环孢素A监测方案评价与选择  

Evaluation and Choice of Cyclosporine A Monitoring Strategy

作　　者：孙增先[1] 邢晓东[2] 赵利东[1] 周金玉[1] 高山[1] 张骞峰[1] 刘金永[1] 洪荣[1] 

机构地区：[1]江苏连云港市第一人民医院临床药学研究中心,连云港市222002 [2]南京理工大学化工学院,南京市210094

出　　处：《中国药房》2011年第46期4361-4364,共4页China Pharmacy

摘　　要：目的:对环孢素A(CsA)简化AUC_(0～12h)监测方案进行验证与评价,选择简便实用、能够准确反映CsA疗效的监测方案。方法:使用12例血液科相关病例数据,采用经典分析方法计算各监测方案预测AUC_(0～12h)的预测误差(PE)、平均绝对估算误差(MAE)、误差均方的平方根(RMSE)等验证参数,对各监测方案进行综合评价。结果:三点监测方案优于二点监测方案,而二点监测方案又要优于单点监测方案。但三点监测方案的准确度和精密度较二点监测方案提高有限(<8%以内),无临床实用意义,而c_0、c_2二点监测方案更值得推荐,特别是简化c_0+c_2监测方案。结论:c_0、c_2二点监测方案不仅能准确评价CsA的疗效,密切反映CsA暴露的峰谷水平,还可用于稳态血药浓度(c_(ss))和c_2/c_0的计算、CsA代谢属性的判别、最佳个体化剂量的精确计算、异质性吸收和代谢的识别与监测、肝功能状态的判别与监测以及CsA肝毒性的监测。OBJECTIVE：To validate and evaluate abbreviated AUC0～12hmonitoring strategy for Cyclosporine A（CsA）,and to select simple and practical CsA monitoring strategy which is able to accurately reflect the effect of CsA.METHODS：The data of 12 related cases from department of hematology was used,validation parameters of various monitoring strategies predicted AUC_（0～12h）（such as PE,MAE,RMSE,etc.）were calculated by classical analysis method,various monitoring strategies were integrated and evaluated.RESULTS：Three point monitoring strategy was better than two point monitoring strategy,and two point monitoring strategy was better than single point monitoring strategy.However,the accuracy and precision of three point monitoring strategy was slightly better than two point monitoring strategy（less than 8%）,there was no clinically practical significance.c_0,c_2 two point monitoring strategy was worthy of being recommended,especially simplified c0＋c2 monitoring strategy.CONCLUSION：c0,c2 two point monitoring strategy could not only evaluate efficacy of CsA accurately and reflect the peak and valley level of CsA exposure closely,but also calculate css and c2/c0,judge CsA metabolic attributes and calculate the best individualized dose accurately,distinguish and monitor absorption and metabolism of CsA heterogeneity,distinguish and monitor liver function status and monitor hepatotoxicity of CsA.

关 键 词：环孢素A 监测方案 评价 验证 简化AUC0~12h 有限样本监测方案 

分 类 号：R969.1[医药卫生—药理学] R979.5[医药卫生—药学]