一次性使用医用三通阀临床试验

Clinical Trial of Disposable Medical Three-way Valve

目的评价一次性使用医用三通阀的有效性和安全性。方法 66例受试者随机进入试验组和对照组,分别使用江苏新智源和扬州五洋的医用三通阀,使用后进行指标评价。结果试验组和对照组医用三通阀临床使用性能、有效性评价指标合格率均为100%,差异无统计学意义(P>0.05);2组均无不良事件发生,基本生命体征比较差异无统计学意义(P>0.05);2组临床综合评价指标合格率均为100%。结论试验组医用三通阀临床使用有效、安全,非劣效于已上市的同类产品。

Objective To evaluate the clinical efficacy and safety of the disposable medical three-way valve produced by Jiangsu Maslech medical technology Co.,Ltd.Methods 66 subjects were randomly divided into two groups.The experimental and control groups were used the medical three-way valve produced by Jiangsu Maslech and Yangzhou Wuyang,separately.The indexes were observed and compared after transfusion.Results The percent of pass was both 100% in clinical functional performance and efficacy,and there was no statistically significant difference between the experimental and control groups（P〉 0.05）.No adverse event was found in two groups and the differences of vital sign between two groups were considered no statistical significance（P 〉 0.05）.The percent of pass was both 100% in comprehensive evaluation of the experimental and control groups.Conclusions The testing medical three-way valve is effective and safe,and it is non-inferior to the similar product on the market.