Madjar H, Prömpeler H J, Del Favero C, Hackelöer B J, Llull J B
Deutsche Klinik für Diagnostik (DKD), Aukammallee 33, 65191, Wiesbaden, Germany.
Eur J Ultrasound. 2000 Dec;12(2):123-30. doi: 10.1016/s0929-8266(00)00105-1.
To determine the diagnostic performance of SonoVue (Bracco) in the enhancement of Doppler signals in breast lesions and in the improvement of diagnostic accuracy.
This multicenter study included 220 patients undergoing investigations of parenchymal lesions, 40 of which had breast tumors. After a baseline Doppler examination, intravenous doses of 0.3, 0.6, 1.2 and 2.4 ml SonoVue were injected. Doppler signal quality before and after injection was compared. Off-site assessment of the global quality of Doppler signal and duration of clinical useful enhancement, as well as off-site and on-site evaluation of quality of color and spectral Doppler, were performed. On-site evaluation of diagnostic accuracy was also carried out. Safety assessments included monitoring of adverse events up to 24 h following the last injection of SonoVue.
On-site evaluations: baseline Doppler was conclusive in only 4/21 carcinomas and in 2/17 benign lesions. Enhanced Doppler improved differential diagnosis in 20/21 carcinomas and in 9/12 benign lesions. Time to color enhancement was 0.55 min for the lowest and 0.35 min for the highest dose. The total duration of enhancement was 3.47 min for the lowest and 5.62 min for the highest dose, respectively. Off-site assessment: SonoVue improved the quality of Doppler blood flow information both in parenchymal and focal lesions. Statistically significant changes from baseline in global quality of Doppler investigations were observed at all four SonoVue doses (P<0.05). The duration of clinically useful signal enhancement increased with doses and a significant dose relationship was obtained (P<0.001). Mild adverse events were observed in two patients only.
The results obtained from this study, following both off-site and on-site assessment, demonstrate that the administration of SonoVue to patients with focal breast lesions provides significant improvement over the baseline of Doppler signal quality and a clinically useful duration of signal enhancement, related to the dose. SonoVue was shown to be a safe and well-tolerated compound.
确定声诺维（博莱科公司）在增强乳腺病变的多普勒信号及提高诊断准确性方面的诊断性能。
这项多中心研究纳入了220例接受实质病变检查的患者，其中40例患有乳腺肿瘤。在进行基线多普勒检查后，静脉注射0.3、0.6、1.2和2.4 ml的声诺维。比较注射前后的多普勒信号质量。对多普勒信号的整体质量和临床有效增强持续时间进行远程评估，同时对彩色和频谱多普勒质量进行远程及现场评估。还进行了现场诊断准确性评估。安全性评估包括在最后一次注射声诺维后长达24小时监测不良事件。
现场评估：基线多普勒检查仅对21例癌症中的4例以及17例良性病变中的2例有诊断意义。增强多普勒检查改善了21例癌症中20例以及12例良性病变中9例的鉴别诊断。最低剂量时彩色增强时间为0.55分钟，最高剂量时为0.35分钟。增强总持续时间最低剂量为3.47分钟，最高剂量为5.62分钟。远程评估：声诺维改善了实质病变和局灶性病变中多普勒血流信息的质量。在所有四个声诺维剂量下，多普勒检查的整体质量与基线相比均有统计学显著变化（P<0.05）。临床有效信号增强的持续时间随剂量增加，且获得了显著的剂量关系（P<0.001）。仅在两名患者中观察到轻度不良事件。
本研究通过远程和现场评估获得的结果表明，对乳腺局灶性病变患者给予声诺维，与剂量相关，能显著改善多普勒信号质量基线，并延长具有临床意义的信号增强持续时间。声诺维被证明是一种安全且耐受性良好的化合物。
