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“得普利麻输注系统”的研发:一种用于丙泊酚的靶控输注系统。

The development of 'Diprifusor': a TCI system for propofol.

作者信息

Glen J B

机构信息

Medical Research and Communications Group, Zeneca Pharmaceuticals, Macclesfield, Cheshire, UK.

出版信息

Anaesthesia. 1998 Apr;53 Suppl 1:13-21. doi: 10.1111/j.1365-2044.1998.53s115.x.

Abstract

The 'Diprifusor' target controlled infusion system has been developed as a standardised infusion system for the administration of propofol by target controlled infusion. A preferred set of pharmacokinetic parameters for propofol was selected using computer simulation of a known infusion scheme with pharmacokinetic parameters described in published literature. The selected model was included in a 'Diprifusor' module that was interfaced with, and later incorporated into, a computer-compatible infusion pump. Clinical trials with such systems led to guidance on appropriate target concentrations for the administration of propofol by 'Diprifusor' target controlled infusion for inclusion in drug prescribing information. Standardisation of the delivery performance (+/- 5%) of commercial systems has been achieved with a laboratory performance specification. Clinical studies indicate that the actual blood concentrations achieved were about 16% greater than the calculated values displayed by the system. In an individual patient, titration of the target concentration is required in the same manner as an anaesthetic vapouriser is adjusted to obtain a specific pharmacodynamic effect.

摘要

“得普利麻输注器”靶控输注系统已被开发为一种通过靶控输注给药丙泊酚的标准化输注系统。利用已发表文献中描述的药代动力学参数,通过对已知输注方案进行计算机模拟,选择了一组丙泊酚的优选药代动力学参数。所选模型被纳入一个“得普利麻输注器”模块,该模块与计算机兼容的输液泵相连,后来又被并入该输液泵。使用此类系统进行的临床试验为通过“得普利麻输注器”靶控输注给药丙泊酚的适当靶浓度提供了指导,以便纳入药品处方信息。商业系统的输送性能(±5%)已根据实验室性能规范实现了标准化。临床研究表明,实际达到的血药浓度比系统显示的计算值约高16%。在个体患者中,需要像调整麻醉蒸发器以获得特定药效学效果那样,以相同方式滴定靶浓度。

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