Ⅰ期临床试验中血液标本溶血相关因素的分析

Analysis of the related factors causing hemolysis in phase Ⅰ clinical trial

目的对本中心Ⅰ期临床试验中血液标本采集时可能引起溶血的相关因素进行分析,探究试验过程中可能引起血样溶血的高危因素,以期在后续临床实践中采取相应的护理干预措施来减少溶血的发生。方法选择2017年12月至2018年8月Ⅰ期临床试验中受试者228例,详细记录每例受试者性别、年龄、留置针埋管部位、留置时间等,观察记录每份血标本的溶血程度,受试者性别、年龄、静脉留置针的留置部位、留置时间为分析因素,对可能引起静脉留置针采血样本溶血原因进行单因素分析,进而筛选样本溶血的有关因素。结果女性受试者较比男性受试者在试验采血过程中发生溶血,年龄轻的受试者比年龄较大的受试者更易发生溶血。结论研究对溶血高危因素进行护理干预能有效降低样本溶血的发生率,进而提高试验质量。

Objective To analyze the related factors causing hemolysis in phaseⅠclinical trial,investigate high risk factors and then take nursing interventional steps accordingly to reduce hemolysis occurrence.Methods A total of 228 subjects from Dec.2017-Aug.2018 in our hospital were erolled,each blood specimen hemolysis degree was also recorded.Gender,age,needle inserted position and inserted time were analyzed for each single factor to screen high risk factors.Results During the process of blood collection,hemolysis was more likely to occur among female/young subjects occurred compared with male/elderly subjects.Conclusion Nursing interventional steps should be taken to reduce hemolysis occurrence and promote the quality of phaseⅠclinical trial.