国产与进口碘帕醇注射液用于肝脏增强计算机断层摄影术检查的比较

目的 :比较国产与进口碘帕醇注射液临床安全性、计算机断层摄影术 (CT)增强扫描效果及不良反应。方法 :采用随机盲法平行对照临床等效试验设计 ,试验药和对照药分别为国产和进口碘帕醇注射液 ,入组病例 4 6例分为 2组 ,试验组 2 3例 ,对照组 2 3例 ,药物剂量按 1.5mL·kg- 1,注射速度2 .5mL·s- 1,分别取肝脏 2点测其增强前后CT值作为增强效果判定指标。结果 :试验组增强后CT值升高 (43±s 9)HU ;对照组为 (41± 10 )HU ,2组差异无显著意义 (P >0 .0 5 ) ,均无明显不良反应。结论 :国产碘帕醇注射液临床应用安全有效与进口产品相似。

Domestic vs imported iopamidol injection in X-ray computed tomography enhancement scanning of liver

AIM: To compare the clinical safety effects in CT enhancement scanning and adverse reactions between domestic and imported non ionic contrast material iopamidol. METHODS: The clinical equivalent test design of random double blind, paralled and control was used. Comparative drug was iopamiro made by Bracco company, Italy. Forty eight patients were divided into 2 groups, that test group 24 patients and control goup 24 patients. The dosage was 1.5 mL·kg -1 , and inject rate was 2.5 mL·s -1 . Two different regions were measured on the liver pre and post enhancrment CT scan, CT value was as estimated criterion for effects of enhancement scanning of liver. RESULTS: CT value was step up(43±9)HU in the test group; and that of control group was (41±10)HU ( P> 0.05). There were the entirely same effects in the CT enhancement scanning of liver between testing drugs, and nobvious adverse reactions were found. CONCLUSION: Domestic iopamidol is safe and effective in the enhancement CT scan and that is as same as iopamiro.