Zotz R J, Genth S, Mitrovic V, Waaler A, Erbel R, Meyer J
II. Med Clinic, Johannes Gutenberg University Mainz, Bad Nauheim, Germany.
Eur Heart J. 1996 Feb;17(2):302-7. doi: 10.1093/oxfordjournals.eurheartj.a014849.
To determine the safety of the ultrasound contrast agent Albunex, its influence on right and left heart haemodynamics in patients with pulmonary artery hypertension or left heart failure was assessed after intravenous injection. Patients with a left ventricular ejection fraction smaller than 40% or a systolic pulmonary artery pressure greater than 40 mmHg received 0.08 and 0.22 ml.kg-1 Albunex and 10 ml albumin in random order during right heart catheterization and transthoracic echocardiography. Right atrial, systolic and diastolic pulmonary artery and capillary wedge pressures were measured at 3 min and 5 min and cardiac output at 5 min after the intravenous injection of Albunex and control. The mean differences of pre- and postinjection values and their confidence intervals were tabulated and significance was anticipated if the confidence interval did not include 0. Significant changes to pre-injection values could be observed in diastolic pulmonary artery pressure 5 min after the injection of albumin and 0.08 ml.kg-1 Albunex, and in right atrial pressure 5 min after the injection of 0.22 ml.kg-1 Albunex only. Since intermediate opacification of the left ventricle was seen in only four patients with 0.22 ml.kg-1 Albunex, in the patients studied higher doses of Albunex and their safety need to be assessed.
为确定超声造影剂Albunex的安全性，在静脉注射后评估了其对肺动脉高压或左心衰竭患者左右心血流动力学的影响。左心室射血分数小于40%或收缩期肺动脉压大于40 mmHg的患者在右心导管检查和经胸超声心动图检查期间，随机接受0.08和0.22 ml·kg-1的Albunex以及10 ml白蛋白。在静脉注射Albunex和对照品后3分钟和5分钟测量右心房、收缩期和舒张期肺动脉及毛细血管楔压，并在5分钟时测量心输出量。将注射前后值的平均差异及其置信区间制成表格，如果置信区间不包括0，则预期具有显著性。仅在注射白蛋白和0.08 ml·kg-1 Albunex后5分钟的舒张期肺动脉压以及仅在注射0.22 ml·kg-1 Albunex后5分钟的右心房压中观察到与注射前值有显著变化。由于仅在4例接受0.22 ml·kg-1 Albunex的患者中观察到左心室中度显影，因此需要评估所研究患者中更高剂量Albunex的安全性。
