20.4%] led to spontaneous abortion. Thirty-five [89.7%] pregnancies on vedolizumab ended in a live birth, two [5.1%] in spontaneous, and two [5.1%] in therapeutic abortion. No significant difference in pregnancy outcome between either the vedolizumab or the ustekinumab group and controls was observed [p >0.05]. Similarly, there was no negative safety signal in the postnatal outcome of exposed children regarding growth, psychomotor development, and risk of allergy/atopy or infectious complications. The median infant-to-maternal ratio of ustekinumab levels was 1.67 and it was 0.59 in vedolizumab. CONCLUSIONS: Use of ustekinumab and vedolizumab in pregnancy seems to be safe, with favuorable pregnancy and postnatal infant outcomes. Placental transfer differed between these two drugs, with ustekinumab having similar and vedolizumab having inverse infant-to-maternal ratio of drug levels compared with anti-TNF preparations.
- MeSH
- Gastrointestinal Agents adverse effects therapeutic use MeSH
- Antibodies, Monoclonal, Humanized * adverse effects therapeutic use MeSH
- Inflammatory Bowel Diseases * drug therapy MeSH
- Tumor Necrosis Factor Inhibitors adverse effects therapeutic use MeSH
- Infant MeSH
- Humans MeSH
- Maternal Exposure MeSH
- Infant, Newborn MeSH
- Placenta MeSH
- Prospective Studies MeSH
- Pregnancy MeSH
- Ustekinumab * adverse effects therapeutic use MeSH
- Pregnancy Outcome MeSH
- Treatment Outcome MeSH
- Check Tag
- Infant MeSH
- Humans MeSH
- Infant, Newborn MeSH
- Pregnancy MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Multicenter Study MeSH
- Observational Study MeSH
Uvedená doporučení pro diagnostiku a léčbu anémie u IBD pacientů byla vytvořena Pracovní skupinou pro idiopatické střevní záněty ČGS ČLS JEP na výjezdním zasedání v Šiškově mlýně u Telče ve dnech 7.-8. 6. 2012. Jsou založena zejména na recentních publikacích evropských i amerických autorů, které byly široce diskutovány s ohledem na lokální dostupnost citovaných diagnostických a terapeutických doporučení. Definitivní doporučený postup je pak konsenzem celé pracovní skupiny. Představuje preferovaný přístup k řešení níže probíraných klinických situací uanemických pacientů s IBD, jehož nedílnou součástí je i doporučení, jak tyto pacienty sledovat. Předkládaný materiál je základem pro efektivní péči o anemické nemocné s IBD.
The below-mentioned guidelines forthe diagnosis and therapy of anaemia in IBD patients were generated by the Czech IBD Working Group (Czech Society for Gastroenterology of the Czech Medical Association of Jan Evangelista Purkyně) during a consensus meeting at Šiškův Mlýn near Telč in June 7-8, 2012. The guidelines are based on data coming from recent publications presented in the US and EU, which were broadly discussed in view of the local availability of the mentioned diagnostic and therapeutic recommendations. The final recommended procedure follows the consensus of all members of the IBD Working Group. It presents the current preferred approach to resolving anaemia in IBD patients as well as a recommendation for following up these patients. We hope that this document is a basic platform forthe current diagnostic and therapeutic regimen for anaemia in IBD patients.
- Keywords
- terapie železem,
- MeSH
- Anemia diagnosis classification physiopathology therapy MeSH
- Crohn Disease MeSH
- Iron Deficiencies MeSH
- Diagnosis, Differential MeSH
- Anemia, Hypochromic therapy MeSH
- Inflammatory Bowel Diseases MeSH
- Infusions, Intravenous MeSH
- Clinical Trials as Topic MeSH
- Humans MeSH
- Colitis, Ulcerative MeSH
- Treatment Outcome MeSH
- Iron administration & dosage therapeutic use MeSH
- Check Tag
- Humans MeSH
- Male MeSH
- Female MeSH
- Publication type
- Practice Guideline MeSH
IBD-AHEAD je celosvětový projekt firmy Abbott, který byl vytvořen s cílem získat jednotné stanovisko k některým důležitým otázkám, jež se objevují u specialistů sledujících a léčících pacienty s Crohnovou chorobou. Mezinárodní konsorcium expertů určilo celkem deset otázek, na které členové české IBD pracovní skupiny vypracovali odpovědi na základě národních doporučení, literárních a osobních zkušeností s léčbou Crohnovy nemoci. V září 2010 proběhlo mezinárodní sympozium v Bruselu, na kterém byl získán konsensus na tyto klíčové otázky.
IBD-AHEAD is a global project supported by Abbott. The aim of the study was to achieve a cohesive attitude towards the most important questions which appear in the clinical practice of physicians who are involved in Crohn's disease therapy. The international consortium of experts selected a total often questions, for which the Czech IBD Working Group members have already prepared answers based on national recommendations and literature and personal experience in Crohn's disease treatment. Consensus with respect to these key questions was achieved in September 2010 at the international symposium in Brussels.
- Keywords
- biologická léčba,
- MeSH
- Biological Therapy methods utilization MeSH
- Crohn Disease drug therapy classification MeSH
- Glucocorticoids administration & dosage MeSH
- Immunosuppressive Agents administration & dosage MeSH
- Professional Staff Committees MeSH
- Medication Therapy Management MeSH
- Practice Guidelines as Topic MeSH
- Dose-Response Relationship, Drug MeSH
Dotazníky jsou jednoduchým psychometrickým nástrojem k hodnocení subjektivních obtíží pacientů s chronickým revmatickým onemocněním. S ohledem na pozdní diagnostiku idiopatických střevních zánětů (IBD) u pacientů se spondyloartritidou (SpA) byl vytvořen dotazník v podobě screeningových kritérií hodnotící střevní a mimostřevní obtíže v čase. Cílem této práce byl český překlad a jeho lingvistická validace, která pozůstávala z několika fází. V první fázi probíhal nezávislý překlad originální anglické verze do českého jazyka a procesem konsenzuální syntézy byly tyto verze autorskou skupinou analyzovány a diskutovány. Ve druhé fázi probíhal zpětný překlad sjednocené české verze dotazníku. Takto byla vytvořená pre-finální verze dotazníku, kterou vyplnilo celkem 68 pacientů trpících axiální formou SpA, z toho 39 pacientů s neradiografickou axiální SpA (nr-AxSpA) a 29 pacientů s ankylozující spondylitidou (AS). Samostatnou část tvořil dotazník zpětné vazby ke zhodnocení obsahové, lingvistické a stylistické stránky. Vznesené připomínky byly zahrnuty ve finální české verzi dotazníku. V této práci prezentujeme českou verzi Screeningového dotazníku IBD určeného pro pacienty se SpA. Oficiální překlad tak umožní jeho běžné použití jak v klinické, tak výzkumné oblasti.
Questionnaires are a simple psychometric tool to assess the subjective ailments of patients with chronic rheumatic diseases. Concerning the late diagnosis of inflammatory bowel disease (IBD) in patients with spondyloarthritis (SpA), a questionnaire was created in the form of screening criteria evaluating intestinal and extraintestinal problems over time. The aim of this work was the Czech translation and its linguistic validation, which consisted of several phases. In the first phase, an independent translation of the original English version into the Czech language was performed, and these versions were analyzed and discussed by the author group through a process of consensus synthesis. In the second phase, the back translation of the unified Czech version of the questionnaire was carried out. In this way, a pre-final version of the questionnaire was created, which was completed by a total of 68 patients suffering from axial SpA, of which 39 patients with non-radiographic axial SpA (nr-AxSpA) and 29 patients with ankylosing spondylitis (AS). A separate part consisted of a feedback questionnaire to evaluate the content, linguistic and stylistic aspects. The comments raised were included in the final Czech version of the questionnaire. In this work, we present the Czech version of the IBD Screening Questionnaire intended for patients with SpA. An official translation will thus enable its common use in both clinical and research fields.
- Keywords
- lingvistická validace,
- MeSH
- Axial Spondyloarthritis * complications MeSH
- Adult MeSH
- Inflammatory Bowel Diseases * diagnosis complications MeSH
- Quality of Life MeSH
- Middle Aged MeSH
- Humans MeSH
- Surveys and Questionnaires MeSH
- Reproducibility of Results MeSH
- Check Tag
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Female MeSH
- Publication type
- Research Support, Non-U.S. Gov't MeSH
- Keywords
- vedolizumab,
- MeSH
- Adalimumab therapeutic use MeSH
- Anti-Bacterial Agents therapeutic use MeSH
- Biosimilar Pharmaceuticals MeSH
- Diagnosis, Differential MeSH
- Child MeSH
- Genetic Predisposition to Disease MeSH
- Antibodies, Monoclonal, Humanized therapeutic use MeSH
- Inflammatory Bowel Diseases * diagnosis drug therapy MeSH
- Immunosuppressive Agents adverse effects therapeutic use MeSH
- Induction Chemotherapy MeSH
- Infliximab therapeutic use MeSH
- Infant MeSH
- Contraceptives, Oral, Hormonal adverse effects therapeutic use MeSH
- Drug Resistance MeSH
- Humans MeSH
- Adolescent MeSH
- Opportunistic Infections prevention & control MeSH
- Child, Preschool MeSH
- Cholangitis, Sclerosing diagnosis drug therapy complications MeSH
- Maintenance Chemotherapy MeSH
- Vaccination MeSH
- Venous Thrombosis complications prevention & control MeSH
- Check Tag
- Child MeSH
- Infant MeSH
- Humans MeSH
- Adolescent MeSH
- Child, Preschool MeSH
- Publication type
- Practice Guideline MeSH
- MeSH
- Crohn Disease * diet therapy MeSH
- Diet Therapy methods MeSH
- Child MeSH
- Enteral Nutrition methods MeSH
- Inflammatory Bowel Diseases diet therapy MeSH
- Humans MeSH
- Check Tag
- Child MeSH
- Humans MeSH
- Publication type
- Practice Guideline MeSH
Cílem práce bylo ověřit incidenci idiopatických střevních zánětů (IBD) v Plzeňském kraji (PLK) u dětí mladších 19 let a zjistit, zda existují geografické či demografické rozdíly v jejich výskytu v přesně definované geografické oblasti PLK. Metoda: Data nově diagnostikovaných pacientů Dětské kliniky FN Plzeň, splňujících diagnostická kritéria IBD, byla sbírána prospektivně. IBD byla diagnostikována podle obecných doporučení odborných společností. Výsledky: Soubor studie tvořilo 128 pacientů, 74 pacientů s Crohnovou chorobou (CD) a 52 dětí s ulcerózní kolitidou (UC), neklasifikovatelné zánětlivé střevní onemocnění (IBDU) bylo zjištěno jen u 2 pacientů. Ve skupině do 19 let byl věkový medián v době diagnózy IBD 14,1 let (rozpětí 1,4–18,3 roků). Ve skupině do 15 let byl věkový medián 11,7 let (rozpětí 1,4–15 roků). Incidence na 100 000 dětí/rok v PLK u dětí mladších 19 let byla 9,24 (IBD), 5,14 (CD) a 4,03 (UC), ve věkové skupině do 15 let byla 7,28 (IBD), 4,37 (CD) a 2,91 (UC). Závěr: Informace získané o 128 dětech a dospívajících v PLK s BD v období 2001–2011 vykazují nárůst incidence oproti údajům z let 1990–2001 a posunutí diagnózy do mladší věkové skupiny, což odpovídá celosvětovému trendu. Byl prokázán vyšší výskyt ve městech o velikosti 5–10 tisíc obyvatel (p <0,01), obce do 5 tisíc obyvatel mají nižší výskyt IBD oproti městům (p <0,01). Byl zjištěn vyšší výskyt CD u žen v okrese Tachov (p <0,01), CD u mužů v okrese Plzeň-sever (p <0,01) a UC u mužů v okrese Plzeň-město (p <0,05). Nejnižší výskyt IBD (p <0,01) a UC (p <0,05) je signifikantně v okrese Klatovy. Výsledky studie ukazují, že životní prostředí hraje roli v rozvoji IBD. Je nutné podrobně analyzovat konkrétní rizikové faktory zevního prostředí v okresech Tachov a Plzeň-sever a dále je prospektivně sledovat ve vztahu ke vzniku IBD.
The objective of the work was to verify the incidence of idiopathic bowel disease (IBD) inflammations in the Plzeň Region (PLK) in children up to 19 years old and to determine, whether there are any geographic or demographic differences in their incidence in a precisely defined area of PLK. Method: The data of newly diagnosed patients of the Children Clinic, Pilsen Faculty Hospital, fulfilling the IBD diagnostic criteria were collected prospectively. IBD was diagnosed according to recommendations of professional medical societies. Results: 128 patients were enrolled into the study, 74 of them with the Crohn’s disease and 52 children with ulcerous colitis (UC), and two patients were found to suffer from inflammatory bowel disease unclassified. The age median at the time of diagnosis in the group of up to 19 years of age proved to be 14.1 years (range 1.4–18.3). In the group of patients up to 15 years these data were 11 .7 (1.4–15). Incidence for 100,000 children up to 19 years of age/year in PLK was 9.24 (IBD), 5.14 (CD) and 4.03 (UC), the data for the group up to 15 years being 7.28 (IBD), 4.37 (CD) and 2.91 (UC). Conclusion: Information obtained about 128 children and adolescents suffering from BD in PLK in the period of 2001-2011 demonstrated increasing incidence compared with the period of 1900-2001 and a shift in establishment of diagnosis to the younger age group, which corresponds to the worldwide trends. A higher incidence was demonstrated in town with the population of 5 to 10,000 (p<0.01), communities with population up to 5 thousands had lower IDB incidence than the towns (p<0.01). A higher incidence of CD was found in women in the Tachov district (p<0.01), and in men of the Plzeň – North district (p<0.01), where the incidence of UC was higher (p<0.01). The significantly lower incidence of IBD (p<0.01) and UC (p<0.05) occurred in the Klatovy district. The results made it clear that life environment plays a role in the development of IBD. Specific risk factors of the environment in the development of IBD should be analyzed in the Tachov district and Plzeň – North district prospectively in relation to the development of IBD.
- MeSH
- Crohn Disease MeSH
- Child MeSH
- Inflammatory Bowel Diseases * MeSH
- Infant MeSH
- Adolescent MeSH
- Child, Preschool MeSH
- Prospective Studies MeSH
- Statistics as Topic MeSH
- Colitis, Ulcerative MeSH
- Environment MeSH
- Check Tag
- Child MeSH
- Infant MeSH
- Adolescent MeSH
- Male MeSH
- Child, Preschool MeSH
- Female MeSH
- Publication type
- Research Support, Non-U.S. Gov't MeSH
- Geographicals
- Czech Republic MeSH
Ulcerózní kolitida je primárně léčena konzervativně. Chirurgická léčba spočívá v odstranění tlustého střeva s uchováním střevní kontinuity nebo bez něj. Třetí část doporučených postupů chirurgické léčby pacientů s idiopatickými střevními záněty se zabývá indikacemi k akutní a elektivní operaci. Doporučení byla zpracována Pracovní skupinou pro IBD při České gastroenterologické společnosti a Sekcí IBD chirurgie při České chirurgické společnosti.
Ulcerative colitis is primarily treated conservatively. Surgical treatment consists of the removal of the large bowel with or without restoration of intestinal continuity. The third part of the recommendations for surgical treatment of patients with inflammatory bowel diseases addresses the indications for acute and elective surgery. The recommendations were elaborated by the Czech IBD Working Group of the Czech Society of Gastroenterology and the IBD Surgery Section of the Czech Surgical Society.
- MeSH
- Acute Disease MeSH
- Digestive System Surgical Procedures MeSH
- Risk Assessment MeSH
- Adrenal Cortex Hormones MeSH
- Colorectal Neoplasms MeSH
- Humans MeSH
- Sepsis MeSH
- Practice Guidelines as Topic MeSH
- Megacolon, Toxic MeSH
- Colitis, Ulcerative * surgery classification physiopathology therapy MeSH
- Check Tag
- Humans MeSH
Chirurgická léčba Crohnovy nemoci je součástí péče o nemocné, kteří jsou primárně léčeni gastroenterologem. Znalost principů chirurgické léčby a indikací k operacím přispívá ke kvalitě péče o tyto nemocné. Proto členové Pracovní skupiny pro IBD při České gastroenterologické společnosti a Sekce IBD chirurgie při České chirurgické společnosti vytvořili na základě dostupné literatury doporučení pro chirurgickou léčbu. Doporučené postupy chirurgické léčby Crohnovy nemoci navazují na 1. část: Předoperační příprava. Práce se zabývá akutními a elektivními indikacemi k operacím, postupy dle jednotlivých lokalizací Crohnovy nemoci, technickými chirurgickými aspekty specifickými pro Crohnovu nemoc a komplikacemi po operaci.
Surgical treatment of Crohn´s disease is a part of care of patients primary treated by gastroenterologist. Understanding of surgical principles and indications to surgery improves the quality of care. Therefore, members of IBD Working group of Czech Society of Gastroenterology and Section of IBD Surgery of Czech Surgical Society created guidelines based on recent literature. These guidelines follow previously published 1st part: Preoperative preparation. Content of this article covers emergent and elective indication to surgery, site specific surgical procedures in Crohn´s disease, description of proper techniques and postoperative complications treatment. Key words: guidelines – surgery – Crohn´s disease The authors declare they have no potential conflicts of interest concerning drugs, products, or services used in the study. The Editorial Board declares that the manuscript met the ICMJE „uniform requirements“ for biomedical papers. Submitted: 5. 6. 2015 Accepted: 15. 6. 2015
- MeSH
- Abscess etiology therapy MeSH
- Anastomosis, Surgical MeSH
- Surgical Procedures, Operative methods MeSH
- Crohn Disease * diagnosis pathology therapy MeSH
- Quality of Life MeSH
- Laparoscopy MeSH
- Humans MeSH
- Fistula therapy MeSH
- Postoperative Complications MeSH
- Precancerous Conditions MeSH
- Prospective Studies MeSH
- Recurrence MeSH
- Rectal Fistula therapy MeSH
- Retrospective Studies MeSH
- Intestinal Neoplasms MeSH
- Intestinal Obstruction therapy MeSH
- Intestine, Small surgery pathology MeSH
- Ostomy MeSH
- Check Tag
- Humans MeSH
- Publication type
- Practice Guideline MeSH
OBJECTIVES: A quality of life assessment is of great importance for patients with chronic diseases, because problems caused by specific diseases impact specific areas of their lives. The goal of this work was to determine, in which areas select diseases (rheumatoid arthritis, Crohn's disease, ischemic disease of the lower extremities and chronic obstructive pulmonary disease) affect patients' quality of life. METHODS: The Czech version of the WHOQOL-100 instrument and specific standardized questionnaires for individual diseases: EuroQol, EQ-5D-5L, IBDQ, PAQ were used to assess quality of life. This paper presents the results of the WHOQOL-100 questionnaire. In total, 5 research samples were put together. The first sample consisted of 200 respondents with rheumatoid arthritis (RA); the second sample included 100 respondents with inflammatory bowel disease (IBD); the third sample was comprised of 404 respondents with ischemic disease of the lower extremities (IDLE); the fourth sample consisted of 449 respondents with chronic obstructive pulmonary disease (COPD); and the fifth sample was represented by 1,456 healthy respondents. The acquired data were then statistically analyzed. A statistical data analysis was performed in two steps. In the first step descriptive statistical analyses were performed in the SASD program (absolute and relative frequencies of respondents' answers, median values and variability characteristics). In the second step differences in means of the subjectively-perceived quality of life in patients with individual diseases and in control group were tested using the Mann-Whitney U test and the non-parametric Wilcoxon pair test. These analyses were computed in the SPSS (Statistical Package for the Social Sciences) program. RESULTS: The results show that a statistically significant difference in average domain score values was found between the healthy population and patients diagnosed with RA in the domains of "physical health", "level of independence", "environment", and "spirituality/religion/personal beliefs". A statistically significant difference was found in all domains for patients with IDLE and COPD. A statistically significant difference was found in four domains for patients with IBD, namely those of "physical health", "level of independence", "social relationships" and "spirituality/religion/personal beliefs". CONCLUSION: All therapeutic and nursing interventions that can contribute to improving QoL in poorly performing domains should be utilized.
- MeSH
- Chronic Disease MeSH
- Pulmonary Disease, Chronic Obstructive physiopathology psychology MeSH
- Activities of Daily Living MeSH
- Crohn Disease physiopathology psychology MeSH
- Adult MeSH
- Quality of Life * MeSH
- Middle Aged MeSH
- Humans MeSH
- Young Adult MeSH
- Peripheral Arterial Disease physiopathology psychology MeSH
- Arthritis, Rheumatoid physiopathology psychology MeSH
- Health Surveys MeSH
- Check Tag
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Young Adult MeSH
- Male MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Research Support, Non-U.S. Gov't MeSH
- Geographicals
- Czech Republic MeSH