Barron B, Hanna C, Passalaqua A M, Lamki L, Wegener W A, Goldenberg D M
University of Texas Medical School, Houston, USA.
Surgery. 1999 Mar;125(3):288-96.
The purpose of this study was to evaluate the safety and efficacy of a technetium 99m-labeled antigranulocyte antibody Fab' fragment (sulesomab) as a diagnostic imaging agent in patients with suspected acute, nonclassic appendicitis.
This prospective multicenter trial involved 141 children and adults with suspected acute, nonclassic appendicitis. The investigators interpreted planar images acquired 15 to 30 minutes and 1, 2, and 4 hours after injection and also by single-photon emission computed tomography (SPECT). The imaging results were confirmed surgically, whereas nonsurgical patients were considered as not having appendicitis (intent to treat).
Sulesomab had a sensitivity of 91% (29/32 patients) and a negative predictive rate of 97% for acute appendicitis. It detected additional abnormalities in 7 of 9 patients with other inflammatory abdominal disease and had a specificity of 92% (91/99 patients) and a positive predictive value of 80% for surgically confirmed right-lower-quadrant disease. In positive studies, 26% were identified by planar imaging at 15 to 30 minutes, 46% by 1 hour, 63% by 2 hours, and 71% by 4 hours; 29% required SPECT to detect the abnormality. Scanning time was 5 to 10 minutes per planar image and about 45 minutes for a SPECT study. Investigators found that sulesomab would have changed clinical management or reduced additional diagnostic studies in 64% of the patients. Adverse events were infrequent, minor, and self-limiting (9/141 patients, 6%). No human antimurine antibody response occurred in 48 evaluable patients.
Sulesomab is safe, well-tolerated, and with no apparent immunogenicity. Focal inflammation or infection in the setting of suspected atypical appendicitis is rapidly and accurately detected. Management decisions incorporating sulesomab imaging potentially provide clear patient benefits, especially by correctly predicting surgery to be unnecessary in 97% of patients without acute appendicitis.
本研究旨在评估锝99m标记的抗粒细胞抗体Fab'片段（舒来昔单抗）作为疑似急性非典型阑尾炎患者诊断成像剂的安全性和有效性。
这项前瞻性多中心试验纳入了141例疑似急性非典型阑尾炎的儿童和成人。研究人员对注射后15至30分钟、1小时、2小时和4小时获取的平面图像以及单光子发射计算机断层扫描（SPECT）图像进行解读。成像结果通过手术得到证实，而非手术患者被视为没有阑尾炎（意向性治疗）。
舒来昔单抗对急性阑尾炎的敏感性为91%（32例患者中的29例），阴性预测率为97%。它在9例患有其他腹部炎症性疾病的患者中检测到了7例的额外异常，对经手术证实的右下腹疾病的特异性为92%（99例患者中的91例），阳性预测值为80%。在阳性研究中，15至30分钟时平面成像发现异常的占26%，1小时时占46%，2小时时占63%，4小时时占71%；29%的患者需要SPECT才能检测到异常。每个平面图像的扫描时间为5至10分钟，SPECT研究约为45分钟。研究人员发现，舒来昔单抗会改变64%患者的临床管理或减少额外的诊断性检查。不良事件很少见，症状轻微且为自限性（141例患者中的9例，6%）。48例可评估患者中未出现人抗鼠抗体反应。
舒来昔单抗安全、耐受性良好且无明显免疫原性。在疑似非典型阑尾炎的情况下，可快速准确地检测到局部炎症或感染。纳入舒来昔单抗成像的管理决策可能会给患者带来明显益处，特别是通过正确预测97%没有急性阑尾炎的患者无需进行手术。
