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中国当代医药  2022, Vol. 29 Issue (17): 61-61转65    
  临床研究 本期目录 | 过刊浏览 | 高级检索 |
正压直型留置针在Ⅰ期临床试验中减少样本溶血的应用
姚薇 黄微 赖凤娇 彭庆海
江西省萍乡市人民医院眼科
Application of positive pressure straight type indwelling needle in reducing sample hemolysis during phase Ⅰclinical trial
YAO Wei HUANG Wei LAI Fengjiao PENG Qinghai
Department of Ophthalmology,Pingxiang People′s Hospital
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摘要 目的 探讨正压直型留置针在Ⅰ期临床试验中减少样本溶血的应用。方法 选择萍乡市人民医院2020年1月至2021年6月参与Ⅰ期临床试验的80 例受试者为研究对象,按随机数字表法分为试验组(n=40)和对照组(n=40)。对照组使用普通一次性静脉留置针采血,试验组使用正压式直型留置针采血,比较两组受试者血标本的溶血率和回血率以及并发症总发生率。结果 试验组的溶血率和回血率均低于对照组,差异有统计学意义(P<0.05);试验组的堵管、采血困难和超窗情况总发生率低于对照组,差异有统计学意义(P<0.05)。结论 正压式直型留置针采血可有效降低血标本的溶血率和回血率,在Ⅰ期临床试验中具有较高的使用价值,有助于试验顺利进行。
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姚薇
黄微
赖凤娇
彭庆海
关键词 留置针Ⅰ期临床试验静脉采血样本溶血    
Abstract:Objective To explore the application of positive pressure straight type indwelling needle in reducing sample hemolysis during phase Ⅰclinical trial.Methods A total of 80 subjects who participated in phase Ⅰclinical trial from January 2020 to June 2021 in Pingxiang People′s Hospital were selected as the research subjects.According to the random number table method,they were divided into the experimental group (n=40) and the control group (n=40).The control group adopted ordinary disposable intravenous indwelling needle for blood collection,and the experimental group applied positive pressure straight type indwelling needle to collect blood.The hemolysis rate,blood return rate and the total incidence of complications were compared between the two groups.Results The hemolysis rate and blood return rate in the experimental group were lower than those in the control group,with statistically significant differences (P<0.05).The total incidence rate of tube plugging,blood collection difficulty and super time window in the experimental group was lower than that in the control group,with statistically significant difference (P<0.05).Conclusion Positive pressure straight type indwelling needle for blood collection can effectively reduce the hemolysis rate and blood return rate of blood samples.It has a high application value during phase Ⅰclinical trial and is helpful for the smooth progress of the trial.
Key wordsIndwelling needle    Phase Ⅰclinical trial    Venous blood collection    Sample hemolysis
    
基金资助:江西省萍乡市科技计划项目(2019PY063)。
引用本文:   
姚薇;黄微;赖凤娇;彭庆海. 正压直型留置针在Ⅰ期临床试验中减少样本溶血的应用[J]. 中国当代医药, 2022, 29(17): 61-61转65.
YAO Wei; HUANG Wei ;LAI Fengjiao; PENG Qinghai. Application of positive pressure straight type indwelling needle in reducing sample hemolysis during phase Ⅰclinical trial. 中国当代医药, 2022, 29(17): 61-61转65.
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