单克隆抗体放免法监测环孢素A血药浓度在造血干细胞移植中的临床价值

The clinical value of monoclonal antibody radioimmunoassay for whole blood concentration of cyclosporine A before and after hematopoietic stem cell transplantation

目的探讨单克隆抗体放免法测定全血环孢素A(CsA)浓度在造血干细胞移植(HSCT)患者免疫抑制治疗中的指导价值。方法采用单克隆抗体放免法检测28例造血干细胞移植后应用CsA患者的血药浓度,从方法学上严格进行实验室批内及批间质量控制指标的评价,同时观察CsA的临床应用与其血药浓度的关系。结果347批、712例次检测的非特异管结合率(NSB%)、零标准管结合率(B0%)、批间有效剂量值ED25、ED50、ED75的变异系数、反应误差关系(RER),以及批内、批间变异等各项指标均较理想。临床上对CsA剂量、剂型的调整皆以其血药浓度为依据,并发现排斥反应与移植物抗宿主病(GVHD)以及CsA毒副作用的发生均与全血CsA浓度改变密切相关,同时也观察到了影响CsA血药浓度的因素。结论单克隆抗体放免法检测全血CsA浓度在造血干细胞移植患者免疫抑制治疗中具有重要的临床意义。

Objective To investigate the clinical value of radioimmunoassay （RIA） based on monoclonal antibody technology for whole blood concentration of cyclosporlne A （CsA） during immunosuppressive therapy for the patients who underwent hematopoietic stem cell transplantation （HSCT）. Methods Whole blood CsA levels were measured by monoclonal antibody RIA for twenty-eight patients treated with CsA before and after undergoing HSCT. The main methodological evaluation parameters of the determination were strictly evaluated in both within-assay and between-assay tests. Meanwhile, the relationship between the clinical application of CsA and its whole blood concentration was observed. Results The methodological evaluation parameters,including NSB%, B0%, RER, CV % of ED25, ED50, ED75, and within-assay variation and between- assay variation were all excellent. The adjustments about the administrative mode and dosage of CsA in clinical applications were based on the patients＇ whole blood concentration of CsA indicated by the monoclonal antibody RIA. The rejected reactions and graft versus host disease （GVHD） were both intimately associated with the fluctuation of CsA levels. Furthermore the influent factors on CsA concentration were observed, Conclusion The clinical value of RIA based on monoclonal antibody technology for whole blood concentration of CsA before and after immunosuppressive therapy for HSCT patients is significant.