Kaps M, Legemate D A, Ries F, Ackerstaff R G, Markus H, Pezzoll C, Llull J B, Spinazzi A
Department of Neurology, Medical Centre of Neurology and Neurosurgery, Justus-Liebig-University of Giessen, Am Steg 14, D-35385 Giessen, Germany.
J Neuroimaging. 2001 Jul;11(3):261-7. doi: 10.1111/j.1552-6569.2001.tb00044.x.
The authors investigated the safety and diagnostic potential of a new ultrasound contrast agent (SonoVue) using transcranial color-coded duplex sonography (TCCS).
Forty patients were enrolled in a multicenter, open-label (on-site), blind (off-site), randomized, dose-ranging crossover study. SonoVue was administered as an intravenous bolus injection of 4 different dosages (0.3, 0.6, 1.2, and 2.4 mL). Efficacy was evaluated as (1) off-site assessment of global quality of the Doppler investigation (based on color or power Doppler images and spectral analysis) at baseline and following each dose of SonoVue according to a 4-point scale (from very poor to excellent imaging of blood flow) and (2) duration of clinically useful signal enhancement and color or power Doppler visualization of blood flow. Additional on-site efficacy assessments performed following each dose of SonoVue included confidence in diagnosis and global consequences of contrast enhancement on diagnosis. Safety evaluations included clinical laboratory tests, neurological examination, injection site tolerability, and incidence of adverse events and their relationship to the study agent.
All doses of SonoVue significantly improved the global quality of Doppler examinations (P < .05). The median duration of clinically useful enhancement was dose related (P < .001) and ranged from 2 to 6 minutes at the highest dose. The administration of the contrast agent changed a nondiagnostic study to a diagnostic one in 66% of patients and increased the confidence in diagnosis in 74% of cases. No serious adverse events were recorded following SonoVue administration. The observed adverse reactions were all transient and mild in intensity.
The results obtained from this multicenter study demonstrate that the administration of SonoVue to patients with ischemic cerebrovascular disease who undergo TCCS examination of cerebral vessels improves the visualization of intracranial arteries, providing a dose-dependent contrast enhancement and a clinically useful duration of signal enhancement related to the dose. During this multicenter study, SonoVue proved to be a safe and well-tolerated compound.
作者使用经颅彩色编码双功能超声检查（TCCS）研究了一种新型超声造影剂（声诺维）的安全性和诊断潜力。
40名患者参与了一项多中心、开放标签（现场）、盲法（非现场）、随机、剂量范围交叉研究。声诺维以静脉推注的方式给予4种不同剂量（0.3、0.6、1.2和2.4 mL）。疗效评估如下：（1）非现场根据4分制（从血流成像非常差到优秀）在基线时以及每次给予声诺维后评估多普勒检查的整体质量（基于彩色或能量多普勒图像以及频谱分析）；（2）临床有用信号增强的持续时间以及血流的彩色或能量多普勒可视化。每次给予声诺维后进行的额外现场疗效评估包括诊断信心以及造影剂增强对诊断的整体影响。安全性评估包括临床实验室检查、神经学检查、注射部位耐受性、不良事件的发生率及其与研究药物的关系。
所有剂量的声诺维均显著改善了多普勒检查的整体质量（P <.05）。临床有用增强的中位持续时间与剂量相关（P <.001），最高剂量时为从至6分钟。给予造影剂后，66%的患者中原本无法诊断的检查变为可诊断，74%的病例中诊断信心增强。给予声诺维后未记录到严重不良事件。观察到的不良反应均为短暂性且强度轻微。
该多中心研究获得的结果表明，对接受脑血管TCCS检查的缺血性脑血管病患者给予声诺维可改善颅内动脉的可视化，提供剂量依赖性的造影剂增强以及与剂量相关的临床有用信号增强持续时间。在这项多中心研究中，声诺维被证明是一种安全且耐受性良好的化合物。
