比较碘海醇 240 毫克碘/毫升、碘帕米醇 250 毫克碘/毫升和碘克沙醇 270 毫克碘/毫升在脑血管造影中的安全性和诊断效果:一项前瞻性多中心研究。

IF 1.2 Q4 CLINICAL NEUROLOGY
Neurointervention Pub Date : 2023-07-01 Epub Date: 2024-06-05 DOI:10.5469/neuroint.2024.00129
Jinwook Baek, Hae Woong Jeong, Young Jin Heo, Suyoung Yun, Myongjin Kang, Byungjun Kim, Eui Jong Kim, Soo Mee Lim, Boeun Lee
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引用次数: 0

摘要

目的:这项多中心前瞻性研究旨在评估使用低浓度碘化造影剂(碘海醇 240 毫克碘/毫升、碘帕醇 250 毫克碘/毫升和碘克沙醇 270 毫克碘/毫升)获得的脑血管造影图像的质量和诊断效果,并评估其安全性。该研究旨在满足对更安全的造影剂替代品的需求,同时不影响识别脑血管疾病的诊断质量:在韩国的 5 家医疗中心进行,我们招募了 19 岁或 19 岁以上在非急诊情况下转诊进行脑血管造影诊断的患者,排除了有特殊健康状况和敏感性的患者。研究设计采用前瞻性观察方法,并通过单因素方差分析(ANOVA)计算样本量,样本总数为 231 人,以获得足够的样本量。图像质量由两名独立的盲人放射科医生采用 4 级评分法进行评估,并对术后即刻和最多 7 天的不良反应进行监测。统计分析包括单因素方差分析和 Kruskal-Wallis 检验,以评估造影剂的图像质量和安全性:在筛选出的 266 名患者中,有 243 人被纳入最终分析。评估结果显示,三种低浓度造影剂在图像质量上没有明显的统计学差异。28.8%的患者出现了不良反应,其中27.2%出现急性反应,主要是轻微反应,3.3%出现延迟反应。总体安全性显示,注射造影剂前后生命体征或心电图读数无明显变化:结论:在脑血管造影术中使用低浓度碘造影剂可获得与传统高浓度造影剂相当的图像质量,且不良反应无明显增加,这对患者来说是一种更安全的选择。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Comparison of Safety and Diagnostic Efficacy of Iohexol 240 mgI/mL, Iopamidol 250 mgI/mL, and Iodixanol 270 mgI/mL in Cerebral Angiography: A Prospective, Multicenter Study.

Purpose: This multicenter prospective study aimed to evaluate the quality and diagnostic effectiveness of cerebral angiography images obtained using low-concentration iodinated contrast agents (iohexol 240 mgI/mL, iopamidol 250 mgI/mL, and iodixanol 270 mgI/mL) and to assess the safety thereof. The study addresses the need for safer contrast agent alternatives without compromising the diagnostic quality of identifying cerebrovascular disease.

Materials and methods: Conducted in 5 medical centers in South Korea, we enrolled patients aged 19 years or older who were referred for diagnostic cerebral angiography under non-emergency conditions, excluding those with specific health conditions and sensitivities. The study design included a prospective, observational approach with a 1-way analysis of variance (ANOVA) for sample size calculation, aiming for a total sample of 231 participants for adequate power. Image quality was evaluated using a 4-level scale by 2 independent, blinded radiologists, and adverse reactions were monitored both immediately and up to 7 days post-procedure. Statistical analysis involved 1-way ANOVA and Kruskal-Wallis tests to assess the image quality and safety profiles of the contrast agents.

Results: Among 266 patients screened, 243 were included in the final analysis. The evaluation revealed no statistically significant differences in image quality among the 3 types of low-concentration contrast agents. Adverse events were observed in 28.8% of patients, with 27.2% experiencing acute reactions, primarily mild reactions, and 3.3% experiencing delayed reactions. The overall safety profile showed no significant changes in vital signs or electrocardiogram readings before and after contrast agent injection.

Conclusion: Using low-concentration iodinated contrast agents for cerebral angiography provides image quality comparable to that of conventional high-concentration agents, with no significant increase in adverse events, suggesting a safer alternative for patients.

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CiteScore
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