Iopentol (Imagopaque(R) 300) compared with ioxaglate (Hexabrix(R) 320) in knee arthrography - A clinical trial assessing immediate and late adverse events and diagnostic information
Iopentol (Imagopaque(R) 300) compared with ioxaglate (Hexabrix(R) 320) in knee arthrography - A clinical trial assessing immediate and late adverse events and diagnostic information
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DOI：
10.1007/pl00006880
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发表时间：
1997-01-01
影响因子：
5.9
通讯作者：
Brekke, O
中科院分区：
文献类型：
--
作者：
Railhac, JJ;Brekke, O
目标。本试验旨在比较单对比膝关节造影中使用 300 mg I/ml 碘喷托（Imagopaque(R)，Nycomed Imaging AS，奥斯陆，挪威）与 320 mg I/ml 碘沙明（Hexabrix(R)，Guerbet，Aulnay-sous-Bois，法国）后迟发性术后疼痛的发生率。还评估了其他不良事件和放射学疗效。方法。对 120 名患者进行了一项随机、双盲研究。注射后 30 分钟内记录即时不良事件，检查后 4 天记录晚期不良事件，包括膝盖疼痛和肿胀（通过使用患者问卷）。使用视觉模拟量表 (VAS) 评估注射后 20 分钟内获得的诊断信息。结果。在检查后 4 天内，碘沙格拉特组 (50%) 的患者报告膝盖疼痛加剧，明显多于碘喷托组 (30%)（p < 0.05）。两个造影剂组中报告的检查后 30 分钟内的不良事件以及除膝盖疼痛之外的晚期不良事件的数量相似。两组的诊断信息相似。结论。碘喷托和碘沙格酯都是用于膝关节造影的有效且安全的造影剂，但碘喷托引起的术后疼痛较少。
Objectives. This trial was designed to compare the incidence of delayed postprocedural pain after administration of iopentol (Imagopaque(R), Nycomed Imaging AS, Oslo, Norway) 300 mg I/ml Versus ioxaglate (Hexabrix(R), Guerbet, Aulnay-sous-Bois, France) 320 mg I/ml in single-contrast knee arthrography. Other adverse events and radiographic efficacy were also evaluated.Methods. A randomized, double-blind study was performed in 120 patients. Immediate adverse events were recorded up to 30 min post-injection, and late adverse events, including knee pain and swelling, up to 4 days after the examination (by using a patient questionnaire). Diagnostic information obtained up to 20 min after injection was assessed using a Visual Analogue Scale (VAS). Results. Significantly more patients in the ioxaglate group (50%) than in the iopentol group (30%) reported increased knee pain during the 4 days following the examination (p < 0.05). Adverse events up to 30 min after the examination, and late adverse events other than knee pain, were reported by similar numbers of patients in the two contrast medium groups. The diagnostic information was similar in both groups.Conclusion. Both iopentol and ioxaglate are effective and safe contrast media for use in knee arthrography, but iopentol induces less postprocedural pain.