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碘克沙醇与碘帕醇在腹主动脉-股动脉血管造影中的比较。

A comparison of iodixanol with iopamidol in aorto-femoral angiography.

作者信息

Verow P, Nossen J O, Sheppick A, Kjaersgaard P

机构信息

Department of Radiology, York District Hospital, UK.

出版信息

Br J Radiol. 1995 Sep;68(813):973-8. doi: 10.1259/0007-1285-68-813-973.

Abstract

This double-blind, randomized, parallel group clinical investigation in 140 consecutive patients undergoing aorto-femoral arteriography was carried out to compare iodixanol (Visipaque) 270 mgI ml-1 with iopamidol (Iopamiro) 300 mgI ml-1. The aims of the study were to compare adverse events and discomfort, clinical chemistry parameters in blood, haemodynamics and diagnostic information of the angiograms in the two groups. The main parameter for statistical analysis was the visual analogue scale (VAS) score for overall discomfort experienced by the patients during the examination. 134 patients, 69 and 65 receiving iodixanol and iopamidol, respectively, were examined according to the protocol and included in the evaluation. The two groups of patients were judged to be comparative. Statistically significant milder discomfort was felt with iodixanol than with iopamidol (p = 0.0001); mean VAS values 16 mm and 51 mm, respectively. Pain was reported far less frequently after iodixanol than after iopamidol (7.4% versus 50.8%) whereas sensation of warmth was less intense after iodixanol than after iopamidol. Four patients in the iodixanol group and two in the iopamidol group reported transient, non-serious adverse events. The difference was not statistically significant (p = 0.68). Systolic blood pressure was affected to a slightly greater degree after injection of iopamidol than after injection of iodixanol. Measurements of diastolic blood pressure, as well as clinical chemistry parameters in blood, revealed no changes of clinical importance, and all arteriograms performed were of diagnostic value. The conclusion is that iodixanol 270 mgI ml-1 is as efficacious as iopamidol 300 mgI ml-1, but produces less discomfort during arteriography. As such, iodixanol is a good alternative to iopamidol in aorto-femoral angiography.

摘要

这项双盲、随机、平行组临床研究纳入了140例连续接受主-股动脉造影的患者,旨在比较碘克沙醇(威视派克)270mgI/ml与碘帕醇(碘必乐)300mgI/ml。研究目的是比较两组的不良事件和不适情况、血液中的临床化学参数、血流动力学以及血管造影的诊断信息。统计分析的主要参数是患者在检查过程中总体不适的视觉模拟量表(VAS)评分。按照方案对134例患者进行了检查并纳入评估,其中69例接受碘克沙醇,65例接受碘帕醇。两组患者被判定具有可比性。与碘帕醇相比,碘克沙醇引起的不适在统计学上显著更轻(p = 0.0001);平均VAS值分别为16mm和51mm。碘克沙醇注射后疼痛报告的频率远低于碘帕醇(7.4%对50.8%),而碘克沙醇注射后温暖感的强度低于碘帕醇。碘克沙醇组有4例患者和碘帕醇组有2例患者报告了短暂的、非严重不良事件。差异无统计学意义(p = 0.68)。注射碘帕醇后收缩压受影响的程度略大于注射碘克沙醇后。舒张压测量以及血液中的临床化学参数显示无具有临床意义的变化,并且所有进行血管造影均具有诊断价值。结论是碘克沙醇270mgI/ml与碘帕醇300mgI/ml一样有效,但在动脉造影过程中引起的不适更少。因此,在主-股动脉血管造影中,碘克沙醇是碘帕醇的良好替代药物。

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