摘要
目的评价扬州美德莱医疗用品有限公司研制的一次性使用自毁式注射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,分别使用扬州美德莱和安徽天康生产的自毁式注射器,注射给药后评价各项指标。结果试验组和对照组产品临床使用性能、有效性合格率均为100%;试验组和对照组均无不良事件发生;试验组产品综合评价非劣效于对照组产品。结论试验组产品使用性能、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 the disposable auto-destruct syringe produced by Yangzhou Medline Industry Co.Ltd..Methods 132 subjects were randomly divided into two groups.The experimental and control groups were used the auto-destruct syringe produced by Yangzhou Medline and Anhui Tiankang,sepa rately.The index was compared after injection.Results The percent of pass was both 100% in clinical functional performance and efficacy of the experimental and control group.No adverse event happened in the experimental and con trol groups.The comprehensive evaluation of the experimental group was non-inferior to that of the control group.Conclusion The clinical functional performance,efficacy and safety of the experimental product are non-inferior to those of the similar product on the market.
出处
《中国医药导报》
CAS
2013年第18期106-107,109,共3页
China Medical Herald
