Loichot Cécile, Bentue-Ferrer Danièle, Bernard Nicole, Bonardet Andrée, Boulieu Roselyne, Kergueris Marie-France, Paintaud Gilles, Peytavin Gilles, Simon Nicolas, Marquet Pierre
Laboratoire de Pharmacologie, Hôpitaux Universitaires, Strasbourg, France.
Fundam Clin Pharmacol. 2006 Feb;20(1):91-6. doi: 10.1111/j.1472-8206.2005.00383.x.
The aim of this retrospective study was to compare the cyclosporine C(2) blood levels in renal transplant recipients with induction therapy, monitored on C(0) levels during the early and long-term post-transplantation periods in different French transplantation centres, to the target values recommended by the International Consensus on Neoral and used in the Mo2art study. A retrospective study was conducted by the therapeutic drug monitoring (TDM) committee of the French Pharmacological Society. Cyclosporine C(0) and C(2) concentrations from 168 renal transplant recipients were collected at different post-transplantation periods by six TDM laboratories of transplantation centres from April 2001 to April 2002. Cyclosporine blood levels were determined by fluorescence polarization immunoassay (mFPIA, AxSYM, Abbott) or enzyme immunoassay (EMIT, Dade Behring). Most patients had C(0) values in the recommended target ranges, with C(2) levels below the targets used in the Mo2art study or proposed by the International Consensus Conference, both during the early and long-term post-transplantation periods. Sixty-eight per cent of patients had C(2) below 1,500 microg/L +/- 20% in the first 2 months post-transplantation and 55% had C(2) below 800 microg/L +/- 20% in the late post-transplantation period (>1 year). Cyclosporine dose should be increased by 40% on average during the first week post-transplantation period and by 50% during the maintenance period to achieve the C(2) targets. In France, most renal transplant recipients receiving induction agents monitored on C(0) had C(2) levels below the targets recommended by the International Consensus Conference. In clinical practice, the optimal therapeutic windows for CsA monitoring based on C(2) needs to be more precisely defined, both during the early and long-term post-transplantation periods in renal transplant recipients receiving induction agents.
这项回顾性研究的目的是，在不同法国移植中心，比较接受诱导治疗的肾移植受者在移植后早期和长期基于C(0)水平监测的环孢素C(2)血药浓度，与《新山地明国际共识》推荐并用于Mo2art研究的目标值。法国药理学会治疗药物监测（TDM）委员会开展了一项回顾性研究。2001年4月至2002年4月期间，6个移植中心的TDM实验室收集了168例肾移植受者在不同移植后时期的环孢素C(0)和C(2)浓度。环孢素血药浓度通过荧光偏振免疫测定法（mFPIA，AxSYM，雅培公司）或酶免疫测定法（EMIT，达德拜林公司）测定。大多数患者的C(0)值在推荐的目标范围内，在移植后早期和长期，C(2)水平均低于Mo2art研究中使用的或国际共识会议提出的目标值。68%的患者在移植后前2个月C(2)低于1500μg/L±20%，55%的患者在移植后期（>1年）C(2)低于800μg/L±20%。移植后第一周环孢素剂量平均应增加40%，维持期应增加50%，以达到C(2)目标值。在法国，大多数接受基于C(0)监测的诱导剂的肾移植受者，其C(2)水平低于国际共识会议推荐的目标值。在临床实践中，对于接受诱导剂的肾移植受者，在移植后早期和长期，基于C(2)监测环孢素的最佳治疗窗需要更精确地界定。
