Sorafenib alone versus a combination of sorafenib and ninjin'yoeito for the treatment of patients with advanced hepatocellular carcinoma: a retrospective study and pharmacological study in rats

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Abstract

A retrospective study was performed to compare the effects of sorafenib alone (as a control) and a combination of ninjin'yoeito and sorafenib on the presence of an abnormal aspartate aminotransferase (AST) level, an abnormal alanine transaminase (ALT) level, or an abnormal platelet count (PLT) in patients with advanced hepatocellular carcinoma. The numbers of patients with abnormal levels of AST, ALT, or PLT were 7, 5, and 9 in the combination group and 8, 6, and 10 in the control group, respectively. The combination of ninjin'yoeito and sorafenib tended to result in an improved AST level (P < 0.1) and a significant decrease in the ALT level (P = 0.048) after 4 weeks of treatment, compared with the results in the control group. Both the AST and ALT levels improved significantly, compared with the pre-treatment values, in the combination group. Furthermore, the change in the PLT after 12 weeks of treatment was significant (P = 0.046), though the improvements between the pre-treatment and post-treatment values were not significant. Throughout the treatment, the dosage of sorafenib was maintained and the treatment was continued in both the control and combination groups, and the levels of tumor markers were also monitored. Furthermore, to verify these findings, experimental rats treated with sorafenib and/or a combination of sorafenib and ninjin'yoeito were used to examine the effect of the combined treatment on liver function. As a result, the repeated administration of sorafenib led to an increase in the AST, total bilirubin (TBIL), and direct bilirubin (DBIL) levels, and they were significantly improved by the combined treatment with ninjin'yoeito. These results suggest that ninjin'yoeito might be useful for reducing the adverse effects of sorafenib treatment, such as liver injury and PLT reductions, possibly contributing to the survival benefit of sorafenib by maintaining its continuous administration.

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