Abstract: Objective To investigate the changes of plasma microRNA（miRNA） -4284 in patients with anti-tuberculosis drug-induced hepatotoxicity（ATDH）. Methods A total of 200 naive patients pulmonary tuberculosis were recruited in this study,and all the patients received standardized WHO-recommended anti-tuberculosis therapy. High throughput real-time fluorescence quantitative PCR was applied to assay plasma miRNA-4284 levels. The ROC curve was drawn to evaluate the efficacy of plasma miRNA-4284 for diagnosis of ATDH. Results At the end of six month anti-tuberculosis,ATDH occurred in 70 cases（35.0%）,and out of them,the hepatocyte injuries in 24,cholestasis in 20,and mixed injuries in 26;plasma miRNA-4284 level in patients with ATDH was （1.9 ±1.6）,significantly higher than 【（0.9±0.6）,P<0.05】 in patients without;the sensitivity was 70.0%,the specificity was 69.9%,the positive predictive value was 77.8%,the negative predictive value was 67.4% and the accuracy was 68.0% when plasma miRNA-4284 level equal to 1.15 acted as the cut-off-value with the AUC being 0.71 （95%CI：0.43-1.45）;after three-month hepatoprotective therapy,serum liver function index in all the patients with ATDH recovered and their plasma miRNA-4284 levels also decreased to（0.8±0.5）. Conclusion Plasma miRNA-4284 level in patients with ATDH significantly increases,which might be helpful in the diagnosis and evaluation of anti-tuberculosis efficacy in clinical practice.

Key words: Drug-induced liver injury, Anti-tuberculosis drug-induced hepatotoxicity, MicroRNA, Diagnosis