单剂量静滴头孢吡肟在中国五个民族人群中的药动学  

Pharmacokinetcs of Single Dose Cefepime Injection in Chinese Han,Mongolia,Korean,Uigur,and Hui Healthy Volunteers

作　　者：郭涛[1] 夏东亚[1] 段威[1,2] 赵龙山[2] 曾平[3] 肖勇[4] 赵东祥[5] 杨长青[6] 白音[7] 

机构地区：[1]沈阳军区总医院药剂科,沈阳110016 [2]沈阳药科大学药学院,沈阳110016 [3]兰州军区乌鲁木齐总医院药剂科,新疆乌鲁木齐830000 [4]解放军第五医院药剂科,宁夏银川750004 [5]解放军第313医院赤峰临床部,内蒙古赤峰024006 [6]延边大学医学院,吉林延吉133002 [7]赤峰学院医学部,内蒙古赤峰024000

出　　处：《中国药学杂志》2012年第14期1134-1138,共5页Chinese Pharmaceutical Journal

基　　金：全军医学科技术研究"十一五"计划科技攻关基金资助项目(06G023)

摘　　要：目的比较单剂量静滴头孢吡肟在中国汉族、蒙古族、维吾尔族、朝鲜族和回族中不同民族及不同性别健康受试者的药动学,为临床和战伤救治能安全、有效、合理的应用本品提供指导和帮助。方法健康汉、蒙、维、朝和回族受试者各10名,男女各半,禁食状态下单剂量静滴头孢吡肟1.0 g,在特定的时间点采血,并采用HPLC-UV法测定血浆中头孢吡肟的浓度;通过DAS软件计算其药动学参数,采用SPSS软件对不同民族和性别的药动学参数进行统计分析。结果①汉、蒙、维、朝和回族五个民族健康受试者单剂量静滴1.0 g头孢吡肟的药动学参数分别为:t1/2β(1.97±0.20)、(2.10±0.33)、(2.06±0.33)、(2.40±0.65)和(1.94±0.24)h;AUC0-∞(139.69±23.78)、(153.92±22.79)、(165.58±24.49)、(142.11±29.77)和(132.78±23.79)mg.h.L-1;ρmax(68.75±10.41)、(78.22±13.87)、(83.19±10.31)、(73.82±9.59)和(62.91±10.09)mg.L-1。②男、女不同性别健康受试者单剂量静滴1.0 g头孢吡肟的药动学参数分别为:t1/2β(2.06±0.54)和(2.13±0.44)h;Vd(20.67±4.36)和(18.97±5.82)L;AUC0-∞(134.06±22.33)和(158.68±24.85)mg.h.L-1;ρmax(66.94±9.14)和(78.95±12.71)mg.L-1。③经ANOVA和Kruskal-Wallis秩和检验分析后,不同民族受试者的药动学参数Vd、CL、lnAUC和t1/2β的差异无统计学意义(P>0.05),而lnρmax的差异有显著的统计学意义(P<0.01);不同性别受试者的药动学参数Vd和t1/2β的差异无统计学意义(P>0.05),而CL、lnAUC和lnρmax的差异有显著的统计学意义(P<0.01);进一步的关联性分析发现,体重与CL、AUC、ρmax存在高度的线性相关(P值均小于0.01);上述有显著差异的药动学参数,经受试者自身的体重校正后,其差异无统计学意义(P>0.05)。结论按体重给药,汉族、蒙古族、维吾尔族、朝鲜族和回族的种族差异及性别差异对头孢吡肟的药动学行为影响不大。ABSTRACT ： 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 nationali- ty. Plasma samples were obtained before dosing and at various predetermined time points after the dosing, and the plasma concentra- tions 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 eefepime in Han, Mongolia, Uigur, Korea and Hui nationalities after a single intravenous administration of 1.0 g were as follows ： t1/2β （ 1.97 ± 0. 20 ） , （ 2. 10 ：t： 0. 33 ） , （ 2. 06 ± 0. 33 ） , （ 2.40 ±0.65）, and（1.94 ± 0.24） h; AUC0-∞ （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;pm,x（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 eefepime in 25 male volunteers and 25 female volunteers after a single intravenous ad- ministration of 1.0 g were as follows： t1/2β （2. 06 ±0. 54） and（2. 13 ±0. 44）h; AUC0-∞ （ 134.06 ±22. 33） and（ 158.68 ±24. 85）mg·h· L^-1 ;Pmax （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 Vd, CL, lnAUC, and t1/2β of different nationalities and in V,j and t1/2β of different genders, but there were significant differences in lnpmax of different nationalities and CL, lnAUC, and lnpmax of d

关 键 词：头孢吡肟 药动学 高效液相色谱法 汉族 蒙古族 维吾尔族 朝鲜族 回族 

分 类 号：R969.1[医药卫生—药理学]