Kopp A F, Mortele K J, Cho Y D, Palkowitsch P, Bettmann M A, Claussen C D
Department of Diagnostic Radiology, Eberhard-Karls-University Tuebingen, Germany.
Acta Radiol. 2008 Oct;49(8):902-11. doi: 10.1080/02841850802282811.
Iodinated X-ray contrast media (CM) are recognized worldwide to be among the safest and most widely used injectable drugs. However, adverse drug reactions (ADRs) may still occur, ranging in severity from minor disturbances to severe and potentially fatal complications.
To prospectively determine the incidence and characteristics of acute ADRs during clinical utilization of a single nonionic monomeric contrast agent, iopromide, in routine radiological practice in a large number of nonselected patients.
74,717 patients were enrolled in a prospective international postmarketing surveillance registry with iopromide (Ultravist; Bayer Schering Pharma AG, Berlin, Germany). A standardized questionnaire was used to collect the following patient information from 762 centers in 27 countries: baseline demographics, risk factors, premedication regimen, type of examination, route of injection, volume and selected concentration of iopromide, and overall tolerance to CM (utilizing specific criteria and descriptors).
The overall rate of ADRs, including tolerance indicators (TI) (i.e., heat sensation and pain at the injection site), was 2%; when TIs were excluded, the rate was 1.5%. Fourteen serious adverse reactions were reported (rate 0.02%), of which none were fatal. There was a higher incidence of ADRs among women and for the age group ranging between 18 and 30 years. Patients with established risk factors, such as a history of previous CM reaction or allergic diathesis (7.4% and 4.1%, respectively), were at an increased risk for developing an ADR when compared to patients without risk factors (1.2%). The incidence of ADRs was not altered by the use of premedication.
The safety of iopromide in routine clinical practice was shown to be comparable to the published safety profiles of other nonionic iodinated contrast agents. Adverse drug reaction rates were affected by age, gender, and risk factors (especially previous CM reactions or allergies), but not by premedication.
碘化X线造影剂（CM）在全球范围内被公认为是最安全、使用最广泛的注射用药物之一。然而，药物不良反应（ADR）仍可能发生，严重程度从轻微不适到严重且可能致命的并发症不等。
前瞻性地确定在大量未经筛选的患者的常规放射学实践中，使用单一非离子单体造影剂碘普罗胺进行临床应用时急性ADR的发生率和特征。
74717名患者被纳入一项关于碘普罗胺（优维显；德国柏林拜耳先灵医药公司）的前瞻性国际上市后监测登记研究。使用标准化问卷从27个国家的762个中心收集以下患者信息：基线人口统计学数据、危险因素、预处理方案、检查类型、注射途径、碘普罗胺的体积和选定浓度，以及对CM的总体耐受性（使用特定标准和描述）。
包括耐受性指标（TI）（即注射部位的热感和疼痛）在内的ADR总发生率为2%；排除TI后，发生率为1.5%。报告了14例严重不良反应（发生率0.02%），其中无一例致命。女性和18至30岁年龄组的ADR发生率较高。与无危险因素的患者（1.2%）相比，有既定危险因素的患者，如既往有CM反应史或过敏体质（分别为7.4%和4.1%）发生ADR的风险增加。使用预处理并未改变ADR的发生率。
碘普罗胺在常规临床实践中的安全性与其他非离子碘化造影剂已公布的安全性相当。药物不良反应发生率受年龄、性别和危险因素（尤其是既往CM反应或过敏）影响，但不受预处理影响。
