Open Access Article
International Journal of Clinical Research. 2024; 8: (8) ; 45-47 ; DOI: 10.12208/j.ijcr.20240295.
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
作者:
黄超超,
徐延 *
南京医科大学附属逸夫医院 江苏南京
*通讯作者:
徐延,单位:南京医科大学附属逸夫医院 江苏南京;
发布时间: 2024-08-20 总浏览量: 164
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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。
关键词: 护士全程护理;I期药物临床试验;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.
Key words: Nurse's full process nursing; Phase I drug clinical trials; Compliance
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引用本文
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.