BACKGROUND Nonalcoholic fatty liver disease(NAFLD)is common in the German population,with an even higher prevalence in inflammatory bowel disease patients.AIM To investigate the risk factors for NAFLD in inflammatory ...BACKGROUND Nonalcoholic fatty liver disease(NAFLD)is common in the German population,with an even higher prevalence in inflammatory bowel disease patients.AIM To investigate the risk factors for NAFLD in inflammatory bowel disease patients.METHODS This monocentric retrospective study with a cross-sectional and a longitudinal part included 694 patients.Inclusion criteria were diagnosed inflammatory bowel disease,age≥18 years,availability of at least one abdominal ultrasound.Patients with infectious or suspected alcoholic fatty liver disease were excluded.NAFLD was defined by increased echogenicity at liver ultrasound.Demographic characteristics,disease activity and medications were analyzed as potential risk factors.Parameters influencing the course of NAFLD were identified by a generalized linear mixed model.RESULTS Forty-eight percent of Crohn’s disease(CD)patients and 44%of ulcerative colitis patients suffered from NAFLD.Its occurrence was associated with greater age,hypertension and body mass index(BMI)in both groups,and with higher disease activity and dyslipidemia in CD.2467 ultrasound results were included in the longitudinal analysis.Risk factors for NAFLD were age,BMI,higher disease activity,bowel resection(s),endoscopic activity and azathioprine use in CD;and BMI and endoscopic activity in ulcerative colitis.CONCLUSION NAFLD was highly prevalent in this cohort of German inflammatory bowel disease patients.Its risk increased mainly with rising age and BMI.This analysis provides a rationale for non-invasive liver screening in inflammatory bowel disease patients.展开更多
BACKGROUND Acute severe ulcerative colitis unresponsive to systemic steroid treatment is a lifethreatening medical condition requiring hospitalization and often colectomy.Despite the increasing choice of medical thera...BACKGROUND Acute severe ulcerative colitis unresponsive to systemic steroid treatment is a lifethreatening medical condition requiring hospitalization and often colectomy.Despite the increasing choice of medical therapy options for ulcerative colitis, the condition remains a great challenge in the field of inflammatory bowel diseases(IBD). The performance of the calcineurin inhibitor tacrolimus in this clinical setting is insufficiently elucidated.AIM To evaluate the short and long-term outcomes of tacrolimus therapy in adult inpatients with steroid-refractory acute severe ulcerative colitis.METHODS We conducted a retrospective monocentric study enrolling 22 patients at a tertiary care center for the treatment of IBD. All patients who were admitted to one of the wards of the Department of Gastroenterology and Hepatology of the Heidelberg University Hospital with acute severe ulcerative colitis between 2007 and 2018, and who received oral or intravenous tacrolimus for steroid-refractory disease were included. Baseline characteristics and data on the disease courses were retrieved from entirely computerized patient charts. The primary study endpoint was clinical response to tacrolimus therapy, resulting in discharge from the hospital. Secondary study endpoints were colectomy rate and time to colectomy, achievement of clinical remission under tacrolimus therapy, and the occurrence of side effects.RESULTSIn the majority of the 22 included patients(68.2%), tacrolimus therapy was initiated intravenously and subsequently converted to oral administration. The treatment duration was 128 ± 28.5 d(mean ± SEM), and the patients were followed up for 705 ± 110 d after treatment initiation. Among all patients, 86.4%were discharged from the hospital under continued oral tacrolimus therapy. In36.4% of the patients, the administration of tacrolimus resulted in clinical remission at some point during the treatment. Thirty-two percent of the patients underwent colectomy between 5 and 194 d after the initiation of tacrolimus treatment(mean: 97.4 ± 20.8 d). Colectomy-free survival rates at 1, 3, 6 and 12 mo after the initiation of tacrolimus therapy were 90.9%, 86.4%, 77.3% and 68.2%,respectively. The safety profile of tacrolimus was overall favorable. Only two patients discontinued the treatment due to side effects.CONCLUSION The short-term outcome of tacrolimus in steroid-refractory acute severe ulcerative colitis was beneficial, and side effects were rare. In all, tacrolimus therapy appears to be a viable option for short-term treatment of steroidrefractory acute severe ulcerative colitis besides ciclosporin and anti-tumor necrosis factor α treatment.展开更多
BACKGROUND Ustekinumab was approved in Europe for the treatment of adults with moderate to severe Crohn's disease(CD)in 2016,and there is an urgent need for data on its everyday use.AIM To obtain data on the daily...BACKGROUND Ustekinumab was approved in Europe for the treatment of adults with moderate to severe Crohn's disease(CD)in 2016,and there is an urgent need for data on its everyday use.AIM To obtain data on the daily use of ustekinumab.METHODS This is a retrospective monocentric study.Patients with moderate to severe CD who began ustekinumab therapy at the inflammatory bowel diseases outpatient clinic of the Heidelberg University Hospital between December 2016 and March 2018 were selected based on electronic patient files.The primary study endpoint was combined steroid-free clinical remission or steroid-free clinical response at 24±6 wk of ustekinumab therapy.Secondary study endpoints were:achievement of mucosal healing,sonographic and magnetic resonance imaging response,biochemical response,the need for intestinal surgery within 24±6 wk after treatment initiation,the occurrence of adverse events,treatment discontinuation due to nonresponse or adverse events,improvement of extraintestinal manifestations,clinical response at 48±6 wk of therapy,and association of response with nucleotid oligodimerisation domain 2 mutations.RESULTS Fifty-seven patients with CD(5.3%anti-tumour necrosis factorαnaive,63.2%having undergone at least one intestinal surgery)were included in the study.Twenty patients(35.1%)achieved steroid-free clinical remission,6(10.5%)steroid-free clinical response and 31(54.4%)were non-responders.Treatment discontinuation due to adverse events occurred in two patients(3.5%).Male sex,the presence of extraintestinal manifestations and the use of steroids at baseline were predictors of nonresponse to ustekinumab therapy.CONCLUSION In a“real-world”treatment-refractory cohort of patients with CD,ustekinumab appeared efficacious and safe.展开更多
The development of adaptation measures to climate change relies on data from climate models or impact models. In order to analyze these large data sets or an ensemble of these data sets, the use of statistical methods...The development of adaptation measures to climate change relies on data from climate models or impact models. In order to analyze these large data sets or an ensemble of these data sets, the use of statistical methods is required. In this paper, the methodological approach to collecting, structuring and publishing the methods, which have been used or developed by former or present adaptation initiatives, is described. The intention is to communicate achieved knowledge and thus support future users. A key component is the participation of users in the development process. Main elements of the approach are standardized, template-based descriptions of the methods including the specific applications, references, and method assessment. All contributions have been quality checked, sorted, and placed in a larger context. The result is a report on statistical methods which is freely available as printed or online version. Examples of how to use the methods are presented in this paper and are also included in the brochure.展开更多
基金the Ethics Committee of the University of Heidelberg(protocol number:S-299/2018).
文摘BACKGROUND Nonalcoholic fatty liver disease(NAFLD)is common in the German population,with an even higher prevalence in inflammatory bowel disease patients.AIM To investigate the risk factors for NAFLD in inflammatory bowel disease patients.METHODS This monocentric retrospective study with a cross-sectional and a longitudinal part included 694 patients.Inclusion criteria were diagnosed inflammatory bowel disease,age≥18 years,availability of at least one abdominal ultrasound.Patients with infectious or suspected alcoholic fatty liver disease were excluded.NAFLD was defined by increased echogenicity at liver ultrasound.Demographic characteristics,disease activity and medications were analyzed as potential risk factors.Parameters influencing the course of NAFLD were identified by a generalized linear mixed model.RESULTS Forty-eight percent of Crohn’s disease(CD)patients and 44%of ulcerative colitis patients suffered from NAFLD.Its occurrence was associated with greater age,hypertension and body mass index(BMI)in both groups,and with higher disease activity and dyslipidemia in CD.2467 ultrasound results were included in the longitudinal analysis.Risk factors for NAFLD were age,BMI,higher disease activity,bowel resection(s),endoscopic activity and azathioprine use in CD;and BMI and endoscopic activity in ulcerative colitis.CONCLUSION NAFLD was highly prevalent in this cohort of German inflammatory bowel disease patients.Its risk increased mainly with rising age and BMI.This analysis provides a rationale for non-invasive liver screening in inflammatory bowel disease patients.
文摘BACKGROUND Acute severe ulcerative colitis unresponsive to systemic steroid treatment is a lifethreatening medical condition requiring hospitalization and often colectomy.Despite the increasing choice of medical therapy options for ulcerative colitis, the condition remains a great challenge in the field of inflammatory bowel diseases(IBD). The performance of the calcineurin inhibitor tacrolimus in this clinical setting is insufficiently elucidated.AIM To evaluate the short and long-term outcomes of tacrolimus therapy in adult inpatients with steroid-refractory acute severe ulcerative colitis.METHODS We conducted a retrospective monocentric study enrolling 22 patients at a tertiary care center for the treatment of IBD. All patients who were admitted to one of the wards of the Department of Gastroenterology and Hepatology of the Heidelberg University Hospital with acute severe ulcerative colitis between 2007 and 2018, and who received oral or intravenous tacrolimus for steroid-refractory disease were included. Baseline characteristics and data on the disease courses were retrieved from entirely computerized patient charts. The primary study endpoint was clinical response to tacrolimus therapy, resulting in discharge from the hospital. Secondary study endpoints were colectomy rate and time to colectomy, achievement of clinical remission under tacrolimus therapy, and the occurrence of side effects.RESULTSIn the majority of the 22 included patients(68.2%), tacrolimus therapy was initiated intravenously and subsequently converted to oral administration. The treatment duration was 128 ± 28.5 d(mean ± SEM), and the patients were followed up for 705 ± 110 d after treatment initiation. Among all patients, 86.4%were discharged from the hospital under continued oral tacrolimus therapy. In36.4% of the patients, the administration of tacrolimus resulted in clinical remission at some point during the treatment. Thirty-two percent of the patients underwent colectomy between 5 and 194 d after the initiation of tacrolimus treatment(mean: 97.4 ± 20.8 d). Colectomy-free survival rates at 1, 3, 6 and 12 mo after the initiation of tacrolimus therapy were 90.9%, 86.4%, 77.3% and 68.2%,respectively. The safety profile of tacrolimus was overall favorable. Only two patients discontinued the treatment due to side effects.CONCLUSION The short-term outcome of tacrolimus in steroid-refractory acute severe ulcerative colitis was beneficial, and side effects were rare. In all, tacrolimus therapy appears to be a viable option for short-term treatment of steroidrefractory acute severe ulcerative colitis besides ciclosporin and anti-tumor necrosis factor α treatment.
文摘BACKGROUND Ustekinumab was approved in Europe for the treatment of adults with moderate to severe Crohn's disease(CD)in 2016,and there is an urgent need for data on its everyday use.AIM To obtain data on the daily use of ustekinumab.METHODS This is a retrospective monocentric study.Patients with moderate to severe CD who began ustekinumab therapy at the inflammatory bowel diseases outpatient clinic of the Heidelberg University Hospital between December 2016 and March 2018 were selected based on electronic patient files.The primary study endpoint was combined steroid-free clinical remission or steroid-free clinical response at 24±6 wk of ustekinumab therapy.Secondary study endpoints were:achievement of mucosal healing,sonographic and magnetic resonance imaging response,biochemical response,the need for intestinal surgery within 24±6 wk after treatment initiation,the occurrence of adverse events,treatment discontinuation due to nonresponse or adverse events,improvement of extraintestinal manifestations,clinical response at 48±6 wk of therapy,and association of response with nucleotid oligodimerisation domain 2 mutations.RESULTS Fifty-seven patients with CD(5.3%anti-tumour necrosis factorαnaive,63.2%having undergone at least one intestinal surgery)were included in the study.Twenty patients(35.1%)achieved steroid-free clinical remission,6(10.5%)steroid-free clinical response and 31(54.4%)were non-responders.Treatment discontinuation due to adverse events occurred in two patients(3.5%).Male sex,the presence of extraintestinal manifestations and the use of steroids at baseline were predictors of nonresponse to ustekinumab therapy.CONCLUSION In a“real-world”treatment-refractory cohort of patients with CD,ustekinumab appeared efficacious and safe.
文摘The development of adaptation measures to climate change relies on data from climate models or impact models. In order to analyze these large data sets or an ensemble of these data sets, the use of statistical methods is required. In this paper, the methodological approach to collecting, structuring and publishing the methods, which have been used or developed by former or present adaptation initiatives, is described. The intention is to communicate achieved knowledge and thus support future users. A key component is the participation of users in the development process. Main elements of the approach are standardized, template-based descriptions of the methods including the specific applications, references, and method assessment. All contributions have been quality checked, sorted, and placed in a larger context. The result is a report on statistical methods which is freely available as printed or online version. Examples of how to use the methods are presented in this paper and are also included in the brochure.
