Abstract
Background and ObjectivesSerum alanine aminotransferase (ALT) activity is the most common tool for the assessment of liver diseases. However, it is not clear whether the current normal ALT range really discriminate patients with or without liver diseases. The present study was to establish a new normal range of ALT and examine its ability to identify patients with hepatitis B or nonalcoholic fatty liver disease (NAFLD) in Chinese Han population.Methods53037 adults were included in this study from January 1st 2008 to August 31st 2010. The 95th percentile of ALT in population with relative low risk factors for liver diseases was set as the new upper limits of normal ALT in gender-specific manner.ResultsThe 95th percentile levels at low risk factors for liver diseases were achieved at 35 U/L for men and 23 U/L for women. The concordance statistics for detection were 0.873 (95%CI: 0.865–0.881) for HBV and 0.932 (95%CI: 0.927–0.937) for NAFLD in men while 0.857 (95%CI: 0.850–0.864) for HBV and 0.909 (95%CI: 0.903–0.915) for NAFLD in women. The median sensitivity of the current used ALT upper limit (40 U/L) was 6.6% for HBV and 29.7% for NAFLD and median specificity was 98.7% for men and 99.4% for women. Using our new-derived thresholds, the sensitivities ranged from 35.3% to 61.1% and the specificities were 94.8% for men and 94.6% for women.ConclusionsOur results suggest that upper limits of ALT 35 U/L for men and 23 U/L for women in Chinese Han population. Re-consideration of normal limits of ALT should be recommended.Trial RegistrationChiCTR.org ChiCTR-OCS-11001173
Highlights
Serum alanine aminotransferase (ALT) concentration is the most widely used tool for the assessment of liver diseases
The upper limit of normal ALT has been re-evaluated in different countries by involving different age groups
These studies suggested that the upper limit of normal ALT should be revised and the recommendations are 30 U/L for men and 19 U/L for women respectively [4,5,6,7]
Summary
Serum alanine aminotransferase (ALT) concentration is the most widely used tool for the assessment of liver diseases. In the treatment of viral hepatitis, ALT is always used for screening the subjects who need anti-viral therapy [1,2,3] It is still not well demonstrated whether the current used ULN standard of ALT is appropriate for clinical events. The upper limit of normal ALT has been re-evaluated in different countries by involving different age groups. Serum alanine aminotransferase (ALT) activity is the most common tool for the assessment of liver diseases. It is not clear whether the current normal ALT range really discriminate patients with or without liver diseases. The present study was to establish a new normal range of ALT and examine its ability to identify patients with hepatitis B or nonalcoholic fatty liver disease (NAFLD) in Chinese Han population
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