Mortelé Koenraad J, Oliva Maria-Raquel, Ondategui Silvia, Ros Pablo R, Silverman Stuart G
Division of Abdominal Imaging and Intervention, Department of Radiology, Brigham and Women's Hospital, Harvard Medical School, 75 Francis St., Boston, MA 02115, USA.
AJR Am J Roentgenol. 2005 Jan;184(1):31-4. doi: 10.2214/ajr.184.1.01840031.
We evaluated the safety of the universal use of the nonionic iodinated contrast agent iopromide in patients undergoing CT in a large urban teaching hospital.
For 2 years, we prospectively recorded all adverse events temporally associated with the administration of iopromide in 29,508 consecutive patients undergoing contrast-enhanced CT at our institution. The types, intensities, treatments, and outcomes of adverse events were recorded along with relevant patient history, including risk factors. Descriptive analyses of the variables, comparisons of means, and proportions using Student's t and chi-square tests, and logistic regressions were conducted.
Adverse events were observed in 211 patients (0.7%) and were categorized as follows: urticaria (n = 161), facial or laryngeal edema (n = 13), bronchospasm (n = 8), severe nausea or vomiting (n = 10), or other (n = 19). One hundred eighty-eight adverse events (89%) were rated mild, 19 moderate (9%), and four severe (2%), including one fatality. Adverse events required treatment in 89 patients (42%). A history of allergy was present in 92 patients (44%), and 29 (14%) had a prior contrast reaction. Other relevant risk factors were identified in 63 patients (30%). No relationship existed between the occurrence of adverse events and any of the following: patient age, dose of iodine administered, or time of study (i.e., month, season, and year). Women (p < 0.001) and outpatients (p < 0.001) had a statistically significant higher incidence of adverse events.
The universal use of iopromide as an IV CT contrast agent has a favorable safety profile.
我们评估了在一家大型城市教学医院中,对接受CT检查的患者普遍使用非离子型碘化造影剂碘普罗胺的安全性。
在两年时间里,我们前瞻性地记录了在我院连续29508例接受增强CT检查的患者中,所有与碘普罗胺给药存在时间关联的不良事件。记录不良事件的类型、严重程度、治疗方法及结果,以及相关患者病史,包括危险因素。对变量进行描述性分析,采用学生t检验和卡方检验比较均值和比例,并进行逻辑回归分析。
211例患者(0.7%)出现不良事件,分类如下:荨麻疹(n = 161)、面部或喉部水肿(n = 13)、支气管痉挛(n = 8)、严重恶心或呕吐(n = 10)或其他(n = 19)。188例不良事件(89%)被评为轻度,19例中度(9%),4例重度(2%),包括1例死亡。89例患者(42%)的不良事件需要治疗。92例患者(44%)有过敏史,29例(14%)曾有过造影剂反应。63例患者(30%)存在其他相关危险因素。不良事件的发生与以下任何因素均无关联:患者年龄、碘给药剂量或检查时间(即月份、季节和年份)。女性(p < 0.001)和门诊患者(p < 0.001)不良事件的发生率在统计学上显著更高。
将碘普罗胺作为静脉CT造影剂普遍使用具有良好的安全性。