From the Departments of Radiology (B.M.M., R.H.C., J.H.E., M.S.D.) and Urology (J.H.E., M.S.D.), University of Michigan Health System, 1500 E Medical Center Dr, Room B2 A209P, Ann Arbor, MI 48109-5030; and Michigan Institute for Clinical and Health Research (S.K.) and Michigan Radiology Quality Collaborative (M.S.D.), University of Michigan, Ann Arbor, Mich.
Radiology. 2017 Nov;285(2):425-433. doi: 10.1148/radiol.2017170107. Epub 2017 Jul 26.
Purpose To determine if the allergic-like breakthrough reaction rate of intravenous corticosteroid prophylaxis administered 5 hours before contrast material-enhanced computed tomography (CT) is noninferior to that of a traditional 13-hour oral regimen. Materials and Methods Institutional review board approval was obtained and informed consent waived for this retrospective noninferiority cohort study. Subjects (n = 202) who completed an accelerated 5-hour intravenous corticosteroid premedication regimen before low-osmolality contrast-enhanced CT for a prior allergic-like or unknown-type reaction to iodine-based contrast material from June 1, 2008, to June 30, 2016, were identified. The breakthrough reaction rate was compared by using the Farrington and Manning noninferiority likelihood score to test subjects premedicated with a traditional 13-hour oral regimen (2.1% [13 of 626]). All subjects were premedicated for a prior allergic-like or unknown-type reaction to iodine-based contrast material. A noninferiority margin of 4.0% was selected to allow for no more than a clinically negligible 6.0% breakthrough reaction rate in the cohort that received 5-hour intravenous corticosteroid prophylaxis. Results The breakthrough reaction rate for 5-hour intravenous prophylaxis was 2.5% (five of 202 patients; 95% confidence interval: 0.8%, 5.7%), which was noninferior to the 2.1% (13 of 626 patients; 95% confidence interval: 1.1%, 3.5%) rate for the 13-hour regimen (P = .0181). The upper limits of the confidence interval for the difference between the two rates was 3.7% (0.4%; 95% confidence interval: -1.6%, 3.7%), which was within the 4.0% noninferiority margin. All breakthrough reactions were of equal or lesser severity to those of the index reactions (two severe, one moderate, and one mild reaction). Conclusion Accelerated intravenous premedication with corticosteroids beginning 5 hours before contrast-enhanced CT has a breakthrough reaction rate noninferior to that of a 13-hour oral premedication regimen. RSNA, 2017.
确定在对比增强计算机断层扫描(CT)前 5 小时给予静脉皮质类固醇预防治疗的过敏样突破性反应率是否不劣于传统的 13 小时口服方案。
本回顾性非劣效性队列研究获得了机构审查委员会的批准,并豁免了知情同意。纳入 2008 年 6 月 1 日至 2016 年 6 月 30 日期间因对碘对比剂发生过敏样或未知类型反应而接受过加速 5 小时静脉皮质类固醇预处理方案的低渗透压对比增强 CT 检查的 202 例患者。采用 Farrington 和 Manning 非劣效性似然比检验比较突破性反应率,以检验接受传统 13 小时口服方案(2.1%[626 例中的 13 例])的受试者。所有患者均因对碘对比剂发生过敏样或未知类型反应而接受了预防治疗。选择 4.0%的非劣效性边界,以允许接受 5 小时静脉皮质类固醇预防治疗的队列中突破性反应率不超过 6.0%的临床可忽略差异。
5 小时静脉预防方案的突破性反应率为 2.5%(202 例患者中的 5 例;95%置信区间:0.8%,5.7%),不劣于 13 小时方案的 2.1%(626 例患者中的 13 例;95%置信区间:1.1%,3.5%)(P =.0181)。两种方案之间差异的置信区间上限为 3.7%(0.4%;95%置信区间:-1.6%,3.7%),在 4.0%的非劣效性边界内。所有突破性反应的严重程度与指数反应相等或更低(2 例严重,1 例中度,1 例轻度)。
在对比增强 CT 前 5 小时开始给予皮质类固醇加速静脉预治疗的突破性反应率不劣于 13 小时口服预治疗方案。RSNA,2017 年。