论文部分内容阅读
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。
OBJECTIVE: To observe the safety and effectiveness of needle-type I.V.-IV needle with protective sheath in clinical trials. Methods: Two clinical centers in China were involved. Randomized, controlled, parallel and open design methods were used to compare the clinical effects of the experimental group and the control group. Results: Needle with protective scalp needle (I.V.-Ⅳ type) indwelling needle could meet the need of hospitalized patients with continuous multi-day infusion of drug solution without any adverse events. There was no significant difference between experimental group and control group. Conclusion: The safety of needle-type I.V.-IV needle with protective sheath is not less than the performance of the listed product, and it has obvious advantages in the protection of medical staff and patients.