Screening for Liver Fibrosis by Using a Noninvasive Biomarker in Patients With Diabetes
2008; Elsevier BV; Volume: 6; Issue: 7 Linguagem: Inglês
10.1016/j.cgh.2008.03.005
ISSN1542-7714
AutoresSophie Jacqueminet, Pascal Lebray, R. Morra, M. Munteanu, Laure Devers, Djamila Messous, Marine Bernard, Agnès Hartemann–Heurtier, Françoise Imbert‐Bismut, Vlad Ratziu,
Tópico(s)Hepatitis B Virus Studies
ResumoBackground & Aims: Patients with diabetes are at risk for nonalcoholic fatty liver disease leading to advanced fibrosis, cirrhosis, and liver cancer. We examined the efficacy of a screening strategy with a noninvasive fibrosis biomarker (FibroTest) in patients with diabetes. Methods: We prospectively studied 1131 consecutive patients without a history of liver disease seen for diabetes. The biomarker data were obtained, and patients with presumed advanced fibrosis were reinvestigated by a hepatologist using elastography and, if necessary, ultrasonography, endoscopy, or liver biopsy. Results: The biomarker predicted advanced fibrosis in 63 of 1131 (5.6%) patients. A total of 45 patients was reinvestigated, and advanced fibrosis was confirmed in 32 patients, a 2.8% (32/1131) prevalence of confirmed advanced fibrosis, 5 cases of cirrhosis, and 4 cases of hepatocellular carcinoma. In the population with type 2 diabetes who were 45 years or older, the prevalence of confirmed advanced fibrosis was 4.3% (30/696), and hepatocellular carcinoma was 5.7 of 1000 (4/696). Conclusions: The fibrosis biomarker might be used for the detection of advanced fibrosis in patients with type 2 diabetes. Background & Aims: Patients with diabetes are at risk for nonalcoholic fatty liver disease leading to advanced fibrosis, cirrhosis, and liver cancer. We examined the efficacy of a screening strategy with a noninvasive fibrosis biomarker (FibroTest) in patients with diabetes. Methods: We prospectively studied 1131 consecutive patients without a history of liver disease seen for diabetes. The biomarker data were obtained, and patients with presumed advanced fibrosis were reinvestigated by a hepatologist using elastography and, if necessary, ultrasonography, endoscopy, or liver biopsy. Results: The biomarker predicted advanced fibrosis in 63 of 1131 (5.6%) patients. A total of 45 patients was reinvestigated, and advanced fibrosis was confirmed in 32 patients, a 2.8% (32/1131) prevalence of confirmed advanced fibrosis, 5 cases of cirrhosis, and 4 cases of hepatocellular carcinoma. In the population with type 2 diabetes who were 45 years or older, the prevalence of confirmed advanced fibrosis was 4.3% (30/696), and hepatocellular carcinoma was 5.7 of 1000 (4/696). Conclusions: The fibrosis biomarker might be used for the detection of advanced fibrosis in patients with type 2 diabetes. See Huwart L et al on page 32 for companion article in the July 2008 issue of Gastroenterology. See Huwart L et al on page 32 for companion article in the July 2008 issue of Gastroenterology. Patients with diabetes are at risk for nonalcoholic fatty liver disease (NAFLD) leading to advanced fibrosis, cirrhosis, and liver cancer, with an increase in liver-related mortality.1Ekstedt M. Franzen L.E. Mathiesen U.L. et al.Long-term follow-up of patients with NAFLD and elevated liver enzymes.Hepatology. 2006; 44: 865-873Crossref PubMed Scopus (1728) Google Scholar, 2El-Serag H.B. Hampel H. Javadi F. The association between diabetes and hepatocellular carcinoma: a systematic review of epidemiologic evidence.Clin Gastroenterol Hepatol. 2006; 4: 369-380Abstract Full Text Full Text PDF PubMed Scopus (645) Google Scholar The aim of the study was to use a noninvasive biomarker (FibroTest [FT]; Biopredictive, Paris, France; FibroSURE in the USA, Labcorp, Burlington, NC)3Poynard T. Morra R. Halfon P. et al.Meta-analyses of Fibrotest diagnostic value in chronic liver disease.BMC Gastroenterol. 2007; 7: 40Crossref PubMed Scopus (262) Google Scholar, 4Morra R. Munteanu M. Imbert-Bismut F. et al.FibroMAX: towards a new universal biomarker of liver disease?.Expert Rev Mol Diagn. 2007; 7: 481-490Crossref PubMed Scopus (52) Google Scholar, 5Ratziu V. Massard J. Charlotte F. et al.Diagnostic value of biochemical markers (FibroTest-FibroSURE) for the prediction of liver fibrosis in patients with non-alcoholic fatty liver disease.BMC Gastroenterology. 2006; 6: 6Crossref PubMed Scopus (343) Google Scholar to identify patients with fibrosis among patients with diabetes. FT has been extensively validated with similar diagnostic value in patients with chronic hepatitis C, chronic hepatitis B, alcoholic liver disease, and NAFLD.3Poynard T. Morra R. Halfon P. et al.Meta-analyses of Fibrotest diagnostic value in chronic liver disease.BMC Gastroenterol. 2007; 7: 40Crossref PubMed Scopus (262) Google Scholar, 4Morra R. Munteanu M. Imbert-Bismut F. et al.FibroMAX: towards a new universal biomarker of liver disease?.Expert Rev Mol Diagn. 2007; 7: 481-490Crossref PubMed Scopus (52) Google Scholar, 5Ratziu V. Massard J. Charlotte F. et al.Diagnostic value of biochemical markers (FibroTest-FibroSURE) for the prediction of liver fibrosis in patients with non-alcoholic fatty liver disease.BMC Gastroenterology. 2006; 6: 6Crossref PubMed Scopus (343) Google Scholar In a retrospective study in hyperlipidemic patients, the prevalence of presumed fibrosis by using FT was 6% in patients with type 2 diabetes.6Ratziu V. Giral P. Munteanu M. et al.Screening for liver disease using non-invasive biomarkers (FibroTest-SteatoTest-NashTest-FibroSURE) in patients with hyperlipidaemia.Aliment Pharmacol Ther. 2007; 25: 207-218Crossref PubMed Scopus (54) Google Scholar Consecutive patients with confirmed diabetes were eligible for inclusion. All procedures were followed in accordance with the current revised guidelines of the Declaration of Helsinki, and all reinvestigated participants gave informed consent. Patients with high-risk profiles of false-negatives/positives for FT were excluded by using security algorithms.7Imbert-Bismut F. Messous D. Thibault V. et al.Intralaboratory analytical variability of biochemical markers of fibrosis (Fibrotest) and activity (Actitest) and reference ranges in healthy blood donors.Clin Chem Lab Med. 2004; 42: 323-333PubMed Scopus (0) Google Scholar Patients with presumed fibrosis were reinvestigated by a single hepatologist including a liver elastography (Fibroscan, Echosens, Paris) and, if necessary, ultrasonography, esophageal endoscopy, or liver biopsy. The analysis was performed in 2 populations, patients without any previous history of liver disease (the naïve population) and patients with a history of liver disease (non-naïve population), used only for the FT validation. A control group was prospectively made up of blood donors to estimate the specificity of FT. FT includes α2-macroglobulin, apolipoprotein A1, haptoglobin, total bilirubin, and γ-glutamyltranspeptidase (GGT), adjusted for age and gender. FT scores range from zero to 1.00.3Poynard T. Morra R. Halfon P. et al.Meta-analyses of Fibrotest diagnostic value in chronic liver disease.BMC Gastroenterol. 2007; 7: 40Crossref PubMed Scopus (262) Google Scholar, 4Morra R. Munteanu M. Imbert-Bismut F. et al.FibroMAX: towards a new universal biomarker of liver disease?.Expert Rev Mol Diagn. 2007; 7: 481-490Crossref PubMed Scopus (52) Google Scholar Fibrosis (many septa, numerous septa, or cirrhosis) was predicted when FT was greater than 0.48, as in all chronic liver diseases, and defined a priori.3Poynard T. Morra R. Halfon P. et al.Meta-analyses of Fibrotest diagnostic value in chronic liver disease.BMC Gastroenterol. 2007; 7: 40Crossref PubMed Scopus (262) Google Scholar, 4Morra R. Munteanu M. Imbert-Bismut F. et al.FibroMAX: towards a new universal biomarker of liver disease?.Expert Rev Mol Diagn. 2007; 7: 481-490Crossref PubMed Scopus (52) Google Scholar, 7Imbert-Bismut F. Messous D. Thibault V. et al.Intralaboratory analytical variability of biochemical markers of fibrosis (Fibrotest) and activity (Actitest) and reference ranges in healthy blood donors.Clin Chem Lab Med. 2004; 42: 323-333PubMed Scopus (0) Google Scholar The biomarker components were analyzed according to published recommendations.8Gomez-Dominguez E. Mendoza J. Rubio S. et al.Transient elastography: a valid alternative to biopsy in patients with chronic liver disease.Aliment Pharmacol Ther. 2006; 24: 513-518Crossref PubMed Scopus (94) Google Scholar Liver stiffness is expressed in kilopascals (kPa). The technique was performed by a trained hepatologist who was blinded and according to the manufacturer's recommendations. When less than 10 successful acquisitions were possible or with a less than 60% success rate or with interquartile range greater than 30% of the mean stiffness, the technique was considered noninterpretable.8Gomez-Dominguez E. Mendoza J. Rubio S. et al.Transient elastography: a valid alternative to biopsy in patients with chronic liver disease.Aliment Pharmacol Ther. 2006; 24: 513-518Crossref PubMed Scopus (94) Google Scholar Advanced fibrosis was presumed when FT was greater than 0.48 and confirmed if elastography was above 6 kPa (a sensitivity analysis was performed with a higher cutoff of 7.0 kPa), if ultrasonography demonstrated signs of cirrhosis (dysmorphia, splenomegaly, patent umbilical vein), there were endoscopic signs of portal hypertension (esophageal varices, gastropathy), or fibrosis was demonstrated on liver biopsy. The Fisher exact, Mann-Whitney, Bonferroni, and Tukey-Kramer tests and logistic regression were used. Number Cruncher Statistical Systems 2007 software (NCSS, Kaysville, UT) was used. One thousand two hundred sixty-one patients were eligible; 74 were excluded because of high-risk profiles of false-positives or false-negatives, duplicate submissions, or unconfirmed diabetes. Among the 1187 included patients, 1131 had no history of liver disease, and 56 had a history of liver disease; 925 blood donors were included (Table 1).Table 1Characteristics of Included PatientsCharacteristicsIncluded diabetics, naïve populationIncluded diabetics, non-naïve populationIncluded controlsNumber of patients113156925Age at serum, y53.8 (14.8)58.3 (10.4)35.7 (12.3)Male602 (53%)35 (63%)457 (49%)BMI, kg/m228.2 (6.1)28.3 (5.8)23.4 (3.2)Daily alcohol ≥30 g/day48 (4%)1 (2%)6/923 (0.6%)Liver fibrosis predicted by FT No advanced fibrosis1068 (95%)21 (38%)925 (100%) F0: no fibrosis799 (71%)6 (11%)856 (92%) F0–F1104 (9%)5 (9%)37 (4%) F1: fibrosis without septa45 (4%)2 (4%)16 (2%) F1–F2120 (11%)8 (14%)16 (2%) Advanced fibrosisaAdvanced fibrosis was presumed when FibroTest was greater than 0.48.63 (5.6%)35 (62%)0 (0%) F2: few septa36 (3.2%)5 (9%)0 (0%) F3: many septa19 (1.7%)9 (16%)0 (0%) F4: cirrhosis8 (0.7%)21 (37%)0 (0%)Markers (normal range) AST, IU/L (17–27 female, 20–32 male)26 (12)54 (37)24 (6) ALT, IU/L (11–26 female, 16–35 male)29 (22)64 (59)23 (13) Total bilirubin, mol/L (1–21)8.8 (4.58)15.4 (16.5)8.2 (4.2) GGT, U/L (7–32 female, 11–49 male)41 (56)159 (172)21 (15) Alpha2-macroglobulin, g/L (female 1.6–4.0, male 1.4–3.3)1.8 (0.7)2.7 (0.9)1.7 (0.5) Apolipoprotein A1, g/L (1.2–1.7)1.6 (0.3)1.4 (0.3)1.6 (0.3) Haptoglobin, g/L (0.35–2.00)1.4 (0.6)1.0 (0.7)1.0 (0.4) Glucose (mmol/L)9.6 (4.0)8.6 (3.0)5.4 (2.4) Cholesterol (mmol/L)4.9 (1.1)4.6 (1.0)4.9 (1.0) Triglycerides (mmol/L)1.5 (1.7)1.9 (1.9)1.1 (0.7)FibroTest0.18 (0.15)0.58 (0.28)0.10 (0.07)SteatoTest0.13 (0.12)0.39 (0.27)0.17 (0.16)Data are mean (standard deviation) or proportion.a Advanced fibrosis was presumed when FibroTest was greater than 0.48. Open table in a new tab Data are mean (standard deviation) or proportion. Among the 1131 patients in the naïve population, 63 (5.6%; 95% confidence interval [CI], 4.3%–7.1%) had an FT with presumed fibrosis (Table 2).Table 2Characteristics of 63 Diabetic Patients With FT >0.48 (Presumed Advanced Fibrosis) in the Population Without a History of Liver Disease (Naïve Patients)All presumed advanced fibrosisReinvestigatedNot reinvestigatedCharacteristicsAdvanced fibrosis confirmedAdvanced fibrosis not confirmedNumber of patients63321318Prevalence of advanced fibrosis63/1131 (5.6%)32/1131 (2.8%)(32 + 13)/1131 (4.0%)aEstimated prevalence assuming that the prevalence of advanced fibrosis would be the same in the population of patients not reinvestigated.Cause of liver disease NAFLD50221216 Chronic hepatitis C2200 Alcoholic liver disease7511 Primary biliary cirrhosis1100 Autoimmune hepatitis2101 Neuroendocrine metastasis1100Liver complications HCC4400 Cholangiocarcinoma1100 Portal hypertension2200Stage advanced fibrosis predictedbAdvanced fibrosis was presumed when FT was greater than 0.48. Few septa3617811 Many septa191045 Cirrhosis8512Mode of confirmation Elastography4030120 Biopsy2200 Endoscopy3210 Ultrasonography9540a Estimated prevalence assuming that the prevalence of advanced fibrosis would be the same in the population of patients not reinvestigated.b Advanced fibrosis was presumed when FT was greater than 0.48. Open table in a new tab Forty-five patients were reinvestigated, and fibrosis was confirmed in 32 (71%) by elastography, biopsy, or endoscopy. Five patients had cirrhosis. Five patients had a primary liver cancer: 4 hepatocellular carcinoma (HCC) and 1 cholangiocarcinoma. Two patients had large varices. There was no clinically obvious cirrhosis, and standard liver tests have been interpreted as NAFLD profile; none of them had an APRI index above 2.0. Elastography was not interpretable in 6 cases out of 40 measurements (15%). In intention to diagnose, the prevalence of fibrosis screened was 2.8% (95% CI, 1.9%–4.0%), and the positive predictive value (PPV) was 50.8% (95% CI, 37.9%–63.6%). In per protocol analysis, assuming that 71% of the noninvestigated patients would have confirmed fibrosis, the prevalence of fibrosis screened would be 4.0% (95% CI, 2.9%–5.3%), and the PPV would be 68.3% (95% CI, 55.3%–79.4%). A sensitivity analysis taking 7 kPa as the optimal cutoff would have obtained a prevalence of 2.5% in intention to diagnose and 3.6% in per protocol analysis. Among the 56 patients of the non-naïve population, 35 (63%) had an FT with presumed fibrosis; 32 patients were reinvestigated, and the presumed fibrosis was confirmed in all 32 (100%). No presumed fibrosis was identified in blood donors. Multivariate analysis identified 3 major risk factors of confirmed fibrosis: age (odds ratio [OR], 1.06; 95% CI, 1.02–1.10; P = .001), male gender (OR, 4.2; 95% CI, 1.6–11.1; P = .004), and type 2 diabetes (OR, 5.8; 95% CI, 0.8–45.0; P = .08). Among patients of the naïve population with type 2 diabetes and aged 45 years or older, the prevalence of confirmed fibrosis was 4.3% (95% CI, 2.9%–6.1%) (30/696), presumed fibrosis was 7.5% (95% CI, 5.6%–9.7%) (52/696), and HCC was 5.7 of 1000 (95% CI, 1.7/1000–14.6/1000 (4/696). Among the 30 confirmed cases of fibrosis in the naïve population, 8 had GGT lower than 50 IU/mL (27% false-negatives), and 182 of 1070 in the presumed nonfibrosis group had greater than 50 IU/mL (17% false-positives); 20 patients with confirmed fibrosis had ALT lower than 50 IU/mL (67% false-negatives), and 87/1070 in the presumed nonfibrosis group had greater than 50 IU/mL (8% false-positives). This prospective study identifies patients with fibrosis and primary liver cancers in a large number of diabetic patients. The major shortcomings of this study are the failure to use liver biopsy to confirm positive test results and the failure to evaluate fibrosis in patients who tested negatively by FT. Several points support our methodology. First, most of the patients with chronic liver disease refused liver biopsy.9Castera L. Denis J. Babany G. et al.Evolving practices of non-invasive markers of liver fibrosis in patients with chronic hepatitis C in France: time for new guidelines?.J Hepatol. 2007; 46: 528-529Abstract Full Text Full Text PDF PubMed Scopus (87) Google Scholar Second, liver biopsy is an imperfect gold standard with a high sampling error.10Ratziu V. Charlotte F. Heurtier A. et al.Sampling variability of liver biopsy in nonalcoholic fatty liver disease.Gastroenterology. 2005; 128: 1898-1906Abstract Full Text Full Text PDF PubMed Scopus (1438) Google Scholar Around 50% of discordances between FT and biopsy can be attributable to biopsy failure.7Imbert-Bismut F. Messous D. Thibault V. et al.Intralaboratory analytical variability of biochemical markers of fibrosis (Fibrotest) and activity (Actitest) and reference ranges in healthy blood donors.Clin Chem Lab Med. 2004; 42: 323-333PubMed Scopus (0) Google Scholar, 11Poynard T. Munteanu M. Imbert-Bismut F. et al.Prospective analysis of discordant results between biochemical markers and biopsy in patients with chronic hepatitis C.Clin Chem. 2004; 50: 1344-1355Crossref PubMed Scopus (278) Google Scholar Third, even if all the misclassified subjects were attributable to FT, the negative predictive value of FT at the 0.48 threshold is still high; among patients with NAFLD, we previously observed a 0.88 negative predictive value.5Ratziu V. Massard J. Charlotte F. et al.Diagnostic value of biochemical markers (FibroTest-FibroSURE) for the prediction of liver fibrosis in patients with non-alcoholic fatty liver disease.BMC Gastroenterology. 2006; 6: 6Crossref PubMed Scopus (343) Google Scholar We acknowledge that an evaluation with elastography of the patients with FT below the 0.48 threshold would have improved the study. We also acknowledge that the control group was not useful for estimating false-negatives of FT. However, the risk of false-negatives seems low, because several comparisons, independent from FT inventors, have observed that FT is the most sensitive fibrosis biomarker.3Poynard T. Morra R. Halfon P. et al.Meta-analyses of Fibrotest diagnostic value in chronic liver disease.BMC Gastroenterol. 2007; 7: 40Crossref PubMed Scopus (262) Google Scholar Fourth, the PPV of FT in the present study was similar to that previously observed with biopsy.3Poynard T. Morra R. Halfon P. et al.Meta-analyses of Fibrotest diagnostic value in chronic liver disease.BMC Gastroenterol. 2007; 7: 40Crossref PubMed Scopus (262) Google Scholar, 5Ratziu V. Massard J. Charlotte F. et al.Diagnostic value of biochemical markers (FibroTest-FibroSURE) for the prediction of liver fibrosis in patients with non-alcoholic fatty liver disease.BMC Gastroenterology. 2006; 6: 6Crossref PubMed Scopus (343) Google Scholar The PPV of FT was 71% among the naïve patients and 100% among non-naïve patients. The high specificity of FT was also confirmed without FT greater than 0.48 among blood donors. Fifth, elastography can be considered as an acceptable validation method in a screening strategy. Health authorities in France have approved elastography in patients with chronic hepatitis C.12La Haute Autorité de Santé (HAS) in FranceThe HAS recommendations for the management of the chronic hepatitis C using non-invasive biomarkers.http://www.has-sante.fr/portail/display.jsp?id=c_5443&pcid=c_5443Google Scholar Several published results validated elastography in NAFLD, despite a lower reproducibility in patients with steatosis, increased body mass index, and lower stage of fibrosis.13Foucher J. Castera L. Bernard P.H. et al.Prevalence and factors associated with failure of liver stiffness measurement using FibroScan in a prospective study of 2114 examinations.Eur J Gastroenterol Hepatol. 2006; 18: 411-412Crossref PubMed Scopus (316) Google Scholar FT has limitations. Less than 5% of FT are not interpretable, mainly related to Gilbert's syndrome, hemolysis, and acute sepsis,3Poynard T. Morra R. Halfon P. et al.Meta-analyses of Fibrotest diagnostic value in chronic liver disease.BMC Gastroenterol. 2007; 7: 40Crossref PubMed Scopus (262) Google Scholar, 4Morra R. Munteanu M. Imbert-Bismut F. et al.FibroMAX: towards a new universal biomarker of liver disease?.Expert Rev Mol Diagn. 2007; 7: 481-490Crossref PubMed Scopus (52) Google Scholar, 7Imbert-Bismut F. Messous D. Thibault V. et al.Intralaboratory analytical variability of biochemical markers of fibrosis (Fibrotest) and activity (Actitest) and reference ranges in healthy blood donors.Clin Chem Lab Med. 2004; 42: 323-333PubMed Scopus (0) Google Scholar which is lower than elastography, which is not interpretable in 15% of cases. The population studied was a population of diabetic patients seen in a tertiary care center. However, all the patients identified in the naïve population had no history and no clinical sign of chronic liver disease. FT has similar diagnostic value than biopsy in the most frequent chronic liver diseases.3Poynard T. Morra R. Halfon P. et al.Meta-analyses of Fibrotest diagnostic value in chronic liver disease.BMC Gastroenterol. 2007; 7: 40Crossref PubMed Scopus (262) Google Scholar In France FT is approved and used by 81% of hepatologists.10Ratziu V. Charlotte F. Heurtier A. et al.Sampling variability of liver biopsy in nonalcoholic fatty liver disease.Gastroenterology. 2005; 128: 1898-1906Abstract Full Text Full Text PDF PubMed Scopus (1438) Google Scholar, 12La Haute Autorité de Santé (HAS) in FranceThe HAS recommendations for the management of the chronic hepatitis C using non-invasive biomarkers.http://www.has-sante.fr/portail/display.jsp?id=c_5443&pcid=c_5443Google Scholar Most previous small studies focused on nonalcoholic steatohepatitis, with prevalence of fibrosis at biopsy ranging from 10%–57%.14Younossi Z.M. Gramlich T. Matteoni C.A. et al.Nonalcoholic fatty liver disease in patients with type 2 diabetes.Clin Gastroenterol Hepatol. 2004; 2: 262-265Abstract Full Text Full Text PDF PubMed Scopus (304) Google Scholar With FT we observed 5.6% cases of presumed fibrosis, including 2.8% cases of confirmed fibrosis. We observed a very high prevalence of HCC in the naïve population, 3.5 of 1000, in accordance with published meta-analysis.2El-Serag H.B. Hampel H. Javadi F. The association between diabetes and hepatocellular carcinoma: a systematic review of epidemiologic evidence.Clin Gastroenterol Hepatol. 2006; 4: 369-380Abstract Full Text Full Text PDF PubMed Scopus (645) Google Scholar A cholangiocarcinoma was also identified, an association previously suspected.15Shaib Y.H. El-Serag H.B. Davila J.A. et al.Risk factors of intrahepatic cholangiocarcinoma in the United States: a case-control study.Gastroenterology. 2005; 128: 620-626Abstract Full Text Full Text PDF PubMed Scopus (436) Google Scholar Indirectly, FT seems effective in the detection of HCC because the majority occurs in patients with cirrhosis. We confirmed that the rates of false-negatives and false-positives of transaminases and GGT were too high for screening purposes.5Ratziu V. Massard J. Charlotte F. et al.Diagnostic value of biochemical markers (FibroTest-FibroSURE) for the prediction of liver fibrosis in patients with non-alcoholic fatty liver disease.BMC Gastroenterology. 2006; 6: 6Crossref PubMed Scopus (343) Google Scholar, 6Ratziu V. Giral P. Munteanu M. et al.Screening for liver disease using non-invasive biomarkers (FibroTest-SteatoTest-NashTest-FibroSURE) in patients with hyperlipidaemia.Aliment Pharmacol Ther. 2007; 25: 207-218Crossref PubMed Scopus (54) Google Scholar We also observed for NAFLD score16Angulo P. Hui J.M. Marchesini G. et al.The NAFLD fibrosis score: a noninvasive system that identifies liver fibrosis in patients with NAFLD.Hepatology. 2007; 45: 846-854Crossref PubMed Scopus (1828) Google Scholar a low sensitivity for confirmed fibrosis: 12 (57%) false-negatives among 28 naïve patients and 18 false-negatives (80%) among 20 non-naïve patients, as already observed.17Munteanu M. Charlotte F. Ratziu V. et al.Direct comparison of two non invasive biomarkers for the diagnosis of advanced fibrosis in patients with non alcoholic fatty liver disease (NAFLD): NAFLD score and FibroTest.Hepatology. 2007; 46: 748AAbstract Full Text Full Text PDF Scopus (1) Google Scholar A screening program should not be considered unless there is an effective therapeutic option. Two screened patients with cirrhosis and large varices were treated with beta-blockers to prevent bleeding; 1 patient with HCC has been successfully treated with radiofrequency and is waiting for a liver transplant. We recognize that for 3 patients with HCC the cancer was already not treatable by surgery. Patients for whom the screening permitted to diagnose hepatitis C, autoimmune hepatitis, and primary biliary cirrhosis received the appropriate treatments. Patients with fibrosis and NAFLD represented 25 of 30 patients with confirmed fibrosis, but new drugs are being investigated with promising results for those with NAFLD. This study suggests that screening diabetic patients with biomarkers such as FT is effective. A high-risk population was identified, which was patients aged 45 years or older with type 2 diabetes. External validation studies are necessary to replicate these results and better estimate the cost-efficiency of such screening.
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