Kang Woong Chol, Kim Minsu, Park Sang Min, Kim Byeong-Keuk, Lee Byoung-Kwon, Kwon Hyuck Moon
Department of Cardiology, Gil Medical Center, Gachon University College of Medicine, Incheon 21565, Korea.
Department of Cardiology, Chuncheon Sacred Heart Hospital, Hallym University College of Medicine, Chuncheon 24253, Korea.
J Clin Med. 2020 Nov 17;9(11):3689. doi: 10.3390/jcm9113689.
This study aimed to evaluate the efficacy of pitavastatin pretreatment on contrast-induced nephropathy (CIN) in patients with chronic kidney disease (CKD) after a coronary procedure. This was a prospective, randomized, double-blinded, placebo-controlled, multicenter clinical trial. All consecutive 70 patients with CKD (eGFR < 60 mL/min/1.73 m) were enrolled and randomized into two groups. Group I consisted of patients who were treated with statins (pitavastatin 4 mg/day) for seven days before and three days after the procedure ( = 37, 52.9%), and group II consisted of patients who were treated with a placebo ( = 33, 47.1%). The primary endpoint was the incidence of CIN, and the secondary endpoints were the change in serum creatinine (∆sCr) level and estimated glomerular filtration rate (∆eGFR) after the procedure. The mean age of the patients (males, 74%) was 70.4 ± 9.0 years. After the coronary procedure, the incidence of CIN was lower in group I than in group II, but the difference was not significant (5.4% vs. 9.1%, = 0.661). The maximal ∆sCr was lower and the maximal ∆eGFR was higher in group I than in group II, but the difference was not significant (-0.11 ± 0.53 mg/dL and -0.04 ± 0.33 mg/dL, = 0.678; 4.3 ± 11.2 mL/min/1.73 m and -2.9 ± 20.4 mL/min/1.73 m, = 0.161, respectively). This study showed the possibility of a clinical benefit of pretreatment with a high dose of pitavastatin for the prevention of CIN in patients with CKD after coronary procedure (ClinicalTrials.gov Identifier: NCT01871792).
本研究旨在评估匹伐他汀预处理对慢性肾脏病（CKD）患者冠状动脉手术后对比剂肾病（CIN）的疗效。这是一项前瞻性、随机、双盲、安慰剂对照、多中心临床试验。所有连续入选的70例CKD患者（估算肾小球滤过率[eGFR]<60 mL/min/1.73 m²）被纳入并随机分为两组。第一组由在手术前7天和手术后3天接受他汀类药物（匹伐他汀4 mg/天）治疗的患者组成（n=37，52.9%），第二组由接受安慰剂治疗的患者组成（n=33，47.1%）。主要终点是CIN的发生率，次要终点是手术后血清肌酐（∆sCr）水平的变化和估算肾小球滤过率（∆eGFR）的变化。患者的平均年龄为70.4±9.0岁（男性占74%）。冠状动脉手术后，第一组CIN的发生率低于第二组，但差异无统计学意义（5.4%对9.1%，P=0.661）。第一组的最大∆sCr较低，最大∆eGFR较高，但差异无统计学意义（分别为-0.11±0.53 mg/dL和-0.04±0.33 mg/dL，P=0.678；4.3±11.2 mL/min/1.73 m²和-2.9±20.4 mL/min/1.73 m²，P=0.161）。本研究表明，高剂量匹伐他汀预处理对预防CKD患者冠状动脉手术后CIN可能具有临床益处（ClinicalTrials.gov标识符：NCT01871792）。
