2012国际卒中大会：新型免提超声装置与tPA联合溶栓安全有效
2012-02-17 MedSci MedSci原创
2012国际卒中大会公布的最新研究结果表明，应用新型免提超声溶栓装置与组织型纤溶酶原激活物（tPA）联用具有较好的安全性，并且有较高的血管再通率。此种联合疗法值得在Ⅲ期有效性试验中进一步评估。 当与静脉（IV）-tPA联用时，经FDA批准的手持式经颅多普勒（TCD）超声装置可改善再通。免提经颅超声和全身t-PA脑出血联合溶栓（CLOTBUST-HF）研究是首次在人类中实
2012国际卒中大会公布的最新研究结果表明，应用新型免提超声溶栓装置与组织型纤溶酶原激活物（tPA）联用具有较好的安全性，并且有较高的血管再通率。此种联合疗法值得在Ⅲ期有效性试验中进一步评估。
当与静脉（IV）-tPA联用时，经FDA批准的手持式经颅多普勒（TCD）超声装置可改善再通。免提经颅超声和全身t-PA脑出血联合溶栓（CLOTBUST-HF）研究是首次在人类中实施的多中心、开放标签、前导性安全研究；在由近端颅内血管阻塞所致的缺血性卒中患者中，对tPA联合免提超声装置进行了评估。
此种免提式装置由18个超声波探头组成；可被连续激活以便为整体颅内循环提供治疗性超声。所有受试者均接受标准剂量IV tPA治疗，并在其后立即接受2小时2-MHz超声治疗。主要转归为症状性颅内出血（sICH）。所有受试者均通过标准化TCD或CT血管造影对治疗前后血管开放性和再通情况进行评估。在2小时收集美国国立卫生研究院卒中量表（NIHSS）评分，90天时统计改良Rankin评分（mRS）。
结果共有20例患者被纳入研究（男性60%，平均年龄为63±14岁，中位NIHSS=15）。治疗前动脉阻塞部位：70%为大脑中动脉（MCA），15%为颈内动脉（ICA）末端，15%为椎动脉。tPA至超声溶栓启动中位时间（IQR）为22分钟。所有患者均可耐受2小时超声治疗，并且无患者发生sICH。目前尚无与在研装置相关的严重不良事件发生。
相关链接：
International Stroke Conference
Late-Breaking Science Poster Abstracts：LB P12
Publishing Title：Combined Lysis of Thrombus in Brain Ischemia With Transcranial Ultrasound and Systemic tPA- Hands-Free: results of a phase II safety pilot study
Abstract :
Background and Purpose: Transcranial Doppler (TCD) ultrasound utilizing hand-held, FDA-approved devices enhances recanalization when combined with IV-tPA. The Combined Lysis of Thrombus in Brain Ischemia With Transcranial Ultrasound and Systemic T-PA- Hands-Free (CLOTBUST-HF) study is a first-inman, NIH-sponsored, multi-center, open-label, pilot safety study of tPA plus a novel operator-independent ultrasound device in patients with ischemic stroke due to proximal intracranial occlusion. The hands-free device is composed of 18 ultrasound probes which are activated sequentially in order to provide therapeutic ultrasound to the entire intracranial circulation. Prior to the current study, 15 healthy volunteers tolerated the procedure without any change on MR permeability imaging.
Subjects & Methods: In the CLOTBUST-HF study (NCT#01240356), all study patients received standard dose IV tPA, and immediately after tPA bolus, 2-hours of 2-MHz therapeutic exposure to CLOTBUST-HF device was begun. The primary outcome was occurrence of symptomatic intracerebral hemorrhage (sICH). All patients underwent pre- and post-treatment assessment of vascular patency and recanalization measured by standardized TCD or CT angiography criteria. NIHSS scores were collected at 2-hours and mRS at 90 days.
Results: All pre-planned 20 patients were enrolled (60% men, mean age 63±14 years, median NIHSS = 15). Sites of pre-treatment arterial occlusion were: 14/20 (70%) MCA, 3/20 (15%) terminal ICA and 3/20 (15%) vertebral. The median (IQR) time tPA to beginning of sonothrombolysis was 22 (13.5, 29) minutes. All patients tolerated the entire 2 hours of insonation and none developed sICH. To date, no serious adverse events have been adjudicated to be related to the study device. Rates of 2 hour recanalization were: 8/20 (40%; 95% CI: 19-64) complete and 2/20 (10%; 95% CI: 1-32) partial. MCA occlusions demonstrated the greatest complete recanalization rate: 8/14 (57%; 95% CI: 29-82). 90 day mRS and NIHSS score data are pending and will be presented at the meeting. Our rate of 2-hour sustained complete recanalization closely parallels the results of the original CLOTBUST study (38%) which utilized operator-dependent hand-held technology.
Conclusion: Sonothrombolysis using a novel, operator-independent device in combination with systemic tPA appears safe and high recanalization rates warrant continued evaluation of this treatment combination in a phase III efficacy trial (CLOTBUSTER, NCT#01098981).
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