Chanalet S, Masson B, Boyer L, Laffont J, Bruneton J N
Hôpital Pasteur, Service de Radiologie, Nice.
J Radiol. 1995 Jul;76(7):417-21.
The development of new non-ionic magnetic resonance (MR) contrast media as gadodiamide injection increased the choice of paramagnetic contrast agents available in MR of the central nervous system (CNS). The purpose of our paper was to compare at the dose of 0.1 mmol/kg b.w. the safety of gadodiamide (Gd-DTPA-BMA) to gadopentetate dimeglumine (Gd-DTPA) and to gadoterate meglumine (Gd-DOTA) in two multicentric double-blind studies. A total of 551 patients were enrolled with 143 patients in the Gd-DTPA group, 132 patients in the Gd-DOTA group and 276 patients in the Gd-DTPA-BMA group. Safety was assessed by recording the adverse events up to 24 hours after the injection. One or more adverse events were recorded in 14% of the Gd-DTPA patients, in 15.1% of the Gd-DOTA patients and in 11.6% of the Gd-DTPA-BMA patients. These reactions were related to the contrast media in 9.1%, 13.6% and 8.7% of the cases respectively. Their intensity was defined as mild in 8.4% of the patients in the Gd-DTPA group, in 13.6% of the patients in the Gd-DOTA group and in 8.3% of the patients in the Gd-DTPA-BMA group. No severe reaction or death were recorded. An injection-site reaction (heat, coldness, pain) has been observed in 43% of the cases although an adverse event other than local reactions (headache, dizziness, nausea) has been noticed in 57% of the cases. No significant statistical difference was observed between the groups. Gadodiamide is a safe and effective contrast agent in MRI of the CNS in comparison with Gd-DTPA and Gd-DOTA currently in routine use.
随着钆双胺注射液这种新型非离子磁共振(MR)造影剂的出现,中枢神经系统(CNS)磁共振成像中可用的顺磁性造影剂的选择增加了。我们论文的目的是在两项多中心双盲研究中,以0.1 mmol/kg体重的剂量比较钆双胺(Gd-DTPA-BMA)与钆喷酸葡胺(Gd-DTPA)和钆特酸葡甲胺(Gd-DOTA)的安全性。总共招募了551名患者,其中Gd-DTPA组有143名患者,Gd-DOTA组有132名患者,Gd-DTPA-BMA组有276名患者。通过记录注射后24小时内的不良事件来评估安全性。在Gd-DTPA组14%的患者、Gd-DOTA组15.1%的患者和Gd-DTPA-BMA组11.6%的患者中记录到了一个或多个不良事件。这些反应分别在9.1%、13.6%和8.7%的病例中与造影剂有关。在Gd-DTPA组8.4%的患者、Gd-DOTA组13.6%的患者和Gd-DTPA-BMA组8.3%的患者中,其强度被定义为轻度。未记录到严重反应或死亡。43%的病例观察到注射部位反应(发热、发冷、疼痛),尽管57%的病例注意到了除局部反应(头痛、头晕、恶心)之外的不良事件。各组之间未观察到显著的统计学差异。与目前常规使用的Gd-DTPA和Gd-DOTA相比,钆双胺在中枢神经系统磁共振成像中是一种安全有效的造影剂。