中华器官移植杂志
中華器官移植雜誌
중화기관이식잡지
CHINESE JOURNAL OF ORGAN TRANSPLANTATION
2014年
8期
473-478
,共6页
焉杰克%王玉珍%刘双德%张旭峰%刘晓立%徐东升%张荣梅%田川%王洪伟
焉傑剋%王玉珍%劉雙德%張旭峰%劉曉立%徐東升%張榮梅%田川%王洪偉
언걸극%왕옥진%류쌍덕%장욱봉%류효립%서동승%장영매%전천%왕홍위
有限采样法%肾移植%曲线下面积%麦考酚酸
有限採樣法%腎移植%麯線下麵積%麥攷酚痠
유한채양법%신이식%곡선하면적%맥고분산
Limited-sampling strategy%Kidney transplantation%Area under curve%Mycophenolic acid
目的 研究肾移植受者口服麦考酚钠肠溶片(EC-MPS)后血麦考酚酸(MPA)药代动力学特征,并通过有限采样法研究0～12h的药物曲线下面积(AUC0-12h).方法 按照入选和排除标准筛选20例接受EC-MPS+他克莫司+泼尼松三联免疫抑制治疗的汉族肾移植受者作为研究对象,在肾功稳定期(肾移植术后21 d)监测受者口服EC-MPS后10个时间点(服药后0.5、1、1.5、2、3、4、6、8、10和12 h)的血浆MPA水平,应用Jackknife技术、多元线性回归分析以及Origin专业函数绘图软件(7.5版)来分析计算MPA AUC.结果 口服EC-MPS后,20例受者间血浆MPA水平及AUC变异很大.最佳有限采样法有三点法(血MPA浓度检测时间点为1.5、4和8 h)和四点法(血MPA浓度检测时间点为1.5、4、6和8 h),公式分别为AUG0-12h=12.820+0.662×C1.5h+1.750×C4h+4.213×C8h以及AUG0-12h=12.119+0.676×C1.5h+1.685×C4h+1.429×C6h+2.573×C8h.三点法校整的相关系数(R)=0.861,P＜0.001;四点法校正的相关系数R=0.882,P＜0.001.结论 对于采用EC-MPS+他克莫司+泼尼松三联免疫抑制方案的汉族肾移植受者,在服药后1.5、4和8h或者1.5、4、6和8h进行有限采样法监测血浆MPA浓度,能够估算EC-MPS的AUC.
目的 研究腎移植受者口服麥攷酚鈉腸溶片(EC-MPS)後血麥攷酚痠(MPA)藥代動力學特徵,併通過有限採樣法研究0～12h的藥物麯線下麵積(AUC0-12h).方法 按照入選和排除標準篩選20例接受EC-MPS+他剋莫司+潑尼鬆三聯免疫抑製治療的漢族腎移植受者作為研究對象,在腎功穩定期(腎移植術後21 d)鑑測受者口服EC-MPS後10箇時間點(服藥後0.5、1、1.5、2、3、4、6、8、10和12 h)的血漿MPA水平,應用Jackknife技術、多元線性迴歸分析以及Origin專業函數繪圖軟件(7.5版)來分析計算MPA AUC.結果 口服EC-MPS後,20例受者間血漿MPA水平及AUC變異很大.最佳有限採樣法有三點法(血MPA濃度檢測時間點為1.5、4和8 h)和四點法(血MPA濃度檢測時間點為1.5、4、6和8 h),公式分彆為AUG0-12h=12.820+0.662×C1.5h+1.750×C4h+4.213×C8h以及AUG0-12h=12.119+0.676×C1.5h+1.685×C4h+1.429×C6h+2.573×C8h.三點法校整的相關繫數(R)=0.861,P＜0.001;四點法校正的相關繫數R=0.882,P＜0.001.結論 對于採用EC-MPS+他剋莫司+潑尼鬆三聯免疫抑製方案的漢族腎移植受者,在服藥後1.5、4和8h或者1.5、4、6和8h進行有限採樣法鑑測血漿MPA濃度,能夠估算EC-MPS的AUC.
목적 연구신이식수자구복맥고분납장용편(EC-MPS)후혈맥고분산(MPA)약대동역학특정,병통과유한채양법연구0～12h적약물곡선하면적(AUC0-12h).방법 안조입선화배제표준사선20례접수EC-MPS+타극막사+발니송삼련면역억제치료적한족신이식수자작위연구대상,재신공은정기(신이식술후21 d)감측수자구복EC-MPS후10개시간점(복약후0.5、1、1.5、2、3、4、6、8、10화12 h)적혈장MPA수평,응용Jackknife기술、다원선성회귀분석이급Origin전업함수회도연건(7.5판)래분석계산MPA AUC.결과 구복EC-MPS후,20례수자간혈장MPA수평급AUC변이흔대.최가유한채양법유삼점법(혈MPA농도검측시간점위1.5、4화8 h)화사점법(혈MPA농도검측시간점위1.5、4、6화8 h),공식분별위AUG0-12h=12.820+0.662×C1.5h+1.750×C4h+4.213×C8h이급AUG0-12h=12.119+0.676×C1.5h+1.685×C4h+1.429×C6h+2.573×C8h.삼점법교정적상관계수(R)=0.861,P＜0.001;사점법교정적상관계수R=0.882,P＜0.001.결론 대우채용EC-MPS+타극막사+발니송삼련면역억제방안적한족신이식수자,재복약후1.5、4화8h혹자1.5、4、6화8h진행유한채양법감측혈장MPA농도,능구고산EC-MPS적AUC.
Objective To investigate the pharmacokinetic (PK) characteristics of enteric-coated mycophenolate sodium (EC-MPS) and area under the curve (AUC) from 0 to 12 h by limited sampling strategies (LSSs) in de novo kidney transplant patients of Chinese ethnicity.Method The PK data from 20 Chinese renal transplant recipients collected during the maintenance period after transplantation were analyzed retrospectively.Ten blood samples were obtained after EC-MPS was given on the postoperative day 21.Blood concentrations of mycophenolic acid were measured and AUC was estimated using high performance liquid chromatography in recipients receiving immunosuppressant EC-MPS plus tacrolimus and steroid.LSSs with jackknife technique,multiple stepwise regression analysis,and Origin 7.5 analysis were developed to estimate mycophenolic acid (MPA) AUC.Result There was wide inter-individual variation in MPA plasma level and the AUC.The best equations obtained in the test group were for 3 and 4 time points:AUC0-12h (mg· h· L-1) =12.820 + 0.662 × C1.5h + 1.750 × C4h + 4.213 × C8h,and AUC0-2h (mg· h· L-1) =12.119 + 0.676 × C1.5h + 1.685 × C4h + 1.429 × C6h + 2.573 × C8h respectively.When these LSSs were.tested in the validation group,the results were acceptable (R =0.861,P＜0.001 for 3 time points,and R =0.882,P＜0.001 for 4 time points).Conclusion LSSs are useful for MPA AUC0-12h estimation in Chinese renal transplantation patients.LSSs using time points at C1.5h-C4h-C8h or C1.5h-C4h-C6h-C8h provide the most reliable and accurate estimation of the AUC0-12h of mycophenolic acid in Chinese stable renal transplant recipients receiving EC-MPS and tacrolimus.
