Ng Tien M H, Shurmur Scott W, Silver Mary, Nissen Lindsay R, O'Leary Edward L, Rigmaiden Richard S, Cieciorka Mike, Porter Laura L, Ineck Beata A, Kline Mary E, Puumala Susan E
Department of Pharmacy Practice, University of Nebraska Medical Center, 986045 Nebraska Medical Center, Omaha, Nebraska 68198-6045, USA.
Int J Cardiol. 2006 May 24;109(3):322-8. doi: 10.1016/j.ijcard.2005.06.038. Epub 2005 Jul 22.
N-acetylcysteine and fenoldopam are commonly prescribed for prevention of contrast mediated nephropathy, however, comparative superiority of either agent is unknown.
In a prospective, randomized, parallel-group trial, adult cardiac catheterization patients at the university and veterans' hospitals with pre-existing stable renal insufficiency were randomized to N-acetylcysteine 600 mg orally twice daily for 4 doses or fenoldopam 0.1 mcg/kg/min intravenously for a minimum of 8 h. All patients received intravenous hydration with normal saline (5% dextrose in normal saline for diabetics on insulin). Randomization was stratified for diabetes. The primary endpoint was mean change in Scr at 72 h. Secondary endpoint was the incidence of contrast-induced nephropathy (25% increase above baseline Scr or absolute increase of 0.5 mg/dL).
Study termination occurred after ninety-five patients (mean age 68+/-10 years, female 25%, diabetic 42%, mean baseline Scr 1.5+/-0.4 mg/dL) were randomized, with 84 completing follow-up (44 N-acetylcysteine, 40 fenoldopam). Overall, there were no significant differences in mean change in Scr at 72 h (N-acetylcysteine 0.20+/-0.72 vs. fenoldopam 0.08+/-0.48 mg/dL, p=0.4) or incidence of contrast-induced nephropathy (N-acetylcysteine 5 vs fenoldopam 8, p=0.4). No differences were detected in subgroup analyses for diabetes, baseline Scr >1.7 or 2.0 mg/dL, gender, age >70 years, or contrast volume >150 mL. Results were similar after multivariate adjustment for diabetes, contrast volume, heart failure and gender.
Our randomized comparison failed to demonstrate a significant difference in the abilities of N-acetylcysteine and fenoldopam to prevent the decline in renal function or the incidence of contrast-induced nephropathy during cardiac catheterization.
N-乙酰半胱氨酸和非诺多泮常用于预防造影剂介导的肾病,然而,两种药物的相对优势尚不清楚。
在一项前瞻性、随机、平行组试验中,大学医院和退伍军人医院中患有稳定肾功能不全的成年心脏导管插入术患者被随机分为两组,一组口服N-乙酰半胱氨酸600毫克,每日两次,共4剂;另一组静脉注射非诺多泮0.1微克/千克/分钟,至少8小时。所有患者均接受生理盐水静脉补液(胰岛素治疗的糖尿病患者用5%葡萄糖生理盐水)。随机分组按糖尿病情况进行分层。主要终点是72小时时血清肌酐(Scr)的平均变化。次要终点是造影剂肾病的发生率(Scr比基线升高25%或绝对值增加0.5毫克/分升)。
在95例患者(平均年龄68±10岁,女性25%,糖尿病患者42%,平均基线Scr 1.5±0.4毫克/分升)被随机分组后,研究终止,84例完成随访(44例使用N-乙酰半胱氨酸,40例使用非诺多泮)。总体而言,72小时时Scr的平均变化(N-乙酰半胱氨酸0.20±0.72与非诺多泮0.08±0.48毫克/分升,p = 0.4)或造影剂肾病的发生率(N-乙酰半胱氨酸组5例与非诺多泮组8例,p = 0.4)无显著差异。在糖尿病、基线Scr>1.7或2.0毫克/分升、性别、年龄>70岁或造影剂用量>150毫升的亚组分析中未检测到差异。在对糖尿病、造影剂用量、心力衰竭和性别进行多变量调整后,结果相似。
我们的随机比较未能证明N-乙酰半胱氨酸和非诺多泮在预防心脏导管插入术期间肾功能下降或造影剂肾病发生率方面的能力存在显著差异。