一次性使用避光输液器有效性和安全性研究  

Efficacy and safety of disposable photophobic infusion set

作　　者：钟小溱[1] 张建平[1] 张会杰[1] 童建东[2] 王正霞[2] 徐小国 

机构地区：[1]南京医科大学第二附属医院,南京210011 [2]扬州市第一人民医院,江苏扬州225000 [3]南京琥瑞医药科技有限公司,南京210029

出　　处：《医疗卫生装备》2015年第11期94-96,共3页Chinese Medical Equipment Journal

摘　　要：目的:评价江苏某医疗器材有限公司研制的一次性使用避光输液器的有效性和安全性。方法:150例受试者随机进入试验组和对照组,分别使用江苏某医疗器材有限公司研制的避光输液器和已上市的山东某集团的避光输液器,分别评价产品的有效性和安全性。结果:试验组和对照组临床使用性能和有效性指标合格率均为100%,无统计学差异(P>0.05);2组患者基本生命体征比较,均未发生不良事件,差异无统计学意义(P>0.05);2组临床综合指标合格率均为100%,无统计学差异。结论:江苏某医疗器材有限公司研制的一次性使用避光输液器的有效性和安全性非劣效于已上市的同类产品。Objective To evaluate the efficacy and safety of a disposable photophobic infusion set produced by some medical materials Co., Ltd. in Jiangsu province. Methods Totally 150 subjects were randomly divided into an experimental group and a control group. The two groups applied the photophobic infusion sets respectively from some medical materials co., ltd. in Jiangsu province and some listed corporation in Shandong province, and the efficacies and safeties of the two sets were evaluated respectively. Results The percents of pass for clinical functional performance and efficacy were both 100% in the two groups, and there was no significant difference between the two groups（P〉0.05）. The differences of vital sign between the two groups were considered no statistical significance（P〈0.05）, and no adverse event was found in the two groups. The percents of pass for comprehensive evaluation were both 100%, and there was no difference between the two groups. Conclusions The disposable photophobic infusion set from some medical materials co., ltd. in Jiangsu province is effective and safe, and is non-inferior to the similar products on the market.

关 键 词：避光输液器 临床试验 有效性 安全性 

分 类 号：R472[医药卫生—护理学]