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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（χn 2=0.800，n 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（χn 2=7.857，n 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（n t=101.15，n P0.05) ; 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 (χn 2=7.857, n 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 (n t=101.15, n P<0.01) .n 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.