临床试验中注射给药及样本采集要点分析  

Analysis of the Main Points of Intravenous Injection and Sample Collection in Drug Clinical Trials

作　　者：陈娟[1] 黄烽如 孙鲁宁[1] 张宏文[1] 谢利军[1] 周辰[1] 刘云[1] 李天萍[1] 王永庆[1] CHEN Juan;HUANG Fengru;SUN Luning;ZHANG Hongwen;XIE Lijun;ZHOU Chen;LIU Yun;LI Tianping;WANG Yongqing(The First Affiliated Hospital with Nanjing Medical University,Nanjing,Jiangsu,China 210029)

机构地区：[1]南京医科大学第一附属医院,江苏南京210029

出　　处：《中国药业》2020年第10期85-87,共3页China Pharmaceuticals

基　　金：国家自然科学基金[81273593,81673515,81870436]。

摘　　要：目的为药物临床试验中静脉注射液的给药及样本采集的科学性和可靠性提供建议。方法以注射用右旋兰索拉唑Ⅰ期临床试验30 mg剂量组为例,对试验中药物的保存与配制、给药过程中及给药后的样本采集进行分析,并计算实际输液准确度,观察不良反应发生情况,以评价试验效果。结果试验中药品无额外损失、无变质,注射液配制过程称量精准,无污染风险,24名受试者10次给药的实际输液准确度均值均小于5%,实际输液准确度相对标准偏差(RSD)均小于2%,无明显不良反应发生。结论静脉注射液给药过程较复杂,应按药物临床试验质量管理规范及标准操作规程操作,以有效保证试验的科学性和可靠性。Objective To provide reference for thescientificity and reliabilityof intravenous injection administration and sample collection in drug clinical trials. Methods Taking the dexlansoprazole for injection 30 mg dose group as an example,the preservation and preparation of the drug during the trial,as well as the collection of samples during and after the administration were analyzed,the actual infusion was calculated,and the adverse reactions were observedto evaluate the effect of the trial. Results During the trial,there was no extra loss and no deterioration of the drugs. The injection preparation process was accurately weighed and there was no risk of contamination. The mean value of the accuracy of 10 times of actual infusions to the 24 subjects was less than 5%,and the standard deviation( RSD%) of the actual infusion accuracy was less than 2%,with no significant adverse reactions. Conclusion The administration process of intravenous injection is relatively complicated. Implementation in accordance with GCP regulations and operation points can effectively ensure the smooth implementation of the trial and the scientificity and reliability of the trial.

关 键 词：临床试验 静脉给药 护理管理 输液泵 静脉留置针 药事管理 

分 类 号：R95[医药卫生—药学]