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目的评价超声弹性成像(UE)诊断乳腺肿块的准确度,分析证实偏倚校正后的灵敏度、特异度,以便临床客观而全面地认识UE诊断结果。方法对1 568例患者分别进行常规彩超及UE检查,检查结果与病理结果对照。然后用最大似然估计法对UE诊断乳腺肿块的灵敏度和特异度进行校正。结果超声诊断为恶性的患者接受手术的概率为70.93%,超声诊断为良性的患者接受手术的概率为19.72%,两者间差异具有统计学意义(P<0.000 1)。证实偏倚校正前灵敏度95.04%,95%CI(92.51~97.57),校正后的灵敏度为84.19%,95%CI(77.21~91.17),两者95%可信区间无交集,差异有统计学意义;证实偏倚校正前特异度为84.16%,95%CI(80.29~88.03),校正后的特异度为95.03%,95%CI(91.06~99.10),两者95%可信区间无交集,差异具有统计学意义;证实偏倚校正后的特异度高于校正前,校正后的灵敏度低于校正前。结论 UE诊断乳腺癌的准确度较高,但因证实偏倚的存在,影响临床对UE诊断乳腺癌的准确度评价。
Objective To evaluate the diagnostic accuracy of ultrasonic elastography (UE) for breast masses and to confirm the sensitivity and specificity of the corrected bias in order to objectively and comprehensively understand the diagnostic results of UE. Methods A total of 1 568 patients underwent routine color Doppler ultrasonography and ultrasonography, respectively. The results were compared with pathological findings. Then, the sensitivity and specificity of UE diagnosis of breast masses are corrected by maximum likelihood estimation. Results The probability of surgery was 70.93% in patients diagnosed as malignant by ultrasound and 19.72% in patients diagnosed as benign by ultrasound. The difference was statistically significant (P <0.0001). The sensitivity before correction was 95.04%, 95% CI (92.51 ~ 97.57), the corrected sensitivity was 84.19%, 95% CI (77.21 ~ 91.17). There was no significant difference between the two 95% confidence intervals. Confirmed the bias before correction was 84.16%, 95% CI (80.29 ~ 88.03), the corrected specificity was 95.03%, 95% CI (91.06 ~ 99.10), 95% confidence interval between the two no intersection, the difference with statistics The significance of the test was confirmed. The corrected specificity after confirming the bias was higher than before the calibration, and the corrected sensitivity was lower than before the calibration. Conclusion The accuracy of UE diagnosis of breast cancer is high, but the accuracy of clinical diagnosis of breast cancer is affected by the existence of bias.