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年龄、性别、肥胖及糖尿病对选择性A2A激动剂瑞加诺生和腺苷在心肌灌注成像中的疗效及安全性的影响——整合ADVANCE-MPI试验结果

Effects of age, gender, obesity, and diabetes on the efficacy and safety of the selective A2A agonist regadenoson versus adenosine in myocardial perfusion imaging integrated ADVANCE-MPI trial results.

作者信息

Cerqueira Manuel D, Nguyen Patricia, Staehr Peter, Underwood S Richard, Iskandrian Ami E

机构信息

Departments of Nuclear Medicine and Cardiovascular Medicine, Cleveland Clinic, 9500 Euclid Avenue, Cleveland, OH 44195, USA.

出版信息

JACC Cardiovasc Imaging. 2008 May;1(3):307-16. doi: 10.1016/j.jcmg.2008.02.003.

Abstract

OBJECTIVES

To compare the effects of age, gender, body mass index, and diabetes on the safety and efficacy of regadenoson stress myocardial perfusion imaging, and to assess the noninferiority of regadenoson to adenosine for the detection of reversible myocardial perfusion defects.

BACKGROUND

Previous reports have shown that a fixed unit bolus of regadenoson is safe and noninferior to adenosine for the detection of reversible perfusion defects by radionuclide imaging.

METHODS

Using a database of 2,015 patients, we evaluated the effects of age, gender, body mass index, and diabetes on the safety and efficacy of regadenoson compared to adenosine.

RESULTS

For detection of ischemia relative to adenosine, noninferiority was demonstrated for all patients (agreement rate difference 0%, 95% CI -6.2% to +6.8%). The average agreement rate between adenosine-adenosine and adenosine-regadenoson were 0.62 +/- 0.03 and 0.63 +/- 0.02. Detection of ischemia was also comparable in specific subgroups. Agreement was less for both agents in women versus men with moderate and large areas of ischemia. Compared to adenosine, regadenoson had a lower combined symptom score and less chest pain, flushing, and throat, neck, or jaw pain, but more headache and gastrointestinal discomfort. This was true in nearly all subgroups. Regadenoson patients reported feeling more comfortable (1.7 +/- .02 vs. 1.9 +/- 0.03, p < 0.001). Based on the overall tolerability score, women felt less comfortable than men with both stress agents. Image quality was rated good or excellent in 92% for both agents.

CONCLUSIONS

Regadenoson can be safely administered as a fixed unit bolus and is as efficacious as adenosine in detecting ischemia regardless of age, gender, body mass index, and diabetes. Regadenoson is better tolerated overall and across various subgroups.

摘要

目的

比较年龄、性别、体重指数和糖尿病对瑞加诺生负荷心肌灌注显像安全性和有效性的影响,并评估瑞加诺生在检测可逆性心肌灌注缺损方面相对于腺苷的非劣效性。

背景

既往报告显示,固定剂量推注的瑞加诺生在通过放射性核素显像检测可逆性灌注缺损方面是安全的,且不劣于腺苷。

方法

利用一个包含2015例患者的数据库,我们评估了年龄、性别、体重指数和糖尿病对瑞加诺生相对于腺苷的安全性和有效性的影响。

结果

与腺苷相比,在检测缺血方面,所有患者均显示出非劣效性(一致性率差异为0%,95%可信区间为-6.2%至+6.8%)。腺苷-腺苷组和腺苷-瑞加诺生组之间的平均一致性率分别为0.62±0.03和0.63±0.02。在特定亚组中,缺血检测结果也具有可比性。在中度和大面积缺血的女性与男性中,两种药物的一致性均较低。与腺苷相比,瑞加诺生的综合症状评分更低,胸痛、潮红以及咽喉、颈部或颌部疼痛更少,但头痛和胃肠道不适更多。几乎在所有亚组中都是如此。瑞加诺生组患者感觉更舒适(1.7±0.02对1.9±0.03,p<0.001)。基于总体耐受性评分,在两种负荷药物使用中,女性比男性感觉更不舒服。两种药物的图像质量评级为良好或优秀的比例均为92%。

结论

瑞加诺生可作为固定剂量推注安全给药,且在检测缺血方面与腺苷一样有效,无论年龄、性别、体重指数和糖尿病情况如何。瑞加诺生在总体上以及各个亚组中耐受性更好。

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