Ng Rita, Li Xin, Tu Tri, Semba Charles P
University of California San Francisco School of Medicine, USA.
J Vasc Interv Radiol. 2004 Jan;15(1 Pt 1):45-9. doi: 10.1097/01.rvi.000099538.29957.f7.
Peripherally inserted central catheters (PICCs) have dramatically improved intravenous therapy, but thrombotic occlusion remains a common problem. Despite the popularity of PICCs, there are few prospective data on the use of fibrinolytic agents to salvage these particular devices. The purpose of this study was to evaluate the efficacy and safety of alteplase treatment.
A subgroup analysis was performed from a phase IIIB prospective, multicenter trial of 995 patients evaluating the use of alteplase to restore function in occluded venous catheters. Two hundred forty patients (126 men; mean age, 53.5 years; range, 2-90 y) with occluded single-lumen (n = 104) or double-lumen (n = 136) PICCs were identified and constitute the study population. Dysfunction was defined as the inability to withdraw 3 mL of blood. Alteplase (2 mg/2 mL) was instilled into the dysfunctional lumen and assessed at 30 and 120 minutes. If the lumen remained occluded, a second alteplase dose was instilled and assessed at 30 and 120 minutes. Patency was defined as the ability to withdraw 3 mL blood and infuse 5 mL of saline solution. The primary efficacy endpoint was the cumulative restored patency rate after a maximum of two doses of alteplase. The primary safety endpoint was the incidence of intracranial hemorrhage within 5 days of treatment. Serious adverse events were recorded for 30 days after treatment.
The primary efficacy endpoint was 92.9% (95% CI: 88.8%, 95.8%). Cumulative efficacy 30 and 120 minutes after first and second doses were 59.4%, 81.1%, 89.1%, and 92.9%, respectively. The primary safety endpoint was 0.0%. One major hemorrhage was reported: a patient with acute flare of ulcerative colitis experienced hematochezia 3 days after treatment. One serious adverse event (fever) was attributed to study drug.
Treatment with use of a maximum of two doses of alteplase is safe and effective in restoring function to occluded PICCs.
外周静脉穿刺中心静脉导管（PICC）显著改善了静脉治疗，但血栓形成导致的堵塞仍是一个常见问题。尽管PICC很常用，但关于使用纤溶药物挽救这些特定导管的前瞻性数据却很少。本研究的目的是评估阿替普酶治疗的有效性和安全性。
对一项III期前瞻性多中心试验进行亚组分析，该试验纳入995例患者，评估使用阿替普酶恢复闭塞静脉导管功能的情况。确定了240例患者（126例男性；平均年龄53.5岁；范围2 - 90岁），其单腔（n = 104）或双腔（n = 136）PICC发生堵塞，构成研究人群。功能障碍定义为无法抽出3 mL血液。将阿替普酶（2 mg/2 mL）注入功能障碍的管腔，并在30分钟和120分钟时进行评估。如果管腔仍堵塞，则注入第二剂阿替普酶，并在30分钟和120分钟时再次评估。通畅定义为能够抽出3 mL血液并注入5 mL生理盐水。主要疗效终点是最多两剂阿替普酶治疗后累积恢复通畅率。主要安全终点是治疗5天内颅内出血的发生率。治疗后30天记录严重不良事件。
主要疗效终点为92.9%（95%CI：88.8%，95.8%）。第一剂和第二剂后30分钟和120分钟的累积有效率分别为59.4%、81.1%、89.1%和92.9%。主要安全终点为0.0%。报告了1例大出血：1例溃疡性结肠炎急性发作患者在治疗3天后出现便血。1例严重不良事件（发热）归因于研究药物。
最多使用两剂阿替普酶治疗可安全有效地恢复堵塞PICC的功能。
