降压新药尼群洛尔片药代动力学研究的临床观察和护理

目的 探讨降压药物药代动力学研究中临床观察和护理的作用。方法 24名健康受试者分为尼群地平组、阿替洛尔组和尼群洛尔组,每组8人。观察3组健康受试者服药前和服药后的坐位、立位和卧位血压和心率变化以及任何不适主诉和体征,通过静脉留置针采得药代动力学研究的血液样本。结果 与尼群地平组和阿替洛尔组比较,尼群洛尔组的健康受试者服药前和服药后坐位、立位和卧位收缩压和舒张压以及心率均未有显著性差异。通过密切观察未发现尼群洛尔组的健康受试者有不良反应。结论 药代动力学研究中临床观察对降压药物安全性的评估是重要的,规范的护理操作和整体护理对药物临床试验的顺利完成起到重要的作用。

Clinical observation and nursing on the pharmacokinetic study of antihypertensive drug in healthy volunteers.

Objective To evaluation the effects on clinical observation and nursing of the pharmacokinetic study of antihypertensive drug in healthy volunteers. Methods The twenty-four healthy volunteers were enrolled and randomly divided into 3 groups (8 subjects in each group), including nitrendiping, atinolol and nitrenolol groups.The changes of blood pressure and heart rate ( positions of seated, standing and lying) as well as clinical symptoms and signs were observed before and after dosing. The blood samples of pharmacokinetic study were drawn by through the intravenous cannulation. Results Compared with nitrendiping group and atinolol group, the charges of seated, standing and lying blood pressure as well as seated, standing and lying heart rates in nitrenolol group were no significant difference(P>0.05)before and after dosing. No adverse reactions were observed in nitrenolol group. Cconclusion It is important that safety of antihypertensive drug was evaluated on the clinical observation in healthy volunteers,standard and holism nursing care play an important role in the successful completion of clinical trials.