University of California, San Diego Medical Center, 200 West Arbor Drive, San Diego, CA 92103-8378, USA.
Am J Respir Crit Care Med. 2011 Sep 15;184(6):708-14. doi: 10.1164/rccm.201104-0624OC. Epub 2011 Jun 16.
We report a new method to diagnose acute pulmonary embolism (PE) by single photon emission computerized tomography (SPECT) after administration of (99m)Tc-labeled anti-D-dimer (DI-80B3) monoclonal antibody Fab' fragments. This novel technique provides an additional approach to diagnosing PE in patients for whom other methods are nondiagnostic or contraindicated.
We performed a prospective, multicenter study to investigate the sensitivity and specificity of (99m)Tc-DI-80B3/SPECT in patients with suspected acute PE.
Subjects with a moderate to high clinical probability of PE or a positive D-dimer test underwent a PE-protocol contrast-enhanced multidetector thoracic computed tomography (CT) scan as well as (99m)Tc-DI-80B3/SPECT (0.5 mg (99m)Tc-DI-80B3 intravenously followed by a thoracic SPECT 2.5 h later). Separate and independent adjudication committees, blinded to clinical data and other test results, interpreted the (99m)Tc-DI-80B3/SPECT scans (PE detected as foci of abnormally increased (99m)Tc uptake) and the thoracic CT scans using Prospective Investigation of Pulmonary Embolism Diagnosis II criteria.
Of the 52 patients who were enrolled and completed both tests, 42 had both evaluable SPECT scans and thoracic CT scans. Using the criterion standard (thoracic CT scan) there were 21 patients with PE and 21 without. (99m)Tc-DI-80B3/SPECT had a sensitivity of 76.2% (95% confidence interval, 52.8-91.8%) and a specificity of 90.5% (95% confidence interval, 69.8-98.8%). Treatment-related serious adverse events did not occur.
(99m)Tc-DI-80B3/SPECT was sensitive and specific for acute PE in subjects with moderate to high clinical probability of PE or a positive D-dimer test. (99m)Tc-DI-80B3/SPECT demonstrated an acceptable safety profile and avoids exposure to contrast.
我们报告了一种通过单光子发射计算机断层扫描（SPECT）诊断急性肺栓塞（PE）的新方法，方法是在给予（99m）Tc 标记的抗 D-二聚体（DI-80B3）单克隆抗体 Fab'片段后。这项新技术为其他方法无法诊断或禁忌的患者提供了一种额外的诊断 PE 的方法。
我们进行了一项前瞻性、多中心研究，以研究（99m）Tc-DI-80B3/SPECT 在疑似急性 PE 患者中的敏感性和特异性。
临床高度怀疑 PE 或 D-二聚体试验阳性的患者行 PE 方案增强型多排 CT（CT）扫描，以及（99m）Tc-DI-80B3/SPECT（静脉注射 0.5mg（99m）Tc-DI-80B3，2.5 小时后行胸部 SPECT）。（99m）Tc-DI-80B3/SPECT 扫描（PE 表现为异常摄取（99m）Tc 的焦点）和胸部 CT 扫描由独立和独立的裁决委员会进行解释，这些委员会对临床数据和其他测试结果不知情。使用前瞻性肺栓塞诊断 II 标准。
52 名入组并完成两项检查的患者中，有 42 名患者的 SPECT 扫描和胸部 CT 扫描均可评估。根据标准（胸部 CT 扫描），有 21 名患者患有 PE，21 名患者没有。（99m）Tc-DI-80B3/SPECT 的敏感性为 76.2%（95%置信区间，52.8-91.8%），特异性为 90.5%（95%置信区间，69.8-98.8%）。未发生与治疗相关的严重不良事件。
（99m）Tc-DI-80B3/SPECT 对临床高度怀疑 PE 或 D-二聚体试验阳性的患者的急性 PE 具有敏感性和特异性。（99m）Tc-DI-80B3/SPECT 具有可接受的安全性，且避免了造影剂的暴露。
