目的

评估生物阻抗谱检测技术(BIS)在乳腺肿物切除术中对所切除包块良恶性快速定性的准确度。

方法

本临床试验选取2015 年1 月至2016 年5 月之间成都市第三人民医院(西南交通大学附属医院)收治的189 例乳腺肿物切除患者的237 个包块进行检测,同一标本按顺序先后使用乳腺组织阻抗分析仪(MScan1.0B)与石蜡切片活组织检查技术进行检测,在该标本的几项检测结果全部得到以后,将MScan1.0B 的检测结果与病理切片结果进行统计学分析,以石蜡切片活组织检查的检测结果为金标准,评估MScan1.0B 检测的特异度和敏感度,采用McNemar χ² 检验比较2 种方法的检出差异。采用Kappa 检验进行2 种方法的一致性检验。

结果

BIS 的敏感度为93.75%(45/48),特异度为96.30%(182/189),假阳性率为3.70%(7/189),假阴性率为6.25%(3/48),阳性似然比为25.31,阴性似然比为0.06。 2 种方法的检出效果差异无统计学意义(P=0.344)。 BIS 与石蜡切片活组织检查的一致性较高(Kappa=0.87,P＜0.001)。

结论

BIS 对乳腺肿物的良恶性鉴定准确度高,可以弥补术中冰冻活组织检查对于某些乳腺肿物不能做出快速判断的不足,而且实现成本低、高效率、操作简便,在进一步更新后有望成为临床快速组织鉴定的补充技术手段。

Objective

To evaluate the accuracy of bioelectrical impedance spectroscopy (BIS) in rapidly distinguishing malignant breast mass from benign mass.

Methods

We selected the specimens from 237 breast masses in 189 patients from January 2015 to June 2016 in the Third People's Hospital of Chengdu(the Affiliated Hospital of Southwest Jiaotong University) for clinical trials. Each specimen was detected sequentially by Breast Tissue Bioimpedance Analyser (MScan1.0B) and pathological examination of paraffin sections. With pathological results as gold standard, the specificity and sensitivity of MScan1.0B detection were evaluated. McNemar χ² test was used to analyze the difference between MScan1.0B and pathological examination. Kappa test was used to check the consistency of the two methods.

Results

The sensitivity of BIS was 93.75%(45/48), the specificity 96.30%(182/189), false positive rate 3.70%(7/189), false negative rate 6.25% (3/48), positive likelihood ratio 25.31 and negative likelihood ratio 0.06. There was no significant difference in detection efficacy between the two methods (P=0.344). BIS technique had high consistence with pathologic examination (Kappa=0.87,P＜0.001).

Conclusion

BIS can identify the benign and malignant breast masses with advantages of high accuracy, low cost, high efficiency and simple operation,which overcomes the shortcomings of intraoperative frozen section biopsy and has potential as a supplementary method of pathological examination for clinical identification.