Wysowski Diane K, Nourjah Parivash
Division of Drug Risk Evaluation, Food and Drug Administration, HFD-433, Silver Spring, MD 20993, USA.
AJR Am J Roentgenol. 2006 Mar;186(3):613-5. doi: 10.2214/AJR.04.1790.
The objectives of our study were to determine the number, rate, and types of deaths attributed to specific X-ray contrast media on the basis of U.S. death certificates and to attempt to assess the comparative safety of commonly used diagnostic X-ray contrast agents using death certificate information.
From 1999 through 2001, deaths attributed to the International Classification of Diseases (ICD) code for contrast media occurred at the rate of 1.1-1.2 per million contrast media packages distributed. An analysis of 1999 death certificates indicated that most deaths attributed to contrast media predictably were associated with renal failure or nephropathy and anaphylaxis or allergic reactions. Risk assessment of the comparative safety of classes or agents was limited by lack of specific contrast media names. Names of administered contrast agents should be recorded in patients' medical records and communicated to primary care physicians and certifiers of death in the event of serious sequelae after an identified recent radiologic procedure.
我们研究的目的是根据美国死亡证明确定归因于特定X线造影剂的死亡数量、发生率和类型,并尝试利用死亡证明信息评估常用诊断性X线造影剂的相对安全性。
1999年至2001年期间,归因于国际疾病分类(ICD)造影剂代码的死亡发生率为每分发100万个造影剂包装中有1.1 - 1.2例。对1999年死亡证明的分析表明,可预见的是,大多数归因于造影剂的死亡与肾衰竭或肾病以及过敏反应或过敏症有关。由于缺乏特定的造影剂名称,对各类造影剂或造影剂的相对安全性进行风险评估受到限制。应将所使用的造影剂名称记录在患者的病历中,并在近期明确的放射学检查后出现严重后遗症时告知初级保健医生和死亡证明开具者。