A pilot randomized clinical safety study of sonothrombolysis augmentation with ultrasound-activated perflutren-lipid microspheres for acute ischemic stroke
A pilot randomized clinical safety study of sonothrombolysis augmentation with ultrasound-activated perflutren-lipid microspheres for acute ischemic stroke
复制标题
DOI：
10.1161/strokeaha.107.505727
复制
发表时间：
2008-05-01
期刊：
影响因子：
8.3
通讯作者：
Grotta, James C.
中科院分区：
文献类型：
--
作者：
Alexandrov, Andrei V.;Mikulik, Robert;Grotta, James C.
背景和目的-超声瞬间膨胀经氟化脂质微球(Mu S)，将能量动量传递给周围液体。我们报道了一项应用全身组织纤溶酶原激活剂(TPA)超声激活沐浴S的安全性/可行性的中试研究。方法：卒中患者在治疗3h内出现脑缺血(TIBI)异常溶栓，经颅多普勒(TCD)检测tPA前残余血流0~3级。随机分为对照组(tPA+tCD)和目标组(tPA=tCD=2.8mL亩S)。主要的安全终点是症状性颅内出血(SICH)，并在72小时内恶化4个NIHSS点。结果：15名受试者被随机分为3：1组(Target，n=12)或对照组(n=3)。治疗后，3名Target和1名对照组出现无症状脑出血，所有研究对象均未见SICH。目标者S到达大脑中动脉闭塞的速度高于周围残余红细胞流量：39.8+/-11.3vs28.8+/-13.8 cm/S，P
Background and Purpose-Ultrasound transiently expands perflutren-lipid microspheres (mu S), transmitting energy momentum to surrounding fluids. We report a pilot safety/feasibility study of ultrasound-activated mu S with systemic tissue plasminogen activator (tPA).Methods-Stroke subjects treated within 3 hours had abnormal Thrombolysis in Brain Ischemia (TIBI) residual flow grades 0 to 3 before tPA on transcranial Doppler (TCD). Randomization included Controls (tPA + TCD) or Target (tPA = TCD = 2.8 mL mu S). The primary safety end point was symptomatic intracranial hemorrhage (sICH) with worsening by >= 4 NIHSS points within 72 hours.Results-Fifteen subjects were randomized 3: 1 to Target, n = 12 or Control, n = 3. After treatment, asymptomatic ICH occurred in 3 Target and 1 Control, and sICH was not seen in any study subject. mu S reached MCA occlusions in all Target subjects at velocities higher than surrounding residual red blood cell flow: 39.8 +/- 11.3 vs 28.8 +/- 13.8 cm/s, P