国产碘克沙醇对老年冠心病患者肾功能影响的安全性研究

Nephrotoxic effects of domestic iodixanol injection in old patients with coronary heart disease

摘要:

目的 评价国产碘克沙醇注射液对进行经皮冠状动脉介入治疗（PCI）的老年冠心病患者肾功能的影响。方法 采用随机分组、单盲设计、阳性对照的多中心研究。于2013年7月至2014年3月在辽宁省5家医院选择60～75岁、拟行PCI的患者88例，随机分为试验组（应用江苏恒瑞医药股份有限公司生产的碘克沙醇注射液，44例）与对照组[应用通用电气药业有限公司生产的威视派克（碘克沙醇商品名），44例]。记录两组术前年龄、性别、体质量指数（BMI）及肾功能等基本临床资料，术后48h检测肾功能，从而比较两者对老年冠心病患者肾功能的影响有无差别。结果 两组共入选88例患者，试验组与对照组均为44例。88例患者均顺利完成冠状动脉造影与PCI，成功率100%。两组年龄、BMI等基本临床资料无统计学差异（P＞0.05）。两组PCI前后肾功能指标相比均无统计学差异（P＞0.05），两组分别有1例患者术后当天出现恶心呕吐，于手术次日恢复正常；两组均未发生对比剂诱发性急性肾损伤及其他不良反应。结论 国产碘克沙醇用于行PCI的老年冠心病患者是安全的。

Abstract:

Objective To evaluate the nephrotoxic effects of domestic iodixanol injection in the elderly patients with coronary heart disease (CHD). Methods A multicenter, single blind, randomized controlled clinic trial was prospectively carried out in 5 hospitals in Liaoning Province from July 2013 to March 2014. Eighty-eight patients of 60 to 75 years old with CHD undergoing percutaneous coronary intervention (PCI) were divided into 2 groups: experimental group (domestic iodixanol injection group, n＝44) and control group [Visipaque (trade name of iodixanol) group, n＝44]. The clinical information including age, gender, body mass index (BMI), serum creatinine (SCr) and blood urea nitrogen (BUN) was recorded before PCI. Their SCr and BUN were determined in 48 h after PCI for renal function in the patients of the 2 groups. Results All of them underwent PCI smoothly, with a successful rate of 100%. There was no significant difference in the age, gender, BMI, SCr and BUN between the 2 groups before PCI (P＞0.05). No difference was found in the renal function in the 2 groups before and after PCI (P＞0.05). One patient of each group had nausea and vomiting respectively just in the day after operation, and recovered on the next day. None of patient had contrast-induced acute kidney injury or other adverse reactions. Conclusion Domestic iodixanol injection is safe for old patients with CHD underwent PCI.