Millward S F, Burbridge B E, Hartman N G, Moher D, Chamberlain M J
Department of Radiological Sciences, University of Ottawa, Ont.
Can Assoc Radiol J. 1996 Feb;47(1):24-9.
To determine the effect of ioxaglate and ioversol on glomerular filtration rate (GFR) in a heterogeneous inpatient group to allow calculation of the necessary sample size for a randomized trial.
The study group consisted of 36 men and 12 women, ranging in age from 25 to 79 (mean 63) years. Fourteen of the patients, those undergoing abdominal aortography with or without renal arteriography, received ioxaglate (Hexabrix 320; 40 to 240 [mean 141] mL), and the remaining 34, those receiving intravenous injections and those undergoing computed tomography with arterioportography or carotid arteriography, received ioversol (Optiray 320; 20 to 180 [mean 87] mL). GFR was measured by determining the clearance of diethyl-enetriaminepenta-acetic acid labelled with technetium-99m up to 72 hours before and 24 hours after administration of the contrast medium. Risk factors for nephrotoxicity included diabetes (7 patients) and pre-existing renal impairment (mild in 11 and severe in 6).
GFR decreased by 20% to 34% in six patients (13%); in only one of these was the serum level of creatinine increased at 24 hours. One of these six patients had received 120 mL of ioversol for carotid arteriography and had no risk factors for nephrotoxicity. The other five had received 40 to 187 (mean 115) mL of ioxaglate, three for abdominal aortography and two for selective renal arteriography. The risk factors in these patients included diabetes (two patients) and severe pre-existing renal impairment (two patients). Renal failure necessitating treatment did not develop in any of the patients.
A decrease in GFR occurred more often with ioxaglate than with ioversol and usually occurred in patients with additional risk factors. Injection of contrast medium into the abdominal aorta or the renal artery may increase the risk of nephrotoxicity. Changes in serum level of creatinine at 24 hours were not reliable in identifying patients with decreased GFR. On the basis of these data, the authors estimate that a group of 194 patients would be necessary for a randomized trial comparing the nephrotoxicity of ioxaglate and ioversol for abdominal aortography.
确定异泛影葡胺和碘海醇对异质性住院患者群体肾小球滤过率（GFR）的影响，以便计算随机试验所需的样本量。
研究组包括36名男性和12名女性，年龄在25至79岁（平均63岁）之间。14名患者，即接受腹部主动脉造影（无论是否同时进行肾动脉造影）的患者，接受了异泛影葡胺（Hexabrix 320；40至240 [平均141] mL），其余34名患者，即接受静脉注射的患者以及接受动脉门静脉造影或颈动脉造影的计算机断层扫描的患者，接受了碘海醇（Optiray 320；20至180 [平均87] mL）。通过在注射造影剂前72小时及注射后24小时测定99m锝标记的二乙三胺五乙酸的清除率来测量GFR。肾毒性的危险因素包括糖尿病（7例患者）和既往存在的肾功能损害（轻度11例，重度6例）。
6例患者（13%）的GFR下降了20%至34%；其中只有1例患者在24小时时血清肌酐水平升高。这6例患者中的1例因颈动脉造影接受了120 mL碘海醇，且无肾毒性危险因素。其他5例接受了40至187（平均115）mL异泛影葡胺，3例用于腹部主动脉造影，2例用于选择性肾动脉造影。这些患者的危险因素包括糖尿病（2例患者）和严重的既往肾功能损害（2例患者）。所有患者均未发生需要治疗的肾衰竭。
与碘海醇相比，异泛影葡胺更常导致GFR下降，且通常发生在有其他危险因素的患者中。将造影剂注入腹主动脉或肾动脉可能会增加肾毒性风险。24小时时血清肌酐水平的变化在识别GFR降低的患者方面并不可靠。基于这些数据，作者估计，对于一项比较异泛影葡胺和碘海醇在腹部主动脉造影中肾毒性的随机试验，需要194名患者。
