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解决第一代胰岛素输注泵的问题:新型微型输注器的临床试验

Meeting the problems of first-generation insulin infusion pumps: clinical trial of a new miniature infuser.

作者信息

Bending J J, Pickup J C, Keen H, Rothwell D, Sutherland I A

机构信息

Unit for Metabolic Medicine, Guy's Hospital Medical School, London, United Kingdom.

出版信息

Diabetes Care. 1983 Sep-Oct;6(5):452-8. doi: 10.2337/diacare.6.5.452.

DOI:10.2337/diacare.6.5.452
PMID:6400705
Abstract

We designed and constructed a new miniature, open-loop insulin infusion pump specifically to overcome the problems of many first generation insulin infusers. Special features are small size, adjustable volumetric basal infusion rate, rapid electronically mediated prandial insulin boosts, facility for doubling and halving the basal infusion rate and/or prandial delivery, and alarms for low battery state, motor over-run, stoppage, and control circuit malfunction. The infuser takes a specially designed syringe prefilled with short-acting insulin, sufficient in most diabetic patients for at least 7 days treatment with 100 U/ml insulin. To test clinical efficacy nine insulin-dependent diabetic patients received continuous subcutaneous insulin infusion (CSII) with the new infuser for periods up to 6 mo. Four patients previously CSII-treated with a first-generation pump and five who were new to CSII achieved and maintained the expected degree of near-normoglycemia. There were no pump breakdowns and a questionnaire completed by patients during the study confirmed ease and simplicity of operation and an appreciation of the advantages of the new pump compared with one widely used first-generation infuser.

摘要

我们设计并制造了一种新型的微型开环胰岛素输注泵,专门用于克服许多第一代胰岛素输注器存在的问题。其特点包括体积小、基础输注速率可调节、能通过电子方式快速增加餐时胰岛素剂量、具备基础输注速率和/或餐时给药加倍或减半的功能,以及低电量状态、电机超速、堵塞和控制电路故障报警功能。该输注器使用一种特别设计的预装短效胰岛素的注射器,对于大多数糖尿病患者而言,使用100U/ml的胰岛素,该注射器中的胰岛素足以进行至少7天的治疗。为了测试临床疗效,9名胰岛素依赖型糖尿病患者使用这种新型输注器进行了长达6个月的持续皮下胰岛素输注(CSII)。4名之前使用第一代泵进行CSII治疗的患者以及5名初次使用CSII的患者均实现并维持了预期的近正常血糖水平。期间没有出现泵故障,患者在研究期间填写的问卷证实了操作的简便性,并表明他们认识到与一种广泛使用的第一代输注器相比,新型泵具有诸多优点。

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引用本文的文献

1
Technology and the diabetic patient.技术与糖尿病患者
Med Biol Eng Comput. 1984 Sep;22(5):385-400. doi: 10.1007/BF02447697.