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摘要:
目的 探讨ThinPrep玻片扫描分析影像系统(ThinPrep Imaging System, TIS)在子宫颈细胞学中的临床应用效果。 方法 回顾性分析中国医学科学院北京协和医院妇产科门诊2016年12月至2017年5月宫颈液基细胞学(liquid-based cytology, LBC)样本人工阅片结果以及2017年12月至2018年5月LBC样本TIS辅助阅片结果，分析两种阅片方式的异常细胞学检出率，并随访细胞学异常患者的组织学活检结果以及异常鳞状上皮细胞标本的高危型人乳头瘤病毒(high risk-human papillomavirus, Hr-HPV)阳性率。 结果 人工阅片共计17 407例，TIS辅助阅片共计16 564例。与人工阅片相比，TIS辅助阅片的总体异常细胞学检出率显著提高(15.21%比9.58%，P＜0.001)，其中非典型鳞状上皮细胞、不除外高度鳞状上皮内病变的非典型鳞状上皮细胞、低度鳞状上皮内病变、高度鳞状上皮内病变、不典型腺细胞和腺癌的检出率分别提高了2.77%、0.28%、2.08%、0.35%、0.08%和0.08%，差异均具有统计学意义(P均＜0.05)。对细胞学异常患者进行组织学随访，TIS辅助阅片较人工阅片的组织学符合率有所提升，但差异均无统计学意义(P均＞0.05)。TIS辅助阅片异常腺细胞的检出数量是人工阅片的1.89倍(53例比28例)，经组织学证实的腺癌数量是人工阅片的2.3倍(37例比16例)。TIS辅助阅片与人工阅片鳞状上皮细胞异常患者的Hr-HPV阳性率均无统计学差异(P均＞0.05)。同时，TIS辅助阅片时间减少了33%~50%，阅片效率显著提升。 结论 使用TIS辅助阅片不仅显著提高了宫颈LBC异常检出率和工作效率，组织学符合率亦有所提升，值得临床进一步推广应用。 Abstract:Objective To investigate the effectiveness of clinical application of ThinPrep Imaging System (TIS) in cervical cytology. Methods Manual screening results of cervical liquid-based cytology (LBC) specimens from December 2016 to May 2017 and TIS-assisted screening results of LBC specimens from December 2017 to May 2018 in the Obstetrics and Gynecology Outpatient Clinic of Peking Union Medical College Hospital were retrospectively analyzed. The diagnostic rates of abnormal cytology, histological follow-up results for abnormal cytology and high risk-human papillomavirus (Hr-HPV) positivity for abnormal cytology specimens were analyzed and compared between the two screening methods. Results A total of 17 407 manual screening results of cervical LBC specimens and 16 564 TIS-assisted screening results of LBC specimens were included. The overall abnormal cytology diagnostic rate was significantly higher in TIS-assisted screening than in manual screening (15.21% vs. 9.58%, P < 0.001), with the diagnostic rate of atypical squamous cells, atypical squamous cells without excluding high-grade squamous intraepithelial lesion, low-grade squamous intraepithelial lesion, high-grade squamous intraepithelial lesion, atypical glandular cells and adenocarcinoma increasing 2.77%, 0.28%, 2.08%, 0.35%, 0.08% and 0.08%, respectively. All results were statistically different (all P < 0.05). In biopsy follow-up of the patients with abnormal cytology, the histological coincidence rates of TIS-assisted screening were higher than those of manual screening, but the differences were not statistically significant (all P > 0.05). The number of abnormal glandular cells diagnosed by TIS-assisted screening was 1.89 times that of manual screening (53 cases vs. 28 cases), and the number of adenocarcinomas (confirmed by histology) in TIS-assisted screening was 2.3 times as many as that in manual screening (37 cases vs. 16 cases). The Hr-HPV positivity rates of patients with abnormal squamous epithelial cells in TIS-assisted screening and manual screening were not statistically different. Meanwhile, TIS-assisted screening was more time efficient, with 33%-50% reduction of time. Conclusion The use of TIS-assisted screening not only improved the detection rate of abnormal cytology and the work efficiency, but also increased histological compliance rate, which is worthy of further clinical application. -
Key words:
- computer-assisted screening /
- manual screening /
- cervical cytology /
- human papillomavirus
作者贡献：孔令华负责设计研究方案、分析数据、撰写及修订论文；肖晓萍、万茹随访组织学结果并编辑图表；向阳负责设计研究方案、终审定稿。利益冲突：所有作者均声明不存在利益冲突 -
图 1 TIS制片(巴氏染色，×400)
A. 成簇HSIL细胞团；B.单个散在HSIL细胞；C. AGC中性粒细胞袋；D.子宫内膜腺癌细胞
TIS、HSIL、AGC：同表 1表 1 两种阅片方式细胞学异常检出结果比较[n(%)]
阅片方法 总检出 ASC-US ASC-H LSIL HSIL SCC AGC AC TIS辅助阅片(n=16 564) 2520(15.21) 1396(8.43) 68(0.41) 813(4.91) 184(1.11) 6(0.04) 34(0.21) 19(0.11) 人工阅片(n=17 407) 1668(9.58) 986(5.66) 22(0.13) 493(2.83) 132(0.76) 7(0.04) 22(0.13) 6(0.03) χ2 249.029 99.414 25.934 98.956 11.446 0.035 5.033 7.431 P值 ＜0.001 ＜0.001 ＜0.001 ＜0.001 0.001 0.851 0.025 0.006 TIS：ThinPrep玻片扫描分析影像系统；ASC-US：不能明确意义的非典型鳞状上皮细胞；ASC-H：不除外高度鳞状上皮内病变的非典型鳞状上皮细胞；LSIL：低度鳞状上皮内病变；HSIL：高度鳞状上皮内病变；SCC：鳞状细胞癌；AGC：不典型腺细胞；AC：腺癌 
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表 2 两种阅片方式细胞学与组织学结果比较[n(%)]
细胞学结果 阅片方式 组织学结果 阴性 凹空细胞/CIN Ⅰ CIN Ⅱ/Ⅲ SCC EIN AIS AC ASC-US TIS辅助阅片(n=285) 94(32.98) 147(51.58) 43(15.09) 0(0) 0(0) 0(0) 1(3.51) 人工阅片(n=119) 35(29.41) 56(47.06) 26(21.85) 1(0.84) 0(0) 0(0) 1(0.84) LSIL TIS辅助阅片(n=214) 19(17.29) 133(62.15) 22(20.56) 0(0) 0(0) 0(0) 0(0) 人工阅片(n=156) 32(20.51) 85(54.49) 38(24.36) 1(0.64) 0(0) 0(0) 0(0) ASC-H TIS辅助阅片(n=22) 5(22.73) 9(40.91) 8(36.36) 0(0) 0(0) 0(0) 0(0) 人工阅片(n=12) 2(16.67) 5(41.67) 4(33.33) 1(8.33) 0(0) 0(0) 0(0) HSIL TIS辅助阅片(n=63) 5(7.94) 7(11.11) 48(76.19) 3(4.76) 0(0) 0(0) 0(0) 人工阅片(n=76) 6(7.89) 14(18.42) 50(65.79) 6(7.89) 0(0) 0(0) 0(0) SCC TIS辅助阅片(n=4) 0(0) 0(0) 0(0) 4(100) 0(0) 0(0) 0(0) 人工阅片(n=4) 0(0) 0(0) 0(0) 4(100) 0(0) 0(0) 0(0) AGC TIS辅助阅片(n=22) 8(36.36) 3(13.64) 1(4.55) 1(4.55) 1(4.55) 1(4.55) 7(31.82) 人工阅片(n=11) 6(54.55) 1(9.09) 0(0) 0(0) 0(0) 1(9.09) 3(27.27) AC TIS辅助阅片(n=15) 0(0) 0(0) 0(0) 0(0) 0(0) 0(0) 15(100) 人工阅片(n=5) 0(0) 0(0) 0(0) 0(0) 0(0) 0(0) 5(100) CIN：宫颈上皮内瘤变；EIN：不典型子宫内膜增生；AIS：原位腺癌；TIS、ASC-US、LSIL、ASC-H、HSIL、SCC、AGC、AC：同表 1
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表 3 两种阅片方式异常腺细胞的组织来源比较[n(%)]
异常腺细胞 阅片方式 组织来源 阳性符合 子宫颈 子宫内膜 输卵管 卵巢 转移性直肠癌 AGC TIS辅助阅片(n=22) 1(4.55) 8(36.36) 0(0) 0(0) 0(0) 9(40.91) 人工阅片(n=11) 1(9.09) 3(27.27) 0(0) 0(0) 0(0) 4(36.36) AC TIS辅助阅片(n=15) 2(13.33) 8(53.33) 0(0) 4(26.67) 1(6.67) 15(100) 人工阅片(n=5) 0(0) 3(60.00) 2(40.00) 0(0) 0(0) 5(100) 合计 TIS辅助阅片(n=37) 3(8.1) 16(43.24) 0(0) 4(10.81) 1(2.7) 24(64.86) 人工阅片(n=16) 1(6.25) 6(37.5) 2(12.5) 0(0) 0(0) 9(56.25) TIS、AGC、AC：同表 1
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表 4 鳞状上皮细胞异常患者Hr-HPV阳性率[%(n/N)]
阅片方式 ASC-US ASC-H LSIL HSIL SCC TIS辅助阅片(N=2333) 87.00(1144/1315) 92.06(58/63) 91.99(712/774) 99.34(150/151) 100(30/30) 人工阅片(N=1026) 89.57(567/633) 100(17/17) 93.71(283/302) 96.97(64/66) 100(8/8) χ2 2.656 1.439 0.922 1.889 0.935 P值 0.103 0.579 0.337 0.220 0.576 Hr-HPV：高危型人乳头瘤病毒；TIS、ASC-US、ASC-H、LSIL、HSIL、SCC、AGC、AC：同表 1
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