CAJ | 학술논문

圣唐胰岛素泵用输注器有效性和安全性研究
골당이도소빙용수주기유효성화안전성연구
Study on efficacy and safety of ShengTang insulin pump infusion device

万方数据

中国医学装备中國醫學裝備 중국의학장비
CHINA MEDICAL EQUIPMENT
2013年 9期 12-14,15 ,共4页

武晋晓%吕肖锋%朱旅云%胡丽叶%赵晶%邱春娟%李晓玲%单巍%李艳俊%王志强%王素玲%王秀慧

무진효%려초봉%주려운%호려협%조정%구춘연%리효령%단외%리염준%왕지강%왕소령%왕수혜

胰岛素泵%输注器%胰岛素%安全性胰島素泵%輸註器%胰島素%安全性
이도소빙%수주기%이도소%안전성
Insulin pump%Infusion device%Insulin%Safety

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。
목적：평고골당일차성이도소빙용수주기림상사용적안전성화유효성。방법：채용골당-A형이도소빙여골당일차성이도소빙용수주기배합，진행전첨성、다중심화수궤성림상대비험증시험。본연구2개림상중심공입조병례126례，기중시험조69례，대조조57례，채용진구이도소빙여진구일차성이도소빙용수주기배합。결과：유효성：일차성이도소빙용수주기통창성시험조위97.01%，대조조위98.18%；만침피하천자일차성공솔시험조위95.65%，대조조위100%；산품각부위밀봉성시험조위98.53%，대조조위100%；균여대조조차이무통계학의의。분합기탁분후통창성、밀봉성균여대조조상동，균체도100%。안전성：종개시사용도결속후7 d，시험조화대조조환자균미출현불량사건，차무명현차이。결론：국산골당일차성이도소빙용수주기유효성화안전성등동우진구동류산품。
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:patency (97.01%of the test 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.