Tianjin Medical University, Tianjin, China.
Department of Cardiology, Tianjin Chest Hospital, No. 261, Taierzhuang South Road, Jinnan District, Tianjin, 300222, China.
Int Urol Nephrol. 2019 Nov;51(11):1999-2004. doi: 10.1007/s11255-019-02244-9. Epub 2019 Aug 5.
Contrast-associated nephropathy (CIN), the third main reason of the acute kidney injury (AKI) in inpatients, is a potentially severe side effect of angiography and the preventive role of nicorandil on CIN is still controversal. The aim of this clinical trial was to evaluate the preventive role of different doses of nicorandil on CIN in patients experiencing cardiac catheterization compared with hydration.
We recorded outcomes from 330 patients who were randomly divided to either a double-dose (30 mg/day) nicorandil group or to a usual-dose (15 mg/day) nicorandil group or a control group (hydration only). The primary endpoint of the current research was the occurrence of CIN, which is defined as a relative elevation of SCr level of 25% above the baseline or an absolute increment of SCr of more than 44.2 µmol/L (0.5 mg/dL) within 48 or 72 h after contrast medium exposure. Additional endpoints were the changes in BUN, SCr, Cys-C, eGFR, and CRP level within 48 h after contrast agent exposure and major adverse events occurring during hospitalization and 14 days of follow-up.
6 out of 111 patients (5.4%) had contrast-induced nephropathy in the double-dose group and it occured 11 out of 107 patients (10.3%) in the usual-dose group, 16 out of 112 patients (14.3%) in the control group. There was a significant difference in the occurrence of CIN between the double-dose group and the control group at 48 h after taking the radiocontrast medium (p = 0.026) while no such significant difference observed in the usual-dose group and the control group (p = 0.367), the double-dose group and usual-dose group (p = 0.180) as well.
Daily peri-procedural usual-dose nicorandil could just relieve contrast-induced renal injury, only double-dose nicorandil was associated with a reduced incidence of CI-AKI compared with hydration.
造影剂相关肾病(CIN)是住院患者急性肾损伤(AKI)的第三大主要原因,是血管造影的潜在严重副作用,而尼可地尔对 CIN 的预防作用仍存在争议。本临床试验的目的是评估与水化相比,不同剂量的尼可地尔对接受心脏导管检查的患者的 CIN 的预防作用。
我们记录了 330 名随机分为尼可地尔双剂量(30mg/天)组、尼可地尔常规剂量(15mg/天)组或对照组(仅水化)的患者的结果。本研究的主要终点是 CIN 的发生,定义为造影剂暴露后 48 或 72 小时内 SCr 水平较基线升高 25%或绝对升高 44.2µmol/L(0.5mg/dL)以上。其他终点包括造影剂暴露后 48 小时内 BUN、SCr、Cys-C、eGFR 和 CRP 水平的变化以及住院期间和随访 14 天内发生的主要不良事件。
双剂量组有 6 例(5.4%)患者发生造影剂肾病,常规剂量组有 11 例(10.3%),对照组有 16 例(14.3%)。在接受造影剂后 48 小时,双剂量组与对照组 CIN 的发生率有显著差异(p=0.026),而常规剂量组与对照组(p=0.367)、双剂量组与常规剂量组(p=0.180)之间无显著差异。
围手术期常规剂量尼可地尔可减轻造影剂引起的肾损伤,仅双剂量尼可地尔与与水化相比可降低 CI-AKI 的发生率。