全氟丙烷人血白蛋白微球注射剂左心声学造影增强左室内膜分辨的有效性和安全性

Enhanced resolution of left ventricular endocardium by perfluoropropane-albumin microsphere injection:results of effect and safety study

目的:探讨全氟丙烷人血白蛋白微球注射剂经静脉注射后增强左室内膜边界识别的效果和安全性。方法:83例研究对象分别经静脉注射稀释的全氟丙烷人血白蛋白微球注射剂0.01mL.kg-1,采用自身前后对照方法,评价左室显影和左室内膜边界识别的效果。结果:注射全氟丙烷人血白蛋白微球注射剂后,左室内膜边界可清晰识别节段数明显增多,两独立研究者间结果无统计学差异。A研究者评价结果:左心室显影II级占1.2%,III级占98.8%;B研究者评价结果:左心室显影II级占2.4%,III级占97.6%。两组研究者分别独立评价的造影有效率均为100%,差异无显著性。造影前后受试者的血压、心率、呼吸等生命体征无明显临床意义的变化心动图无明显改变,血常规、肝功能等化验检查结果的改变亦在正常范围内。结论:全氟丙烷人血白蛋白微球注射剂径静脉注射后左心显影效果显著,安全性好,适合临床应用。

OBJECTIVE A clinical trial were carried out to evaluated the LV echo enhancement effect and safety of perfluoropropane-albumin microsphere injection. METItODS Diluted perfluoropropane-albumin microsphere injection was given intravenously to 83 permitted objects at a dose of 0. 01 mL.kg^-1. Observer A and observers B evaluated the contrast effect respectively by self-comparison between pre-injection and post-injection. RESULTS Both observers considered the number of clearly recognized endocardial border segments increased significantly. The interobserver difference is not of significance（P〉0. 05）. Observer A had a result that 1.2%patients the LV endocardial border enhancemen reached Grade Ⅱ and 98. 8% patients reached grade Ⅲ, while observers B had a result that 2. 4% patients reached grade Ⅱ and 97. 6~ patients reached grade Ⅲ. The results between two observers had no significant difference （P〉0. 05）. Perfluoropropane-albumin microsphere injection had no significant effection on vital signs such as blood pressure, heart rate and respiration. Electrocardiogram didn＇t change markedly and the variance of the laboratory findings like blood and urine routine examination, hepatic and renal function was in normal range. CONCLUSION Perfluoropropane-albumin microsphere injection could enhance the resolution of left ventricular endocardium, it has little side effect and will be appropriate for clinical application.