Objective: To evaluate the clinical safety and diagnostic efficacy of domestic gadoxetate disodium (GdEOBDTPA). Methods: The imaging data from patients with space-occupying liver lesions who underwent GdEOBDTPA enhanced magnetic resonance examination at West China Hospital of Sichuan University between January 2020 and September 2020 were analyzed retrospectively. Clinical indicators were evaluated by the incidental condition of transient severe respiratory motion artifacts (TSM) in the arterial phase to assess the safety profile.The differences in quantitative and qualitative indicators for the risk factors of TSM in the arterial phase between the TSM group and the non-TSM group were compared by t-test and χ2 test. Observational indicators of the accuracy of diagnostic procedures: The 2018 version of the Liver Imaging Reporting and Data System (LI-RADS) was used to evaluate the main signs, auxiliary signs, and LR grades of lesions. Postoperative pathological findings were used as the gold standard for evaluating and diagnosing hepatocellular carcinoma (HCC). Simultaneously, the relative enhancement degree of the liver, the contrast between the lesion and the liver, and the cholangiography in the hepatobiliary phase were evaluated. The McNemar test was used to compare the differences in the diagnostic efficiency of physician 1 and physician 2 in the diagnosis of hepatocellular carcinoma according to the 2018 version of LI-RADS. Results: A total of 114 cases were included in this study. The incidence rate of TSM was 9.6% (11/114). Age [(53.8 ± 11.3) years vs. (55.4 ± 15.4) years, t = 0.465, P = 0.497], body weight [(65.8 ± 11.1) kg vs. (60.8 ± 7.6) kg, t = 1.468, P = 0.228], body mass index [(23.9 ± 3.1) kg/m(2) vs. (23.4 ± 3.0) kg/m(2), t = 0.171, P = 0.680], liver cirrhosis ratio (39 cases vs. 4 cases, χ (2) =1.776, P = 0.183), proportion of mild to moderate pleural effusion (32 cases vs. 4 cases, χ (2) = 0.000, P = 0.986), and proportion of mild to moderate ascites (47 cases vs. 5 cases χ (2) = 0.000, P = 0.991) had no statistically significant difference between the groups of non-TSM and TSM patients. According to the 2018 version of LI-RADS for the LR5 category, there was no statistically significant difference between the two physicians' HCC diagnoses in terms of sensitivity (91.4% vs.86.4%, χ (2) = 1.500, P = 0.219), specificity (72.7 % vs. 69.7%, χ (2) = 0.000, P = 1.000), positive predictive value (89.2% vs. 87.5%, χ (2) = 2.250, P = 0.125), negative predictive value (77.4% vs. 67.6%, χ (2) = 2.250, P = 0.125), and accuracy (86.0% vs. 81.6%, χ (2) = 0.131, P = 0.125). According to physicians 1 and 2 film review results, 91.2% (104/114) and 89.5% (102/114) of the contrast agent were discharged into the common bile duct or duodenum, respectively. In addition, 86.0% (98/114) of the patients had good liver enhancement, and 91.2% (104/114) of the lesions showed low signals relative to the liver background. Conclusion: Domestic gadoxetate disodium has a good clinical safety profile and diagnostic efficacy.
目的： 评价国产钆塞酸二钠（GdEOBDTPA）的临床安全性和诊断有效性。 方法： 回顾性分析2020年1月至2020年9月于四川大学华西医院行GdEOBDTPA增强磁共振检查的肝占位患者影像资料。临床安全性评估指标为动脉期发生瞬时严重呼吸运动伪影（TSM）情况。对于动脉期发生TSM的危险因素，采用t检验及χ(2)检验分别比较TSM组与非TSM组的定量指标及定性指标的差异。诊断有效性的观察指标：根据2018版肝脏影像报告及数据系统（LIRADS）评估病灶的主要征象、辅助征象及LR分级，以术后病理学结果为金标准评估肝细胞癌（HCC）的诊断效能，同时，评估肝胆期肝脏相对强化程度、病灶与肝脏对比度及胆道显影情况。采用McNemar检验比较医师1和医师2根据2018版LIRADS诊断肝细胞癌效能的差异。 结果： 共纳入114例患者，其中TSM的发生率为9.6%（11/114）。非TSM组与TSM组患者的年龄[（53.8±11.3）岁与（55.4±15.4）岁，t = 0.465，P = 0.497]、体质量[（65.8±11.1）kg与（60.8±7.6）kg，t = 1.468，P = 0.228]、体质量指数[（23.9±3.1）kg/m(2)与（23.4±3.0）kg/m(2)，t = 0.171，P = 0.680]、肝硬化比例（39例比4例，χ(2) = 1.776，P = 0.183）、轻中度胸腔积液比例（32例比4例，χ(2) = 0.000，P = 0.986）、轻中度腹水比例（47例比5例，χ(2) = 0.000，P = 0.991）的差异无统计学意义。以LR5作为诊断依据，2名医师根据2018版LIRADS诊断肝细胞癌的灵敏度（91.4%与86.4%，χ(2) = 1.500，P = 0.219）、特异度（72.7%与69.7%，χ(2) = 0.000，P = 1.000）、阳性预测值（89.2%与87.5%，χ(2) = 2.250，P = 0.125）、阴性预测值（77.4%与67.6%，χ(2) = 2.250，P = 0.125）、准确率（86.0%与81.6%，χ(2) = 0.131，P = 0.125）的差异无统计学意义。根据医师1的阅片结果，91.2%（104/114）的对比剂排出至胆总管或十二指肠；根据医师2的阅片结果，89.5%（102/114）的对比剂排出至胆总管或十二指肠。此外，86.0%（98/114）的患者肝脏强化程度良好，91.2%（104/114）的病灶相对于背景肝呈低信号。 结论： 国产钆塞酸二钠具有良好的临床安全性和诊断有效性。.
Keywords: Clinical safety; Contrast agent; Diagnostic effectiveness; Liver cancer; Magnetic resonance imaging.