瑞舒伐他汀对糖尿病合并轻、中度肾功能不全应用利尿剂患者介入诊治术后对比剂肾病的预防作用观察

Effect and safety of rosuvastatin for prevention of contrast-induced acute kidney injury after percutaneous coronary intervention in patients with diabetes associated with mild-moderate renal insufficiency

目的探讨瑞舒伐他汀对糖尿病合并轻、中度肾功能不全患者围术期应用利尿剂行冠脉或外周血管介入诊治术后发生对比剂肾病(CIAKI)的影响。方法选取2008年12月-2011年10月由53家中心共同参研的TRACK-D研究中糖尿病合并轻、中度肾功能不全同时应用利尿剂的患者650例,其中瑞舒伐他汀组321例,对照组329例。瑞舒伐他汀组患者从入选开始每晚顿服瑞舒伐他汀10mg,术前至少2剂,并持续应用至术后3剂。对照组患者术前至术后72h内不服用任何他汀类药物。分别于术前,术后48、72h测定患者血清肌酐(Scr)水平,同时观察CIAKI发生率,随访观察术后30d时患者心功能恶化,全因死亡,因肾功能恶化需透析、血滤的发生情况。结果 650例患者中48例发生CIAKI,总发生率为7.4%。其中瑞舒伐他汀组有16例(5.0%),对照组有32例(9.7%),两组间差异有统计学意义(P=0.024)。术后随访30d,心功能恶化1级、因肾功能恶化需透析或血滤及全因死亡的发生率两组间差异无统计学意义(P>0.05)。结论对于糖尿病合并轻、中度肾功能不全且围术期应用利尿剂的患者,瑞舒伐他汀可有效预防其经皮冠状动脉介入治疗(PCI)术后CIAKI的发生。

Objective To explore the safety and efficacy of rosuvastatin on development of contrast-induced acute kidney injury （CIAKI） due to application of diuretic furosemide after coronary or peripheral vascular intervention during perioperative period in patients with diabetes mellitus （DM） associated with mild-moderate renal insufficiency （MMRI）. Methods From Dec. 2008 to Oct. 2011, 2998 patients from 53 centers in China were enrolled in a TRACK-D project. Of them 650 patients with type 2 DM and concomitant MMRI, who received furosemide, were divided into rosuvastatin group （n=321） and control group （n=329）, and all underwent coronary/peripheral arterial diagnostic angiography or left heart ventricular angiography. Patients in rosuvastatin group were treated by percutaneous intervention with rosuvastatin 10mg/d every evening for five days （two days before and three clays after operation）, while those in control group did not receive any statins before operation and within 72 hours after operation. Serum creatinine （Scr） was measured 48 hours before and 48 and 72 hours after exposure to contrast medium, and the incidence of CIAKI was simultaneously observed. Clinical follow-up of cardiovascular events was done at the 30th day after treatment, including heart function aggravation, all-cause mortality, renal dysfunction-induced dialysis and hemofiltration, etc. Results Baseline data were similar between the two groups. Patients randomized to the rosuvastatin group had a significantly lower incidence of CIAKI compared with controls （5.0% vs 9.7%, P=0.024）. Clinical follow-up done at the 30th day after treatment indicated that there was no statistical difference in incidence of dialysis, hemofiltration and all-cause mortality between rosuvastatin group and control group. Conclusions Rosuvastatin may significantly reduce the risk of CIAKI in patients with DM associated with MMRI and receive the furosemide during the perioperative period.