新型口服降糖药Ⅲ期临床试验中的护理职责

摘要

Objective To summarize methods and experiences of nursing in Phase Ⅲ clinical trials of new oral hypoglycaemic drugs.Methods Nurses learned related knowledge of GCP to understand the mechanism of drug effect,research objectives and procedures before trials,use proficient nursing skills and manage drugs strictly during trials,as well as provide patients with good health education and psychological nursing.Results Nurses played an active role in clinical trials,so as to ensure smooth progress of the research project.Conclusions Nurses hold important duties in clinical trials,which can expand their traditional roles and functions to further guarantee the efficacy and safety of clinical trials.%目的 总结护士在口服降糖新药Ⅲ期临床试验工作中的护理职责.方法 临床试验前护士认真学习药品临床试验质量管理规范(GCP)相关知识,了解研究药物作用机制、研究目的、研究程序,在试验过程中熟练运用护理操作技能,严格进行研究药物的管理,做好患者的教育工作及心理护理.结果 积极发挥研究护士在临床试验研究中的作用,保证了研究项目的顺利进行.结论 在临床试验中护士担负重要的工作职责,通过参与临床药物试验拓展了传统护士角色和功能,进一步保障了试验的有效性和安全性.