5 %声振人血白蛋白注射液左心声学造影增强左室内膜分辨的II 期多中心临床研究报告

目的　为评价 5 %声振人血白蛋白注射液经静脉左心声学造影的显影效果及耐受性 ,进行了多中心临床研究。方法　应用广州南方医院研制的 5 %声振人血白蛋白注射液静脉注射 ,评价左室显影和改善左室内膜识别的效果。结果　静注该造影剂后左室可清晰识别的节段数明显增加 ,第一次注射由 3 5 9± 0 87增加到 5 2 9± 1 14(P<0 0 1) ,其中 5 9例第二次注射的患者由 3 39± 0 93增为 4 71± 1 2 3(P <0 0 1) ;两独立研究者间结果无显著差异。左室显影等级 ,注射 0 0 8ml/kg时 ,左室 2级以上显影有效率平均达 80 3%。其余 5 9例左室显影未达 2级者 ,再次注射 0 2 2ml/kg时 ,显影有效率上升至 94 3% ,左室显影效果显著 ,两独立研究者间结果亦无显著差异。研究提示 ,左心显影效果受某些因素影响 ,如年龄较大、体重指数较高和心功能较差。结论　 5 %声振人血白蛋白注射液经静脉声学造影的左心显影效果显著 ,耐受性良好 ,适合在临床上应用。

Enhanced Resolution of Left Ventricular Endocardium by 5 %SonicatedHuman Albumin A Multiple Center Stage II Cl inical Study

Objective A multiple center clinical study were carried out to evaluated the LV echo enhancement effect andthe side effects of 5 % sonicated human albumin. OMethods 5 % sonicated human albumin made by Southern Hospital inGuangzhou was injected intravenously to assess LV echo enhancement effect . Results The number of clearly recognizedsegments increased significantly from 3.59 ±0.87 to 5.29 ±1.14 ( P < 0.01) in all 300 studied patients after the firstintravenous injection. In 59 of these patients the number increased from 3.39 ±0.93 to 4.71 ±1.123 ( P < 0.01) after thesecond injection. The interobserver difference is not of significance. In 80.3 percent of these patients the left ventricular contrast enhancement reached above Grade 2 at a dose of 0.08ml/ kg. In 94.3 percent of the rest 59 ones the left ventricle echowas enhanced after the second injection in spite of the poor effect in the first time. The results showed that the contrasteffect was influenced by some fatctors such as old age ,high body weight index and poor heart function. Conclusion 5 %sonicated human albumin could enhance the resolution of left ventricular endocardium ,has little side effect and will be appropriate for clinical use.