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碘克沙醇和碘普罗胺对肾功能异常患者在冠状动脉造影和介入治疗前接受N-乙酰半胱氨酸和水化治疗时的肾毒性作用:一项随机试验。

Nephrotoxic effects of iodixanol and iopromide in patients with abnormal renal function receiving N-acetylcysteine and hydration before coronary angiography and intervention: a randomized trial.

作者信息

Juergens C P, Winter J P, Nguyen-Do P, Lo S, French J K, Hallani H, Fernandes C, Jepson N, Leung D Y C

机构信息

Department of Cardiology, Liverpool Hospital, University of New South Wales, Elizabeth Street, Liverpool BC, NSW 1871, Australia.

出版信息

Intern Med J. 2009 Jan;39(1):25-31. doi: 10.1111/j.1445-5994.2008.01675.x. Epub 2008 Sep 2.

Abstract

BACKGROUND

The use of contrast agents during coronary intervention can result in nephropathy, particularly in patients with renal dysfunction. We aimed to determine whether the use of iso-osmolar iodixanol is less nephrotoxic than that of low-osmolar iopromide when patients are adequately prehydrated and have received N-acetylcysteine.

METHODS

We conducted a randomized, double-blind, multicentre study of patients with impaired renal function undergoing a coronary interventional procedure. Primary end-point was the incidence of contrast-induced nephropathy (CIN) on day 2, defined as an increase in serum creatinine concentration of > or =44 micromol/L (0.5 mg/dL) or by a relative increase of > or =25% from baseline. Secondary end-points included peak increase in serum creatinine between baseline and day 7.

RESULTS

Of 191 patients recruited, 15% (95% CI: 8-22) of the patients receiving iopromide and 12% (95% CI: 5-19) of the patients receiving iodixanol developed CIN (95% CI of the difference: 13 to -7, P = 0.56). When including peak serum creatinine on day 7, CIN developed in 23% of patients receiving iopromide and in 27% of patients receiving iodixanol (95% CI of the difference: 8 to -16, P = 0.48). The peak increase in serum creatinine concentration at day 7 was similar in both groups (patients receiving iopromide, 18.4 +/- 24.4 micromol/L, vs patients receiving iodixanol, 21.9 +/- 24.2 micromol/L; P = 0.33).

CONCLUSION

There remains a high incidence of CIN despite prehydration and routine use of N-acetylcysteine in patients with pre-existing renal dysfunction undergoing coronary interventional procedures. Although our study is underpowered, iodixanol was not associated with a statistically significant lower incidence of CIN when compared with iopromide.

摘要

背景

在冠状动脉介入治疗过程中使用造影剂可导致肾病,尤其是在肾功能不全的患者中。我们旨在确定当患者充分水化并接受N-乙酰半胱氨酸时,等渗的碘克沙醇的肾毒性是否低于低渗的碘普罗胺。

方法

我们对接受冠状动脉介入手术的肾功能受损患者进行了一项随机、双盲、多中心研究。主要终点是第2天造影剂诱发肾病(CIN)的发生率,定义为血清肌酐浓度升高≥44微摩尔/升(0.5毫克/分升)或较基线相对升高≥25%。次要终点包括基线至第7天血清肌酐的峰值升高。

结果

在纳入的191例患者中,接受碘普罗胺的患者中有15%(95%CI:8-22)发生CIN,接受碘克沙醇的患者中有12%(95%CI:5-19)发生CIN(差异的95%CI:13至-7,P=0.56)。当纳入第7天的血清肌酐峰值时,接受碘普罗胺的患者中有23%发生CIN,接受碘克沙醇的患者中有27%发生CIN(差异的95%CI:8至-16,P=0.48)。两组在第7天血清肌酐浓度的峰值升高相似(接受碘普罗胺的患者为18.4±24.4微摩尔/升,接受碘克沙醇的患者为21.9±24.2微摩尔/升;P=0.33)。

结论

在接受冠状动脉介入手术的已有肾功能不全的患者中,尽管进行了水化和常规使用N-乙酰半胱氨酸,CIN的发生率仍然很高。虽然我们的研究样本量不足,但与碘普罗胺相比,碘克沙醇在CIN发生率上并无统计学意义的显著降低。

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