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新型超声心动图造影剂OPTISON(FS069)改善左心室心内膜边界描绘及显影。一项III期多中心试验的结果

Improved left ventricular endocardial border delineation and opacification with OPTISON (FS069), a new echocardiographic contrast agent. Results of a phase III Multicenter Trial.

作者信息

Cohen J L, Cheirif J, Segar D S, Gillam L D, Gottdiener J S, Hausnerova E, Bruns D E

机构信息

New Jersey VA Medical Center, East Orange 07018, USA.

出版信息

J Am Coll Cardiol. 1998 Sep;32(3):746-52. doi: 10.1016/s0735-1097(98)00311-8.

DOI:10.1016/s0735-1097(98)00311-8
PMID:9741522
Abstract

OBJECTIVES

The echocardiographic contrast-enhancing effects and safety profile of ALBUNEX (a suspension of air-filled albumin microspheres) were compared with the new contrast agent OPTISON (formerly FS069: a suspension of albumin microspheres containing the gas perfluoropropane) in 203 patients with inadequate noncontrast echocardiograms.

BACKGROUND

The efficacy of ALBUNEX has been limited by its short duration of action. By using perfluoropropane instead of air within the microsphere, its duration of action is increased.

METHODS

Each patient received ALBUNEX (0.8 and 0.22 mL/kg) and OPTISON (0.2, 0.5, 3.0, and 5.0 mL) on separate days a minimum of 48 hours apart. Echocardiograms were evaluated for increase in left ventricular (LV) endocardial border length, degree of LV opacification, number of LV endocardial border segments visualized, conversion from a nondiagnostic to a diagnostic echocardiogram, and duration of contrast enhancement. A thorough safety evaluation was conducted.

RESULTS

Compared with ALBUNEX, OPTISON more significantly improved every measure of contrast enhancement. OPTISON increased well-visualized LV endocardial border length by 6.0+/-5.1, 6.9+/-5.4, 7.5+/-4.7, and 7.6+/-4.8 cm, respectively, for each of the four doses, compared with only 2.2+/-4.5 and 3.4+/-4.6 cm, respectively, for the two ALBUNEX doses (p < 0.001). 100% LV opacification was achieved in 61%, 73%, 87%, and 87% of the patients with the four doses of OPTISON, but in only 16% and 36% of the patients with the two ALBUNEX doses (p < 0.001). Conversion of nondiagnostic to diagnostic echocardiograms with contrast occurred in 74% of patients with the optimal dose of OPTISON (3.0 mL) compared with only 26% with the optimal dose of ALBUNEX (0.22 mL/kg) (p < 0.001). The duration of contrast effect was also significantly greater with OPTISON than with ALBUNEX. In a subset of patients with potentially poor transpulmonary transit of contrast (patients with chronic lung disease or dilated cardiomyopathy), OPTISON more significantly improved the same measures of contrast enhancement compared with ALBUNEX and did so to the same extent as in the overall population. Side effects were similar and transient with the two agents.

CONCLUSION

OPTISON appears to be a safe, well-tolerated echocardiographic contrast agent that is superior to ALBUNEX.

摘要

目的

在203例非增强超声心动图检查效果不佳的患者中,比较了ALBUNEX(充气白蛋白微球混悬液)与新型造影剂OPTISON(原名FS069:含全氟丙烷气体的白蛋白微球混悬液)的超声心动图增强效果和安全性。

背景

ALBUNEX的疗效受其作用持续时间短的限制。通过在微球内使用全氟丙烷代替空气,其作用持续时间得以延长。

方法

每位患者在至少间隔48小时的不同日期分别接受ALBUNEX(0.8和0.22 mL/kg)和OPTISON(0.2、0.5、3.0和5.0 mL)。对超声心动图进行评估以观察左心室(LV)心内膜边界长度的增加、LV的显影程度、可见的LV心内膜边界节段数量、从不诊断性超声心动图转变为诊断性超声心动图以及造影增强的持续时间。进行了全面的安全性评估。

结果

与ALBUNEX相比,OPTISON在造影增强的各项指标上改善更为显著。OPTISON的四个剂量组分别使清晰可见的LV心内膜边界长度增加了6.0±5.1、6.9±5.4、7.5±4.7和7.6±4.8 cm,而ALBUNEX的两个剂量组分别仅增加了2.2±4.5和3.4±4.6 cm(p<0.001)。OPTISON的四个剂量组分别有61%、73%、87%和87%的患者实现了100%的LV显影,而ALBUNEX的两个剂量组分别只有16%和36%的患者达到此效果(p<0.001)。使用OPTISON最佳剂量(3.0 mL)时,74%的患者通过造影从不诊断性超声心动图转变为诊断性超声心动图,而使用ALBUNEX最佳剂量(0.22 mL/kg)时只有26%的患者实现转变(p<0.001)。OPTISON的造影效果持续时间也显著长于ALBUNEX。在一部分造影剂经肺传输可能不佳的患者(慢性肺病或扩张型心肌病患者)中,与ALBUNEX相比,OPTISON在相同的造影增强指标上改善更为显著,且改善程度与总体人群相同。两种药物的副作用相似且为一过性。

结论

OPTISON似乎是一种安全、耐受性良好的超声心动图造影剂,优于ALBUNEX。

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