Fifth Hospital of the PLA
Fifth Hospital of the PLA
Guo T.,Shenyang Military Area Command of PLA |
Xia D.-Y.,Shenyang Military Area Command of PLA |
Duan W.,Shenyang Military Area Command of PLA |
Duan W.,Shenyang Pharmaceutical University |
And 5 more authors.
Chinese Pharmaceutical Journal | Year: 2012
OBJECTIVE: To investigate and compare the pharmacokinetics of cefepime in healthy volunteers of different Chinese nationalities (Han, Mongolia, Uigur, Korea, and Hui) and different genders, thus to provide instruction and help for using cefepime safely, rationaly and effectively in both ordinary clinic and remedy of battle wound. METHODS: A single dose of 1.0 g cefepime was given by intravenous infusion under fasting condition to ten healthy volunteers (five males and five females) of each Chinese nationality. Plasma samples were obtained before dosing and at various predetermined time points after the dosing, and the plasma concentrations were determined by a validated HPLC-UV method. The pharmacokinetic parameters were calculated by DAS2.0 software and were compared by SPSS11.5 software. RESULTS: The PK parameters of cefepime in Han, Mongolia, Uigur, Korea and Hui nationalities after a single intravenous administration of 1.0 g were as follows: t 1/2β (1.97 ± 0.20), (2.10 ± 0.33), (2.06 ± 0.33), (2.40 ± 0.65), and (1.94 ± 0.24) h; AUC 0-β (139.69 ± 23.78), (153.92 ± 22.79), (165.58 ± 24.49), (142.11 ± 29.77), and (132.78 ± 23.79) mg · h · L -1;ρ max(68.75 ± 10.41), (78.22 ± 13.87), (83.19 ± 10.31), (73.82 ± 9.59), and (62.91 ± 10.09) mg · L -1 , respectively. The PK parameters of cefepime in 25 male volunteers and 25 female volunteers after a single intravenous administration of 1.0 g were as follows: t 1/2β (2.06 ± 0.54) and (2.13 ± 0.44)h; AUC 0-β (134.06 ± 22.33) and (158.68 ± 24.85)mg · h · L -1;ρ max (66.94 ± 9.14) and (78.95 ± 12.71)mg · L -1, respectively. Results of ANOVA and Kruskal-Wallis rank test showed that there were no significant differences in the PK parameters V d, CL, InAUC, and t 1/2β of different nationalities and in V d and t 1/2β of different genders, but there were significant differences in lnρ max of different nationalities and CL, InAUC, and lnρ max of different genders. Then, it was found there was high linear correlation( P < 0.01) between body weight and CL, InAUC and lnρ max. The differences of the above PK parameters became insignificant after normalization by body weight. CONCLUSION: When cefepime is given in doses based on body weight, its pharmacokinetics has no significant differences among five nationalities and between genders. Copyright 2012 by the Chinese Pharmaceutical Association.