Safety and efficacy of domestic iodixanol injection in interventional neuroradiology:a multicenter clinical trial
10.3969/j.issn.1672-5921.2015.11.004
- VernacularTitle: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
- Author:
Chuanchuan WANG
;
Qinghai HUANG
;
Jianmin LIU
- Publication Type:Journal Article
- Keywords:
Angiography,digital subtraction;
Contrast media;
Iodixanol;
Interventional neuroradiology
- From:
Chinese Journal of Cerebrovascular Diseases
2015;(11):577-580
- CountryChina
- Language:Chinese
-
Abstract:
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 the 442 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)(χ2 = 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 signifi-cance. 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.
