Ⅰ期药物临床试验中静脉留置针采集血标本发生溶血的原因分析  

Analysis of the causes of hemolysis in blood samples collected by venous indwelling needle in phaseⅠdrug clinical trials

作　　者：李昆[1] 付增丽 LI Kun;FU Zeng-li(PhaseⅠClinical Research Center,Liaocheng People's Hospital,Liaocheng 252000,China)

机构地区：[1]聊城市人民医院Ⅰ期临床研究中心,252000

出　　处：《中国实用医药》2025年第7期155-158,共4页China Practical Medicine

摘　　要：目的分析Ⅰ期药物临床试验中静脉留置针采集血标本发生溶血的原因。方法80例实施Ⅰ期药物临床试验患者,依据患者在Ⅰ期药物临床试验中静脉留置针采集血标本是否发生溶血将其分为溶血组(溶血指数>15,28例)、非溶血组(溶血指数≤15,52例)。采集两组患者的一般基线资料、诊疗护理资料,基于Logistic回归分析发生溶血的影响因素。结果单因素分析显示:两组患者的饮食情况、性别、年龄、止血带绑扎情况、封管液浓度比较差异无统计学意义(P>0.05);溶血组患者的静脉留置针型号>22号、静脉留置针留置时间≥12 h、静脉留置针留置部位为前臂、采集弃血与药物代谢动力学(药代学)间隔时间>30 s占比分别为71.43%、78.57%、78.57%、85.71%,均高于非溶血组的19.23%、53.85%、38.46%、38.46%,差异具有统计学意义(P<0.05)。经Logistic回归分析显示:静脉留置针型号>22号、静脉留置针留置部位为前臂、静脉留置针留置时间≥12h、采集弃血及药代学间隔时间>30 s是静脉留置针采集血标本发生溶血的独立危险因素(P<0.05)。结论Ⅰ期药物临床试验中静脉留置针采集血标发生溶血的危险因素比较多,包括静脉留置针型号>22号、静脉留置针留置部位为前臂、静脉留置针留置时间≥12 h、采集弃血及药代学间隔时间>30 s。护理工作在降低溶血发生率中有着重要意义,因此需要做好护理工作,既能确保试验顺利的实施、进行,也能保证受试者安全。Objective To analyze the causes of hemolysis in blood samples collected by venous indwelling needle in phaseⅠdrug clinical trials.Methods 80 patients undergoing phaseⅠdrug clinical trials were divided into a hemolysis group(hemolysis index>15,28 cases)and a non-hemolysis group(hemolysis index≤15,52 cases)based on whether blood samples were collected by venous indwelling needle during the phaseⅠdrug clinical trials.Collection of general baseline data,diagnosis and treatment nursing data of two groups of patients,and analysis of the influencing factors of hemolysis based on Logistic regression.Results Univariate analysis showed that there were no significant differences in diet,gender,age,tourniquet ligation and tube-sealing fluid concentration between the two groups(P>0.05).In the hemolysis group,the percentages of patients with venous indwelling needle type>22 G,retention time of venous indwelling needle≥12 h,indwelling needle site on the forearm,and interval of discarded blood collection and parmacokinetic blood collection>30 s accounted for 71.43%,78.57%,78.57%,and 85.71%,which were higher than 19.23%,53.85%,38.46%,and 38.46%in non-hemolytic group,and the difference was statistically significant(P<0.05).Logistic regression analysis showed that venous indwelling needle type>22 G,retention time of venous indwelling needle≥12 h,indwelling needle site on the forearm,and interval of discarded blood collection and parmacokinetic blood collection>30 s were independent risk factors for hemolysis in blood samples collected by venous indwelling needle(P<0.05).Conclusion There are many risk factors for hemolysis during the collection of blood samples using venous indwelling needle in phaseⅠdrug clinical trials,including indwelling needle type>22 G,retention time of venous indwelling needle≥12 h,indwelling needle site on the forearm,and interval of discarded blood collection and parmacokinetic blood collection>30 s.Nursing work is of great significance in reducing the incidence of hemolysis,so it is necessa

关 键 词：临床试验 静脉留置针 血标本 溶血 

分 类 号：R472[医药卫生—护理学]