慢性肾脏病患者行计算机断层扫描时对比剂所致肾病：碘克沙醇与碘帕醇的双盲比较
Contrast-induced nephropathy in patients with chronic kidney disease undergoing computed tomography: a double-blind comparison of iodixanol and iopamidol.
作者信息
Barrett Brendan J, Katzberg Richard W, Thomsen Henrik S, Chen Nan, Sahani Dushyant, Soulez Gilles, Heiken Jay P, Lepanto Luigi, Ni Zhao-hui, Ni Zhou-Hui, Nelson Rendon
机构信息
Patient Research Centre, Health Science Center, St. John's, NL, Canada.
出版信息
Invest Radiol. 2006 Nov;41(11):815-21. doi: 10.1097/01.rli.0000242807.01818.24.
BACKGROUND
Based on a single clinical trial, it has been suggested that the contrast agent iodixanol, which is isotonic to human plasma, may be less nephrotoxic than other nonionic contrast agents in renally impaired patients after intra-arterial injection. We compared the effects on renal function of iopamidol-370 injection (796 mOsm/kg) and iodixanol-320 (290 mOsm/kg) in patients with chronic kidney disease undergoing contrast-enhanced multidetector computed tomography (CE-MDCT) examinations using a multicenter, double-blind, randomized, parallel-group design.
METHODS
A total of 166 patients with stable moderate-to-severe chronic kidney disease (screening and baseline serum creatinine, SCr, > or =1.5 mg/dL and/or creatinine clearance, CrCl, < or =60 mL/min) who were undergoing CE-MDCT of the liver or peripheral arteries were randomized to receive equi-iodine IV doses (40 gI) of either iopamidol-370 (370 mgI/mL) or iodixanol-320 (320 mgI/mL) at 4 mL/s. SCr and CrCl were obtained at screening, baseline, and at 48-72 +/- 6 hours after dose (mean, 57.4 hours). Contrast-induced nephropathy (CIN) was defined as an absolute increase > or =0.5 mg/dL (44.2 micromol/L) and/or a relative increase in SCr > or =25% from baseline.
RESULTS
A total of 153 patients were included in the final analysis (13 patients excluded because of lack of follow-up, hemodialysis to remove contrast, average daily CrCl variation >1% at screening). The 2 study groups were comparable with regard to age, gender distribution, the presence of diabetes, concomitant medications, hydration, and contrast dose. Mean predose SCr was 1.6 +/- 0.4 mg/dL in both groups (P = 0.9). An absolute increase > or =0.5 mg/dL (44.2 micromol/L) in SCr was observed in none of the patients receiving iopamidol-370 and in 2.6% (2/76) of patients receiving iodixanol-320 (95% confidence interval -6.2, 1.0, P = 0.2). A relative increase > or =25% in SCr occurred in 4% (3/77) of patients receiving iopamidol-370 and in 4% (3/76) of the patients receiving iodixanol-320 (95% confidence interval -6.2, 6.1, P = 1.0).
CONCLUSION
The rate of CIN was similarly low in risk patients after intravenous administration of iopamidol-370 or iodixanol-320 for CE-MDCT.
背景
基于一项临床试验，有人提出与人体血浆等渗的造影剂碘克沙醇在肾损害患者动脉内注射后，可能比其他非离子型造影剂的肾毒性更小。我们采用多中心、双盲、随机、平行组设计，比较了碘帕醇-370注射液（796毫渗量/千克）和碘克沙醇-320（290毫渗量/千克）对接受对比增强多层螺旋CT（CE-MDCT）检查的慢性肾脏病患者肾功能的影响。
方法
共有166例稳定的中重度慢性肾脏病患者（筛查和基线血清肌酐，SCr，≥1.5毫克/分升和/或肌酐清除率，CrCl，≤60毫升/分钟）接受肝脏或外周动脉的CE-MDCT检查，被随机分为两组，以4毫升/秒的速度静脉注射等碘剂量（40克碘）的碘帕醇-370（370毫克碘/毫升）或碘克沙醇-320（320毫克碘/毫升）。在筛查、基线以及给药后48 - 72±6小时（平均57.4小时）测定SCr和CrCl。对比剂肾病（CIN）定义为SCr绝对值增加≥0.5毫克/分升（44.2微摩尔/升）和/或SCr较基线相对增加≥25%。
结果
共有153例患者纳入最终分析（13例患者因缺乏随访、进行血液透析清除造影剂、筛查时平均每日CrCl变化>1%而被排除）。两个研究组在年龄、性别分布、糖尿病的存在、伴随用药、水化情况和造影剂剂量方面具有可比性。两组的平均给药前SCr均为1.6±0.4毫克/分升（P = 0.9）。接受碘帕醇-370的患者中无一例SCr绝对值增加≥0.5毫克/分升（44.2微摩尔/升），接受碘克沙醇-320的患者中有2.6%（2/76）出现这种情况（95%置信区间-6.2，1.0，P = 0.2）。接受碘帕醇-370的患者中有4%（3/77）SCr相对增加≥25%，接受碘克沙醇-320的患者中有4%（3/76）出现这种情况（95%置信区间-6.2，6.1，P = 1.0）。
结论
对于接受CE-MDCT检查的高危患者，静脉注射碘帕醇-370或碘克沙醇-320后CIN发生率同样较低。
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