突换钆贝葡胺对比钆喷替酸葡胺对过敏样反应发生率的影响。
Effect of abrupt substitution of gadobenate dimeglumine for gadopentetate dimeglumine on rate of allergic-like reactions.
机构信息
Department of Radiology, B2-A209P, University of Michigan Health System, 1500 E Medical Center Dr, Ann Arbor, MI 48103, USA.
出版信息
Radiology. 2013 Mar;266(3):773-82. doi: 10.1148/radiol.12120253. Epub 2012 Dec 13.
PURPOSE
To evaluate the effect of abruptly substituting gadobenate dimeglumine for gadopentetate dimeglumine on allergic-like reactions.
MATERIALS AND METHODS
The institutional review board approved and waived patient consent for this HIPAA-compliant retrospective study. Allergic-like reactions related to gadolinium-based contrast media were assessed 2 years before and 3.5 years after gadobenate dimeglumine was substituted for gadopentetate dimeglumine. Reaction rates and severity were compared by using χ(2) tests, Fisher exact tests, odds ratios (ORs), and confidence intervals (CIs).
RESULTS
Allergic-like reactions (137 mild, 19 moderate, and six severe) occurred in 162 (0.15%) of 105 607 injections of gadolinium-based contrast media (gadopentetate dimeglumine, 31 540; gadobenate dimeglumine, 66 152; other, 7915). Gadobenate dimeglumine was associated with significantly more overall (0.19% [123 of 66 152] vs 0.08% [24 of 31 540]; OR, 2.4; 95% CI: 1.6, 3.8; P < .0001) and mild (0.16% [107 of 66 152] vs 0.06% [18 of 31 540]; OR, 2.8; 95% CI: 1.7, 4.7; P < .0001) allergic-like reactions than was gadopentetate dimeglumine. The reaction rate for gadobenate dimeglumine peaked (maximum per quarter, 0.38% [16 of 4262]; minimum per quarter, 0.07% [three of 4237]) in the 2nd year after it replaced gadopentetate dimeglumine (maximum per quarter, 0.10% [four of 4122]; minimum per quarter, 0.05% [two of 4222]) and then declined in the 3rd year. The final gadobenate dimeglumine reaction rate (last 3 quarters, 0.12% [17 of 14 387]) did not significantly differ from the original baseline reaction rate with gadopentetate dimeglumine.
CONCLUSION
After gadobenate dimeglumine was substituted for gadopentetate dimeglumine, a significant transient increase occurred in the frequency of reported allergic-like reactions that demonstrated a temporal pattern suggestive of the Weber effect (a transient increase in adverse event reporting that tends to peak in the 2nd year after a new agent or indication is introduced). © RSNA, 2012.
目的
评估突 然用钆贝葡胺替代钆喷替酸葡甲胺对过敏样反应的影响。
材料与方法
本 HIPAA 合规性回顾性研究经机构审查委员会批准并豁免了患者同意。在钆贝葡胺替代钆喷替酸葡甲胺之前的 2 年和之后的 3.5 年，评估了与基于钆的造影剂相关的过敏样反应。采用 χ(2)检验、Fisher 确切概率检验、比值比（OR）和置信区间（CI）比较反应率和严重程度。
结果
在 105607 次基于钆的造影剂注射（钆喷替酸葡甲胺 31540 次，钆贝葡胺 66152 次，其他 7915 次）中，发生 137 例轻度、19 例中度和 6 例重度过敏样反应（162 例[0.15%]）。钆贝葡胺与总体过敏样反应（0.19%[123 例/66152 例] vs 0.08%[24 例/31540 例]；OR，2.4；95%CI：1.6，3.8；P<.0001）和轻度过敏样反应（0.16%[107 例/66152 例] vs 0.06%[18 例/31540 例]；OR，2.8；95%CI：1.7，4.7；P<.0001）的发生率显著更高。钆贝葡胺的反应率在替代钆喷替酸葡甲胺后的第 2 年达到峰值（每季度最高，0.38%[16 例/4262 例]；每季度最低，0.07%[3 例/4237 例]）（每季度最高，0.10%[4 例/4122 例]；每季度最低，0.05%[2 例/4222 例]），然后在第 3 年下降。最后一个钆贝葡胺反应率（最后 3 个季度，0.12%[17 例/14387 例]）与最初使用钆喷替酸葡甲胺的基线反应率无显著差异。
结论
在钆贝葡胺替代钆喷替酸葡甲胺后，过敏样反应的报告频率显著增加，呈现出与 Weber 效应（新药物或新适应证引入后不良事件报告的一过性增加，往往在第 2 年达到峰值）相一致的时间模式。 ©RSNA，2012。
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