Liu Chin Y, Jain Vikash, Shields Anthony F, Heilbrun Lance K
Department of Pharmacy, Karmanos Cancer Institute/Harper University Hospital, Detroit Medical Center, 3990 John R, Detroit, MI 48201, USA.
J Vasc Interv Radiol. 2004 Jan;15(1 Pt 1):39-44. doi: 10.1097/01.rvi.0000106385.63463.ec.
To evaluate the efficacy and safety of reteplase for central venous catheter (CVC) occlusion in patients with cancer.
An open-label, single-arm, prospective study was conducted. Reteplase (0.4 U) was instilled into each catheter lumen with a dwell time of 30 minutes in patients with cancer with a dysfunctional CVC. If the function of the catheter was not restored in 30 minutes, an additional dwell time of 30 minutes was allowed (a total of 60 minutes possible dwell time for the first dose). A second dose was repeated at 60 minutes after the first dose if catheter function was not restored (a total of 120 minutes for up to two doses). The primary efficacy outcome was the restoration of CVC function.
Of 139 patients who received reteplase, the first-attempt success rate after a 30-minute dwell time was 66.9%. The cumulative success rates at 60, 90, and 120 minutes were 88.5%, 94.7%, and 94.7%, respectively. The variation of patient age, catheter age, CVC occlusion age, CVC type, number of lumen, or occlusion type was not associated with the efficacy of reteplase. There were no treatment-associated adverse events reported during the study period.
Reteplase at 0.4-U dosing per catheter lumen is an effective and safe alternative that rapidly restores the patency of occluded CVCs in patients with cancer.
评估瑞替普酶对癌症患者中心静脉导管(CVC)闭塞的疗效和安全性。
进行了一项开放标签、单臂前瞻性研究。对CVC功能障碍的癌症患者,将瑞替普酶(0.4单位)注入每个导管腔,保留时间为30分钟。如果30分钟内导管功能未恢复,则允许额外保留30分钟(首剂总保留时间可达60分钟)。如果导管功能未恢复,在首剂后60分钟重复第二剂(两剂总时间可达120分钟)。主要疗效指标是CVC功能的恢复。
139例接受瑞替普酶治疗的患者中,保留30分钟后的首次尝试成功率为66.9%。60、90和120分钟时的累积成功率分别为88.5%、94.7%和94.7%。患者年龄、导管使用时长、CVC闭塞时长、CVC类型、腔数或闭塞类型的变化与瑞替普酶的疗效无关。研究期间未报告与治疗相关的不良事件。
每个导管腔注入0.4单位剂量的瑞替普酶是一种有效且安全的选择,可迅速恢复癌症患者闭塞CVC的通畅。