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N-乙酰半胱氨酸或抗坏血酸与安慰剂相比在接受择期心导管插入术患者中预防造影剂诱发急性肾损伤的有效性:一项单中心、前瞻性、随机、双盲、安慰剂对照试验

Usefulness of N-acetylcysteine or ascorbic acid versus placebo to prevent contrast-induced acute kidney injury in patients undergoing elective cardiac catheterization: a single-center, prospective, randomized, double-blind, placebo-controlled trial.

作者信息

Brueck Martin, Cengiz Huelya, Hoeltgen Reinhard, Wieczorek Marcus, Boedeker Rolf-Hasso, Scheibelhut Christine, Boening Andreas

机构信息

Department of Cardiology, Clinic of Wetzlar, Forsthausstrasse 1, 35578 Wetzlar, Germany.

出版信息

J Invasive Cardiol. 2013 Jun;25(6):276-83.

Abstract

BACKGROUND

Contrast-induced acute kidney injury (CI-AKI) is a serious complication of procedures requiring contrast media associated with rising costs, prolonged hospitalization, and increased mortality. The aim of this study was to assess whether prophylactic administration of standard dosages of intravenous N-acetylcysteine or ascorbic acid reduce the incidence of CI-AKI in patients with chronic renal insufficiency undergoing elective cardiac catheterization.

METHODS

In a single-center, prospective, randomized, double-blind, placebo-controlled trial, the preventive effects of N-acetylcysteine and ascorbic acid were evaluated in 520 patients with chronically impaired renal function (serum creatinine ≥1.3 mg/dL) undergoing elective cardiac catheterization. The study drugs (600 mg N-acetylcysteine, 500 mg ascorbic acid, placebo) were administered intravenously twice (at 24 hours and 1 hour before the procedure). Serum creatinine, estimated glomerular filtration rate (eGFR) and serum urea were assessed at baseline and at 24 hours and 72 hours after contrast media exposure. CI-AKI was defined as a postangiographical increase in serum creatinine ≥0.5 mg/dL. Results. The incidence of CI-AKI was 27.6% in the N-acetylcysteine group (P=.20 vs placebo group) and in 24.5% in the ascorbic acid group (P=.11 vs placebo group). CI-AKI occurred in 32.1% of the placebo group.

CONCLUSIONS

Standard doses of N-acetylcysteine and ascorbic acid did not prevent CI-AKI in patients at high risk undergoing cardiac catheterization with non-ionic, low-osmolality contrast agent.

摘要

背景

对比剂诱导的急性肾损伤(CI-AKI)是需要使用对比剂的检查操作的一种严重并发症,与费用增加、住院时间延长和死亡率上升相关。本研究的目的是评估预防性给予标准剂量的静脉注射N-乙酰半胱氨酸或维生素C是否能降低接受择期心导管检查的慢性肾功能不全患者发生CI-AKI的发生率。

方法

在一项单中心、前瞻性、随机、双盲、安慰剂对照试验中,对520例肾功能慢性受损(血清肌酐≥1.3mg/dL)且接受择期心导管检查的患者评估N-乙酰半胱氨酸和维生素C的预防效果。研究药物(600mg N-乙酰半胱氨酸、500mg维生素C、安慰剂)在术前24小时和1小时静脉注射两次。在基线、对比剂暴露后24小时和72小时评估血清肌酐、估算肾小球滤过率(eGFR)和血清尿素。CI-AKI定义为血管造影术后血清肌酐升高≥0.5mg/dL。结果。N-乙酰半胱氨酸组CI-AKI的发生率为27.6%(与安慰剂组相比,P = 0.20),维生素C组为24.5%(与安慰剂组相比,P = 0.11)。安慰剂组CI-AKI的发生率为32.1%。

结论

对于使用非离子型、低渗性对比剂进行心导管检查的高危患者,标准剂量的N-乙酰半胱氨酸和维生素C不能预防CI-AKI。

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