注射用替莫唑胺零期临床试验中微量泵给药体外模型的设计

In vitro model of administration of temozolomide injection using micro-pumps during phase 0 clinical trial

目的建立注射用替莫唑胺零期临床试验微量泵给药的体外模型,检测和校准微量泵,保证后续零期试验微剂量给药的准确性。方法在相同的实验环境下,对Ⅰ期临床实验研究室12台微量注射泵进行定量检测,采用注射用替莫唑胺零期试验相同的给药速度(0.8 ml/h)和给药时间(90 min),模拟零期试验的给药过程,对实际测量液体量与理论值进行对比和误差计算。所有试验重复3次,取3组数据平均值计算每台微量泵的误差值。结果 12台微量泵的误差值范围在±5%以内,根据国家计量规定和零期临床试验微剂量给药要求,表明本研究室的12台微量泵给药精确度高,可以用于后续零期试验给药。结论在整个实验的过程中,重视微量泵使用的相关因素,保证零期试验给药的准确性。

Objective To develop an in vitro model for temozolomide injection infused by micro-pumps and to assess the performance of micro-pumps so as to guarantee the accuracy of infusion during the phase 0 clinical trial. Methods Twelve micro-pumps were tested under the same conditions, involving temperature, humidity, operators and IV line of the same type. In order to simulate the infusion process of phase 0 clinical trial, the infusion speed and duration were set at 0.8 ml/h and 90 min respectively based on the phase 0 study protocol of temozolomide. Each pump was tested three times and the mean liquid amount was calculated to compare with the theoretical amount. Results The errors of the twelve miro-pumps, ranging from - 5%-5%, met the national measurement provision and requirements of micro-pumps used during phase 0 clinical trials, suggesting that the high accuracy of our micro-pumps could guarantee the subsequent administration in the clinical trials. Conclusion It is necessary to attach importance to the use of micro-pumps to ensure the accuracy of administration during the phase 0 clinical trials.