离子型低渗与非离子型等渗对比剂在慢性肾衰竭患者血管成形术后避免肾功能恶化的比较：ICON（离子型与非离子型对比剂在慢性肾衰竭患者血管成形术后避免肾功能恶化的研究）。
Ionic low-osmolar versus nonionic iso-osmolar contrast media to obviate worsening nephropathy after angioplasty in chronic renal failure patients: the ICON (Ionic versus non-ionic Contrast to Obviate worsening Nephropathy after angioplasty in chronic renal failure patients) study.
机构信息
Center for Interventional Vascular Therapies, Columbia University Medical Center, New York, New York 10032, USA.
出版信息
JACC Cardiovasc Interv. 2009 May;2(5):415-21. doi: 10.1016/j.jcin.2009.03.007.
OBJECTIVES
This randomized, prospective, double-blind, multicenter study compared nephrotoxicity of the nonionic iso-osmolar contrast media (CM) iodixanol versus the ionic low-osmolar CM ioxaglate in patients with chronic renal insufficiency undergoing coronary angiography.
BACKGROUND
The properties of iodinated CM might contribute to the incidence of contrast-induced nephropathy (CIN).
METHODS
Patients with renal impairment undergoing coronary angiography were randomly assigned to iodixanol (n = 72) or ioxaglate (n = 74).
RESULTS
Baseline characteristics were well-matched between the 2 groups. The predicted risk score for CIN was similar in the iodixanol and in the ioxaglate groups (11.9 +/- 4.1 vs. 11.8 +/- 4.1), as was the use of N-acetylcysteine (70% vs. 73%). The primary end point of the study, median peak increase of serum creatinine from day 0 through day 3 after angiography, did not differ between the iodixanol (0.09 mg/dl; interquartile range 0.00 to 0.30 mg/dl) and the ioxaglate (0.15 mg/dl; interquartile range 0.00 to 0.40 mg/dl; p = 0.07) groups. The percentages of patients with a peak increase of serum creatinine >or=0.5 mg/dl (15.9% in iodixanol vs. 18.2% in ioxaglate), >or=1.0 mg/dl (1.4% vs. 4.5%), and >or=25% or >or=0.5 mg/dl (15.9% vs. 24.2%, respectively) also did not differ significantly between the 2 groups.
CONCLUSIONS
In high-risk patients undergoing coronary angiographic procedures, use of the nonionic iso-osmolar CM iodixanol does not reduce renal deterioration in patients with renal impairment, compared with the ionic low-osmolar CM ioxaglate. Given that the study was underpowered to compare nephrotoxicity of the 2 groups under the active medical protection of CIN, a larger randomized study is warranted that will enroll patients with higher risks of CIN under a strict control of hydration regimens and adjunctive medications.
目的
本随机、前瞻性、双盲、多中心研究比较了慢性肾功能不全患者行冠状动脉造影时应用非离子型等渗造影剂碘克沙醇和离子型低渗造影剂碘海醇的肾毒性。
背景
碘造影剂的特性可能与造影剂肾病（CIN）的发生有关。
方法
行冠状动脉造影的肾功能损害患者被随机分配至碘克沙醇组（n = 72）或碘海醇组（n = 74）。
结果
两组间基线特征匹配良好。碘克沙醇组和碘海醇组的 CIN 预测风险评分相似（11.9 ± 4.1 比 11.8 ± 4.1），N-乙酰半胱氨酸的使用率也相似（70%比 73%）。研究的主要终点为造影后 0 至 3 天血清肌酐的峰值升高中位数，碘克沙醇组（0.09 mg/dl；四分位距 0.00 至 0.30 mg/dl）与碘海醇组（0.15 mg/dl；四分位距 0.00 至 0.40 mg/dl；p = 0.07）之间无差异。血清肌酐峰值升高>0.5 mg/dl（碘克沙醇组 15.9%比碘海醇组 18.2%）、>1.0 mg/dl（1.4%比 4.5%）和升高>25%或>0.5 mg/dl（15.9%比 24.2%）的患者比例在两组间也无显著差异。
结论
在接受冠状动脉造影的高危患者中，与离子型低渗造影剂碘海醇相比，应用非离子型等渗造影剂碘克沙醇并不能减轻肾功能损害患者的肾功能恶化。由于该研究在 CIN 的积极药物保护下比较两组的肾毒性效力不足，因此需要进行一项更大规模的随机研究，在严格控制水化方案和辅助药物的情况下，纳入发生 CIN 风险更高的患者。
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