Drug-induced liver injury (DILI) is an important clinical problem, which has received more attention in recent decades. It can be induced by small chemical molecules, biological agents, traditional Chinese medicines (TCM), natural medicines (NM), health products (HP), and dietary supplements (DS). Idiosyncratic DILI is far more common than intrinsic DILI clinically and can be classified into hepatocellular injury, cholestatic injury, hepatocellular-cholestatic mixed injury, and vascular injury based on the types of injured target cells. The CSH guidelines summarized the epidemiology, pathogenesis, pathology, and clinical manifestation and gives 16 evidence-based recommendations on diagnosis, differential diagnosis, treatment, and prevention of DILI.

The model of safety monitoring and risk management of TCM drugs is still under exploration. Indeed, the characteristics and risk factors associated with these drugs require both proper understanding and control of the risk by strengthening standardization of clinical applications, basic science research, quality control in manufacturing, exploration of the actives monitoring methodology and enhancement of international communication and cooperation.

No abstract

The authors conclude that the published hepatotoxicity case reports in connection with the use of GTE provide no clinical evidence that GTE may increase the risk of DILI by drugs that had been comedicated in only few cases. Although partial inhibition of human hepatic and intestinal microsomal CYP2C8, CYP2B6, CYP3A4, CYP2D6 and CYP2C19 by GTE catechins was observed in vitro, a clinical study of drug bioavailability attributed a small risk of increased plasma drug levels only for substrates metabolized by CYP3A4, lacking clinical relevance.

The short-term clinical efficacy and the quality of life of patients with PHC can be improved by combining JLC with TACE. The serum OPN levels in PHC patients can reflect the curative effect of treatment and the prognosis of the disease.