Post-operative morbidity and mortality of a cohort of steroid refractory acute severe ulcerative colitis: Nationwide multicenter study of the GETECCU ENEIDA Registry.

BACKGROUND: Despite the increased use of rescue medical therapies for steroid refractory acute severe ulcerative colitis, mortality related to this entity still remains high. We aimed to assess the mortality and morbidity related to colectomy and their predictive factors in steroid refractory acute severe ulcerative colitis, and to evaluate the changes in mortality rates, complications, indications of colectomy, and the use of rescue therapy over time. METHODS: We performed a multicenter observational study of patients with steroid refractory acute severe ulcerative colitis requiring colectomy, admitted to 23 Spanish hospitals included in the ENEIDA registry (GETECCU) from 1989 to 2014. Independent predictive factors of mortality were assessed by binary logistic regression analysis. Mortality along the study was calculated using the age-standardized rate. RESULTS: During the study period, 429 patients underwent colectomy, presenting an overall mortality rate of 6.3% (range, 0-30%). The main causes of death were infections and post-operative complications. Independent predictive factors of mortality were: age ≥50 years (OR 23.34; 95% CI: 6.46-84.311; p < 0.0001), undergoing surgery in a secondary care hospital (OR 3.07; 95% CI: 1.01-9.35; p = 0.047), and in an emergency setting (OR 10.47; 95% CI: 1.26-86.55; p = 0.029). Neither the use of rescue medical treatment nor the type of surgical technique used (laparoscopy vs. open laparotomy) influenced mortality. The proportion of patients undergoing surgery in an emergency setting decreased over time (p < 0.0001), whereas the use of rescue medical therapy prior to colectomy progressively increased (p > 0.001). CONCLUSIONS: The mortality rate related to colectomy in steroid refractory acute severe ulcerative colitis varies greatly among hospitals, reinforcing the need for a continuous audit to achieve quality standards. The increasing use of rescue therapy is not associated with a worse outcome and may contribute to reducing emergency surgical interventions and improve outcomes.

Long-Term Efficacy and Safety of Cyclosporine in a Cohort of Steroid-Refractory Acute Severe Ulcerative Colitis Patients from the ENEIDA Registry (1989-2013): A Nationwide Multicenter Study.

OBJECTIVES: To determine the efficacy and safety of cyclosporine (CyA) in a large national registry-based population of patients with steroid-refractory (SR) acute severe ulcerative colitis (ASUC) and to establish predictors of efficacy and adverse events. METHODS: Multicenter study of SR-ASUC treated with CyA, based on data from the ENEIDA registry. SR-ASUC patients treated with infliximab (IFX) or sequential rescue therapy (CyA-IFX or IFX-CyA) were used as comparators. RESULTS: Of 740 SR-ASUC patients, 377 received CyA, 131 IFX and 63 sequential rescue therapy. The cumulative colectomy rate was higher in the CyA (24.1%) and sequential therapy (32.7%) than in the IFX group (14.5%; P=0.01) at 3 months and 5 years. There were no differences in early and late colectomy between CyA and IFX in patients treated after 2005. 62% of patients receiving CyA remained colectomy-free in the long term (median 71 months). There were no differences in mortality between CyA (2.4%), IFX (1.5%) and sequential therapy (0%; P=0.771). The proportion of patients with serious adverse events (SAEs) was lower in CyA (15.4%) than in IFX treated patients (26.5%) or sequential therapy (33.4%; P<0.001). This difference in favor of CyA was maintained when only patients treated after 2005 were analyzed. CONCLUSIONS: Treatment with CyA showed a lower rate of SAE and a similar efficacy to that of IFX thereby supporting the use of either CyA or IFX in SR-ASUC. In addition, the risk-benefit of sequential CyA-IFX for CyA non-responders is acceptable.

Extracolonic Cancer in Inflammatory Bowel Disease: Data from the GETECCU Eneida Registry.

OBJECTIVES: The objective of this study was (a) To know the prevalence and distribution of extracolonic cancer (EC) in patients with inflammatory bowel disease (IBD); (b) To estimate the incidence rate of EC; (c) To evaluate the association between EC and treatment with immunosuppressants and anti-tumor necrosis factor (TNF) agents. METHODS: This was an observational cohort study. INCLUSION CRITERIA: IBD and inclusion in the ENEIDA Project (a prospectively maintained registry) from GETECCU. EXCLUSION CRITERIA: Patients with EC before the diagnosis of IBD, lack of relevant data for this study, and previous treatment with immunosuppressants other than corticosteroids, thiopurines, methotrexate, or anti-TNF agents. The Kaplan-Meier method was used to evaluate the impact of several variables on the risk of EC, and any differences between survival curves were evaluated using the log-rank test. Stepwise multivariate Cox regression analysis was used to investigate factors potentially associated with the development of EC, including drugs for the treatment of IBD, during follow-up. RESULTS: A total of 11,011 patients met the inclusion criteria and were followed for a median of 98 months. Forty-eight percent of patients (5,303) had been exposed to immunosuppressants or anti-TNF drugs, 45.8% had been exposed to thiopurines, 4.7% to methotrexate, and 21.6% to anti-TNF drugs. The prevalence of EC was 3.6%. In the multivariate analysis, age (HR=1.05, 95% CI=1.04-1.06) and having smoked (hazards ratio (HR)=1.47, 95% confidence interval (CI)=1.10-1.80) were the only variables associated with a higher risk of EC. CONCLUSIONS: Neither immunosuppressants nor anti-TNF drugs seem to increase the risk of EC. Older age and smoking were associated with a higher prevalence of EC.

Evolution After Anti-TNF Discontinuation in Patients With Inflammatory Bowel Disease: A Multicenter Long-Term Follow-Up Study.

OBJECTIVES: The aims of this study were to assess the risk of relapse after discontinuation of anti-tumor necrosis factor (anti-TNF) drugs in patients with inflammatory bowel disease (IBD), to identify the factors associated with relapse, and to evaluate the overcome after retreatment with the same anti-TNF in those who relapsed. METHODS: This was a retrospective, observational, multicenter study. IBD patients who had been treated with anti-TNFs and in whom these drugs were discontinued after clinical remission was achieved were included. RESULTS: A total of 1,055 patients were included. The incidence rate of relapse was 19% and 17% per patient-year in Crohn's disease and ulcerative colitis patients, respectively. In both Crohn's disease and ulcerative colitis patients in deep remission, the incidence rate of relapse was 19% per patient-year. The treatment with adalimumab vs. infliximab (hazard ratio (HR)=1.29; 95% confidence interval (CI)=1.01-1.66), elective discontinuation of anti-TNFs (HR=1.90; 95% CI=1.07-3.37) or discontinuation because of adverse events (HR=2.33; 95% CI=1.27-2.02) vs. a top-down strategy, colonic localization (HR=1.51; 95% CI=1.13-2.02) vs. ileal, and stricturing behavior (HR=1.5; 95% CI=1.09-2.05) vs. inflammatory were associated with a higher risk of relapse in Crohn's disease patients, whereas treatment with immunomodulators after discontinuation (HR=0.67; 95% CI=0.51-0.87) and age (HR=0.98; 95% CI=0.97-0.99) were protective factors. None of the factors were predictive in ulcerative colitis patients. Retreatment of relapse with the same anti-TNF was effective (80% responded) and safe. CONCLUSIONS: The incidence rate of inflammatory bowel disease relapse after anti-TNF discontinuation is relevant. Some predictive factors of relapse after anti-TNF withdrawal have been identified. Retreatment with the same anti-TNF drug was effective and safe.

Safety and effectiveness of direct-acting antiviral drugs in the treatment of hepatitis C in patients with inflammatory bowel disease.

BACKGROUND AND AIMS: Hepatitis C virus (HCV) management in Inflammatory Bowel Disease (IBD) is uncertain. The ECCO guidelines 2021 recommended HCV treatment but warn about the risk of IBD reactivation. We aimed to evaluate 1) the effectiveness and safety of direct-acting antivirals (DAAs) in IBD; 2) the interaction of DAAs with IBD drugs. METHODS: Multicentre study of IBD patients and HCV treated with DAAs. Variables related to liver diseases and IBD, as well as adverse events (AEs) and drug interactions, were recorded. McNemar's test was used to assess differences in the proportion of active IBD during the study period. RESULTS: We included 79 patients with IBD and HCV treated with DAAs from 25,998 IBD patients of the ENEIDA registry. Thirty-one (39.2 %) received immunomodulators/biologics. There were no significant differences in the percentage of active IBD at the beginning (n = 11, 13.9 %) or at the 12-week follow-up after DAAs (n = 15, 19 %) (p = 0.424). Sustained viral response occurred in 96.2 % (n = 76). A total of 8 (10.1 %) AEs occurred and these were unrelated to activity, type of IBD, liver fibrosis, immunosuppressants/biologics, and DAAs. CONCLUSIONS: We demonstrate a high efficacy and safety of DAAs in patients with IBD and HCV irrespective of activity and treatment of IBD.

Safety of thiopurines and anti-TNF-α drugs during pregnancy in patients with inflammatory bowel disease.

OBJECTIVES: The safety of thiopurines and anti-tumor necrosis factor-α (TNF-α) drugs during pregnancy remains controversial, as the experience with these drugs in this situation is limited. Our aim is to assess the safety of thiopurines and anti-TNF-α drugs for the treatment of inflammatory bowel disease (IBD) during pregnancy. METHODS: Retrospective, multicenter study in IBD patients. Pregnancies were classified according to the therapeutic regimens during pregnancy or during the 3 months before the conception: non-exposed group, pregnancies exposed to thiopurines alone (group A), and pregnancies exposed to anti-TNF-α drugs (group B). An unfavorable Global Pregnancy Outcome (GPO) was considered if pregnancy developed with obstetric complications in the mother and in the newborn. RESULTS: A total of 187 pregnancies in the group A, 66 pregnancies in the group B, and 318 pregnancies in the non-exposed group were included. The rate of unfavorable GPO was different among the three groups (31.8% in non-exposed group, 21.9% in group A, and 34.8% in group B), being lower in pregnancies under thiopurines than among non-exposed (P = 0.01). The rate of pregnancy complications was similar among the three groups (27.7% in non-exposed, 20.9% in group A, and 30.3% in group B). The rate of neonatal complications was different among the three groups (23.3% in non-exposed group, 13.9% in group A, and 21.2% in group B), being lower in pregnancies under thiopurines than among non-exposed (P = 0.01). In the multivariate analysis, the treatment with thiopurines (odds ratio = 0.6; 95% confidence interval = 0.4-0.9, P = 0.02) was the only predictor of favorable GPO, whereas maternal age >35 years at conception was the only predictor of unfavorable GPO. The treatment with anti-TNF-α drugs was not associated with an unfavorable GPO. CONCLUSION: The treatment with thiopurines and anti-TNF-α drugs does not seem to increase the risk of complications during pregnancy and does seem to be safe for the newborn.

Long-term follow-up of 1,000 patients cured of Helicobacter pylori infection following an episode of peptic ulcer bleeding.

OBJECTIVES: To evaluate the effect of Helicobacter pylori (H. pylori) eradication on ulcer bleeding recurrence in a prospective, long-term study including 1,000 patients. METHODS: Patients with peptic ulcer bleeding were prospectively included. Prior non-steroidal anti-inflammatory drug (NSAID) use was not considered exclusion criteria. H. pylori infection was confirmed by rapid urease test, histology, or (13)C-urea breath test. Several eradication therapies were used. Subsequently, ranitidine 150 mg o.d. was administered until eradication was confirmed by (13)C-urea breath test 8 weeks after completing therapy. Patients with therapy failure received a second, third, or fourth course of eradication therapy. Patients with eradication success did not receive maintenance anti-ulcer therapy and were controlled yearly with a repeat breath test. NSAID use was not permitted during follow-up. RESULTS: Thousand patients were followed up for at least 12 months, with a total of 3,253 patient-years of follow-up. Mean age 56 years, 75% males, 41% previous NSAID users. In all, 69% had duodenal ulcer, 27% gastric ulcer, and 4% pyloric ulcer. Recurrence of bleeding was demonstrated in three patients at 1 year (which occurred after NSAID use in two cases, and after H. pylori reinfection in another one), and in two more patients at 2 years (one after NSAID use and another after H. pylori reinfection). The cumulative incidence of rebleeding was 0.5% (95% confidence interval, 0.16-1.16%), and the incidence rate of rebleeding was 0.15% (0.05-0.36%) per patient-year of follow up. CONCLUSION: Peptic ulcer rebleeding virtually does not occur in patients with complicated ulcers after H. pylori eradication. Maintenance anti-ulcer (antisecretory) therapy is not necessary if eradication is achieved. However, NSAID intake or H. pylori reinfection may exceptionally cause rebleeding in H. pylori-eradicated patients.

Liver dysfunction related to hepatitis B and C in patients with inflammatory bowel disease treated with immunosuppressive therapy.

BACKGROUND: There is no information about the frequency of liver dysfunction in patients with inflammatory bowel disease (IBD) treated with immunosuppressants and infected with hepatitis B (HBV) and/or C virus (HCV). AIM: To assess the influence of immunosuppressants on the course of HBV and HCV infection in IBD. METHODS: Patients with IBD with HBV and/or HCV infection from 19 Spanish hospitals were included. Clinical records were reviewed for the type of immunosuppressant used, treatment duration, liver function tests and viral markers before, during and after each immunosuppressant. Logistic and Cox regression analysis were used to identify predictors of outcome. RESULTS: 162 patients were included; 104 had HBV markers (25 HBsAg positive) and 74 had HCV markers (51 HCV-RNA positive), and 16 patients had markers of both infections. Liver dysfunction was observed in 9 of 25 HBsAg positive patients (36%), 6 of whom developed hepatic failure. Liver dysfunction in HCV was observed in 8 of 51 HCV-RNA positive patients (15.7%), and only one developed hepatic failure. The frequency and severity of liver dysfunction was significantly higher in HBV-infected patients than in HCV-infected patients (p=0.045 and p=0.049, respectively). Treatment with ≥2 immunosuppressants was an independent predictor of HBV reactivation (OR 8.75; 95% CI 1.16 to 65.66). The majority of patients without reactivation received only one immunosuppressant for a short period and/or prophylactic antiviral treatment. No definite HBV reactivations were found in anti-HBc positive patients lacking HBsAg. CONCLUSION: Liver dysfunction in patients with IBD treated with immunosuppressants is more frequent and severe in those with HBV than in HCV carriers and is associated with combined immunosuppression.

Prospective evaluation of liver fibrosis in chronic viral hepatitis C infection using the Sabadell NIHCED (Non-Invasive Hepatitis-C-Related Cirrhosis Early Detection) index.

INTRODUCTION: liver disease resulting from chronic hepatitis C virus (HCV) infection follows an asymptomatic course towards cirrhosis and its complications in 20-40% of cases. Earlier studies demonstrated that advanced fibrosis is a prognostic factor. The "gold standard" for the evaluation of fibrosis grade is liver biopsy. Our group validated a predictive index - NIHCED - based on demographic, laboratory parameters, and echographic data to determine the presence of cirrhosis. OBJECTIVE: our objective is to evaluate whether the NIHCED score predicts the presence of advanced fibrosis in patients with chronic HCV infection. MATERIAL AND METHODS: this prospective study included patients with chronic HCV infection who underwent liver biopsy and were administered the NIHCED score. Fibrosis grade correlated with the NIHCED score using the ROC curve analysis and Spearman s correlation coefficient. RESULTS: in total 321 patients were included (male/female ratio 1.27) with a mean age of 48 +/- 14 years. Liver biopsy showed that 131 (30.5%) had no fibrosis or had portal expansion while 190 (69.5%) had advanced fibrosis or cirrhosis. At a cut-off point of 6, sensitivity was 72%, specificity was 76.3%, positive predictive value (PPV) was 81%, negative predictive value (NPV) was 63.7%, and diagnostic accuracy was 72.5%, with an area under the curve (AUC) of 0.787, and a Spearman s correlation coefficient of r = 0.65. CONCLUSIONS: the NIHCED score predicts the presence of advanced fibrosis in an elevated percentage of patients with a need of liver biopsy.

Effectiveness and Safety of the Switch from Remicade® to CT-P13 in Patients with Inflammatory Bowel Disease.

BACKGROUND AND AIMS: To evaluate the clinical outcomes in patients with IBD after switching from Remicade® to CT-P13 in comparison with patients who maintain Remicade®. METHODS: Patients under Remicade® who were in clinical remission with standard dosage at study entry were included. The 'switch cohort' [SC] comprised patients who made the switch from Remicade® to CT-P13, and the 'non-switch' cohort [NC] patients remained under Remicade®. RESULTS: A total of 476 patients were included: 199 [42%] in the SC and 277 [58%] in the NC. The median follow-up was 18 months in the SC and 23 months in the NC [p < 0.01]. Twenty-four out of 277 patients relapsed in the NC; the incidence of relapse was 5% per patient-year. The cumulative incidence of relapse was 2% at 6 months and 10% at 24 months in this group. Thirty-eight out of 199 patients relapsed in the SC; the incidence rate of relapse was 14% per patient-year. The cumulative incidence of relapse was 5% at 6 months and 28% at 24 months. In the multivariate analysis, the switch to CT-P13 was associated with a higher risk of relapse (HR = 3.5, 95% confidence interval [CI] = 2-6). Thirteen percent of patients had adverse events in the NC, compared with 6% in the SC [p < 0.05]. CONCLUSIONS: Switching from Remicade® to CT-P13 might be associated with a higher risk of clinical relapse, although this fact was not supported in our study by an increase in objective markers of inflammation. The nocebo effect might have influenced this result. Switching from Remicade® to CT-P13 was safe.

Variation among endoscopy units in the achievement of the standards of colonoscopic performance indicators.

BACKGROUND/AIMS: To assess the achievement of quality standards of colonoscopy at six endoscopy units. METHODOLOGY: Three indicators were used to assess the quality of 1056 colonoscopies performed at six hospitals: cecal intubation; adequate colon cleansing; and removal and recovery of all detected polyps. Analyses were performed on the total number of colonoscopies and on colonoscopies in which polyps were actually detected. The accomplishment of each indicator and a global compound index of all three indicators, named the Problem Rate, were analyzed. Results from each endoscopy unit were compared to previously established standards. RESULTS: Adequate colon cleansing was the most frequent problem for quality in all centers; adequate colon preparation was 67% (range 50 to 84%). The cecum was reached in 84% of all colonoscopies (range 76 to 90%). 75% of all patients (range 28. 79%) had all polyps excised and recovered. All centers had rates below standard for one or several indicators (p<0.01, all cases). Two of the participant hospitals had an overall problem rate above the estimated standard (p<0.01). CONCLUSIONS: There is a significant variation in the achievement of quality standards of colonoscopy between endoscopy units. Colon cleansing is the most frequent quality problem for colonoscopy.

Phenotype and natural history of elderly onset inflammatory bowel disease: a multicentre, case-control study.

BACKGROUND: Onset during old age has been reported in upto 10% of total cases of inflammatory bowel disease (IBD). AIM: To evaluate phenotypic characteristics and the use of therapeutic resources in patients with elderly onset IBD. METHODS: Case-control study including all those patients diagnosed with IBD over the age of 60 years since 2000 who were followed-up for >12 months, identified from the IBD databases. Elderly onset cases were compared with IBD patients aged 18 to 40 years at diagnosis, matched by year of diagnosis, gender and type of IBD (adult-onset). RESULTS: One thousand three hundred and seventy-four elderly onset and 1374 adult-onset cases were included (62% ulcerative colitis (UC), 38% Crohn's disease (CD)). Among UC patients, elderly onset cases had a lower proportion of extensive disease (33% vs 39%; P < 0.0001). In CD, elderly onset cases showed an increased rate of stenosing pattern (24% vs 13%; P < 0.0001) and exclusive colonic location (28% vs 16%; P < 0.0001), whereas penetrating pattern (12% vs 19%; P < 0.0001) was significantly less frequent. Regarding the use of therapeutic resources, there was a significantly lower use of corticosteroids (P < 0.0001), immunosuppressants (P < 0.0001) and anti-TNFs agents (P < 0.0001) in elderly onset cases. Regarding surgery, we found a significantly higher surgery rate among elderly onset UC cases (8.3% vs 5.1%; P < 0.009). Finally, elderly onset cases were characterised by a higher rate of hospitalisations (66% vs 49%; P < 0.0001) and neoplasms (14% vs 0.5%; P < 0.0001). CONCLUSIONS: Elderly onset IBD shows specific characteristics and they are managed differently, with a lower use of immunosuppressants and a higher rate of surgery in UC.

Epinephrine injection versus epinephrine injection and a second endoscopic method in high risk bleeding ulcers.

BACKGROUND: Endoscopic therapy reduces rebleeding rate, need for surgery, and mortality in patients with bleeding peptic ulcers. Injection of epinephrine is the most popular therapeutic method. Guidelines disagree on the need for a second haemostatic procedure immediately after epinephrine. OBJECTIVES: The objective of this review was to determine whether the addition of a second procedure improves efficacy or patient outcomes or both after epinephrine injection in adults with high risk bleeding ulcers. SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials - CENTRAL (which includes the Cochrane Upper Gastrointestinal and Pancreatic Diseases Group Trials Register) (The Cochrane Library Issue 1, 2006), MEDLINE (1966 to February 2006), EMBASE (1980 to February 2006) and reference lists of articles. We also contacted experts in the field. SELECTION CRITERIA: Randomised studies comparing endoscopic treatment: epinephrine alone versus epinephrine associated with a second haemostatic method in adults with haemorrhage from peptic ulcer disease with major stigmata of bleeding as defined by the Forrest classification. Bleeding must have been confirmed by endoscopy. DATA COLLECTION AND ANALYSIS: Two authors independently assessed trial quality and extracted data. MAIN RESULTS: Seventeen studies including 1763 people were included. Adding a second procedure reduced further bleeding rate from 18.8% to 10.4%; Peto Odds Ratio 0.51; 95% confidence interval (CI) 0.39 to 0.66, and emergency surgery from 10.8% to 7.1%; OR 0.63; 95% CI 0.45 to 0.89. Mortality fell from 5% to 2.5% OR 0.50; 95% CI 0.30 to 0.82. Subanalysis showed that the risk of further bleeding decreased regardless of which second procedure was applied. In addition, the risk was reduced in all subgroups. AUTHORS' CONCLUSIONS: Additional endoscopic treatment after epinephrine injection reduces further bleeding, the need for surgery and mortality in patients with bleeding peptic ulcer.

Usefulness of a delayed test for the diagnosis of Helicobacter pylori infection in bleeding peptic ulcer.

AIM: To evaluate (i) the diagnostic usefulness of a delayed test in initially negative patients; and (ii) the reliability of the rapid urease test, histology or a combination of the two to diagnose Helicobacter pylori during emergency endoscopy in a large clinical practice series. PATIENTS AND METHODS: Records of patients with ulcer bleeding from 1995 to 2000 were reviewed. Patients with initially negative tests were retested 4-8 weeks after the bleeding episode. Sensitivity of urease, histology or a combination of the two to detect H. pylori at initial endoscopy and the efficacy of delayed Urea Breath Test in detecting missed infection was determined. RESULTS: The study included 429 patients. A delayed second test detected H. pylori infection in 57 out of 72 (79%) of initially negative patients. The sensitivity for detecting H. pylori was 76%, 78% and 86% for urease, histology and their combination, respectively. The prevalence of H. pylori was 95% in duodenal and 88% in gastric ulcer. In addition, only one test was performed in 17 of the 32 patients who were considered negative. CONCLUSION: Not even the combination of a negative urease and histology in the initial endoscopy is able to rule out infection in bleeding ulcer patients. A delayed test should be performed to rule out Helicobacter pylori infection completely.

[Helicobacter pylori does not contribute to iron deficiency in hemodialysis patients]. / Helicobacter pylori no contribuye al déficit de hierro de los pacientes en hemodiálisis.

BACKGROUND: Many studies in the general population have shown a link between Helicobacter pylori infection and iron-deficiency, often resulting in iron-deficient anaemia. Despite the high prevalence of iron deficiency in hemodialysis patients, no studies have been performed in this population. OBJECTIVE: To evaluate the role of Helicobacter pylori infection in the appearance of anemia and the iron requirements in our hemodialysis population. MATERIAL AND METHODS: After excluding patients with severe pathology and short life expectancy and those with blood losses secondary to other causes, 79 patients were included.Iron requirements and anaemia were determined by iron serum, ferritin, and hematocrit values; and by transfusion, eritropoietin and iron requirements. The diagnosis of Helicobacter pylori status was established by the concordance of at least two of the three non invasive diagnostic methods performed (breath test, serology and fecal antigen of Helicobacter pylori). RESULTS: Prevalence of Helicobacter pylori infection was 43%. No significant differences between patients infected or not by Helicobacter pylori were found in any of the variables analysed: hematocrit (33.5% versus 34.1%), serum iron (58.9 versus 63.7 pg/dl), ferritin(340.3 versus 264.2 ng/ml), transferrin saturation index (22.5% versus 25.2%), dose of eritropoietin administered (96.6 versus 93.5 U/kg/weekly), and parenteral iron (1,389 versus 1,538 mg/year). A noteworthy finding was that patients with Helicobacter pylori infection had been on hemodialysis for a shorter period than those without (37.4 versus 63.7 months,p = 0.04). CONCLUSION: Helicobacter pylori infection has no effect on anaemia (hematocrit, Eritropoietin dose or iron needs) in our hemodialysis patients. Prevalence of Helicobacter pylori is lower in patients with longer time on dialysis. We consider that the diagnosis of Helicobacter pylori infection must be reserved for clinical peptic ulcer suspicion or patients on transplant waiting list.

Tuberculosis in Anti-Tumour Necrosis Factor-treated Inflammatory Bowel Disease Patients After the Implementation of Preventive Measures: Compliance With Recommendations and Safety of Retreatment.

BACKGROUND AND AIMS: Despite having adopted preventive measures, tuberculosis (TB) may still occur in patients with inflammatory bowel disease (IBD) treated with anti-tumour necrosis factor (anti-TNF). Data on the causes and characteristics of TB cases in this scenario are lacking. Our aim was to describe the characteristics of TB in anti-TNF-treated IBD patients after the publication of the Spanish TB prevention guidelines in IBD patients and to evaluate the safety of restarting anti-TNF after a TB diagnosis. METHODS: In this multicentre, retrospective, descriptive study, TB cases from Spanish hospitals were collected. Continuous variables were reported as mean and standard deviation or median and interquartile range. Categorical variables were described as absolute and relative frequencies and their confidence intervals when necessary. RESULTS: We collected 50 TB cases in anti-TNF-treated IBD patients, 60% male, median age 37.3 years (interquartile range [IQR] 30.4-47). Median latency between anti-TNF initiation and first TB symptoms was 155.5 days (IQR 88-301); 34% of TB cases were disseminated and 26% extrapulmonary. In 30 patients (60%), TB cases developed despite compliance with recommended preventive measures; *not performing 2-step TST (tuberculin skin test) was the main failure in compliance with recommendations. In 17 patients (34%) anti-TNF was restarted after a median of 13 months (IQR 7.1-17.3) and there were no cases of TB reactivation. CONCLUSIONS: Tuberculosis could still occur in anti-TNF-treated IBD patients despite compliance with recommended preventive measures. A significant number of cases developed when these recommendations were not followed. Restarting anti-TNF treatment in these patients seems to be safe.

Meta-analysis: role of Helicobacter pylori eradication in the prevention of peptic ulcer in NSAID users.

AIM: To evaluate whether eradication of Helicobacter pylori prevents peptic ulcer in non-steroidal anti-inflammatory drug users by means of a meta-analysis. MATERIAL AND METHODS: A systematic search was performed in MEDLINE, EMBASE, the Cochrane Controlled Trials Register and the AGA congress. Randomized trials comparing H. pylori eradication vs. non-eradication or eradication vs. a proton pump inhibitor in patients receiving a non-steroidal anti-inflammatory drug were selected. RESULTS: Five studies and 939 patients were included in the analysis; 34 of 459 (7.4%) patients developed a peptic ulcer in the eradicated group vs. 64 of 480 (13.3%) in the control group. The odds ratio was 0.43 (95% confidence interval: 0.20-0.93). Sub-analyses showed a significant reduction of risk for non-steroidal anti-inflammatory drug-naive (odds ratio = 0.26; 95% confidence interval: 0.14-0.49) but not for previously treated patients (odds ratio = 0.95, 95% confidence interval: 0.53-1.72). Two studies with a total of 385 patients compared eradication vs. a proton pump inhibitor; five of 196 (2.6%) developed a peptic ulcer in the eradicated group vs. zero of 189 (0%) in the proton pump inhibitor group (odds ratio = 7.43; 95% confidence interval: 1.27-43.6). CONCLUSION: Helicobacter pylori eradication reduces the incidence of peptic ulcer in the overall population receiving non-steroidal anti-inflammatory drugs. It appears to be especially effective when performed in non-steroidal anti-inflammatory drug-naïve patients. Nonetheless, eradication seems less effective than treatment with a maintenance proton pump inhibitor for preventing non-steroidal anti-inflammatory drug-associated ulcers.

7-day rescue therapy with ranitidine bismuth citrate after Helicobacter pylori treatment failure.

BACKGROUND: Quadruple rescue therapy requires a complex scheme with four drugs. AIM: To evaluate the efficacy of ranitidine bismuth citrate-tetracycline-metronidazole rescue regimen, and to compare two different metronidazole dose schemes. METHODS: Prospective multicentre study including proton-pump inhibitor + clarithromycin + amoxicillin failures. Rescue regimen included two 7-day treatment: (i) ranitidine bismuth citrate (400 mg b.d.)-tetracycline (500 mg q.d.s.)-metronidazole (500 mg t.d.s.; RTM1); or (ii) the same regimen but with metronidazole 250 mg q.d.s. (RTM2). Eradication was confirmed with (13)C-urea breath test. RESULTS: A total of 150 patients were included (58 RTM1, 92 RTM2). All patients but two (one in each group) returned after treatment. About 86% in group RTM1 and 95% in RTM2 correctly took all the medications (P = 0.076). Per-protocol eradication rates with RTM1 and RTM2 were 74 (95% CI: 60-84) and 69% (59-78). The intention-to-treat eradication rates were 64 (51-75) and 70% (59-78; P > 0.05). The type of regimen was not associated with eradication in the multivariate analysis. Adverse effects were more frequent with RTM1 (41%) than with RTM2 (30%; P > 0.05). CONCLUSION: Seven-day triple rescue therapy with ranitidine bismuth citrate-tetracycline-metronidazole is effective for Helicobacter pylori eradication, and represents an encouraging alternative to quadruple therapy, with the advantage of simplicity. The administration of metronidazole every 6 h (together with tetracycline), and at a low dose (250 mg), achieves similar efficacy and is probably associated with a better compliance and a lower incidence of adverse effects.

[Endoscopic treatment of bleeding ulcers: has everything been said and done?]. / Tratamiento endoscópico de la úlcera hemorrágica: 'todo dicho, todo hecho?

Endoscopic treatment reduces bleeding recurrence, the need for surgery and mortality in patients with bleeding ulcers. However endoscopic treatment fails in 10-15% of patients, leading to high morbidity and mortality. The therapeutic measures with demonstrated effectiveness in reducing the risk of hemorrhagic recurrence and its complications are combined endoscopic treatment (adrenaline plus a second hemostatic intervention) and proton pump inhibitors. Also useful, although there is less evidence, are immediate resuscitation and <> endoscopy. Some studies suggest that activated recombinant factor VII infusion or supra-selective arterial embolization can be useful in severe hemorrhage. Further studies are required to determine optimal treatment according to the characteristics of each patient.

[Cecal cytomegalovirus infection following appendicectomy in a patient with ulcerative colitis]. / Infección cecal por citomegalovirus en paciente apendicectomizado con colitis ulcerosa.

We report a patient who, 3 months after being diagnosed with ulcerative colitis, was admitted to hospital because of malaise and right lower abdominal pain. An open appendectomy was performed. Histological study showed ulcerative colitis affecting the appendix. After surgery, the patient presented a refractory outbreak of ulcerative colitis requiring treatment with steroids and cyclosporin A. Despite this treatment, the patient continued to pass abundant fresh blood associated with severe anemia. Colonoscopy showed only granular and congestive cecal mucosa. Biopsies showed intracytoplasmic inclusion bodies with immunohistochemical stains positive for cytomegalovirus (CMV) infection. Rectorrhagia and anemia quickly disappeared after beginning treatment with ganciclovir. Appendicular ulcerative colitis is not uncommonly associated with distal colitis. In addition, diffuse CMV infection complicating ulcerative colitis treatment is not unusual. By contrast, isolated, segmentary infection by CMV in the proximal colon is extremely rare. Until now, only three patients with localized CMV infection have been described, and all three cases occurred in the context of ileoanal anastomosis.