Efficacy of ferric carboxymaltose on haemoglobin response among older patients with gastrointestinal bleeding: a randomised clinical trial.

BACKGROUND: Acute gastrointestinal bleeding (AGIB) is common in older patients but the use of iron in this context remains understudied. AIMS: This study aimed to evaluate prospectively the efficacy of ferric carboxymaltose to treat anaemia in older patients after AGIB. METHODS: This randomised double-blinded placebo-controlled clinical trial was conducted in 10 French centres. Eligible patients were 65 years or more, had controlled upper or lower gastrointestinal bleeding and a haemoglobin level of 9-11 g/dl. Patients were randomly assigned, in a 1:1 ratio, to receive either one intravenous iron injection of ferric carboxymaltose or one injection of saline solution. The primary endpoint was the difference in haemoglobin level between day 0 and day 42. Secondary endpoints were treatment-emergent adverse events, serious adverse events, rehospitalisation and improvement of quality of life (QOL) at day 180. RESULTS: From January 2013 to January 2017, 59 patients were included. The median age of patients was 81.9 [75.8, 87.3] years. At day 42, a significant difference in haemoglobin level increase was observed (2.49 g/dl in the ferric carboxymaltose group vs. 1.56 g/dl in the placebo group, P = 0.02). At day 180, QOL, measured on European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30, improved by 10.5 points in the ferric carboxymaltose group and by 8.2 points in the placebo group (P = 0.56). Rates of adverse events and rehospitalisation were similar in the two groups. CONCLUSIONS: Intravenous iron seems safe and effective to treat anaemia in older patients after AGIB and should be considered as a standard-of-care treatment. ClinicalTrials.gov (NCT01690585).

Enhanced liver fibrosis score is stable after withdrawal in patients with heavy alcohol consumption: A pilot study.

BACKGROUND: Enhanced liver fibrosis (ELF) score is an accurate, noninvasive test for assessing the severity of liver fibrosis in chronic liver disease, including alcohol-related liver disease. However, whether the ELF score changes during alcohol withdrawal is unknown. This pilot study assessed changes in the ELF score during withdrawal in patients with a history of excessive alcohol intake. METHODS: In this prospective study, ELF was performed on day 0 (D0, at the beginning of hospitalization), at day 7 (D7, on discharge from hospital), and at follow-up visits on days 30 (D30) and 90 (D90). Transient elastography (TE) was also assessed on days 4 (D4) and D30. RESULTS: The study included 35 patients (71% male) with a mean alcohol intake of 139 g/day. On D30 and D90, 8 and 13 patients had resumed alcohol consumption (mean intake of 90 and 80 g/day, respectively). In patients who remained abstinent, the mean ELF score was 8.93 on D0, 9.14 on D30 (p = 0.32), and 9.27 on D90 (p = 0.14). In patients who resumed alcohol, mean ELF score was 9.7 on D0, 10.05 on D30 (p = 0.09), and 9.71 on D90 (p = 0.12). ELF score was comparable over the first months after withdrawal, although there was a slight increase in the first week (mean ELF score increased from 9.24 on D0 to 9.74 on D7, p < 0.001). Mean TE value was 7.9 kPa on D4 and 8.1 kPa on D30 (p = 0.84) in patients who resumed alcohol consumption, and 8.3 and 7.5 kPa (p = 0.03) on D4 and D30, respectively, in abstinent patients. CONCLUSION: The ELF score is stable during the first months after withdrawal and thus appears to be a useful tool to assess liver fibrosis or cirrhosis in this setting. Nevertheless, because in the first week there is a transient increase in ELF score, caution in interpretation is warranted.

CT-guided percutaneous catheter drainage of acute infectious necrotizing pancreatitis: assessment of effectiveness and safety.

OBJECTIVE: The purpose of this study is to assess retrospectively the effectiveness and safety of CT-guided percutaneous drainage and to determine the factors influencing clinical success and mortality in patients with infectious necrotizing pancreatitis. MATERIALS AND METHODS: From April 1997 to December 2005, 48 consecutive patients (33 men and 15 women; median age, 58.5 years) with proven infectious necrotizing pancreatitis underwent percutaneous catheter drainage via CT guidance. Evaluated factors included clinical, biologic, and radiologic scores; drainage and catheter characteristics; and complications. Clinical success was defined as control of sepsis without requirement for surgery. Univariate analysis was performed to determine factors that could have affected the clinical success and the mortality rates. RESULTS: Clinical success was achieved in 31 of 48 patients (64.6%) and was significantly associated with Ranson score (p = 0.01) and with the delay between admission and the beginning of the drainage (p = 0.005), with a calculated threshold delay of 18 days (p = 0.001). The global mortality rate (14/48 [29%]) was also influenced by the Ranson score (p = 01) and the delay of drainage (p = 0.04) with the same threshold delay (p = 0.01). Only two major nonlethal procedure-related complications were observed. CONCLUSION: Percutaneous catheter drainage is a safe and effective technique to treat acute infectious necrotizing pancreatitis.

Effect of detoxification on liver stiffness assessed by Fibroscan® in alcoholic patients.

AIMS: The aims of this study were to determine whether alcohol consumption or cessation influences transient elastography (TE) measurements and whether TE is a useful tool to monitor alcoholic patients. PATIENTS: Twenty-three consecutive heavy drinkers (20 men and 3 women; mean age 47.2 years) admitted for a 7-day hospitalization for alcohol detoxification were included. On admission (D0), a detailed medical history was taken and the following laboratory tests were performed [aspartate aminotransferase (ASAT), gamma glutamyltransferase (γGT), and carbohydrate-deficient transferrin (CDT) levels, and Fibroscan(®)]. All examinations were repeated on D8, D30, and D60. Variation in the median Fibroscan value of >20% was considered significant. RESULTS: After 1 week of detoxification, the % variation in TE was -21.67 ± -27.6%. The median variation in TE between D8 and D60 was -20% in the abstinent group and 32% in the relapse group (p = 0.007). An increase in proportion of patients with a significant decrease in TE was observed with an increased duration of abstinence: 41.7% at D8 and 66.7% at D60. TE values were significantly correlated with ASAT, γGT, and CDT at D0 and D8, and with ASAT and γGT at D60. CONCLUSIONS: TE in alcoholics is influenced by major variations in the biochemical activity of the disease. The kinetics of variation of TE suggest that this method may be useful to assess alcohol abuse and control.

[A comparative study of coding and information systems for the evaluation of medical and social conditions: the case of addictive disorders]. / Étude comparative de systèmes de codage pour l'évaluation des situations médicales et sociales : le cas des troubles addictifs.

The purpose of this study was to conduct a descriptive and comparative analysis of the tools used by healthcare professionals specializing in addictive disorders to promote a rapprochement of information systems. The evaluation guide used to assess the compensation needs of disabled persons treated in "Maisons Départementales des Personnes Handicapées" (centres for disabled people) organizes information in different areas, including a psychological component. The guide includes social and environmental information in the "Recueil Commun sur les Addictions et les Prises en charges" (Joint Report on Drug Addiction and Drug Treatment). While the program for the medicalization of information systems includes care data, the current information about social situations remains inadequate. The international classification of diseases provides synthetic diagnostic codes to describe substance use, etiologic factors and the somatic and psychological complications inherent to addictive disorders. The current system could be radically simplified and harmonized and would benefit from adopting a more individualized approach to non-substance behavioral addictions. The international classification of disabilities provides tools for evaluating the psychological component included in the recent definition of addictive disorders. Legal information should play an integral role in the structure of the information system and in international classifications. The prevalence of episodes of care and treatment of addictive and psychological disorders was assessed at Nice University Hospital in all disciplines. Except in addiction treatment units, very few patients were found to have a RECAP file.

Glucose intolerance and hypoadiponectinemia are already present in lean patients with chronic hepatitis C infected with genotype non-3 viruses.

OBJECTIVES: Steatosis and metabolic abnormalities seem to be frequent and deleterious in chronic hepatitis C. Changes in glucose homeostasis and in adiponectin levels, an adipokine with anti-inflammatory and insulin-sensitive properties, were evaluated in patients with chronic hepatitis C according to steatosis, liver fibrosis and body mass index. METHODS: Seventy-three patients with chronic hepatitis C (40 men, 33 women) infected with genotypes non-3 and 22 healthy controls (11 men and 11 women) were included in the study and all had a biochemical evaluation, including metabolic parameters, adiponectin measurement, and a liver biopsy. Insulin sensitivity was assessed with the HOMA 1-IR insulin resistance model. RESULTS: Steatosis was found in 65.7% of the patients and significant fibrosis (METAVIR F2-F4) was present in 28.7%. The presence of steatosis could only be predicted by fibrosis, whereas significant fibrosis could be predicted by steatosis and age. Adiponectin levels were significantly decreased (-32%) with the severity of the steatosis. Although overweight chronic hepatitis C patients (body mass index>or=25 kg/m2) had insulin resistance and hypoadiponectinemia, lean chronic hepatitis C patients (body mass index<25 kg/m2) had already significantly higher glycemia and lower adiponectin levels than in controls. CONCLUSIONS: This study confirms the high incidence of steatosis in patients infected by hepatitis C virus genotypes non-3, well linked to the development of fibrosis and metabolic abnormalities. Importantly, the present findings put emphasis on the early development of these metabolic abnormalities as they were already found in lean patients with chronic hepatitis C. The direct implication of hepatitis C virus is thus further stressed in the development of steatosis and insulin resistance, with or without involvement of host factors.

Fatigue in irritable bowel syndrome: characterization and putative role of leptin.

OBJECTIVES: Fatigue has received little attention in the irritable bowel syndrome. Emerging evidence exists that leptin may be involved in the pathogenesis of fatigue in several conditions. We aimed to evaluate the occurrence of fatigue and its characteristics in irritable bowel syndrome and to analyze the relationship between fatigue and leptin. METHODS: We enrolled 51 consecutive irritable bowel syndrome patients and 22 healthy controls without fatigue. None of them were depressed. The Fatigue Impact Scale was used to evaluate fatigue. RESULTS: In all, 62.7% of irritable bowel syndrome patients verbally expressed fatigue and rated more than 4 on the visual analog scale. The total score of fatigue was significantly higher in irritable bowel syndrome than in controls. In irritable bowel syndrome patients, but not in controls, a significant association was found between the total score of fatigue and leptin and this association was more pronounced in 32 irritable bowel syndrome patients who verbally expressed fatigue (r=0.60; P=0.0003). In irritable bowel syndrome, leptin correlated with fatigue independently from age, sex, fat mass and body mass index. CONCLUSIONS: Our study shows that fatigue occurs in 62.7% of irritable bowel syndrome patients when systematically asked for. Fatigue influences all three domains of the Fatigue Impact Scale in irritable bowel syndrome, the most being the physical and the psychosocial domains. Fatigue is associated with circulating leptin levels independently from age, sex, fat mass and body mass index in irritable bowel syndrome. The metabolic sequence involved in the occurrence of fatigue remains to be determined.

Factors predictive of alcohol abstention after resident detoxication among alcoholics followed in an hospital outpatient center.

OBJECTIVES: A cohort of patient hospitalized for alcohol detoxification between January 2004 and January 2005 were followed prospectively to search for factors predictive factors of sustained abstinence. PATIENTS AND METHODS: One hundred and fifteen patients (79 males, 36 females, median age 45.9+/-10.7 years), were hospitalized for alcohol detoxification. Demographic, social, and medical data including daily alcohol intake and co-addictions were noted at inclusion and six months later. Patients who did not attend their six-month visit were contacted by phone. RESULTS: Among the 115 included patients, six month follow-up data could be collected for 73. Abstinence rate was 54.8%. Factors predictive of unsuccessful cessation were homelessness (P=0.004), duration of alcohol consumption (P=0.004), smoking (P=0.02), drug substitution (P=0.04) and multiple addictions (P=0.04). At multivariate analysis, multiple addictions was the only independent factor predictive of unsuccessful detoxification. Naltrexone or acamprosate treatments were not associated with a better rate of alcohol detoxification. CONCLUSION: Patient follow-up is problematic due to the large number of dropouts among alcoholics. Early screening in search for factors predictive of unsuccessful detoxification (long duration of alcohol consumption, multiple addiction) would be helpful in elaborating appropriate pluridisciplinary management.

[Cholestatic hepatitis: an uncommon presentation of Churg-Strauss syndrome]. / Hépatite cholestatique: une présentation inhabituelle du syndrome de Churg et Strauss.

Churg-Strauss syndrome is a rare form of severe vasculitis characterized by severe asthma and hypereosinophilia. Liver involvement is rare. We report a case of a woman with serious cholestatic hepatitis and vasculitis, without severe asthma. Marked hypereosinophilia and liver biopsy confirmed diagnosis. Churg-Strauss syndrome must be recognized because digestive involvement is very serious and affect the prognosis of this disease.

Assessment of D-Dimers for the Early Prediction of Complications in Acute Pancreatitis.

OBJECTIVES: Severe acute pancreatitis (AP) is characterized by early microcirculation defects causing hypercoagulability. The purpose of this study was to evaluate the early predictive value of D-dimers in complicated AP. METHODS: This was a prospective single-center study conducted between September 2010 and April 2012. All patients had AP for less than 48 hours duration at admission. The plasma D-dimer level was determined at admission and every 12 hours over 3 days and compared to other validated severity criteria. RESULTS: Of 71 patients admitted with AP, 36 (53.1%) developed complicated AP. A threshold D-dimer level greater than 1474 ng/mL at 48 hours after pain onset was predictive of complications with an area under the curve (AUC) of 0.76. Combining D-dimers and C-reactive protein levels at 48 hours increased the prediction of complications (AUC of 0.83). At 36 hours, D-dimers greater than 1474 ng/mL predicted the occurrence of complications with an AUC of 0.75. CONCLUSIONS: D-Dimer levels were predictive of complications of AP as early as 36 hours after the onset of pain. This simple and reproducible marker might be useful in clinical practice to improve the early management of complicated AP.

[Association of Budd-Chiari syndrome with a coeliac disease in patient native from North Africa]. / Association d'un syndrome de Budd-Chiari et d'une maladie coeliaque chez une malade originaire d'Afrique du Nord.

We report the case of a 46 year-old woman who developed a celiac disease and Budd-Chiari syndrome. No etiology for the Budd-Chiari syndrome was found. The patient was from North Africa. The long term outcome is favourable with a gluten-free diet and antivitamin K treatment.

Serum C-reactive protein: a non-invasive marker of alcoholic hepatitis.

OBJECTIVE: To determine the diagnostic accuracy of C-reactive protein (CRP) for alcoholic hepatitis in heavy drinkers. MATERIAL AND METHODS: A total of 101 heavy drinkers (67 M, 34 F) with elevated transaminase activity and negative HBsAg, anti-HCV and anti-HIV antibodies were included in the study. All patients underwent standard liver function tests, CRP determination and liver biopsies. None of the patients had signs of infection or inflammatory disease and none of them were taking antibiotics. The severity of alcoholic hepatitis was assessed semi-quantitatively using a Metavir-derived scoring system. The receiver operating curve (ROC) for CRP was constructed to assess different areas under the curve (AUCs) and the best threshold value for predicting alcoholic hepatitis (an AUC of 1.0 for an ideal test and of 0.5 for a less indicative test). RESULTS: Pathological signs of alcoholic hepatitis were found in 29 patients (30%) and significant fibrosis (F > 1) in 46 (45.1%). CRP increased significantly with the severity of acute alcoholic hepatitis (p<0.001). Total bilirubin (OR = 1.03 CI 95% (1.01-1.06), p=0.04) and CRP (OR = 1.1 CI 95% (1.02-1.19), p=0.01) were independent factors for predicting alcoholic hepatitis. The area under the ROC curve of CRP was 0.78. Using optimized cut-off values (CRP > 19 mg/L), the sensitivity, specificity, positive, negative predictive value and diagnostic accuracy were 41%, 99%, 92%, 81% and 82%, respectively. CONCLUSION: CRP is an accurate marker of alcoholic hepatitis.

Diagnostic and predictive factors of significant liver fibrosis and minimal lesions in patients with persistent unexplained elevated transaminases. A prospective multicenter study.

BACKGROUND/AIMS: In patients with unexplained elevated transaminases, prognosis of the liver disease and factors associated with increased risk of liver fibrosis and normal/subnormal liver are unknown. The aim of this prospective study was to identify diagnosis and clinical and biological factors associated with significant (bridging) fibrosis and minimal lesions of the liver in patients with persistent unexplained elevated ALT levels. METHODS: From July 2002 through October 2004, all consecutive asymptomatic patients with unexplained chronically elevated ALT levels were included. All patients had clinical, biological, ultrasonographic examination and a liver biopsy. RESULTS: 272 patients (60.3% males, mean age 46.4 years, BMI 26.7) were included. Pathological findings were: minimal lesions (18.7%), steatosis (26.8%), NASH (32.7%), and miscellaneous (21.7%). Significant fibrosis was found in 27.4% of cases, including 9 cases of cirrhosis. By multivariate analysis, independent predictors of significant fibrosis were tobacco use (OR 2.5, 95% CI 1.34-4.74 p=0.04), BMI>25 (2.49, 1.31-4.73 p=0.005) and diabetes (4.41, 1.73-11.29 p=0.002). Independent factors associated with minimal lesions were female gender (OR 3.4 95% CI 1.73-6.75 p<0.0001) and BMI<25 (3.55, 1.8-6.98, p<0.0001). CONCLUSIONS: In patients with unexplained chronically elevated transaminases, significant fibrosis is statistically associated with tobacco use, BMI>25 and diabetes, and minimal lesions are significantly associated with female gender and BMI<25.