Cole E, Deshpande R
Renal Transplant Program, Toronto General Hospital, University of Toronto, Toronto, Ontario, Canada.
Transplant Proc. 2004 Mar;36(2 Suppl):408S-413S. doi: 10.1016/j.transproceed.2004.01.041.
The availability of Neoral in place of Sandimmun offered better pharmacokinetics and improved results but emphasized the poor accuracy of trough levels as a tool for monitoring drug exposure and dosage adjustment. Subsequent studies confirmed that Neoral exposure correlated with clinical events and it was found that C2 was the single point that correlated best with exposure as determined by AUC(0-4h). Single and multicenter studies have now shown that C2 monitoring is practically feasible and that its use resulted in very low rates of acute rejection with excellent renal function. One retrospective comparison suggested that rates of acute rejection were lower with C2 than with C0 monitoring. This tool has now been shown to be effective in managing African-American renal transplants and those with delayed graft function. A very recent international randomized trial has shown equivalent rates of acute rejection in liver transplant recipients treated with both Neoral and Prograf. Studies now in progress will permit further refinement of target levels with the potential to improve long-term results.
与山地明相比，新山地明的可用性提供了更好的药代动力学并改善了结果，但强调谷浓度作为监测药物暴露和剂量调整工具的准确性较差。随后的研究证实，新山地明的暴露与临床事件相关，并且发现C2是与AUC(0-4h)所确定的暴露相关性最佳的单一指标。单中心和多中心研究现已表明，监测C2在实际操作上是可行的，并且使用C2监测导致急性排斥反应发生率极低且肾功能良好。一项回顾性比较表明，C2监测组的急性排斥反应发生率低于C0监测组。现已证明该工具在管理非裔美国人肾移植以及移植肾功能延迟者方面有效。最近一项国际随机试验表明，接受新山地明和普乐可复治疗的肝移植受者的急性排斥反应发生率相当。目前正在进行的研究将进一步优化目标水平，有可能改善长期结果。
