Research on nursing intervention in preventing hemolysis of blood samples caused by venous blood samplers in phase I clinical trials of drugs
药物I期临床试验中护理干预在预防静脉采血器致血标本溶血中的研究

摘要

目的 药物I期临床试验中护理干预在预防静脉采血器致血标本溶血中的研究。方法 选取2021年6月-2023年6月期间在我院进行I期药物临床试验的受试者228例，随机分为观察组（n=114）和对照组（n=114）。对照组受试者给予常规护理干预，观察组受试者给予护士全程护理干预。结果 两组受试者干预前的SAS、SDS评分，均相当，P>0.05比较差异无统计学意义；观察组受试者干预后的SAS、SDS评分，均低于对照组，P<0.05比较差异均具有统计学意义。观察组受试者的溶血发生率（7.89%），显著低于对照组（23.68%），P<0.05比较差异具有统计学意义。观察组受试者的依从性（90.48%），显著高于对照组（71.43%），P<0.05比较差异具有统计学意义。结论 护士全程护理干预能够减轻I期药物临床试验受试者的焦虑、抑郁情绪，可降低溶血发生率，从而显著提升其依从性。

Abstract

Objective: To study the effect of nursing intervention in preventing hemolysis of blood samples caused by venous blood samplers in phase I clinical trials of drugs. Method: 228 subjects who underwent Phase I drug clinical trials in our hospital from June 2021 to June 2023 were randomly divided into an observation group (n=114) and a control group (n=114). The control group subjects received routine nursing intervention, while the observation group subjects received full course nursing intervention from nurses. Result: The SAS and SDS scores of the two groups of subjects before intervention were comparable, with no statistically significant difference (P>0.05); The SAS and SDS scores of the observation group after intervention were lower than those of the control group, and the difference was statistically significant (P<0.05). The incidence of hemolysis in the observation group (7.89%) was significantly lower than that in the control group (23.68%), and the difference was statistically significant (P<0.05). The compliance of subjects in the observation group (90.48%) was significantly higher than that in the control group (71.43%), and the difference was statistically significant (P<0.05).
Conclusion  : Nursing intervention throughout the entire process can alleviate anxiety and depression among participants in phase I drug clinical trials, reduce the incidence of hemolysis, and significantly improve their compliance.