摘要
目的由6家医院进行多中心研究,评价南方医科大学南方医院研制的全氟丙烷人血白蛋白微球注射剂经静脉注射后增强左心室内膜边界识别的效果和安全性。方法采用自身注射前后对照方法,对符合纳入标准的研究对象分别经静脉注入稀释的全氟丙烷人血白蛋白微球注射剂0.01ml/kg,由A和B研究者分别独立进行给药前、后造影效果评判比较。结果6家医院的303例受试者,单次静脉注射全氟丙烷人血白蛋白微球注射剂0.01ml/kg。A研究者评价结果左心室显影Ⅱ级占0.7%,Ⅲ级占99.3%;B研究者评价结果左心室显影Ⅱ级占0.3%,Ⅲ级占99.7%。两组研究者分别独立评价的造影有效率均为100%,差异无统计学意义(P>0.05)。各研究中心间用药后左心室显影等级差异亦无统计学意义(P>0.05)。A和B研究者评价左心室可清晰识别的节段数均显著增加,A研究者由(2.68±0.95)节段增加至(5.99±0.10)节段,B研究者由(2.82±1.03)节段增加至(5.99±0.11)节段(P<0.01)。两组研究者分别独立评价的结果差异无统计学意义(P>0.05),造影后内膜节段显示平均增强率为99.7%。全氟丙烷人血白蛋白微球注射剂对血压、心率、呼吸等生命指征无明显临床意义的影响。心电图无明显改变。血尿常规、肝肾功能等化验检查结果的变化亦在正常范围内。仅1例出现不良反应,为轻度恶心、腹泻,发生率为0.33%(1/303),提示该造影剂临床应用安全。结论全氟丙烷人血白蛋白微球注射剂经静脉注射后左心室内膜的分辨效果显著增强,明显提高对室壁节段性运动状态的判定。该造影剂不良反应少,且轻微,适合在临床上应用。
Objective A multiple center research involving 6 hospitals was carried out to evaluate the left ventricular（LV） endocardial border echo enhancement effect and safety of perfluoropropane-albumin microsphere injection. Methods Diluted perfluoropropane-albumin microsphere injection was given intravenously to permitted objects at a dose of 0.01 ml/kg. Observers A and observers B evaluated the contrast effect respectively by self-comparison between pre-injection and post-injection. Results All 303 patients of 6 hospitals need to be given the microsphere injection only once at a dose of 0.01 ml/kg. Observers A had a result that in 0.7% patients the LV endocardial border enhancemen reached Grade Ⅲ and in 99.3% patients reached grade Ⅲ , while obervers B had a result that in 0. 3% patients reached grade Ⅱ and in 99.7% patients reached grade Ⅲ. Both results were effective and had no statistic difference（ P〉 0.05）. The intercenter difference of LV contrast grade was also not of significance（ P 〉0.05）. After once injection both observers considered the number of clearly recognized endocardial border segments increased significantly. The number evaluated by observers A increased from 2.68± 0.95 to 5.99± 0.10 while from 2.82±1.03 to 5.99±0.11 by observers B（P 〈0.01）. The results between two observers had no significant difference（ P 〉 0. 05）. The average contrast enhancement rate of LV endocardial border was 99.7%. Perfluoropropane-albumin microsphere injection had no significant effection on vital signs such as blood prssure, 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. Only one case（0.33%） had slight side-effects who suffered from mild nausea and diarrhea, which suggested the clinical safety of this contrast agent. Conclusions Perfluoropropane-albumin microsphere injection could enhance the resolution of LV endocardial borders and make the judgement of regional myocardial movement easier. It has little side-effects and will be appropriate for clinical use.
出处
《中华超声影像学杂志》
CSCD
2006年第4期241-246,共6页
Chinese Journal of Ultrasonography
