丹红注射液防治急性冠脉综合征患者冠状动脉介入术后对比剂肾病的临床研究

Prevention of Contrast-Induced Nephropathy with Danhong Injection in Acute Coronary Syndrome Patients Undergoing Percutaneous Coronary Intervention

目的探讨在常规治疗的基础上加用丹红注射能否更有效地减少急性冠脉综合征患者冠状动脉介入治疗术后对比剂肾病(CIN)的发生率。方法将住院治疗拟行冠状动脉介入术的急性冠脉综合征患者144例随机分为丹红治疗组(丹红组,72例)和基础治疗组(72例)。基础治疗组常规给予抗血小板、抗凝、扩冠、调脂及水化等治疗。丹红组PCI开始前1 h给予丹红注射液40 ml加入0.9%氯化钠溶液250 ml静脉滴注。所有患者分别于术前、术后第1天及第2天测定血肌酐(SCr)和尿素氮(BUN),留取尿液标本检测尿中性粒细胞明胶酶相关脂质运载蛋白(NGAL)。并根据MDRD公式计算肾小球滤过率(eGFR),比较两组患者CIN的发生率。结果对照组11例(15.3%)发生CIN,丹红组有2例(2.8%),两组CIN发生率差异有统计学意义(P<0.05)。对照组及丹红组SCr、eGFR各时间点比较,差异无统计学意义(P>0.05)。但术后12 h对照组尿NGAL较丹红组明显升高,差异有统计学意义(P<0.05)。结论对于对比剂引发的急性肾损伤,在常规治疗的基础上加用丹红注射液可以更有效地预防CIN的发生。

Objective To evaluate the safety and efficacy of Danhong injection in prevention of contrast-induced nephropathy（CIN） in acute coronary syndrome patients undergoing percutaneous coronary intervention（PCI）.Methods A single-center prospective randomized controlled trial was performed,in which 144 ACS patients undergoing PCI were divided randomly into the control group（n=72） and the intervention group（n=72）.Both groups received routine treatment including anti-platelet therapy,anti-coagulation therapy,coronary artery dilation,lipid adjusting,and hydration while the intervention group received additional Danhong injection one hour before PCI.Serum creatinine,blood urea nitrogen（BUN） and urinary neutrophil gelatinase associated lipocalin（NGAL） were checked at baseline,1 day and 2 days after PCI.GFR was calculated according to modified MDRD formula.Incidence rates of CIN were compared between the two groups.Results Incidence rates of CIN were significantly different between the control group and the intervention group（15.3%（11 cases） vs 2.8%（2 cases）,P0.05）.Levels of SCr and eGFR showed no significant differences between the two groups（P0.05）.Urinary NGAL levels in the control group were significantly higher than those in the intervention group 12 hours after PCI（P0.05）.Conclusion Danhong injection is effective in the prevention of CIN in ACS patients undergoing PCI.