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

Research on nursing intervention in preventing hemolysis of blood samples caused by venous blood samplers in phase I clinical trials of drugs

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DOI 10.12208/j.ijcr.20240295
刊名
International Journal of Clinical Research
年,卷(期) 2024, 8(8)
作者
作者单位

南京医科大学附属逸夫医院 江苏南京 ;

摘要
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.
关键词
护士全程护理;I期药物临床试验;依从性
KeyWord
Nurses full process nursing; Phase I drug clinical trials; Compliance
基金项目
页码 45-47
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黄超超,徐延*. 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 [J]. 国际临床研究杂志. 2024; 8; (8). 45 - 47.

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