国产碘克沙醇在心血管高危人群冠脉造影和介入治疗的安全性观察

The use of domestic iodixanol in coronary angiography and cardiovascular intervention in the population with high cardiovascular risk: clinical observation of its safety

目的探讨国产碘克沙醇在心血管高危人群冠脉造影、PCI的安全性观察。方法将210例心血管高危人群随机分为国产碘克沙醇组110例和进口碘克沙醇100例,观察两组不良反应的发生率和造影效果,以及术前、术后国产碘克沙醇组肾功能的变化。结果两组不良反应发生率比较差异无统计学意义(P>0.05);造影效果相比差异也无统计学意义(P>0.05);术前及术后比较,国产碘克沙醇组术前术后肾功能变化不明显,与进口碘克沙醇比较差异无统计学意义(P>0.05)。结论国产碘克沙醇在心血管高危人群冠脉造影、PCI的安全有效,造影效果好,对肾功能影响等方面,与进口制剂无异。

Objective To investigate the safety of domestic iodixanol used in coronary angiography and percutaneous cardiovascular intervention in the population with high cardiovascular risk. Methods A total of 210 cases with high risk of cardiovascular disorders were randomly divided into domestic iodixanol group（n = 110） and imported iodixanol group（n = 100）. The incidence of adverse reactions and the postoperative changes of renal function were analyzed, and the results were compared between the two groups.Results No statistically significant difference in the incidence of adverse reactions existed between the two groups（P 0.05）. The image quality of the two groups was the same（P 0.05）. In the domestic iodixanol group, the postoperative changes of renal function was not obvious when compared with the preoperative renal function（P 0.05）. Conclusion As the same as the imported iodixanol, the domestic iodixanol can be safely used in the population with high-risk of cardiovascular disorders in coronary angiography and percutaneous cardiovascular intervention, and it has little influence on the renal function.