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使用计算机闭环给药系统的阿巴胺负荷铊-201单光子发射计算机断层扫描。评估安全性和诊断准确性的多中心试验。国际阿巴胺研究小组。

Arbutamine stress thallium-201 single-photon emission computed tomography using a computerized closed-loop delivery system. Multicenter trial for evaluation of safety and diagnostic accuracy. The International Arbutamine Study Group.

作者信息

Kiat H, Iskandrian A S, Villegas B J, Starling M R, Berman D S

机构信息

Cedars-Sinai Medical Center, Los Angeles, California 90048, USA.

出版信息

J Am Coll Cardiol. 1995 Nov 1;26(5):1159-67. doi: 10.1016/0735-1097(95)00298-7.

DOI:10.1016/0735-1097(95)00298-7
PMID:7594027
Abstract

OBJECTIVES

This study sought to evaluate the efficacy and safety of arbutamine when used in conjunction with thallium-201 single-photon emission computed tomography (SPECT) in a multicenter trial and to compare arbutamine stress and treadmill exercise thallium-201 SPECT for diagnostic sensitivity and myocardial perfusion pattern.

BACKGROUND

Arbutamine is a potent beta-agonist developed specifically for pharmacologic stress testing.

METHODS

Arbutamine was administered by a novel computerized closed-loop device that measures heart rate and adjusts arbutamine infusion to achieve a selected rate of heart rate increase toward a predetermined limit. The cohort included 184 patients who underwent arbutamine stress testing, of whom 122 (catheterization group) had angiographically defined coronary artery disease ( > or = 50% diameter stenosis of a major coronary artery), and 62 had a low pretest likelihood of coronary artery disease (low likelihood group). A subset of 69 patients from the catheterization group underwent both arbutamine and exercise stress testing.

RESULTS

Hemodynamic responses during arbutamine and exercise stress testing demonstrated no significant difference in percent increase in heart rate (81% vs. 76%) or systolic blood pressure (26% vs. 30%). The sensitivity for detecting coronary artery disease ( > or = 50% stenosis) using arbutamine thallium-201 SPECT was 87% (95% for detecting > or = 70% stenoses), and the normalcy rate in the low likelihood group was 90%. In patients completing both arbutamine and exercise stress testing, thallium-201 SPECT sensitivity for detecting coronary artery disease ( > or = 50% stenosis) was 94% and 97% (p = NS), respectively Furthermore, SPECT segmental visual score agreement (defect vs. no defect) showed a concordance of 92% between arbutamine and exercise results (kappa 0.80, p < 0.001). The stress thallium-201 SPECT segmental scores showed 83% exact agreement (kappa 0.69, p < 0.001), and analysis of the reversibility of segments with stress perfusion defects demonstrated 86% exact agreement (kappa 0.68, p < 0.001). In general, side effects associated with arbutamine were well tolerated and resolved with discontinuation of infusion.

CONCLUSIONS

Arbutamine, administered by a closed-loop feed-back system was shown to be a safe and effective pharmacologic stress agent. Arbutamine stress thallium-201 SPECT appears to be accurate for the diagnosis of coronary artery disease with a diagnostic efficacy similar to that of treadmill exercise thallium-201 studies.

摘要

目的

本研究旨在通过一项多中心试验评估阿巴胺与铊 - 201单光子发射计算机断层扫描(SPECT)联合使用时的疗效和安全性,并比较阿巴胺负荷试验与平板运动铊 - 201 SPECT的诊断敏感性和心肌灌注模式。

背景

阿巴胺是一种专门为药物负荷试验开发的强效β受体激动剂。

方法

通过一种新型计算机化闭环装置给予阿巴胺,该装置可测量心率并调整阿巴胺输注量,以实现选定的心率增加速率并趋向预定极限。该队列包括184例接受阿巴胺负荷试验的患者,其中122例(导管插入术组)经血管造影确定患有冠状动脉疾病(主要冠状动脉直径狭窄≥50%),62例冠状动脉疾病预测试验可能性较低(低可能性组)。导管插入术组的69例患者子集同时接受了阿巴胺和运动负荷试验。

结果

阿巴胺和运动负荷试验期间的血流动力学反应显示,心率增加百分比(81%对76%)或收缩压增加百分比(26%对30%)无显著差异。使用阿巴胺铊 - 201 SPECT检测冠状动脉疾病(≥50%狭窄)的敏感性为87%(检测≥70%狭窄时为95%),低可能性组的正常率为90%。在同时完成阿巴胺和运动负荷试验的患者中,铊 - 201 SPECT检测冠状动脉疾病(≥50%狭窄)的敏感性分别为94%和97%(p = 无显著性差异)。此外,SPECT节段视觉评分一致性(缺损与无缺损)显示阿巴胺与运动结果之间的一致性为92%(kappa 0.80,p < 0.001)。负荷铊 - 201 SPECT节段评分显示精确一致性为83%(kappa 0.69,p < 0.001),对有负荷灌注缺损节段的可逆性分析显示精确一致性为86%(kappa 0.68,p < 0.001)。总体而言,与阿巴胺相关的副作用耐受性良好,停止输注后症状缓解。

结论

通过闭环反馈系统给予的阿巴胺被证明是一种安全有效的药物负荷剂。阿巴胺负荷铊 - 201 SPECT在诊断冠状动脉疾病方面似乎准确,诊断效能与平板运动铊 - 201研究相似。

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