两种采血方法在药代动力学标本采集中的效果比较

Comparison of two methods in pharmacokinetic blood specimen collection

目的探讨两种采血方法在药代动力学标本采集中的应用比较，以寻找科学安全的采血方法，确保药代动力学采血时间及血液质量的精确。方法选取248例参加药物临床试验的受试者为研究对象，随机分为对照组和试验组各124例，对照组采用5ml一次性无菌注射器经静脉留置针采血后再注入采血管的方法收集血标本6118管，试验组采用一次性静脉采血针连接留置针与真空采血管采血的方法收集血标本6118管。比较两组血标本溶血、采血延时、采血量未达标、血污染及针刺伤情况。结果对照组6118例血标本溶血、采血延时、采血量未达标、血污染发生数分别为304，92，1530，765例，分别高于试验组的25，15，122，21例，差异均有统计学意义（x2分别为243．1362，55．9000，1387．3464，750．3247；P〈0．01）。结论一次性静脉采血针配合安全性静脉留置针使用进行药代动力学标本采集的方法安全可靠、采血效率高。

Objective To find the scientific and safe blood specimen collection method by comparing two methods and to ensure the efficiency and quality of pharmacokinetic blood specimen collection. Methods 248 volunteers participating the clinical pharmacology experiment were randomly divided into control group and experimental group with 124 volunteers in each group. 6 118 blood samples were collected in both groups. In the control group, blood was taken by intravenous catheter needle with 5 ml disposable sterile syringes. However, blood was collected with vacuum blood collection method that took blood by disposable venous blood-taking needle at the experimental group. Hemolysis, delay in collection time, insufficient quantities of specimen, contamination and needle injuries were compared in two groups. Results Hemolysis, delay in collection time, insufficient quantity of sample, contamination and needle injuries in the control group （ 304,92,1 530,765 cases） were all significantly higher than the experimental group （25,15,122,21 cases）, the differences were statistically significant （ X2 = 243. 136 2,55. 900 0, 1 387. 346 4,750, 324 7, respectively; P 〈 0. 01 ）. Conclusions Disposable venous blood-taking needle is safe and highly effective in pharmacokinetic blood specimen collection. It is worthy to be utilized at the Phase I clinical trial ward.