Two hundred and twenty-three female patients in Beijing Friendship Hospital from October 2012 to April 2013 were choosen. All the cases were diagnosed as mammary gland hyperplasia clinically, and their breast ultrasound images show the breast imaging-reporting and data system (BI-RADS) grad was 0 or 1. These patients were divided into 3 groups according to their age, Group A: 20 to 35 age (36 cases), Group B: 36 to 50 age (102 cases), and Group C: order than 50 year-old (85 cases). The pathological diagnosis were obtained by ultrasound guided breast biopsy. With pathological diagnosis as the gold standard and "Leopard sign" as ultrasound diagnostic criteria, the sensitivity, specificity, accuracy, positive predictive value and negative predictive value were calculated. The consistency between the ultrasonic and the pathological diagnosis were analyzed by Kappa statistical test.

The diagnostic consistency test of the total sample of 223 cases: in terms of the ultrasonic Leopard sign" for the diagnosis of breast hyperplasia, the sensitivity was 69% (59/85),the specificity was 46% (64/138), the accuracy was 55% (123/223), the positive predictive value was 44% (59/133), the negative predictive value was 71% (64/90), the consistency was poor (Kappa=0.14, P<0.05). Group A:the sensitivity was 90% (18/20), the specificity was 50% (8/16),the accuracy was 72% (26/36), the positive predictive value was 69% (18/26), the negative predictive value was 80% (8/10), the consistency was good (Kappa=0.42, P<0.05);Group B:the sensitivity was 70% (33/47), the specificity was 49% (27/55),the accuracy was 59% (60/102), the positive predictive value was 54% (33/61), the negative predictive value was 66% (27/41), the consistency was poor (Kappa=0.19, P<0.05); Group C: the sensitivity was 44% (8/18), the specificity was 43% (29/67), the accuracy was 44% (37/85), the positive predictive value was 17% (8/46), the negative predictive value was 74% (29/39), the consistency was poor (Kappa=0.08, P<0.05).

"Leopard pattern" sign is not suitable as an independent standard in diagnosing breast hyperplasia disease.