| ABSTRACT Objective: To analyze and detecte the anti infectious agents associated hepatic adverse drug reaction (ADR) signals using data mining methods, and provide reference for the prevention and treatment of anti infective agents related hepatic ADRs. Methods: The hepatic ADR reports of anti infective agents were collected from PLA ADR monitoring center during 2009 to 2013, and then analyzed in respect to age, gender and categories of suspected anti infective agents. The relationships between anti infectious agents and hepatic ADRs were assessed by 4 kinds of data mining methods, including the proportional reporting ratio（PRR）, the reporting odds ratio, combination χ2 test PRR measure used by the Medicines and Healthcare Products Regulatory Agency, and Bayesian Condence Propagation Neural Network. Results:From 67 145 reports submitted in our database, 1 699 cases regarded hepatic ADRs, and 572 were related to anti infective agents. The most frequently drug classes inducing hepatic ADRs in anti infective agents were anti tuberculotics, cephalosporins, and antifungal drugs. Fifteen kinds of anti infective agents, mainly including anti tuberculosis drugs and antifungal drugs generated significant disproportionality using 4 kinds of data mining measures, indicating the post marketing risk signals of liver injury. Conclusion:The anti tuberculosis drugs and antifungal drugs were the most common suspects of the hepatic ADRs in anti infective drugs. Clinicians must be aware of anti infective drugs related liver injury and monitor patients when the prescription of these drugs. |
