基于风险的精细化控制静脉给药剂量的管理在零期临床试验中的应用

Risk-based control for precise dosage in intravenous administration of anti-tumor drug phase 0 clinical trials

目的:探讨基于风险的精细化控制静脉给药剂量的管理在零期临床试验中的效果。方法:在某具有抗肿瘤活性烷化剂药物的零期临床试验中,我们从人机料法环对应的人员、设备、耗材和配药给药环节进行风险精细化控制管理。试验结束后,通过测量注射器实际推移刻度计算流量误差,以评价效果。结果:人员培训的合格率均为100%。选择的设备是本次测量误差小(误差范围0.34%～1.68%)的7台注射泵;选择的耗材是与泵配套的注射器;选择的留置针空腔体积为0.3 m L。注射泵给药前安装出现5次报警,报警解除后均顺利给药。受试者注射部位均无肿胀和外渗。给药后估计的泵入量与泵设置的总量误差几乎为0。结论:质量控制设计是保证临床试验顺利实施的关键环节,要达到给药剂量精准的预期目标,需要从人机料法环方面进行风险控制。

Objective： To evaluate the effect of risk-based strategies in precise dosage controlin intravenous anti-tumor drug administration in phase 0 clinical trials. Methods： Personal staff training,facilities calibration,medical supplies,and drug admixture and administration were considered as the key risk factors in the design.After the administration,visual scale of the changed volume in the syringe was valued in phase 0 trial,which was used to calculate flow errors by comparing the volume to be infused（ VTBI） from pump. Results： 100% nurses were eligible in training and evaluation. Seven injection pumps with matched syringe were determined by flow error calibrated（ error range： 0. 34% ～ 1. 68%）. In-dwelling vein-infusion needle volume was 0. 3 m L used in phase 0 clinical trial. 5-times alarm in syringe pump were occurred before drug administration. After the alarm was lifted,the drug was given smoothly. No infusion site swelling appeared for subjects. The flow error estimated in final dosage evaluation was 0%. Conclusion： Risk control with delicate dosage is essential for the clinical trial. Exact and precise dosage administration is influenced and controlled by personnel,facilities and medical supplies etc.