Objective To compare the difference in risk of drug-induced liver injury (DILI) between Runzao Zhiyang capsules and loratadine tablets.

Methods Based on electronic medical records obtained through active drug safety monitoring in China, a retrospective cohort study was conducted to collect clinical data of patients who took oral Runzao Zhiyang capsules or loratadine tablets between January 1, 2004, and December 31, 2021. After balancing the confounding factors with a 1 ∶ 1 propensity score, the logistic regression model was used to analyze the risk of DILI between the two groups. Additionally, the sensitivity analysis of the data before matching and after inverse probability weighting method was conducted.

Results  A total of 31 636 patients were included, with 26 840 patients taking Runzao Zhiyang capsules orally. After matching there were 4 072 patients in each group, the risk of DILI in the Runzao Zhiyang capsules group was significantly lower than in the loratadine tablets group (0.12% vs. 0.83%), OR=0.15 (95% CI 0.06 to 0.38). Before matching and after inverse probability weighting, the incidence of DILI in the Runzao Zhiyang capsules group was still lower than that in the loratadine tablets group, and the difference was statistically significant (P<0.001).

Conclusion Runzao Zhiyang capsules have a better safety profile in terms of liver injury compared to the loratadine tablets. The hepatotoxicity of Polygonum multiflorum and its preparations should be scientifically evaluated and rationally treated to ensure medication safety and health.

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