Objective: To evaluate the 3 different clinical management strategies for patients with cervical cytological atypical squamous cells of undetermined significance (ASC-US) recommended by the guideline of The 2001 Bethesda system and the 2001 American Society for Colposcopy and Cervical Pathology (ASCCP).
Methods: 1394 patients with a cytopathological diagnosis of ASC-US by use of liquid-based thin-layer preparation were managed by three different clinical strategies, and evaluated by the percentage of histological diagnosis > or = high-grade intraepithelial lesion (HSIL), i.e., cervical intraepithelial neoplasia (CIN2 and 3) as standard. 421 patients in Group A underwent colposcopically directed cervical biopsy, 475 patients in Group B were followed-up after 6 months by cytology, colposcopy and biopsy were performed if the results were > or = ASC-H or ASC-US and HPV-DNA (+). 498 patients in Group C: underwent HC-II test, colposcopy and biopsy were performed on those aged > or = 30 and with the HPV-DNA (+), if the patients were aged < 30 and with the HPV-DNA (+), HC-II test and cytology would be performed after 6 months; colposcopy and biopsy were performed on those with the results > or = ASC-H or HPV-DNA (+).
Results: (1) The results of histological diagnosis > or = CIN2 were found in 27 cases (6.41%) of Group A, 26 cases (5.78%) of Group B, and 34 cases (6.91%) of Group C. There was no statistically significant difference among these 3 groups (all P > 0.05). (2) Convenience was significantly different among these 3 groups (P < 0.01). The workloads for the doctors and the discomfort resulting from biopsy for the patients were the greatest in Group A. The patient's compliance of Group B was low because of the necessity to wait for follow-up six months later. The cost of Group C was relatively higher. (3) In Group C, 66% of the ASC-US patients with HPV-DNA (+) were aged > or = 30. The percentage of histological diagnosis > or = CIN2 was 5.69% in those aged > or = 30 and was 1.22% in those aged < 30.
Conclusion: Both protocols B and C are practical for clinical management of ASC-US in China. HPV infection is the necessary cause of cervical carcinoma, so the protocol C (cytology and HC-II test) is better for cervical lesion screening. The ASC-US patients aged > or = 30 and with HPV-DNA (+) are at high risk.