Department of Interventional Ultrasound, The General Hospital of Chinese People's Liberation Army, Beijing, China.
Department of Ultrasound, Tianjin Medical University General Hospital, Tianjin, China.
J Ultrasound Med. 2019 Sep;38(9):2417-2425. doi: 10.1002/jum.14940. Epub 2019 Jan 25.
This study aimed to compare the efficacy of Sonazoid and SonoVue in subjects with focal liver lesions.
The patients who had untreated focal solid liver lesions confirmed by B-mode ultrasonography were eligible for the study. The target lesion and whole liver were scanned by gray scale ultrasonography; then, contrast-enhanced ultrasonography was performed, and the results were evaluated blindly. The main end point was accuracy improvement with postcontrast versus precontrast ultrasound examination for diagnosis of the target lesion of interest as malignant or benign against the reference standard.
There were 65 patients with 65 hepatic tumors enrolled in the study. The improvement of diagnostic accuracy was 0.30 in the Sonazoid group and 0.16 in the SonoVue group (95% confidence interval, -0.828-0.168; P = .24). Using 20% as the noninferiority margin, the upper limit of the 95% confidence interval (0.168) was less than 0.20. The number of lesions detected during the whole-liver scanning in the Sonazoid group was significantly more than that detected in the SonoVue group (P = .024).
The diagnosis value of Sonazoid is noninferior to SonoVue, and this new contrast agent can improves the whole-liver image quality.
本研究旨在比较 SonoVue 和 Sonazoid 对局灶性肝病变患者的疗效。
本研究纳入了经 B 型超声检查证实为未经治疗的局灶性实性肝病变的患者。对目标病变和全肝进行灰阶超声扫描；然后进行对比增强超声检查，并进行盲法评估。主要终点是与参考标准相比，超声检查后与检查前相比，对目标病变良恶性的诊断准确性提高。
共有 65 例 65 个肝肿瘤患者纳入本研究。Sonazoid 组的诊断准确性提高了 0.30，SonoVue 组提高了 0.16（95%置信区间，-0.828-0.168；P=0.24）。使用 20%作为非劣效性边界，95%置信区间的上限（0.168）小于 0.20。Sonazoid 组全肝扫描检测到的病变数量明显多于 SonoVue 组（P=0.024）。
Sonazoid 的诊断价值不劣于 SonoVue，这种新型造影剂可以提高全肝图像质量。
