The Development of a Screening Tool for the Risk of Hepatotoxicity Prediction in Patients Receiving Anti-tuberculosis Agents

Abstract

The purpose of this study was to investigate the incidences and factors affecting the hepatotoxicity related to anti-tuberculosis agents. The development of a screening tool included the risk factors of liver toxicity prediction in patients receiving anti-tuberculosis agents.

This research was a two-month prospective cohort study within 5 hospitals in the northeast of Thailand. This study was conducted from March 2010 to May 2011. Bivariate analysis of each variable was performed, followed by multivariate analysis of those with statistical significance. Predictive scores were derived from statistically significant factors at the cut-off point of receiveroperating curve that yielded the best area under the curve.

The risk factors associated with the hepatotoxicity from binary logistic regression analysis included age (> 60 years)(OR 2.399,95%CI 1.203,4.784), HIV infection (OR 3.778, 95%CI 1.606,8.888), anemia (OR 2.946, 95%CI 1.312,6.613), low body mass index (<18.5 kg/m²) (OR 2.058, 95%CI 1.106,6.562 ), low serum albumin level (<3.5 mg%) (OR 3.593, 95%CI 1.967,3.828), and the exposure of other drugs induced hepatotoxicity (OR 2.273, 95%CI 1.104,4.680). By integrating risk factors into the screening tool, the cut-off point for hepatotoxicity prediction is equally to 9 (0-24). The sensitivity was 72.73 percent, the specificity was 79.29 percent. The screening tool for the risk of hepatotoxicity prediction should be performed by the medical staff prior to antituberculosis treatment. It is recommended that all patients with a score ranging from 9 to 24 points should be monitored for liver function before and after receiving anti-tuberculosis agent within 4 weeks to prevent the occurrence of severe hepatotoxicity.