摘要
目的评估介入诊治围术期应用瑞舒伐他汀对2型糖尿病(T2DM)合并轻度肾功能不全(CKD)2期患者尿微量蛋白的影响。方法选取2008年12月-2011年10月53家中心共同参研的TRACK-D研究中T2DM合并CKD 2期患者2360例,其中瑞舒伐他汀组(n=1185)和对照组(n=1175)。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。患者于术前48h、术后72h测定患者尿微量白蛋白、尿白蛋白排泄率、血清肌酐(Scr)水平,同时观察对比剂肾病(CIAKI)的发生率,随访观察术后30d时患者心功能恶化、全因死亡及药物不良反应事件的发生情况。结果瑞舒伐他汀组患者术前、术后尿微量白蛋白(分别为0.25±0.38、0.19±0.31mg/L),对照组患者术前、术后尿微量白蛋白(分别为0.28±0.41、0.22±0.38mg/L),术前、术后两组比较差异均无统计学意义(P=0.274、P=0.08)。瑞舒伐他汀组72h内CIAKI的发生率[1.5%(18/1185)]明显低于对照组[3.4%(40/1175)],差异有统计学意义(P<0.01)。患者术后30d随访时发现,瑞舒伐他汀组有28例发生心功能恶化大于1级(发生率2.4%),对照组49例(发生率4.2%),差异有统计学意义(P=0.02);瑞舒伐他汀组1例死亡(死亡率0.3%);对照组3例死亡(死亡率0.7%),差异有统计学意义(P=0.04);瑞舒伐他汀组有13例发生药物不良反应(发生率1.0%),对照组15例(发生率1.3%),差异无统计学意义(P=0.71)。结论在T2DM合并轻度CKD患者围术期连续应用瑞舒伐他汀可使CIAKI的发生率及心血管事件的发生明显降低,同时不增加T2DM合并CKD 2期患者的尿蛋白排泄率。
Objective To assess the effect of rosuvastatin used during perioperative period on urine trace protein in patients with type 2 diabetes mellitus （T2DM） and concomitant chronic kidney disability （CKD, stage 2）. Methods From Dec. 2008 to Oct. 2011, 2998 patients from 53 centers in China were enrolled in a TRACK-D project. Of them, 2360 patients with T2DM and concomitant CKD （stage 2） were assigned to rosuvastatin group （n=1185） and control group （n=1175）. Patients in rosuvastatin group were treated by an intake of rosuvastatin 10mg/d every night for five days （two days pre- and three days post-operation）, while those in control group did not receive statins before operation and within 72 hours after operation. The urine trace protein, serum creatinine （Scr） and the excretion of urinary microalbumin were measured 48 hours before and 72 hours after the operation, and the incidence of contrast-induced aucte kidney injury （CIAKI） was simultaneously observed. A 30-day clinical follow-up was done, including the incidence of cardiovascular events, drug adverse events and all-cause mortality. Results There was no significant difference in urinary microalbumin excretion between rosuvastatin group and control group in either pre-operative stage （0.25 ± 0.38mg/L vs 0.28 ± 0.41mg/L, P=0.274） and post-operative stage （0.19 ± 0.31mg/L vs 0.22 ± 0.38mg/L, P-0.08）. Rosuvastatin group had a significantly lower incidence of CIAKI compared with that in control group （1.5% vs 3.4%, P〈0.01）. The 30-day clinical follow-up revealed that, compared between rosuvastatin group and control group, the rate of aggravation of heart dysfunction （2.4% vs 4.2%, P=0.02） and all-cause mortality rate （0.3% vs 0.7%, P=0.04） were significantly different （P〈0.05）, while the incidence of adverse drug reaction （1.0% vs 1.3%, P=0.71） was not significantly different. Conclusion Rosuvastatin may significantly decrease the risk of CIAKI and cardiovascular events in patients with T2DM and concomitant CKD （stages 2） undergoing arterial contrast media injection. Moreover, it does not increase the excretion of urinary microalbumin.
出处
《解放军医学杂志》
CAS
CSCD
北大核心
2014年第4期271-276,共6页
Medical Journal of Chinese People's Liberation Army
基金
国家科技重大专项课题(2012ZX09303016-002)
辽宁省科技攻关项目(2013225089)~~
关键词
肾功能不全
慢性
糖尿病
2型
瑞舒伐他汀
白蛋白尿
renal insufficiency, chronic
diabetes mellitus, type 2
rosuvastatin
albuminuria
