Sciubba J J
Department of Dental Medicine, Long Island Jewish Medical Center, New Hyde Park, N.Y, USA.
J Am Dent Assoc. 1999 Oct;130(10):1445-57. doi: 10.14219/jada.archive.1999.0055.
A study group composed of researchers from across the United States undertook a study to evaluate the sensitivity and specificity of OralCDx (OralScan Laboratories Inc.), a computer-assisted method of analysis of the oral brush biopsy, in the detection of precancerous and cancerous lesions of the oral mucosa.
The study group conducted a multicenter double-blind study comparing results of OralCDx analysis with those of scalpel biopsy of suspicious oral lesions, as well as using OralCDx on oral lesions that appeared benign clinically.
In 945 patients, OralCDx independently detected every case of histologically confirmed oral dysplasia and carcinoma (sensitivity = 100 percent, false-negative rate = 0 percent). Every OralCDx "positive" result was subsequently confirmed by histology as dysplasia or carcinoma. The specificity for the OralCDx "positive" result was 100 percent, while the specificity for the OralCDx "atypical" results was 92.9 percent. In 4.5 percent of clinically benign-appearing lesions that would not have received additional testing or attention other than clinical follow-up, OralCDx uncovered dysplasia or carcinoma (statistical sensitivity > 96 percent, P < .05, n = 131; statistical specificity for the OralCDx "positive" result > 97 percent and for the "atypical" result > 90 percent, P < .05, n = 196).
The authors propose that this multicenter trial demonstrates that OralCDx is a highly accurate method of detecting oral precancerous and cancerous lesions. OralCDx can aid in confirming the nature of apparently benign oral lesions and, more significantly, revealing those that are precancerous and cancerous when they are not clinically suspected of being so. All OralCDx "atypical" and "positive" results should be referred for scalpel biopsy and histology to completely characterize the lesion.
Given the difficulty in clinically differentiating premalignant and malignant lesions from benign lesions with a similar appearance, OralCDx appears to determine the significance of an oral lesion definitively and detect innocuous-appearing oral cancers at early, curable stages.
一个由来自美国各地的研究人员组成的研究小组开展了一项研究，以评估口腔刷检活检的计算机辅助分析方法OralCDx（OralScan实验室公司）在检测口腔黏膜癌前病变和癌性病变方面的敏感性和特异性。
该研究小组进行了一项多中心双盲研究，将OralCDx分析结果与可疑口腔病变的手术刀活检结果进行比较，并将OralCDx用于临床上看似良性的口腔病变。
在945名患者中，OralCDx独立检测出每一例经组织学证实的口腔发育异常和癌（敏感性 = 100%，假阴性率 = 0%）。随后，每一个OralCDx“阳性”结果均经组织学确认为发育异常或癌。OralCDx“阳性”结果的特异性为100%，而OralCDx“非典型”结果的特异性为92.9%。在4.5%临床上看似良性的病变中，若不是OralCDx检测，这些病变除了临床随访外不会接受额外检测或关注，而OralCDx却发现了发育异常或癌（统计敏感性>96%，P<0.05，n = 131；OralCDx“阳性”结果的统计特异性>97%，“非典型”结果的统计特异性>90%，P<0.05，n = 196）。
作者认为，这项多中心试验表明OralCDx是一种检测口腔癌前病变和癌性病变的高度准确的方法。OralCDx有助于确认看似良性的口腔病变的性质，更重要的是，能发现那些临床上未被怀疑为癌前病变和癌性病变的情况。所有OralCDx“非典型”和“阳性”结果均应进行手术刀活检和组织学检查以完整地明确病变特征。
鉴于临床上难以将外观相似的癌前和恶性病变与良性病变区分开来，OralCDx似乎能明确确定口腔病变的意义，并在早期可治愈阶段检测出外观无害的口腔癌。
