Lasser E C, Berry C C, Mishkin M M, Williamson B, Zheutlin N, Silverman J M
Department of Radiology (0632), School of Medicine, University of California, San Diego, La Jolla 92093-0632.
AJR Am J Roentgenol. 1994 Mar;162(3):523-6. doi: 10.2214/ajr.162.3.8109489.
The purpose of this study was to determine whether patients receiving a two-dose corticosteroid regimen before IV injection of nonionic contrast medium gain protection against adverse reactions to contrast material.
A randomized, blinded study involving three institutions was initiated in 1988. Patients were divided into two groups. One group received a 32-mg oral dose of methylprednisolone administered 6-24 hr before and again 2 hr before injection of contrast material. The other group received placebo tablets administered in the same time periods. During a 3-year period, 1155 patients and control subjects successfully completed the protocol. Demographic characteristics, including histories of previous reactions and histories of asthma or allergy, did not differ in the two groups. All signs and symptoms that appeared after injection of contrast material were carefully recorded and graded according to an earlier scheme [1]. Patients, control subjects, and all attending personnel were blinded regarding the premedication.
Corticosteroid pretreatment conferred protection for overall reactions (1.7% vs 4.9%, p = .005) and grade I (mild) reactions (0.2% vs 1.9%, p = .004). Subjects receiving corticosteroids also had fewer grade II (moderate) (p = .63) and grade III (severe) (p = .11) reactions, but the total numbers involved were small, and the differences were not significant.
A rigidly controlled study of the potential protective effects of a two-dose oral corticosteroid regimen preceding IV injection of nonionic contrast medium indicates that corticosteroid pretreatment confers significant protection, at least for overall reactions and grade I reactions.
本研究旨在确定在静脉注射非离子型造影剂前接受两剂皮质类固醇治疗方案的患者是否能预防造影剂不良反应。
1988年启动了一项涉及三个机构的随机、双盲研究。患者分为两组。一组在注射造影剂前6 - 24小时口服32毫克甲泼尼龙,注射前2小时再次口服。另一组在相同时间段服用安慰剂片。在3年期间,1155名患者和对照受试者成功完成了该方案。两组的人口统计学特征,包括既往反应史和哮喘或过敏史,无差异。注射造影剂后出现的所有体征和症状均根据先前的方案[1]仔细记录并分级。患者、对照受试者和所有参与人员对预处理情况均不知情。
皮质类固醇预处理对总体反应(1.7%对4.9%,p = 0.005)和I级(轻度)反应(0.2%对1.9%,p = 0.004)有预防作用。接受皮质类固醇治疗的受试者II级(中度)(p = 0.63)和III级(重度)(p = 0.11)反应也较少,但涉及的总数较少,差异不显著。
一项对静脉注射非离子型造影剂前两剂口服皮质类固醇治疗方案潜在保护作用的严格对照研究表明,皮质类固醇预处理具有显著保护作用,至少对总体反应和I级反应如此。