阿托伐他汀预防对比剂肾损害的随机化临床研究

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目的对比剂诱导的急性肾损害(Contrast induced acute kidney injury,CIAKI)是医源性急性肾功能衰竭的主要原因之一,本项前瞻性、随机化临床试验,旨在探讨围手术期使用阿托伐他汀能否降低冠状动脉介入诊断及治疗术后的急性肾损害。方法连续筛选2006年5月1日至2009年5月1日在郑州大学第二附属医院心内科因不稳定型心绞痛入院,拟行冠状动脉造影和(或)冠状动脉介入治疗术的患者210例,随机分入阿托伐他汀组(105例)及对照组(105例)。阿托伐他汀组患者于术前及术后3天服用阿托伐他汀40mg,1次/d。介入术中使用低渗非离子型对比剂-碘海醇。术后全部患者立即接受水化治疗12h(1ml/h/kg)。入院时及术后3d连续监测肾功能。术后72h内血清肌酐(Scr)较基线值增高25%或44.2μmol/L(0.5mg/dl)定义为CIAKI。结果两组患者大部分基线指标差异无统计学意义。总CIAKI发生率为10.00%。多因素回归分析显示,基线Scr≥132.6μmol/l(OR=20.88,95%CI 1.97~55.21,P<0.001),Ccr<60ml/min(OR=4.72,95%CI 1.96~10.12,P<0.001),心功能分级(NYHA)>Ⅱ级(OR=6.32,95%CI 2.82~17.22,P<0.001),糖尿病(OR=2.051,95%CI 1.21~5.82,P<0.001),年龄≥70岁(OR=4.27,95%CI 1.82~8.26,P<0.001),冠状动脉造影显示的冠状动脉钙化(OR=4.37,95%CI 1.92~9.34,P<0.001)等因素与CIAKI相关。阿托伐他汀组CIAKI发生率低于对照组(P<0.05)。阿托伐他汀组与对照组相比,术后Scr峰值[(98.21±40.76)μmol/L比(29.32±65.36)μmol/L]及其与基线Scr的差值(△Scr)[(14.61±15.22)μmol/L比(23.34±13.41)μmol/L]明显降低(<0.05)。结论对不稳定型心绞痛接受冠状动脉造影和(或)冠状动脉介入治疗的患者在围手术期预防性使用阿托伐他汀具有保护肾功能,减轻肾损害的作用。 Objective Contrast induced acute kidney injury (CIAKI) is one of the major causes of iatrogenic acute renal failure. This prospective, randomized clinical trial is aimed to investigate the perioperative use of Atto Can statin be reduced in the diagnosis and treatment of acute renal injury after coronary intervention. Methods A total of 210 patients undergoing coronary angiography and / or coronary intervention were enrolled in this study from May 1, 2006 to May 1, 2009 at the Department of Cardiology of the Second Affiliated Hospital of Zhengzhou University who were admitted for unstable angina pectoris. Were randomly divided into atorvastatin group (105 cases) and control group (105 cases). Patients in the atorvastatin group received atorvastatin 40 mg 3 times a day before and 3 days after surgery. Interventional use of hypotonic non-ionic contrast agent - iohexol. All patients received immediate hydration therapy 12h (1ml / h / kg). On admission and postoperative 3d continuous monitoring of renal function. Serum creatinine (Scr) increased by 25% at baseline within 72 h or 44.2 μmol / L (0.5 mg / dl) was defined as CIAKI. Results Most of the two groups had no significant difference in baseline indexes. Total CIAKI incidence was 10.00%. Multivariate regression analysis showed that baseline Scr≥132.6μmol / l (OR = 20.88,95% CI 1.97-55.21, P <0.001), Ccr <60ml / min (OR = 6.32, 95% CI 2.82 ~ 17.22, P <0.001), diabetes (OR = 2.051, 95% CI 1.21-5.82, P <0.001) (OR = 4.27, 95% CI 1.82-8.26, P <0.001). Coronary angiography showed coronary artery calcification (OR = 4.37, 95% CI 1.92-9.34, P <0.001). The incidence of CIAKI in atorvastatin group was lower than that in control group (P <0.05). Compared with the control group, the difference of Scr peak value [(98.21 ± 40.76) μmol / L vs (29.32 ± 65.36) μmol / L) and the difference between Scr and baseline Scr ([14.61 ± 15.22) μmol / L (23.34 ± 13.41) μmol / L] significantly decreased (P <0.05). Conclusions The prophylactic use of atorvastatin during perioperative period in patients with unstable angina who underwent coronary angiography and / or coronary intervention has the function of protecting renal function and reducing renal damage.
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