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外周置入中心静脉导管与植入式港静脉导管在癌症患者中的临床影响:一项开放标签、随机、两中心试验。

Clinical impact of peripherally inserted central catheters vs implanted port catheters in patients with cancer: an open-label, randomised, two-centre trial.

机构信息

University of Linköping, Linköping, Sweden; Department of Anaesthesia and Intensive Care Medicine, Ryhov County Hospital, Jönköping, Sweden.

University of Linköping, Linköping, Sweden; Department of Anaesthesia and Intensive Care Medicine, Ryhov County Hospital, Jönköping, Sweden.

出版信息

Br J Anaesth. 2019 Jun;122(6):734-741. doi: 10.1016/j.bja.2019.01.038. Epub 2019 Apr 17.

DOI:10.1016/j.bja.2019.01.038
PMID:31005243
Abstract

BACKGROUND

Centrally inserted totally implanted vascular access ports (PORTs) and peripherally inserted central catheters (PICCs) are widely used for the administration of chemotherapy. Our aim was to study the incidence of catheter-related deep venous thrombosis in patients with cancer receiving chemotherapy through either a PICC or a PORT.

METHODS

Adults with non-haematological cancer (mainly breast and colorectal) from two Swedish oncology centres were included and followed for up to 1 yr. Patients were randomly assigned to receive a single-lumen PICC or PORT. The primary end point was the occurrence of a clinically significant catheter-related deep venous thrombosis, and the secondary end point was a composite of adverse events related to the catheter: insertion complication, thrombosis, occlusion, infection, and mechanical problems.

RESULTS

The trial recruited 399 participants (PICC, n=201; PORT, n=198) between March 2013 and February 2017. The PICCs were associated with 16 (8%) deep venous thromboses compared with two (1%) in the PORT group (HR=10.2; 95% confidence interval, 2.3-44.6; P=0.002). The overall incidence of composite adverse events was higher for patients with a PICC compared with those with a PORT (HR=2.7; 95% confidence interval, 1.6-4.6; P<0.001).

CONCLUSIONS

PICCs are associated with higher risk for catheter-related deep venous thrombosis and other adverse events when compared with PORTs. This increased risk should be considered when choosing a vascular access device for chemotherapy, especially in patients with solid malignancy.

CLINICAL TRIAL REGISTRATION

NCT01971021.

摘要

背景

中央静脉置管(PORT)和外周静脉置入中心静脉导管(PICC)广泛用于化疗药物的输注。本研究旨在比较接受化疗的癌症患者使用 PICC 和 PORT 时导管相关深静脉血栓(DVT)的发生率。

方法

纳入了来自瑞典两个肿瘤中心的非血液学癌症(主要为乳腺癌和结直肠癌)患者,并随访了 1 年。患者被随机分配接受单腔 PICC 或 PORT。主要终点是发生有临床意义的导管相关 DVT,次要终点是与导管相关的不良事件的复合终点,包括置管并发症、血栓形成、导管堵塞、感染和机械问题。

结果

该试验于 2013 年 3 月至 2017 年 2 月共纳入 399 名患者(PICC 组 201 例,PORT 组 198 例)。PICC 组有 16 例(8%)发生 DVT,而 PORT 组有 2 例(1%)(HR=10.2;95%置信区间,2.3-44.6;P=0.002)。PICC 组复合不良事件的总体发生率高于 PORT 组(HR=2.7;95%置信区间,1.6-4.6;P<0.001)。

结论

与 PORT 相比,PICC 与导管相关 DVT 及其他不良事件风险增加相关。在选择化疗用血管通路装置时,尤其是在患有实体瘤的患者中,应考虑这种增加的风险。

临床试验注册

NCT01971021。

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