负压真空采血联合免封管技术在Ⅰ期临床药物试验静脉采血中的应用

目的探讨在Ⅰ期临床试验药代动力学血标本采集中,采用负压真空采血联合免封管技术的可行性及效果。方法采用便利抽样方法,选取2017年11月—2019年10月江苏省人民医院收治的60例Ⅰ期临床试验采血患者为研究对象,按照入院顺序分为对照组和改进组,其中2017年11月—2018年10月收集的31例患者作为对照组,采用注射器在开放式留置针中进行采血,收集血标本390管;2018年11月—2019年10月收集的29例患者作为改进组,采用负压真空采血联合免封管技术在开放式留置针中采血,收集血标本388管。比较两组患者留置针堵管发生率、血标本溶血发生率及单次采血时长。结果在留置针堵管发生率上,改进组为3.09%(12/388),对照组为2.05%(8/390),两组差异无统计学意义(χ²=0.800,P>0.05);在血标本溶血发生率上,改进组为2.66%(10/376),对照组为7.33%(28/382),两组差异有统计学意义(χ²=7.857,P<0.01);改进组单次采血时长为(29.40±1.99)s,对照组为(40.74±0.88)s,两组差异有统计学意义(t=101.15,P<0.01)。结论新药Ⅰ期临床试验药代动力学血标本采集中,采用负压真空采血联合免封管技术在保护受试者血管的同时,可以实现12 h内密集采血时间的精确控制,节省采血操作时间,保障血样质量,保证试验科学规范进行,值得推广。

Application of evacuated blood collection combined with non sealing technique in venous blood collection of phase I clinical drug test

Objective To explore the feasibility and effect of evacuated blood collection combined with non sealing technique in the collection of pharmacokinetic blood samples in phase I clinical trials.Methods Using convenient sampling method,60 patients in phase I clinical trial who were admitted between November 2017 and October 2019 were selected as the research objects,and were divided into control group and improvement group according to the admission sequence.Among them,31 patients collected from November 2017 to October 2018 were taken as the control group,and blood samples were collected in 390 tubes by syringe in open indwelling needle;from November 2018 to October 2019,29 patients were selected as the improvement group,and 388 blood samples were collected by evacuated blood collection combined with non sealing technique in the open indwelling needle.The incidence of indwelling needle plugging,hemolysis of blood samples and the duration of single blood sampling were compared between the two groups.Results In the incidence of indwelling needle plugging,the improvement group was 3.09%(12/388),the control group was 2.05%(8/390),there was no significant difference between the two groups(χ²=0.800,P>0.05);in the incidence of hemolysis of blood samples,the improvement group was 2.66%(10/376),the control group was 7.33%(28/382),the difference between the two groups was statistically significant(χ²=7.857,P<0.01);the improvement group was(29.40±1.99)seconds in the duration of single blood sampling,the control group was(40.74±0.88)seconds,the difference between the two groups was statistically significant(t=101.15,P<0.01).Conclusions In the collection of pharmacokinetic blood samples of phase I clinical trials of new drugs,evacuated blood collection combined with non sealing technique can not only protect the blood vessels of the subjects,but also control the time of intensive blood collection within 12 hours,save the operation time of blood collection and guarantee the quality of blood samples.It is worth popularizing to ensure the scientific and standard test.