抗肿瘤药物的Ⅰ期临床试验中保证静脉给药剂量精准的质控设计效果  

Effect of quality control design for precise dosage on intravenous administration in anti-tumor drug phase Ⅰ clinical trials

作　　者：王泽娟[1] 刘晓娜[1] 陈刚[1] 刘英[1] 王进[1] 刘晨[1] 雷春璞 冯丽[1] 漆璐[1] 王瑜[1] 周保利[2] 王兴河 

机构地区：[1]首都医科大学附属北京世纪坛医院药物Ⅰ期临床试验研究室,北京100038 [2]首都医科大学附属北京世纪坛医院党委,北京100038

出　　处：《中国临床药理学杂志》2016年第24期2311-2314,共4页The Chinese Journal of Clinical Pharmacology

基　　金：北京市科委课题"重大项目科技成果转化落地培育"项目基金资助项目(Z111100059411059);北京市留学人员科技活动择优资助经费(2014ZYZZ1);国家科技重大专项-重大新药创制基金资助项目(2014ZX09303302);首都医科大学附属北京市世纪坛医院科研课题基金资助项目(2013-q05)

摘　　要：目的探讨抗肿瘤药物的Ⅰ期临床试验中用于保证静脉给药剂量精准的质控设计效果。方法本课题组从人员操作、设备、耗材环节设计进行了严格质量控制设计,尤其是配药给药过程。试验结束后通过以下两种方式评价效果:测量剩余药液推算泵入流量与泵设置的流量之间的误差,药代动力学(PK)分析的结果与文献报道的结果一致性。结果护士的培训合格率均为100.00%,并确定首选流量误差小(2.51%)的1台输液泵与配套输液器,输液器空腔体积为15.00 m L。输液泵给药运行顺利,受试者注射部位均无肿胀和外渗。给药后估计推算的泵入流量与泵设置的总流量误差为2.93%,主要药代动力学参数(t_(max),C_(max),AUC_(0-t),AUC_(0-∞),t_(1/2))的结果与文献报道结果一致性好,这两者均反映剂量准确。结论质量控制设计是保证临床试验顺利实施的关键环节,要达到预期的给药剂量精准的目的,需要从人、机和物等方面进行质量控制设计把关。Objective To evaluate the effect of quality control design for the precise dosage of antineoplastic agents tion in phase I clinical trials. Methods in intravenous drug administra- Personal staff training, facili- ties calibration, medical supplies, especially drug admixture and admi- nistration were considered as key elements in the design. After adminis- tration, the effect of the design was evaluated by the following methods： the deviation between the volume fixed in pump and pump flow estimated by the drug residual, as well as the consistency between pharmacokinetic （PK） data analysis of this study and that of other researches. Results 100. 00% nurses were eligible in training and evaluation. One infusion pump with matched infusion sets were determined by lower flow error cal- ibrated （2. 51% ）. Infusion sets volume were 15.00 mL used in this trial. No infusion site swelling appeared 2. 93% flow error was estimated in final dosage evaluation. Main PK parameters （tmax, Cmax, AUC0-t, AUC0-∞ ,t1/2） were consistent with the existing data. Conclusion Quality control design is essential for clinical trial. Precise dosage administration is controlled by personnel, facilities, medical supplies and so on.

关 键 词：Ⅰ期临床试验 肿瘤药物 静脉精确给药 质量控制设计 

分 类 号：R979.1[医药卫生—药品]