Analysis of Mycophenolate Mofetil Exposure in Kidney Transplant Patients Receiving Immunosuppressive Therapy
LI Shu1,2, CHEN Wen-qian1, ZHANG Xiang-lin1*
1. Pharmacy Department of China-Japan Friendship Hospital, Beijing 100029, China;
2. Department of Pharmacy Administration & Clinical Pharmacy School of Pharmaceutical Sciences of Peking University Health Science Center, Beijing 100191, China
OBJECTIVE To analyze the individual features of mycophenolate mofetil exposure in renal transplantation patients receiving immunosuppressive therapy postoperatively to provide reference for clinical individualized medication.METHODS Ninety-seven cases of renal transplantation patients were included in the study, with mycophenolic acid blood concentrations determined by HPLC method. The mycophenolic acid exposure characteristics was analyzed,using the domestic and foreign recommended drug exposure target value of 30-60 μg·h·mL-1 as reference. SPSS20.0 was used to analyze the data.Normal distribution diagram was drawn for the data and single factor analysis of variance with a completely randomized design was performed to compare the drug exposures under different conditions.RESULTS The study included 526 cases of mycophenolic acid plasma concentration data. The trough concentration was (2.51±1.79) μg·mL-1, and 332 cases reached the recommended plasma concentration range. The average plasma concentration was (2.08±0.71) μg·mL-1, and the target achievement rate was 63.0%. There was no significant difference in the plasma concentrations between male and female patients (P>0.05). The plasma concentrations were significantly different between middle-aged (18-64 y) and elderly (65 to 77 y) patients (P<0.05). There was no significant difference in the plasma concentrations among different dosage groups (P>0.05). Between the different treatment groups, ie MMF+CsA+Pre group and MMF+FK506+Pre group (P=0.00), MMF+CsA group and MMF+FK506 group (P=0.00), MMF+FK506+Pre group and MMF+CsA group (P=0.00), MMF+CsA+Pre group and MMF+FK506 group (P=0.00), the plasma concentrations were significantly different (P<0.05). There was no statistically significant difference in the plasma drug concentrations among patients with different GFRs (P>0.05).CONCLUSION There is remarkable inter-individual difference in the plasma concentration of mycophenolic acid, and a variety of clinical factors affect the drug exposure. Therefore, it is necessary to carry out therapeutic drug monitoring for mycophenolic acid in order to lay the foundation for individualized treatment.
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