【摘要】 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。更多还原

【Abstract】 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.更多还原