The goal of this prospective study is to describe the pharmacokinetic characteristics of liposomal amphotericin B during plasma exchange therapy for severe invasive fungal infections in Chinese patients, preliminarily explore the influencing factors of in vivo exposure variability of liposomal amphotericin B, and integrate the findings with efficacy and safety outcomes.
The main questions it aims to answer is: Clarifying the correlation between the concentration, efficacy, and safety of different forms of liposomal amphotericin B in a special population, explore the changes in drug concentration mediated by plasma exchange, elucidate the mechanism of individual differences in efficacy and the optimal dosage, in order to provide a basis for personalized treatment of liposomal amphotericin B.
The study plans to collect pharmacokinetic samples from 10 adult (aged ≥ 18 years) severe invasive fungal infection patients receive liposomal amphotericin B who undergo plasma exchange therapy.
Currently receiving treatment with liposomal amphotericin B;
Undertaking plasma exchange support therapy;
Understand the research procedure and voluntarily sign a written informed consent form.
None
critically ill patients with invasive fungal infections undergoing plasma exchange therapy who receive liposomal amphotericin B therapy
Cohort
Prospective
Collection of pharmacokinetic samples to explore the pharmacokinetic characteristics in severe invasive fungal infection patients receive liposomal amphotericin B who undergo plasma exchange therapy.
Other interventionCollection of pharmacokinetic samples to explore the pharmacokinetic characteristics in severe invasive fungal infection patients receive liposomal amphotericin B who undergo plasma exchange therapy.
Pharmacokinetic characteristics of liposomal amphotericin B in patients with severe invasive fungal infections undergoing plasma exchange therapy.
Pharmacokinetic characteristics of liposomal amphotericin B in patients with severe invasive fungal infections undergoing plasma exchange therapy. Plot the concentration time data and mean values of amphotericin B from different time samples of each patient, along with a list of standard deviations. Using a non-compartmental model method, fit the drug time data of each patient and component using Phoenix WinNonlin software. Calculate the following pharmacokinetic parameters, mean values, and standard deviations: • Maximum blood drug concentration (Cmax)
Pharmacokinetic characteristics of liposomal amphotericin B in patients with severe invasive fungal infections undergoing plasma exchange therapy.
Pharmacokinetic characteristics of liposomal amphotericin B in patients with severe invasive fungal infections undergoing plasma exchange therapy. Plot the concentration time data and mean values of amphotericin B from different time samples of each patient, along with a list of standard deviations. Using a non-compartmental model method, fit the drug time data of each patient and component using Phoenix WinNonlin software. Calculate the following pharmacokinetic parameters, mean values, and standard deviations: • Blood drug concentration before next administration (Ctrough)
Time to reach maximum blood drug concentration
Pharmacokinetic characteristics of liposomal amphotericin B in patients with severe invasive fungal infections undergoing plasma exchange therapy. Plot the concentration time data and mean values of amphotericin B from different time samples of each patient, along with a list of standard deviations. Using a non-compartmental model method, fit the drug time data of each patient and component using Phoenix WinNonlin software. Calculate the following pharmacokinetic parameters, mean values, and standard deviations: • Time to reach maximum blood drug concentration (Tmax)
the area under the blood drug concentration time curve during the dosing cycle and up to infinity
Pharmacokinetic characteristics of liposomal amphotericin B in patients with severe invasive fungal infections undergoing plasma exchange therapy. Plot the concentration time data and mean values of amphotericin B from different time samples of each patient, along with a list of standard deviations. Using a non-compartmental model method, fit the drug time data of each patient and component using Phoenix WinNonlin software. Calculate the following pharmacokinetic parameters, mean values, and standard deviations: The area under the blood drug concentration time curve during the dosing cycle and up to infinity (AUC0- τ and AUC 0- ∞, respectively)
Terminal elimination of half-life
Pharmacokinetic characteristics of liposomal amphotericin B in patients with severe invasive fungal infections undergoing plasma exchange therapy. Plot the concentration time data and mean values of amphotericin B from different time samples of each patient, along with a list of standard deviations. Using a non-compartmental model method, fit the drug time data of each patient and component using Phoenix WinNonlin software. Calculate the following pharmacokinetic parameters, mean values, and standard deviations: Terminal elimination half-life (t1/2)
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