基于生物等效性研究不同封管液封管的有效性和安全性比较  

The study of the effectiveness and safety of different sealing fluidsin tube sealingbased on bioequivalence study

作　　者：涂盛青 徐玉芬 刘娜 肖双双 杨林 谢丽辉 柳鸣 TU Shengqing;XU Yufen;LIU Na;XIAO Shuangshuang;YANG Lin;XIE Lihui;LIU Ming(The Third Hospital of Changsha phase Ⅰ drug clinic trial center)

机构地区：[1]湖南省长沙市第三医院药物Ⅰ期临床研究中心,长沙410015

出　　处：《当代护士（下旬刊）》2022年第12期1-5,共5页Modern Nurse

基　　金：长沙市科技局基础研究项目(项目编号:kq1907006)。

摘　　要：目的比较肝素钠盐水和生理盐水封管液的有效性和安全性。方法随机选择参加生物等效性研究项目的健康受试者309例,设肝素钠盐水组(A)、生理盐水组(B)、生理盐水+肝素钠盐水组(C)进行对照研究。结果3组比较,B、C组的护理干预频次、静脉留置针堵管及样本溶血情况明显多于A组(P<0.05)。B、C组比较,C组静脉留置针堵管发生率和样本溶血率低于B组(P<0.05)。A、C组给药后12 h部分凝血活酶时间、凝血酶时间延长,较B组差异有统计学意义(P<0.05)。3组静脉炎发生率、出血发生率、血栓发生率的差异无统计学意义(P>0.05)。结论在生物等效性研究试验中,肝素钠盐水封管的有效性和安全性优于生理盐水封管。Objective To compare the effectiveness and safety of heparin sodium saline and normal saline tube sealing fluid.Methods A total of 309 healthy subjects were randomly selected to participate in the bioequivalence study,and the heparin sodium saline group(A),normal saline group(B)and normal saline group+heparin sodium saline group(C)were divided into control study.Results Compared among the three groups,the frequency of nursing intervention,retention needle blockage and sample hemolysis in group B and C were significantly higher than those in group A(P<0.05).Compared with group B,the incidence of tube blockage and sample hemolysis in group C were lower than those in group B(P<0.05).APTT and TT were prolonged at the12 h after administration in group A and C,and the difference was statistically significant compared with group B(P<0.05).There were no significant differences in the incidence of phlebitis,bleeding and thrombosis among the three groups(P>0.05).Conclusion In the bioequivalence study,the effectiveness and safety of heparin sodium saline sealing solution are better than that of normal saline sealing solution.

关 键 词：生物等效性研究 封管液 有效性 安全性 

分 类 号：R472[医药卫生—护理学]