Morris R G
Department of Clinical Pharmacology, Queen Elizabeth Hospital, Woodville South, South Australia.
Ther Drug Monit. 1994 Dec;16(6):564-9. doi: 10.1097/00007691-199412000-00006.
A detailed questionnaire was distributed to the 30 Australian laboratories known to provide cyclosporin-A (CsA) therapeutic drug monitoring (TDM) services with a view to evaluating the range of approaches to such monitoring. Replies were received from all 30 laboratories. The data suggested there was a wide discordance in approaches to CsA TDM due to the fact that laboratories appeared to have adopted individual approaches to this service, both in method selection(s) and proposed therapeutic range(s). In many cases, patients served were shown to travel to more distant centers for their graft, returning to their home city/town for longer term management. Hence, services of several laboratories were involved during their clinical care. A strong mandate was received from respondents for development of national guidelines for the monitoring of CsA and other immunosuppressant drugs in order to avoid such discrepancies in the future. The approaches to external analytical quality assurance (QA) and, to a lesser extent, internal quality control (QC) were generally inadequate.
一份详细的调查问卷被分发给了已知提供环孢素A(CsA)治疗药物监测(TDM)服务的30家澳大利亚实验室,旨在评估此类监测的方法范围。收到了所有30家实验室的回复。数据表明,由于各实验室在方法选择和建议治疗范围方面似乎都采用了各自的方法,因此在CsA TDM方法上存在很大差异。在许多情况下,接受治疗的患者显示要前往更远的中心进行移植手术,然后回到自己的家乡城市/城镇进行长期治疗。因此,在他们的临床护理过程中涉及了多个实验室的服务。受访者强烈要求制定国家关于CsA和其他免疫抑制药物监测的指南,以避免未来出现此类差异。外部分析质量保证(QA)的方法,以及在较小程度上内部质量控制(QC)的方法,总体上都不够完善。