国产碘克沙醇注射液在神经介入中安全性和有效性的多中心试验

Safety and efficacy of domestic iodixanol injection in interventional neuroradiology:a multicenter clinical trial

目的探讨国产对比剂碘克沙醇注射液在神经介入应用中的效果和安全性。方法采用前瞻性、多中心、非对照临床试验设计,纳入11家研究中心应用碘克沙醇注射液行全脑DSA检查或介入治疗的442例患者。记录和评价指标主要包括:用药后不良反应,用药前后肌酐、尿素氮指标的变化,DSA机型,DSA图像质量和对比剂使用剂量等。统计分析肾功能损害、药物不良反应发生率和影像质量。结果入组442例均完成检查或治疗。(1)术中造影质量评价均达到优良,其中优98.2%(434例),良1.8%(8例);4种不同DSA机型(SIEMENS、PHILIPS、GE、TOSHIBA)的图像质量比较,差异有统计学意义(χ2=31.518,P<0.01)。(2)仅1例血肌酐浓度较注射对比剂前升高44.2μmol/L,未出现有临床意义的血肌酐和尿素氮异常,无一例出现肾功能不全。(3)术中有3例(0.7%)发生轻度药物不良反应,其中2例皮肤出现变态反应,1例为短暂性视物不清。结论国产碘克沙醇注射液在神经介入领域的临床应用安全有效,不良反应少。不同DSA机型可能对造影图像质量产生影响。

Objective To investigate the safety and efficacy of domestic contrast iodixanol injection in the application of interventional neuroradiology. Methods A total of 442 patients from 11 research centers using iodixanol injection for whole brain DSA examination or interventional therapy were enrolled in a prospective,multicenter,and non-controlled clinical trial. The recording and evaluation indicators included the adverse reactions after drug treatment,changes of creatinine and urea nitrogen indicators before and after drug treatment,DSA types,DSA effects,the dosage of contrast agent,etc. The renal function damage,incidence of adverse drug reactions,and image quality were counted and analyzed. Results All the442 patients were completed the examination or treatment.（ 1） All the results of intraoperative angiography achieved excellent,including 98. 2 %（ n = 434） were excellent and 1. 8 %（ n = 8） were good. There were significant differences in the comparison of angiographic results in the 4 different types of DSA（ SIEMENS,PHILIPS,GE,and TOSHIBA）（ χ^2= 31. 518,P〈0. 001）.（ 2） Only 1 patient had increased serum creatinine 〉44. 2 μmol / L. There was no urea nitrogen abnormality of clinical significance. None of the patients had renal insufficiency.（ 3） Three patients had adverse drug reaction（ 0. 7%）during procedure,including 2 patients had dermal allergic reactions and 1 patient had transient blurred vision. Conclusion Domestic iodixanol injection is safe and effective and has less adverse reaction in the clinical application of interventional neuroradiology. The different types of DSA may impact on the contrast image quality.