环孢素A血药浓度的影响因素

口服环孢素的生物利用度个体差异大,其影响因素较多。笔者通过总结给药方案、使用剂型、术后时间、胃肠功能、肝胆功能等对环孢素A血药浓度的影响,寻找影响血药浓度变化的可能因素,以降低其毒性和不良反应。     

影响环孢素A血药浓度的因素分析

应用荧光偏振免疫法（ＦＰＩＡ）测定２５例尸肾移植后患者全血环孢素Ａ（ＣｓＡ）浓度。结合合用酮康唑，西咪替丁后ＣｓＡ血浓度增高２．２１和１．６８倍，肝功能异常患者ＣｓＡ血浓度比正常组高１．６６倍，另外血中有凝血块也是影响原因之一。     

影响环孢素A血药浓度的因素分析

应用荧光偏振免疫法(FPIA)测定25例尸肾移植后患者全血环孢素A(CsA)浓度。结果合用酮康唑.西咪替丁后CsA血浓度增高2.21和1.68倍,肝功能异常患者CsA血浓度比正常组高1.66倍。另外血中有凝血块也是影响原因之一。     

肾移植后环孢素A血药浓度与红细胞及血红蛋白的相关性分析

目的 探讨肾移植受者术后ＣｓＡ血药浓度与ＢＲＣ数及ＨＧＣ含量的相关性。方法 应用ＦＰＩＡ法测定４０例肾移植受者术后ＣｓＡ血药浓度,分析术后不同时间ＲＢＣ数及ＨＧＢ含量对ＣｓＡ血药浓度的影响。结果 在术后早期ＣｓＡ用量基本不变的情况下,ＣｓＡ血药浓度与ＲＢＣ数及ＨＧＢ含量有显著正相关。结论 术后早期ＲＢＣ和ＨＧＢ可能是影响ＣｓＡ血药浓度的因素之一。     

高效液相色谱法测定环孢素A血药浓度的方法改进

目的:用高效液相色谱法(HPLC法)测定环孢素A的血药浓度。方法:采用SPHPLC仪,Nova-PakCN色谱柱(150mm×3.9mm,4μm),流动相为甲醇-水(47∶53),流速为0.6mL/min,检测波长为214nm,AT=16,柱温为50℃,按外标法用峰高定量,回归方程为C=13.02H+8.14,r=0.9998。结果:回收率试验结果稳定、可靠。结论:采用Nova-PakCN柱,当温度升至50℃时环孢素A即能达到良好的分离度,并且分析柱寿命大大延长。     

新疆维族与汉族肾移植后环孢素A血药浓度分析

目的　通过监测肾移植后维族与汉族CsA全血浓度,比较不同时期维族与汉族肾移植患者之间CsA全血浓度的差别,为CsA临床用药个体化提供依据。方法　采用荧光偏振免疫法,对354例次维族与汉族患者肾移植后CsA全血谷浓度进行监测,按不同时间与族别分别比较。结果　CsA在肾移植后小于1　mon、1～3　mon、4～6　mon、7～12　mon、13～24　mon、大于24　mon全血谷浓度维吾尔族为(549±166)、(475±87)、(411±96)、(370±51)、(352±91)、(257±111)　μg     

环孢素A血药浓度监测的临床讨论

环孢素的应用明显地提高肾移植器官的成活率。采用荧光偏振免疫仪（ＴＤＸ）＾「１」,监测肾移植术后现人服环孢素Ａ口服液的血药浓度。同时检查肝肾功能,指导临床用药。发现肾移植术后６月内,ＣｓＡ剂量维持在每日５－７ｍｇ／ｋｇ,服山地明时血药浓度２５０－６００ｎｇ／ｍｌ,赛斯平血药浓度３００－７００ｎｇ／ｍｌ范围内,肾功能最佳;     

反相高效液相色谱法测定环孢素A的血药浓度

目的建立反相高效液相色谱（RP-HPLC）法测定全血中环孢素A（CsA）的质量浓度。方法将全血经多步处理后以Agilent Zorbax SB-C18柱（150mm×4．6mm,5μm）分离,乙腈-水（78：22）为流动相,流速为1．0mL／min,柱温为60℃,检测波长为210nm。结果全血中杂质不干扰样品的测定,CsA的质量浓度在20-1000ng／mL（r=0．9997）范围内与峰面积线性关系良好;高、中、低质量浓度的CsA平均回收率分别为99．2％,98．0％,97．2％;日内精密度的RSD为0．25％-2．28％,日间精密度的RSD分别为0．37％-2．62％。结论所用方法操作简单,回收率高,精密度好,适用于临床常规监测CsA的血药浓度。     

超高效液相色谱法测定环孢素A的血药浓度

目的建立超高效液相色谱法测定全血中环孢素A的质量浓度。方法血样经乙醚萃取后,经WATERS BEH C18（2.1×50mm,1.7μm）分离,乙腈-水为流动相,70℃柱温下进行色谱分析,检测波长为210nm。结果本方法线性范围为0.05～1.0μg·mL-1（r=0.9930）,高、中、低血样的平均回收率分别为94.04%、100.81%、98.95%,日内RSD小于10%。结论本法操作简便,回收率高,精密度好,适用于临床常规检测CsA的血药浓度。     

环孢素A临床血药浓度监测影响因素分析

应用ＨＰＬＣ法测定２１例肾移植术后患者全血环孢素Ａ（ＣｓＡ）谷值血药浓度。结果表明，合并用药、肝功能异常及凝血和不正确服药方法是影响ＣｓＡ血药浓度的重要因素。     

两种单克隆抗体荧光免疫偏振法测定人全血中环孢素浓度的比较

目的：考察TDx与AxSYM单克隆抗体荧光免疫偏振法测定全血中环孢素A浓度结果的差异。方法：采集12名肾移植患者服药后12h内不同时间点的血样。样本分别用TDx与AxSYM进行测定。测定结果通过均数比较、Passing—Bablok回归法和Bland-Altman偏差图法进行分析。结果：TDx和AxSYM两法的测定结果相关。服药后0．5～4h的血样，两法测定结果差异无显著性。而服药6h后两法的测定结果差异有显著性，且TDx的测定结果高于AxSYM。结论：TDx与AxSYM法测定人全血中环孢素浓度的结果有差异，且与采样时间有关。     

AxSYM与RP—HPLC法测定卡马西平血药浓度的相关性分析

目的分析AxSYM与RP-HPLC两种方法测定卡马西平血药浓度结果相关性。方法利用AxSYM和RP—HPLC两种方法同时测定卡马西平血药浓度，以AxSYM测定值为X，RP—HPLC测定值为Y进行线性回归，评价其相关性。结果92组数据经线性回归得回归方程：Y=0．013731＋0．969354x（n=92，r=0．992451）。结论AxSYM测定卡马西平血药浓度结果与RP—HPLC测定结果具有较好相关性，适用于卡马西平血药浓度的常规监测。     

An evaluation of the cyclosporine and metabolites whole blood TDx assay

The new Abbott TDx cyclosporine and metabolites fluorescent polarization immunoassay procedure provides a 20-min sample turn-around time, using 50 microliters of sample for the analysis of cyclosporine in whole blood. A precipitation agent and a lysing agent are utilized as a pretreatment step. The range of the whole blood assay is from 0 to 2,000 ng/ml, with a sensitivity of 50 ng/ml. Precision studies at 3 control levels provided coefficients of variation of 2.1-4.8% for both assays. In order to compare this assay with the currently used Sandoz polyclonal radioimmunoassay (RIA) method. 200 whole blood samples were obtained from 20 renal, cardiac, and hepatic transplant recipients. The mean whole blood cyclosporine concentrations for samples above the sensitivity level were as follows: TDx 754 ng/ml (+/- 31) and RIA 619 ng/ml (+/- 22). Blood TDx levels correlated strongly with RIA levels, with a regression coefficient of r = 0.915. This new assay provides reliable blood cyclosporine concentrations that correlate well with RIA measurements. This assay offers rapid sample turn-around times, making same-day results for outpatient drug monitoring possible.     

AxSYM替代TDXFLX应用于环孢素血药浓度检测的可行性研究

目的:研究AxSYM与TDXFLX两台仪器测定环孢素(cyclosporin,CsA)血药浓度结果的相关性,评价AxSYM替代TDXFLX用于常规治疗药物监测的可行性。方法:收集第二军医大学长海医院门诊和住院共113例肾移植和造血干细胞移植病人的血样,在同一天内用AxSYM和TDXFLX两种仪器同时测定CsA的血药浓度。以TDXFLX测定值为x,以AxSYM测定值为y,进行相关回归分析,评价其相关性。对测定值x和y进行配对t检验,P<0.05为差异有统计学意义。结果:AxSYM和TDXFLX测定的CsA血药浓度相关性良好,线性方程为y=1.001 9x-6.101 7(n=113,r=0.988 3)。AxSYM测定值比TDXFLX测定值平均低4.76%,有显著性差异(n=113,P<0.05)。结论:AxSYM可以替代TDXFLX用于本院临床CsA的血药浓度检测。     

Comparison of cyclosporine blood levels measured by radioimmunoassay and TDx assay using monoclonal antibodies

Whole blood steady-state trough concentrations of cyclosporine were measured by radioimmunoassay (RIA) and TDx assays employing monoclonal antibodies in 82 samples from 39 renal transplant patients. Intra- and interassay coefficients of variation for the new TDx technique averaged 3.2 and 5.4%, respectively. In the concentration range of 40 to 717 ng/ml, there was a linear correlation (r = 0.884, p less than 0.001) between both assays [slope of 0.863; y intercept (RIA values) = 15 ng/ml], indicating that the methods can be used interchangeably. Since the automated TDx assay is faster and causes less waste problems, this reliable technique offers some definite advantages for routine clinical use.     

不同免疫分析仪在环孢素A血药浓度监测中的差异

目的:考察不同分析方法对环孢素A(CsA)血药浓度监测中的影响.方法:71例肝肾移植术后CsA样品分别用AxSYM和TDx测定.结果:TDx监测结果大于AxSYM监测结果.结论:AxSYM和TDx在环孢素A血药浓度监测中存在差异.     

用HPLC法和TDx法测定卡马西平血清浓度的相关性研究

目的 :研究用HPLC法和TDx法测定卡马西平血清浓度的相关性。方法 :分别用HPLC和TDx测定39例癫痫患者的卡马西平血清浓度 ,比较两种方法的测定结果。结果 :HPLC法 (Y)与TDx法 (X)测定的卡马西平血清浓度的回归方程为Y=1 0616X—0 4677(r=0 9294) ,两种方法在统计学上无显著性差别 (P>0 05)。结论 :用HPLC法和TDx法测定卡马西平血清浓度具有良好的相关性 ,在无TDx血药浓度测定仪时 ,HPLC可作为测定卡马西平血清浓度的常规方法。     

Comparative evaluation of digoxin concentrations determined by three assay systems: TDx, IMx and OPUS

Digoxin concentrations measured by three automated immunoassay systems, i.e. OPUS, TDx and IMx assays, were compared in order to evaluate precision and accuracy performance, and data compatibility. Coefficients of variation for all methods in within-run and between-run precision were less than 10% at weighed-in concentrations of 0.545, 1.090 and 2.180 ng/ml. The accuracy relative to the three weighed-in concentrations ranged from 97% to 123% for all methods. One hundred and three plasma samples from 60 patients receiving digoxin were used to evaluate the data compatibility. Digoxin concentrations measured by the three immunoassay systems correlated well with one another. These results suggest that there are few problems when switching between digoxin assay methods, and that IMx and OPUS are more useful than TDx because they do not require sample pretreatment. The digoxin concentrations of the plasma samples from one patient receiving both digoxin and potassium canrenoate were investigated as a case report. The digoxin concentrations measured by TDx and IMx became higher than those measured by OPUS after starting the combination treatment. In another patient suffering from bilirubinaemia, the digoxin concentrations measured by TDx or IMx were higher than those measured by OPUS. These results suggest that OPUS has a higher specificity for measuring the plasma digoxin concentrations compared with TDx or IMx.     

荧光偏振免疫法测定丙戊酸钠血清药物浓度

目的检测丙戊酸钠血药浓度。方法采用荧光偏振免疫（TDx）法。结果测定目标血清血药浓度在有效范围内的占受试58.7%。结论本方法简便、快速,适用于临床常规检查。     

Evaluation of the AxSYM monoclonal cyclosporin assay and comparison with radioimmunoassay

Recently, a semiautomated fluorescence polarization immunoassay (FPIA) for determination of parent cyclosporin (CsA) has been developed for the Abbott AxSYM system. The new CsA assay measures the drug from an extracted whole blood specimen. The authors report here the evaluation of this new assay and the comparison with a previously validated radioimmunoassay (RIA) method (CYCLO-Trac SP). To assess the imprecision, the authors used tri-level controls supplied by both Abbott and Bio-Rad manufacturers. The within-run CV ranged from 4.4% to 7.3% and the between-day CV ranged from 4.4% to 7.6%. Mean recovery of the drug from clinical specimens spiked with kit calibrators was 108.4%. Fluorescence polarization immunoassay AxSYM (y) was correlated to RIA (x) by using 132 trough blood specimens (44 renal, 44 liver, and 44 heart) from transplant recipients and resulted in the following Passing-Bablok linear regression equation: y = 6.7 + 0.97x, r = 0.989, S(x/y) = 12.9. The percentage of overestimation (mean, range) by FPIA AxSYM versus RIA was (3.8%, range -17.7% to 39.1%). The results observed with this new method from follow-up studies in patients during the early course after transplant were not consistently higher than those obtained by RIA. These findings contrast with previously reported results that compared FPIA TDx assay with RIA. The authors conclude that FPIA AxSYM is a precise method for measuring CsA and offers results similar to those obtained by RIA with a marked reduction in assay time.