一次性使用精密过滤输液器临床试验

摘要

Objective To evaluate the clinical efficacy and safety of the disposable precise filtering infusion apparatus produced by Changzhou Medical Appliances General Factory.Methods A total of 132 subjects were randomly divided into two groups.The experimental and control groups used the precise filtering infusion apparatus produced by Changzhou and Shandong Weigao,respectively.The indexes were observed and compared after transfusion.Results There was no statistically significant difference in clinical functional performance and efficacy between the experimental and control group (P＞0.05).Adverse event was not found in two groups and the differences of safety between the two groups were considered of no statistical significance (P＞0.05).The comprehensive evaluation of the experimental group was non-inferior to that of the control group.Conclusions The testing product is safe and effective,and it is non-inferior to the similar products on the market.%目的:评价常州医疗器材总厂研制的一次性使用精密过滤输液器的有效性和安全性.方法:132例受试者随机进入试验组和对照组,分别使用常州医疗器材总厂和山东威高生产的精密过滤输液器,输液治疗后进行指标评价.结果:试验组和对照组的产品使用性能、有效性评价差异无统计学意义(P＞0.05);2组均无不良事件发生,安全性评价2组差异无统计学意义(P＞0.05);临床综合评价试验组非劣效于对照组.结论:试验产品临床使用安全、有效,非劣效于已上市的同类产品.