紫杉醇药代动力学参数TC>0.05临床应用横断面调查及影响因素分析  

Cross-sectional Survey on Paclitaxel Pharmacokinetic Parameters TC>0.05 and Its Influence Factors in Clinical Application

作　　者：黄玲玲 王君萍 吴正宇 吴婷婷 姚媛 陈美玲 朱文靖 朱凤琴 HUANG Lingling;WANG Junping;WU Zhengyu;WU Tingting;YAO Yuan;CHEN Meiling;ZHU Wenjing;ZHU Fengqin(Center of Pharmacy,Hefei Cancer Hospital,Chinese Academy of Sciences,Hefei 230031,China;Center of Gynecologic Oncology,Hefei Cancer Hospital,Chinese Academy of Sciences,Hefei 230031,China)

机构地区：[1]中国科学院合肥肿瘤医院药学中心,合肥230031 [2]中国科学院合肥肿瘤医院妇科肿瘤中心,合肥230031

出　　处：《药学与临床研究》2023年第4期332-335,351,共5页Pharmaceutical and Clinical Research

基　　金：安徽省重点研究与开发计划项目(202104j07020009);中国科学院合肥肿瘤医院院长基金项目(YZJJ2019A05)。

摘　　要：目的:探讨紫杉醇(PTX)药代动力学参数临界血药浓度(0.05μmol·L^(-1))以上暴露时间(T_(C>0.05))在临床应用中的实用性及存在的问题。方法:采用横断面调查方法,收集2019年11月至2021年12月我院89例在院期间接受PTX 3周方案化疗并行PTX血药浓度监测患者的临床资料。PTX血药浓度监测采用MyPaclitaxel^(TM)试剂盒,药代动力学参数T_(C>0.05)的计算利用MyCare药物暴露计算器。87例患者的125例次PTX血药浓度监测结果被纳入T_(C>0.05)与血液学毒性结果分析,45例患者69例次PTX血药浓度监测结果被纳入T_(C>0.05)与近期疗效关系的分析,89例133例次PTX血药浓度监测结果被纳入T_(C>0.05)影响因素分析。结果:将T_(C>0.05)分为<26 h组、26~31 h组和>31 h组,三组间血液学毒性发生率和近期临床获益率差异无统计学意义(P>0.05)。患者年龄和PTX剂型对PTX药代动力学参数的T_(C>0.05)存在一定影响(P<0.05)。结论:PTX T_(C>0.05)的靶目标值在临床常规化应用尚需进一步研究论证。另外,在PTX临床应用中要重点关注年龄≥65岁的老年患者和使用不同PTX制剂患者T_(C>0.05)结果,保障用药安全。Objective:To investigate the practicality and existing problems of paclitaxel(PTX)pharmacokinetic parameter exposure time above the critical plasma concentration(0.05μmol·L^(-1))(T_(C>0.05))in clinical applications,so as to provide reference for improving PTX pharmaceutical monitoring schemes and rational drug use.Methods:A cross-sectional survey method was used to collect the clinical data of 89 patients who received in-hospital PTX 3-week chemotherapy and PTX blood concentration monitoring from November 2019 to December 2021.PTX plasma concentrations were monitored by the MyPaclitaxel^(TM) Kit,and the pharmacokinetic parameters T_(C>0.05) were calculated using the MyCare Drug Exposure Calculator.A total of 125 PTX blood concentration monitoring results of 87 patients were included in the analysis of T_(C>0.05) and hematological toxicity results,and 69 PTX blood concentration monitoring results of 45 patients were included in the analysis of T_(C>0.05) relationship with short-term clinical benefits,and 133 PTX blood concentration monitoring results of 89 patients were included in the analysis of T_(C>0.05) influencing factors.Results:T_(C>0.05) was divided into<26 h group,26-31 h group and>31 h group.There was no significant difference in the incidence of hematological toxicity and the short-term clinical benefit rate among the three groups(P>0.05).Further analysis of the results showed that the age of patients and the dosage form of PTX had certain effects on the T_(C>0.05) of PTX(P<0.05).Conclusion:The target value of PTX pharmacokinetic parameter T_(C>0.05) needs further research and demonstration in clinical routine application.In addition,in the clinical application of PTX,it is necessary to focus on the T_(C>0.05) results of elderly patients aged≥65 years and patients using different PTX preparations.

关 键 词：紫杉醇 药代动力学参数 血液学毒性 疗效 影响因素 

分 类 号：R969.1[医药卫生—药理学]