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CORDIS血管通路端口系统的临床评估:一项多中心研究。

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

作者信息

Hoekstra A, Bassot V, Bertoglio S, Bobin J Y, Delassus P, Egeli R, Khayat D, Ranchere J Y, Santini J, Segol P

机构信息

Department of Research and Technology, CORDIS International, Brussels, Belgium.

出版信息

Med Oncol Tumor Pharmacother. 1993;10(3):131-8. doi: 10.1007/BF02987780.

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.

摘要

法国CORDIS S.A.公司研发的两种非金属血管通路端口系统,即多用途接入端口(MPAP)和微型端口,已在78例癌症患者中进行了临床评估。在涵盖总计369个治疗周期和1370个输液日的研究期间,未观察到感染或败血症病例。尽管与治疗疗程(周期)数相比,药物外渗和导管阻塞等严重并发症的发生率相对较低(±1%),但就本研究纳入的患者数量而言,MPAP的操作相关并发症发生率为17.5%,微型端口为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,可以避免操作相关并发症。就治疗终止而言,即端口 - 导管系统的取出,最终并发症发生率(总计减去操作相关)MPAP为12.1%,微型端口为12.5%,这总体上证实了其他研究组的结果。在评估结束时,两种端口 - 导管系统中超过87%仍可正常使用。

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