维生素C预防冠心病合并糖尿病患者发生对比剂肾病的临床疗效研究

Prevention of Contrast-induced Nephropathy with Ascorbic Acid in Coronary Heart Disease Patients with Diabetes Mellitus

目的探讨冠心病合并糖尿病患者应用维生素C预防对比剂肾病的安全性和临床疗效。方法本研究为单中心前瞻性随机对照临床试验,连续入选96例合并糖尿病的冠心病患者,随机分为两组。对照组(n=50)患者仅用0.9%氯化钠溶液进行常规水化;干预组(n=46)患者在常规水化的基础上于术前2～4h予3.0g维生素C静脉滴注,术后第1、2天分别口服1.0g维生素C(早晚各服0.5g),静脉滴注及口服的维生素C总量为5.0g。观察术后患者的肾功能及心脏不良事件发生情况。结果维生素C干预组对比剂肾病发生率较对照组低,但差异无统计学意义(6.5%vs10.0%,P=0.540)。研究期间有1例患者出现支架内亚急性血栓形成,其余患者均未观察到严重的心脏不良事件。结论对于合并糖尿病的冠心病患者短程应用大剂量维生素C有降低对比剂肾病发生的趋势,但与对照组相比差异无统计学意义,维生素C预防对比剂肾病的有效性尚需大样本临床试验来证实。

Objective To evaluate the safety and efficacy of ascorbic acid in prevention of contrast-induced nephropathy in coronary heart disease （CHD） patients with diabetes mellitus （DM）.Methods A single-center prospective randomized controlled trial was performed,96 CHD patients with DM were divided randomly into groups control （n=50,receiving only 0.9% sodium chloride solution for routine hydration） and intervention （n=46,based on routine hydration receiving vitamin C intravenous infusion,3.0 g,2～4 h before operation,and oral vitamin C,1.0 g,on day 1,2,respectively,after operation）.The total dosage of intravenous and oral vitamin was 5.0 g.The renal function and the occurrence of adverse cardiac events were observed after operation.Results The incidence of contrast-induced nephropathy was lower in intervention group than in control,but the difference was not significant （6.5% vs 10.0%,P=0.540）.No severe adverse cardiac events were noted in all patients during the research except 1 presenting with subacute stent thrombosis.Conclusion Short-term application of high-dosage vitamin C has a trend of lowering contrast-induced nephropathy in CHD patients with DM,but is not significantly different from control group.The efficacy of vitamin C in prevention of contrast-induced nephropathy needs large sample trials to confirm.