Miller D D, Rivera F J, Garcia O J, Palmaz J C, Berger H J, Weisman H F
Department of Medicine (Cardiology), St. Louis University Medical Center, Mo. 63110-0250.
Circulation. 1992 Apr;85(4):1354-63. doi: 10.1161/01.cir.85.4.1354.
To evaluate the in vivo safety, biodistribution, and diagnostic accuracy of a monoclonal Fab' antibody (S12) that is specific for the platelet membrane glycoprotein (GMP-140) expressed during platelet activation at vascular injury sites, 11 peripheral percutaneous transluminal angioplasty (PTA) patients (age, 61 +/- 8 years) with severe vascular disease had serial 99mTcS12 radionuclide imaging at 5 and 90 minutes, 4-6 hours, and 20-24 hours after a total of 23 angiographically successful PTA procedures. No acute allergic reactions or hematologic toxicity occurred.
The average PTA percent angiographic diameter stenosis (DS) at all 23 sites decreased from 85 +/- 12% to 12 +/- 11%, with a mean before-to-after-PTA change of 73 +/- 14% (p less than 0.01). The mean radionuclide image-derived ratio of 99mTc S12 activity in PTA versus contralateral non-PTA arterial segments for all angioplasty sites was 1.6 +/- 0.5. Vascular 99mTc S12 antibody activity was qualitatively evident in the majority (78%) of PTA sites at 4-6 hours after injection. 99mTc S12 target-to-background (muscle) ratio equaled 2.3 +/- 0.6 at PTA sites. Nine PTA sites (39%) had residual 99mTc S12 activity at 24 hours after injection (mean PTA site-to-contralateral artery ratio, 1.5 +/- 0.4). The mean vascular 99mTc S12 activity ratios in 10 procedurally complicated (defined as extensive dilation [greater than 2 cm] or grade I or greater arterial dissection) and 13 uncomplicated PTA segments were 1.9 +/- 0.5 versus 1.2 +/- 0.1, respectively (p less than 0.01). The associated before-to-after-PTA angiographic improvement was significantly less in procedurally complicated PTA sites (66 +/- 12% versus 80 +/- 12% DS; p less than 0.01).
99mTc S12 activity is significantly increased at angiographically patent PTA sites that are procedurally complicated and are associated with less significant before-to-after-PTA angiographic improvement. 99mTc S12 monoclonal Fab' antibody imaging permits noninvasive identification of local vascular platelet activation resulting from angioplasty balloon injury in humans.
为评估一种单克隆Fab'抗体（S12）的体内安全性、生物分布及诊断准确性，该抗体特异性针对血管损伤部位血小板激活时表达的血小板膜糖蛋白（GMP - 140），11例患有严重血管疾病的外周经皮腔内血管成形术（PTA）患者（年龄61±8岁）在总共23次血管造影成功的PTA手术后，于5分钟和90分钟、4 - 6小时以及20 - 24小时进行了连续的99mTcS12放射性核素成像。未发生急性过敏反应或血液学毒性。
所有23个部位的平均PTA血管造影直径狭窄百分比（DS）从85±12%降至12±11%，PTA前后的平均变化为73±14%（p＜0.01）。所有血管成形术部位PTA与对侧非PTA动脉段的99mTc S12活性的平均放射性核素图像衍生比值为1.6±0.5。注射后4 - 6小时，大多数（78%）PTA部位在血管内99mTc S12抗体活性在定性上很明显。PTA部位99mTc S12靶本底（肌肉）比值等于2.3±0.6。9个PTA部位（39%）在注射后24小时有残留的99mTc S12活性（平均PTA部位与对侧动脉比值，1.5±0.4）。10个手术复杂（定义为广泛扩张[＞2 cm]或I级或更高级别的动脉夹层）和13个未复杂的PTA节段的平均血管内99mTc S12活性比值分别为1.9±0.5和1.2±0.1（p＜0.01）。手术复杂的PTA部位PTA前后血管造影改善明显较少（DS为66±12%对80±12%；p＜0.01）。
在血管造影显示通畅的PTA部位，99mTc S12活性显著增加，这些部位手术复杂且PTA前后血管造影改善不显著。99mTc S12单克隆Fab'抗体成像可无创识别人类血管成形术球囊损伤导致的局部血管血小板激活。
