Discussion
gastrointestinal reaction, delirium, death, diplopia, fungal infection, rash, hallucinations, liver injury, QT abnormality, headache, mental disorders, osteotoxicity
ADVERSE REACTIONS, DIPLOPIA, FUNGAL INFECTION, LIVER FAILURE, INVASIVE FUNGAL INFECTION
In order to preliminarily verify the pharmacokinetic characteristics and safety of the test formulation, two doses of 4 mg/kg and 6 mg/kg were selected in the clinical dose range of the reference formulation for an open, randomized, two cycle and crossover comparative study.Invasive fungal infection refers to fungal infection that not only invades the skin and subcutaneous tissue, but also involves deep tissues and organs. Common fungi include Candida, Cryptococcus and Aspergillus [Triazole drugs mainly inhibits sterol 14α-sterol demethylase activityby binding with fungal cytochrome P-450, resulting in the accumulation of 14α-methylated sterols and interfering with the synthesis of cell membrane lipids, which destroys the structure and function of cell membrane,and finally leads to the death of fungal cells [Although high individual variability in Voriconazole pharmacokinetics have been observed and the therapeutic range is relatively narrow, the metabolism of Voriconazole has not been fully elucidated yet. In addition, the nonlinear pharmacokinetics caused by self inhibition or induction and the polymorphism of metabolic enzymes impede the safe and effective administration of Voriconazole in clinic [Triazole drugs are well tolerated. The common adverse reactions are rash, headache, gastrointestinal reaction, QT abnormality, liver injury, and occasionally liver failure. In addition, Voriconazole may also produce some unique adverse reactions, such as mental disorders (hallucinations, delirium), reversible visual changes (hallucinations, diplopia) and osteotoxicity [