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Journal of Tuberculosis and Lung Health ›› 2017, Vol. 6 ›› Issue (3): 241-245.doi: 10.3969/j.issn.2095-3755.2017.03.000

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Clinical study of Silibin Meglumine Tablets and Inosine Tablets on the prevention of drug induced liver injury by anti tuberculosis fixed dose combination

LIU Yi,LIU Yang,HAN Dong-wei   

  1. Center for Disease Control and Prevention in Yingkou City,Liaoning Province, Yingkou 115004,China
  • Received:2017-06-28 Online:2017-09-30 Published:2017-09-30

Abstract: Objective To compare the effects of Silibin Meglumine Tablets and Inosine Tablets on the prevention and treatment of drug induced liver injury(DILI) by anti tuberculosis (TB) fixed dose combination (FDC). Methods From January 2015 to December 2015, 103 TB patients treated by TB clinic in Yingkou Center for Disease Control and prevention were selected and divided into group A(FDC+ Six Vitamin Pilles+ Silibin Meglumine Tablets, 52 cases)and group B(FDC+ Six Vitamin Pilles+ Inosine Tablets, 51 cases)randomly. The patients in the two groups were treated with 2HREZ/4HR regimen for TB, and the changes of liver function indexes and liver injury in the two groups were observed within 6 months. The measurement data were analyzed by t test, and the enumeration data were analyzed by chi square test (or Fisher exact probability method), and the rank data of clinical efficacy were analyzed by Wilcoxon rank sum test. The inspection level was two-sided test, the difference was statistically significant if P<0.05. Results There were no severe liver damage cases in the two groups. The numbers of abnormal liver function, slight liver damage and medium liver damage in the two groups were 3 vs. 6, 1 vs. 9 and 1 vs. 4 respectively. The incidence rate of drug-induced liver injury (DILI) were 9.6% (5/52) in group A and 37.3% (19/51) in group B, and that of group A was significantly lower than group B (Z=3.37, P=0.001).Of the 24 patients with DILI, only 1 of the B group occurred within 12 weeks after treatment, and the others occurred within 8 weeks after treatment. Conclusion The use of Silibin Meglumine Tablets for the prevention of DILI than Inosine Tablets has better preventive effect, and has clinical significance.