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首页> 外文期刊>AJR: American Journal of Roentgenology : Including Diagnostic Radiology, Radiation Oncology, Nuclear Medicine, Ultrasonography and Related Basic Sciences >The PREDICT study: a randomized double-blind comparison of contrast-induced nephropathy after low- or isoosmolar contrast agent exposure.
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The PREDICT study: a randomized double-blind comparison of contrast-induced nephropathy after low- or isoosmolar contrast agent exposure.

机译：PREDICT研究：低或等渗造影剂暴露后，对比剂诱发的肾病的随机双盲比较。

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OBJECTIVE: The objective of the PREDICT (patients with renal impairment and diabetes undergoing computed tomography) study was to compare the incidence of contrast-induced nephropathy (CIN) after administration of low-osmolar (iopamidol 370, 796 mOsm/kg) or isoosmolar (iodixanol 320, 290 mOsm/kg) contrast medium in patients with diabetes and chronic kidney disease undergoing CT. SUBJECTS AND METHODS: Two hundred sixty-three patients with moderate to severe chronic kidney disease (estimated glomerular filtration rate [GFR] = 20-59 mL/min/1.73 m(2)) and diabetes mellitus were randomized to receive at least 65 mL of iopamidol 370 or iodixanol 320 for a CT procedure. Serum creatinine levels were measured at baseline and 48-72 hours after contrast administration. CIN was defined as an increase in the serum creatinine level after contrast administration of >or= 25% from the baseline level. The incidence of CIN in the total study population and the incidence of CIN in patients at increased risk for CIN were compared using Fisher's exact test. RESULTS: Two hundred forty-eight patients were included in the CIN analysis: 125 receiving iopamidol 370 and 123 receiving iodixanol 320. Study population demographics were comparable, as was baseline renal function (estimated GFR = 47.6 mL/min/1.73 m(2) for the iopamidol 370 group vs 49.9 mL/min/1.73 m(2) for the iodixanol 320 group; p = 0.16). Increases in the serum creatinine value of >or= 25% occurred in seven patients (5.6%) receiving iopamidol 370 and in six patients (4.9%) receiving iodixanol 320 (95% CI, -4.8% to 6.3%; p = 1.0). The mean serum creatinine change from the baseline level was 0.04 mg/dL in both groups (analysis of covariance, p = 0.80). In patients with a baseline serum creatinine value of >or= 2.0 mg/dL, baseline estimated GFR of 140 mL of contrast medium, the incidence of CIN was low and comparable between the two study groups (p = 1.0 in all instances). CONCLUSION: The incidence of CIN in patients with diabetes and chronic kidney disease receiving IV contrast medium was not significantly different after CT using iopamidol 370 or iodixanol 320.
机译：目的：PREDICT（肾功能不全和糖尿病患者接受计算机断层扫描）研究的目的是比较低渗透压（iopamidol 370、796 mOsm / kg）或等渗压（接受CT扫描的患有糖尿病和慢性肾脏疾病的患者使用碘克沙醇320（290 mOsm / kg）造影剂。研究对象和方法：263例中度至重度慢性肾脏病（估计肾小球滤过率[GFR] = 20-59 mL / min / 1.73 m（2））和糖尿病患者被随机分配至至少65 mL CT程序中使用碘帕醇370或碘克沙醇320的方法。在基线和对比剂给药后48-72小时测量血清肌酐水平。 CIN被定义为对比给药后血清肌酐水平从基线水平升高>或= 25％。使用Fisher精确检验比较了整个研究人群中CIN的发生率和CIN风险增加的患者中CIN的发生率。结果：CIN分析中包括248例患者：125例接受碘帕醇370和123例接受碘克沙醇320。研究人群的统计学与基线肾功能相当（估计GFR = 47.6 mL / min / 1.73 m（2））。碘帕醇370组vs碘克沙醇320组49.9 mL / min / 1.73 m（2）; p = 0.16）。接受碘帕醇370的7例患者（5.6％）和接受碘克沙醇320的6例患者（4.9％）的血清肌酐值升高≥25％（95％CI，-4.8％至6.3％; p = 1.0） 。两组患者血清肌酐相对于基线水平的平均变化为0.04 mg / dL（协方差分析，p = 0.80）。在基线血清肌酐值大于或等于2.0 mg / dL，基线估计GFR小于或等于40 mL / min / 1.73 m（2）的患者或接受大于140 mL造影剂的患者中，CIN的发生率为较低，在两个研究组之间具有可比性（在所有情况下，p = 1.0）。结论：使用碘帕醇370或碘克沙醇320进行CT扫描后，接受IV造影剂的糖尿病和慢性肾脏病患者的CIN发生率无显着差异。

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