圣唐胰岛素泵用输注器有效性和安全性研究

目的:评估圣唐一次性胰岛素泵用输注器临床使用的安全性和有效性。方法:采用圣唐-A型胰岛素泵与圣唐一次性胰岛素泵用输注器配合,进行前瞻性、多中心和随机性临床对比验证试验。本研究2个临床中心共入组病例126例,其中试验组69例,对照组57例,采用进口胰岛素泵与进口一次性胰岛素泵用输注器配合。结果:有效性:一次性胰岛素泵用输注器通畅性试验组为97.01%,对照组为98.18%;弯针皮下穿刺一次成功率试验组为95.65%,对照组为100%;产品各部位密封性试验组为98.53%,对照组为100%;均与对照组差异无统计学意义。分合器拆分后通畅性、密封性均与对照组相同,均达到100%。安全性:从开始使用到结束后7 d,试验组和对照组患者均未出现不良事件,且无明显差异。结论:国产圣唐一次性胰岛素泵用输注器有效性和安全性等同于进口同类产品。

Study on efficacy and safety of ShengTang insulin pump infusion device

Objective： To assess the clinical safety and effectiveness of ShengTang disposable insulin pump infusion device. Methods： A prospective, multi-center, randomized clinical validation test were conducted. Two centers enrolled a total of 126 cases, including 69 cases of the test group, used ShengTang-A type of insulin pump with ShengTang disposable insulin pump infusion device, and 57 cases of the control group, used the imported insulin pumps with imported disposable insulin pump infusion device. Results： Effectiveness： patencv （97.01% of thetest group, 98.18% of the control group）, the looper subcutaneous puncture success rate （95.65% of the test group, 100% of the control group）, tightness of the product of eachparts （98.53% of the test group, 100% of the control group） are no statistically significant difference compared to the control group; Patency and tightness the division is split are the same as the control group, all of 100%. Security： none of the test group and the control group patients experienced adverse events, the test group and the control group had no significant difference from getting started to seven days after the end. Conclusion： The domestic ShengTang disposable insulin pump infusion device on the efficacy and safety is not inferior to imported products.