Safarcík K, Komzáková I, Bartos V, Grundmann M
Klinika nukleární medicíny FNsP, Ostrava-Poruba.
Ceska Slov Farm. 2002 May;51(3):112-20.
The standard method for determination of CyA in blood is a good validated HPLC method. HPLC methods were developed which make it possible to determine not only the parent drug, but also the main metabolites of CyA: AMI (M17), AM9 (M1), and AM4N (M21). HPLC methods for determination of CyA are very laborious and expensive. Most transplantation centres in the world use immunoanalytical methods for TDM of CyA. In recent years there has been an increase in the number of users of nonisotopic automated methods (Abbott TDx mono, AxSYM, Dade-Behring EMIT or Microgenic Cedia), which render instantaneous analysis possible. The analysis of the results of CyA in the blood in patients after transplantation shows that all immunoanalytical methods overestimate the concentration of CyA against HPLC results. The usually presented series of results is as follows: HPLC < RIA = EMIT < CEDIA < AxSYM < TDx. The differences are difficult to explain only by a different degree of cross reactivity for particular metabolites of CyA with the antibody used in the immunoanalytical method. The criterion of IFCC, which should be met by each immunoanalytical method in order to be used for TDM of CyA, should be redrawn, because it is not able to ensure sufficient specificity of the method. A suitable, cheap, and quick analytical method for TDM of CyA is still wanted. Some transplantation centres, including ours, carry out not only one method for effective TDM of CyA.
血液中环孢素A(CyA)的标准测定方法是一种经过充分验证的高效液相色谱(HPLC)法。已开发出的HPLC方法不仅能够测定母体药物,还能测定CyA的主要代谢产物:氨基甲酰基环孢素A(AMI,M17)、AM9(M1)和AM4N(M21)。测定CyA的HPLC方法非常繁琐且昂贵。世界上大多数移植中心使用免疫分析方法进行CyA的治疗药物监测(TDM)。近年来,非同位素自动化方法(雅培TDx单克隆法、AxSYM、达德-拜耳EMIT或微基因Cedia)的用户数量有所增加,这些方法能够实现即时分析。对移植患者血液中CyA结果的分析表明,所有免疫分析方法测得的CyA浓度相对于HPLC结果都存在高估。通常呈现的结果序列如下:HPLC<放射免疫分析(RIA)=EMIT<Cedia<AxSYM<TDx。这些差异仅通过CyA特定代谢产物与免疫分析方法中使用的抗体的不同交叉反应程度难以解释。国际临床化学和检验医学联合会(IFCC)的标准应重新制定,因为它无法确保该方法具有足够的特异性,而每种免疫分析方法要用于CyA的TDM都应符合该标准。目前仍需要一种合适、廉价且快速的CyA TDM分析方法。包括我们中心在内的一些移植中心不止采用一种方法进行有效的CyA TDM。