Wackers F J, Berman D S, Maddahi J, Watson D D, Beller G A, Strauss H W, Boucher C A, Picard M, Holman B L, Fridrich R
Dept. of Diagnostic Radiology, Yale University School of Medicine, New Haven, CT 06510.
J Nucl Med. 1989 Mar;30(3):301-11.
The biodistribution, dosimetry, and safety of a new myocardial imaging agent, 99mTc-hexakis-2-methoxyisobutyl isonitrile (HEXAMIBI), was evaluated in 17 normal volunteers at rest and exercise (Phase I studies). Technetium-99m HEXAMIBI clears rapidly from the blood with good myocardial uptake and favorable myocardial-to-background ratios for myocardial imaging. Dosimetry allows for administration of up to 30 mCi (1, 110 Bq) of [99mTc]HEXAMIBI. The myocardial images were of good quality and appeared less granular with sharper myocardial walls compared to 201T1 images. The clinical efficacy of [99mTc]HEXAMIBI planar stress and rest imaging was evaluated in a multicenter Phase II clinical trial involving 38 patients. Of 36 patients with significant coronary artery disease, 35 patients (97%) had abnormal 201T1 stress images, and 32 (89%) had abnormal [99mTc]HEXAMIBI stress images (P = N.S.). Technetium-99m HEXAMIBI images correlated in 31/35 patients (86%) who had either scar or ischemia on 201T1 images. By segmental myocardial analysis, exact concordance was obtained in 463/570 myocardial segments (81%). This multicenter Phase I and II study indicates that planar [99mTc]HEXAMIBI stress imaging is safe and compares well with 201T1 stress imaging for detection of coronary artery disease.
一种新型心肌显像剂99mTc-六甲基异丁基异腈（HEXAMIBI）的生物分布、剂量测定及安全性在17名静息和运动状态下的正常志愿者中进行了评估（I期研究）。99mTc-HEXAMIBI能迅速从血液中清除，心肌摄取良好，心肌与本底比值有利于心肌显像。剂量测定允许给予高达30mCi（1110Bq）的[99mTc]HEXAMIBI。与201Tl图像相比，心肌图像质量良好，颗粒感较少，心肌壁更清晰。[99mTc]HEXAMIBI平面负荷和静息显像的临床疗效在一项涉及38例患者的多中心II期临床试验中进行了评估。在36例患有严重冠状动脉疾病的患者中，35例（97%）201Tl负荷图像异常，32例（89%）[99mTc]HEXAMIBI负荷图像异常（P=无显著性差异）。在201Tl图像上有瘢痕或缺血的31/35例患者（86%）中，99mTc-HEXAMIBI图像与之相关。通过节段性心肌分析，在570个心肌节段中的463个（81%）获得了完全一致性。这项多中心I期和II期研究表明，平面[99mTc]HEXAMIBI负荷显像安全，在检测冠状动脉疾病方面与201Tl负荷显像效果相当。
