Myhr G, Rinck P A, Børseth A
MR-Center, University Hospital, Trondheim, Norway.
Acta Radiol. 1992 Sep;33(5):405-9.
A double-blind, randomized parallel phase III study in MR imaging of the central nervous system was conducted to compare the safety and diagnostic utility of gadodiamide injection and gadopentetate dimeglumine at a dose of 0.1 mmol/kg b.w. in 60 adult patients. Seven patients in the gadodiamide injection group experienced 10 adverse events, 5 of the events possibly related to the contrast agent. In the gadopentetate dimeglumine group 5 patients reported 3 contrast agent-related adverse events out of 8 events. All events were transient and required no treatment. Seven incidents of patient discomfort, and some minor changes in vital signs and laboratory parameters were of no clinical concern. Contrast enhancement was observed in 60% and 44% of the patients with structural abnormalities in the gadodiamide injection group and gadopentetate dimeglumine group, respectively. No difference in overall efficacy was observed. Gadodiamide injection was found to be a safe and effective contrast agent.
开展了一项关于中枢神经系统磁共振成像的双盲、随机平行三期研究，以比较剂量为0.1 mmol/kg体重的钆双胺注射液和钆喷酸葡胺对60例成年患者的安全性和诊断效用。钆双胺注射液组有7例患者发生了10起不良事件，其中5起事件可能与造影剂有关。钆喷酸葡胺组有5例患者在8起事件中报告了3起与造影剂相关的不良事件。所有事件均为短暂性，无需治疗。7例患者出现不适，生命体征和实验室参数有一些轻微变化，但无临床意义。钆双胺注射液组和钆喷酸葡胺组分别有60%和44%有结构异常的患者出现了对比增强。未观察到总体疗效有差异。钆双胺注射液被发现是一种安全有效的造影剂。
