基于冠状动脉CT血管成像图像质量的碘克沙醇注射液仿制药与原研药临床等效性评价OA

AIM To compare the image quality between generic and original iodixanol injections in coronary computed-tomography angiography(CCTA),providing imaging evidence for validating the clinical equivalence of the generic product.METHODS Patients who underwent CCTA using iodixanol injection between January 1,2022,and October 31,2022,were enrolled and divided into a generic group(n=86)and an original group(n=92).Subjective image quality assessment was performed using the Likert scale for the left main coronary artery(LM),proximal left anterior descending artery(LAD),proximal left circumflex artery(LCX),and proximal right coronary artery(RCA).Objective metrics,including CT values,standard deviation(SD),signal-to-noise ratio(SNR),and contrast-to-noise ratio(CNR),were measured in the luminal and adjacent adipose regions of LM,LAD,LCX,and RCA.RESULTS Both groups exhibited subjective image quality scores ≥ 3 for all coronary segments(over 95％),with no significant intergroup differences(P＞0.05).The CT value,SD value,SNR and CNR of the 2 groups all reached the clinical diagnostic threshold.The LM-CT values,LAD-CT values,RCA-CT values,LM-SD values,and LCX-SD values in the generic group were significantly higher than those in the original group(all P＜0.05).However,there were no statistically significant differences in SNR and CNR,across all vascular territories(the 95％CIs of all differences included 0,with P＞0.05,and effect sizes r ranged from 0 to 0.13).CONCLUSION The generic iodixanol injection demonstrates equivalent image quality to the original product in coronary artery imaging,supporting its role as a cost-effective alternative for diagnosing coronary pathologies.