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

发布时间：2018-04-17 01:15

本文选题：Ⅰ期临床试验 + 肿瘤药物　；参考：《中国临床药理学杂志》2016年24期

【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。
[Abstract]:Objective to investigate the effect of quality control design in phase I clinical trial of anti-tumor drugs.Methods the strict quality control design was carried out from personnel operation, equipment and consumables design, especially the drug dispensing process.At the end of the experiment, the results were evaluated by the following two ways: measuring the error between the flow rate calculated by the residual liquid and the flow rate set by the pump, and the results of the pharmacokinetics analysis were consistent with the results reported in the literature.Results the qualified rate of training for nurses was 100.00m, and the first choice of flow error was determined as follows: 1 infusion pump and matching infusion device, the volume of cavity of infusion device was 15.00 mL.The infusion pump was running smoothly and there was no swelling and exosmosis at the injection site.The estimated total flow error between the pump inflow and pump setting is 2.93 after administration. The main pharmacokinetic parameters are: the main pharmacokinetic parameter: t _ (max) C _ (1) C _ (+) ~ (1 / 2)). The results of the main pharmacokinetic parameters are good agreement with the results reported in the literature, and both of them reflect the accuracy of the dosages, and the results are in good agreement with the results reported in the literature, and the results of the main pharmacokinetic parameters are as follows: (1 / 2).Conclusion quality control design is the key link to ensure the successful implementation of clinical trials. In order to achieve the goal of accurate dosage, it is necessary to check the quality control design from human, mechanical and material aspects.
【作者单位】：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;首都医科大学附属北京世纪坛医院党委;
【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)
【分类号】：R969

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