Prognostic evaluation in cirrhosis.
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Biomedical subjects
Publications and source records attributed to T Poynard.
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The aim of the study was to determine whether the number of Nd:YAG laser sessions necessary to produce the maximal endoscopic effect was different with the noncontact method using the coaxial fiber than with the contact method using the naked fiber inserted into the tumor. Over a 6-month period, 40 consecutive patients were treated for esophageal and rectal cancers or for benign tumors too large to be removed with a diathermy snare. All of the patients who were offered this treatment had been assessed as unsuitable for surgery and radiotherapy. Twenty patients were randomly assigned to the coaxial fiber group and 20 patients to the naked fiber group. Before treatment, patients in the two groups were not different with respect to age, sex, kind of tumor, contraindication for surgery and radiotherapy, luminal patency, and tumor circumferential extent. At the end of the treatment, the endoscopic score, the transit score, and the evolution of rectal hemorrhage and mucous secretions were not different between the two groups. The number of treatments required to achieve the maximal endoscopic benefit was 6.7 +/- 4.9 (range, 2 to 20) (median = 5) in the coaxial fiber group and 3.4 +/- 1 (range, 2 to 5) (median = 3) in the naked fiber group (p = 0.01). Treatment tolerance and complications were not different between the two groups, but the financial cost related to the fiber was lower in the naked fiber group than in the coaxial fiber group. Therefore, we recommend the contact method using the naked fiber inserted into the tumor in endoscopic Nd:YAG laser therapy for gastrointestinal tumors.
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The follow up of patients with chronic liver diseases and the data from multicentric clinical studies are affected by the variability of assay results for the same parameter between the different laboratories. Today, the main objective in clinical chemistry throughout the world is to harmonise the assay results between the laboratories after the confirmation of their traceability, in relation to defined reference systems. In this context, the purpose of our study was to verify the homogeneity of haptoglobin, apolipoprotein A1, total bilirubin, GGT activity, ALAT activity results, which are combined in Fibrotest and Actitest, between Dimension Analysers RXL, ARX and X-PAND (Dade Behring Society). Moreover, we verified the transferability of Fibrotest and Actitest results between the RXL, and either the BN2 (haptoglobin and apolipoprotein A1) or the Modular DP (total bilirubin, GGT and ALAT activity concentrations). The serum samples from 150 hospitalised patients were analysed on the different analysers. Specific protein assays were calibrated using solutions standardised against reference material on Dimension and BN2 analysers. Total bilirubin assays were performed by a diazoreaction on Dimension and Modular DP analysers. The GGT and ALAT activity measurements on the Dimension analysers were performed in accordance with the reference methods defined by the International Federation of Clinical Chemisty and Laboratory Medicine (IFCC). On the Modular, enzyme activity measurements were performed according to the Szasz method (L-gamma- glutamyl-4-nitroanilide as substrate) modified by Persijn and van der Slik (L-gamma- glutamyl-3-carboxy- 4-nitroanilide as substrat) for GGT and according to the IFCC specifications for ALAT. The methods of enzymatic activity measurement were calibrated on the Modular only. Liver fibrosis and necroinflammatory activity indices were determined using calculation algorithms, after having adjusted each component's result of Fibrotest and Actitest for gender and age. Our study has shown, for each parameter, harmonious results between the Dimension analysers and between RXL and BN2- Modular DP. Disregarding alpha-2 macroglobulin which cannot be assayed on RXL, the results of Fibrotest and Actitest were similar as performed on BN2- Modular DP and RXL.
BACKGROUND: Alpha2Macroglobulin (A2M) measure showed a revival since it was introduced into FibroTest-ActiTest-Fibro (FT-AT-Fibro) algorithm. More often than not, this assay is performed in immunonephelemetry. Progresses in the comprehension of fibrosis dynamics and better treatment efficacy follow-up will increase FT-AT-Fibro prescriptions. Despite efforts to standardize methods of enzymatic activity measure and proteins measure, we still observe important interlaboratory and intersystem variability. AIM: The primary aim of the study is to validate immunoturbidimetric measure of A2M on Modular P and Cobas Integra analysers (Roche Diagnostics) in utility channel using DakoCytomation reagents in order to extend the analytical system range allowed to measure A2M. The secondary aim of the study is to verify transferability of the six FT-AT composants (A2M, haptoglobin, apolipoprotein A1, total bilirubin, GGT and ALT) to Roche Diagnostics equipment by comparing with results measured on the reference system. RESULTS: A2M measures (n = 146) showed linearity, repetitiveness and were reproducible. Readjustments to adapt A2M measures were required. A corrector factor of 0.84 for Modular P and of 0.87 for Cobas Integra was introduced in order to readjust the immunoturbidimetric method to the immunonephelemetric method. The rationale of proposed corrector factors is based on the use of Dade Behring and DakoCytomation reagents (antisera and calibrant). Biologist vigilance is required to point out modifications or variations in reagents that could be done by the company. The six parameters results transferability from the reference system to Roche Diagnostics was demonstrated by statistic analysis. FT-AT showed excellent correlations to the reference system for Modular P and Cobas Integra analysers. In this study no difference more than 0.11 was recorded and only few subjects had differences between 0.05 and 0.10. Therefore this very low inter-analysers variability has no significant clinical impact. CONCLUSION: This study showed that the analytical system made of Modular P, Cobas Integra, Roche Diagnostics and DakoCytomation reagents can be used for FibroTest-ActiTest-Fibro parameters assessment. Their statistical and clinical variability were acceptable compared to the reference system.
Among 471 healthy Antoine Béclère hospital workers, (61 male, 410 female) 386 with no serological markers for hepatitis B virus (HBV) received three intramuscular doses of HEVAC B at intervals of 1 month. Ninety-three p. cent of vaccine recipients showed good antibody anti-HBs levels after the third injection. Fifty p. cent of subjects with no response after the third dose seroconverted after a booster dose. Vaccine responders' mean age (30 years) was lower than vaccine non responders' mean age (36 years). Anti-HBs antibody levels were significantly higher in women (P less than 0.001) and were independently correlated with age and sex. Two vaccine recipients developed anti-HBc in addition to anti-HBs, probably due to an HBV infection that occurred just before vaccination.
The aim of this study was to describe the clinical and endoscopic signs, the nutritional status, the consumption of alcohol and tobacco, and other associated factors in a population of 1,800 patients with endoscopically proven gastric (n = 501) or duodenal ulcer (n = 1235) and then to identify the risk factors in comparison to the French population. Patients with gastric ulcer were older, more often widowed if male, otherwise more often female, were more frequently treated by non-steroid drugs, and had a lipid-rich nutrition more often in comparison to patients with duodenal ulcers. Patients with duodenal ulcer were more often native from the Magreb and their nutrition was more often rich in spices in comparison to patients with gastric ulcer. The associations between use of non-steroidal drugs and consumption of spices disappeared after adjustment by multidimensional analysis. Patients with duodenal ulcer lived more frequently in the Ile de France area in comparison to patients with gastric ulcer. Patients with gastric ulcer worked more often as farmers in comparison to patients with duodenal ulcer and in comparison to the total French population. These differences remained after adjustment. The consumption of tobacco was higher in patients with gastric or duodenal ulcer in comparison to the mean consumption of the total French population.
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A group of 249 patients with alcoholic cirrhosis was prospectively studied in order to assess the prognostic value of 23 clinical and biochemical factors. Methods included the Cox model completed with validation by assessing the proportionality and by comparing the estimated and observed results, a study of the influence on the results of the truncated data and the factors with non normal distribution, and an expression of the results using predictive values. Results showed that encephalopathy, age, serum albumin and total bilirubin concentrations and serum gamma glutamyl transpeptidase activity had an independent prognostic value. The Cox model was validated and results showed that taking into account the truncated data and the non normal distribution modified the results. An index using the five independent prognostic factors had a good negative predictive value, permitting to predict, in one third of the patients, survival i. e. which patient had a probability to be alive at two years greater than 90 p. 100.
From 1974 to 1981, 55 patients, 18 with Zollinger-Ellison syndrome (ZES) histologically confirmed and 37 patients with duodenal ulcer (DU) without pylorostenosis were followed for a minimal period of 5 years. The diagnostic values of a) basal acid output (BAO mEq/h); b) 60 min acid output after secretin infusion, 3 CU-GIH/kg, (MAO-SE mEq/h); c) basal serum gastrin (BSG pg/ml: mean of 4 gastrin determinations) and d) serum gastrin after secretin (SG-SE pg/ml: mean of 4 gastrin determinations during secretin infusion) were calculated. Cut off point values of 100 p. 100 specificity (i. e. no DU patient reached these values) with a positive predictive value of 100 p. 100 (i. e. probability for gastrinoma when this cut off point was attained) were BAO greater than 26 mEq/h, MAO-SE greater than 18 mEq/h, BSG greater than 221 pg/ml, SG-SE greater than 186 pg/ml. The sensitivities of these parameters (i. e. percent of ZES which reached the given cut off point) were respectively (p. 100): 39, 78, 72 and 94. Ranking these parameters according to their own discriminative value expressed by R2 (square correlation coefficient) gave SG-SE, R2 = 0.559; BSG, R2 = 0.508; MAO-SE, R2 = 0.456; BAO, R2 = 0.414. The most discriminative association of 2 variables was SG-SE and MAO-SE (R2 = 0.650). Association of SG-SE, MAO-SE and BAO or BSG (or BAO and BSG) did not increase significantly the discrimination between ZES and DU (R2 = 0.672).
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The aim of this study was to report results of endoscopic YAG laser therapy in palliative treatment of esophageal and cardial carcinoma. Twenty-eight patients were treated: 9 with adenocarcinoma and 19 with squamous cell carcinoma. Among these patients, 9 had complete aphagia; radiotherapy was contraindicated in 17; in the remaining 2 patients the aim of laser therapy was to achieve sufficient luminal enlargement to allow the endoscopic insertion of a prothesis. Dysphagia improved in 24 cases; destruction of a major portion of the intraluminal tumor was achieved in 17 patients, and incomplete destruction was possible in 9 patients. In one case, the treatment had no effect. Among 22 subjects in maintenance treatment, 13 good results were obtained. Several complications of laser therapy were observed: 2 cases of minor bleeding, 2 cases of esophagitis and 1 perforation of the upper esophagus. The patient died after surgical operation. It is concluded that endoscopic YAG laser therapy for palliative treatment of esophageal and cardial carcinoma is effective, providing rapid improvement of dysphagia. Maintenance treatment is necessary to sustain the improvement. Randomized studies are now needed to compare endoscopic laser therapy with other palliative treatment of malignant tumors of the upper gastrointestinal tract.
The assessment of diagnostic technologies, concerns today both clinicians and health care administrators. This assessment is based upon calculation of various indices measuring the informative value of diagnostic test: sensitivity, specificity, accuracy, predictive value. Despite their extreme semplicity, these indices can be misinterpreted and misused; in addition they are often calculated from very particular patients sample, especially when retrospective data are used. The main points which influence the value confered to a diagnostic test, the major bias to avoid designing such studies are pointed out this paper. The likeness between controlled therapeutic trial and comparative assessment of diagnostic technologies is particularly emphasized.
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Ascites is an uncommon feature of hypothyroidism. We report two patients with hypothyroidism revealed by ascites. Among the 44 myxedema ascites cases found in the literature, there were observed 17 cases of ascites as the first manifestation of hypothyroidism. In this rare presentation of hypothyroidism, diagnosis is often delayed. Biological analysis of ascites usually shows high protein and cholesterol concentrations and a low or high cell count with a high proportion of lymphocytes. An increase in capillary permeability may play a role in the pathogenesis of ascites.
AIM: To assess the benefit risk ratio of interferon and ribavirin in the treatment of patients with post hepatitis C cirrhosis we summarize the spontaneous over mortality of this disease, and made an overview of the randomized trials and of other controlled studies. RESULTS: In comparison to controls, patients with post hepatitis C cirrhosis have a 17 fold increase risk of dying from a liver disease that a control population, and a 6 fold increase from primary liver cancer. In France the hepatitis C epidemic which start in the sixties explains now the observed dramatic increase in mortality by primary liver cancer, both in men and women. Meta-analysis of randomized trials and controlled retrospective studies showed that interferon treatment is associated with a significant increase in ALT response at the end of the treatment, with a decrease in hepatocellular incidence as well as a decrease in mortality in comparison with controls. Very few data are published concerning ribavirin alone or in combination with interferon in patients with cirrhosis. Preliminary data suggest that this combination during 48 weeks permit to obtain in patients with compensated cirrhosis 20% of sustained virological response. The safety was acceptable but patients with low initial blood cells count must be carefully followed. In conclusion this overview clearly demonstrates a benefit-risk ratio in favor of treatment in patients with post hepatitis C cirrhosis by interferon.