国产中心静脉导管包的临床验证

Clinical verification test of central venous catheter pack

目的:评价深圳市安特高科实业有限公司生产的中心静脉导管包临床应用的安全性能及操作性能。方法:在重症加强治疗病房(ICU)住院且需要进行中心静脉置管的各种危重患者60例,签署知情同意书后入选。穿刺时采用的中心静脉导管包为深圳市安特高科实业有限公司生产的中心静脉导管(验证组)和我院正在使用的由韩国SUNGWON MEDICAL CO.,Ltd.生产的中心静脉导管包(对照组),对产品的外观设计、组成元件以及各元件的性能进行验证,同时观察其不良反应的发生情况。数据采用SPSS13.0统计软件进行处理。结果:入选病例共60例,两组年龄、性别以及导管留置时间比较,均无显著性差异(P>0.05)。两组产品的穿刺顺应性、感染率、堵管及渗漏等方面的不良反应比较,也均无显著性差异(P>0.05)。验证产品的组成元件较对照组多、操作方便性更为满意。结论:本验证产品组成元件多,操作更为方便,性能可靠、安全,该产品能满足临床使用需要。

Objective： To evaluate the performance of clinical safety and operational feasibility of the central venous catheter packs produced by Shenzhen Ante Gaoxin Industry Company. Methods： 60 ICU patients who were in need of central venous catheter placing were enrolled for the test after signing informed consents. The central venous catheter packs from Shenzhen Ante Gaoxin Industry Company were verification group and those from Korea SUNGWON MEDICAL Co., Ltd. were control group. The test aimed to verificate the shape design, composition elements and the performance of every element, and also observe the occurrence of side effects. The data were analyzed with SPSS 13.0 statistical software. Results： There was no significant difference in age, gender and the catheter placing time between verification group and control group （P〉0.05）. As a result, there was also no significant difference in the puncture compliance, infection rate, adverse reaction such as catheter obstruction and leak （P〉0.05）. The verification group had more composition dements and more operational convenience than control group. Conclusion： The verification product has more composition elements and more operational convenience. Its performance is reliable and safety. It can meet the clinical requirement.