带保护壳头皮针型(I.V.-Ⅳ型)留置针临床试验设计及观察

摘要

Objectives:From clinical investigation, observe the safety and efficacy of Intravenous Catheter (I.V.-IV type) with Shielded-Shel . Methods:Conducted by two clinical investigation centers, use randomized, control ed, paral el and open design methods, compare and observe the clinical effect of the test and control groups. Results:The Intravenous Catheter (I.V.-IV type) with Shielded-Shel can meet the requirements of consecutive days’ infusion for patients, haven't any adverse event, and the test group and the control group haven’t significant difference. Conclusion:The safety and efficacy of Intravenous Catheter (I.V.-IV type) with Shielded-Shel is same or bet er than the performance of the products on the market, and has obvious advantages in protection of medical staff.%　　目的：通过临床试验，观察带保护壳头皮针型(I.V.-Ⅳ型)留置针的安全性、有效性.方法：由国内2个临床中心参加，采取随机、对照、平行、开放的设计方法，对比观察试验组和对照组的临床应用效果.结果：带保护壳头皮针型(I.V.-Ⅳ型)留置针能够满足连续多天输注药液的住院患者输注药物的需求，无不良事件出现，试验组与对照组无显著性差异.结论：带保护壳头皮针型(I.V.-Ⅳ型)留置针安全性、有效性不低于上市品的性能，且在对医护人员和患者的保护方面有明显优势.