Effectiveness of preventively using hepatoprotectors in patients with anti-tuberculosis treatment
METHODS: With stratified cluster sampling strategy, a prospective cohort with 4,488 sputum smears positive pulmonary TB patients was established from 52 counties of four regions in China. Prescriptions of hepatoprotectors and other drugs were documented in detail during the treatment. Liver function was routinely monitored during anti-TB treatment. Anti-TB drug induced liver injury (ATLI) was assessed based on liver function results following the criteria of American Thoracic Society. The incidence of ATLI between the preventive usage group and reference group was compared by propensity score adjusted Cox proportional hazard analysis. Pre-existing diseases, history of liver disease, HBsAg status, income per year and liver function before anti-TB treatment were included in the propensity score model.
RESULTS: After 6-9 months follow-up and monitoring, 4304 patients sustained in our cohort. 2752 (63.9%) patients preventively took hepatoprotectors with a median course of 183 days. Most frequently used drugs were Hu Gan Pian, silymarin, glucurone and inosine. 2144 (77.9%) patients took those drugs more than 6 months or during their whole anti-TB treatment course. Totally 106 patients developed ATLI, and 69 patients of preventive usage group and 37 of reference group experienced ATLI, respectively. Statistical significances were not found by propensity score analysis for the association between using hepatoprotectors (HR=0.99, 95%CI: 0.65-1.52), using hepatoprotectors in the whole course (HR=0.94, 95%CI: 0.60-1.48), using Hu Gan Pians, silymarin, glucurone and inosine with ATLI occurrence.
CONCLUSIONS: Although preventively using hepatoprotectors seems popular, the preventive effect was not observed in this study, which should be confirmed by large-scale randomized controlled trials.