Reports on contrast media reactions: Analysis of data from reports to the US Food and Drug Administration
Reports on contrast media reactions: Analysis of data from reports to the US Food and Drug Administration
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DOI：
10.1148/radiology.203.3.9169676
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发表时间：
1997-06-01
期刊：
影响因子：
19.7
通讯作者：
Berry, CC
中科院分区：
文献类型：
--
作者：
Lasser, EC;Lyon, SG;Berry, CC
目的：比较美国食品和药物管理局（FDA）和制造商1990年至1944年间患者对离子和非离子、低渗透压和高渗透压造影剂的反应数据。材料和方法：比较所有可用的高渗透压造影剂和四种低渗透压造影剂（碘草酸酯、碘己醇、iopamidol和ioversol）的反应。Ioxaglate由带电粒子组成，数据单独报道。反应还比较了1980年至1984年的数据，当时只有高渗透压造影剂可用。结果：与三种不带电的低渗透压造影剂相比，使用高渗透压造影剂的所有报告反应的发生率（每百万次检查）最高（193.8 vs 44.4），严重反应（37.4 vs 10.5）和死亡（3.9 vs 2.1）。与ioxagate相比，高渗透压介质的总反应发生率更高（193.8 vs 142.5），严重反应发生率几乎相同（37.4 vs 33.6），死亡发生率更低（3.9 vs 6.4）。非离子介质（23.7%）和ioxagate（23.6%）的严重反应发生率高于离子介质（19.3%）。严重反应的死亡率在非离子介质中为19.7%，在ioxagate中为19.0%，在高渗透压介质中为10.4%。通常在有病理性心脏疾病的患者中，所有低渗造影剂（2.3%）的肾衰竭发生率（占总报告的百分比）约为高渗造影剂（0.6%）的3.6倍。结论：在评估造影剂的效用时，所有这些因素都值得考虑。
PURPOSE: To compare U.S. Food and Drug Administration (FDA) and manufacturer data about patient reactions to ionic and nonionic, low- and high-osmolar contrast media from 1990 through 1944.MATERIALS AND METHODS: Reactions to all available high-osmolar and four low-osmolar contrast media (ioxaglate, iohexol, iopamidol, and ioversol) were compared. Ioxaglate is composed of charged particles, and data are reported separately. Reactions were also compared with data from 1980 to 1984, when only high-osmolar contrast media were available.RESULTS: With high-osmolar contrast media compared with the three noncharged low-osmolar media, the incidence (per million examinations) was highest for all reported reactions (193.8 vs 44.4), severe reactions (37.4 vs 10.5), and deaths (3.9 vs 2.1). With high-osmolar media compared with ioxaglate, respectively, the incidence of total reactions was higher (193.8 vs 142.5), of severe reactions was almost the same (37.4 vs 33.6), and of death was lower (3.9 vs 6.4). The incidence of severe reactions to total reactions was higher with nonionic media (23.7%) and ioxaglate (23.6%) than with ionic media (19.3%). The incidence of death to severe reactions was 19.7% with nonionic media, 19.0% with ioxaglate, and 10.4% with high-osmolar media. The incidence of renal failure (as a percentage of total reports) was approximately 3.6 times higher with all low-osmolar contrast media (2.3%) than with high-osmolar media (0.6%), usually in patients with pathologic cardiac conditions.CONCLUSION: All of these factors merit consideration in the evaluation of the utility of a given contrast medium.