Clinical evaluation of the CORDIS vascular access port systems: a multicenter study.

A Hoekstra, V Bassot, S Bertoglio, J Y Bobin, P Delassus, R Egeli, D Khayat, J Y Ranchere, J Santini, P Segol
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引用次数: 5

Abstract

Two non-metallic vascular access port systems, the Multipurpose Access Port (MPAP) and Miniport, developed by CORDIS S.A., France, have been evaluated clinically in 78 cancer patients. During the investigational period covering a total experience of 369 treatment cycles and 1,370 infusion days, no cases of infection or septicemia were observed. Serious complications such as drug extravasation and catheter occlusion occurred, although the incidence was relatively low (+/- 1%) when compared with the number of treatment courses (cycles), but in relation to the number of patients included in this study, the procedure-related complication rate was 17.5% for the MPAP and 15.8% for the Miniport. Procedure-related complications can be avoided by proper handling and use of suitable drug combinations to minimize crystallization reactions within the port-catheter systems. The final complication rate (total minus procedure-related) in terms of termination of treatment, i.e. explantation of the port-catheter system was 12.1% for the MPAP and 12.5% for the MINIPORT, which generally confirms the results of other groups. More than 87% of both port-catheter systems were still functional at the end of evaluation.

CORDIS血管通路系统的临床评价:一项多中心研究。
由法国CORDIS S.A公司开发的两种非金属血管通道系统,Multipurpose access port (MPAP)和Miniport,已经在78例癌症患者中进行了临床评估。在369个治疗周期和1370个输注日的研究期间,未观察到感染或败血症病例。虽然与疗程(周期)相比发生率相对较低(+/- 1%),但与本研究纳入的患者数量相比,MPAP的手术相关并发症发生率为17.5%,Miniport的手术相关并发症发生率为15.8%。通过正确处理和使用合适的药物组合,以尽量减少端口-导管系统内的结晶反应,可以避免手术相关的并发症。MPAP和MINIPORT的最终并发症发生率(总减去手术相关)在治疗终止方面,即port-catheter系统的拔出,分别为12.1%和12.5%,这与其他组的结果基本一致。在评估结束时,超过87%的两种端口导管系统仍然有效。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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