四川省门诊女性中TruScreen检查用于子宫颈癌前病变早期诊断的准确性研究  

Accuracy of TruScreen in the Early Diagnosis of Cervical Precancerous Lesions in Outpatients in Sichuan Province

作　　者：赵宇倩 石宇 张国楠 周丹[3] 李延[4] 王以锋[5] 闵爱萍[6] 谢珊莉 李毅[8] 王平 王薇 刘玉娟[11] 吴海 蔡春华[13] 齐小雪[14] 宋化雨 姜静[16] Zhao Yuqian;Shi Yu;Zhang Guonan;Zhou Dan;Li Yan;Wang Yifeng;Min Aiping;Xie Shanli;Li Yi;Wang Ping;Wang Wei;Liu Yujuan;Wu Hai;Cai Chunhua;Qi Xiaoxue;Song Huayu;Jiang Jing(Center for Cancer Prevention and Research,Sichuan Cancer Hospital&Institute,Sichuan Cancer Center,School of Medicine,University of Electronic Science and Technology of China,Chengdu 610041,Sichuan,China;Gynecologic Oncology Center,Sichuan Cancer Hospital&Institute,Sichuan Cancer Center,School of Medicine,University of Electronic Science and Technology of China,Chengdu 610041,Sichuan,China;Department of Obstetrics and Gynecology,the First People's Hospital of Neijiang,Neijiang 641099,Sichuan,China;Department of Gynecology,Sichuan Provincial People's Hospital,Chengdu 610072,Sichuan,China;Department of Obstetrics and Gynecology,Panzhihua Central Hospital,Panzhi-hua 617067,Sichuan,China;Department of Obstetrics and Gynecology,the People's Hospital of Leshan,Leshan 614000,Sichuan,China;Department of Obstetrics and Gynecology,the First First People's Hospital of Guangyuan,Guangyuan 628040,Sichuan,China;Department of Obstetrics and Gynecology,Ya'an People 1 s Hospital,Ya'an 625099,Sichuan,China;Department of Gynecology,West China Second University Hospital,Sichuan University,Chengdu 610044,Sichuan,China;Department of Obstetrics and Gynecology,Chengdu Women’s and Children’s Central Hospital,Chengdu 610073,Sichuan,China;Department of Obstetrics and Gynecology,Affiliated Hospital of North Sichuan Medical College,Nanchong 637002,Sichuan,China;Department of Obstetrics and Gynecology,Leshan Maternal and Child Health Hospital,Leshan 614000,Sichuan,China;Department of Obstetrics and Gynecology,the Third People y s Hospital of Chengdu,Chengdu 610014,Sichuan,China;Department of Obstetrics and Gynecology,Chengdu First People9 s Hospital,Chengdu 610095,Sichuan,China;Department of Obstetrics and Gynecology,Affiliated Hospital of Panzhihua University,Panzhihua 617099,Sichuan,China;Department of Obstetrics and Gynecology,Second PeopleJ s Hospital of Yib-in,Yibin 6

机构地区：[1]四川肿瘤医院·研究所,四川省癌症防治中心,电子科技大学医学院肿瘤预防研究中心,成都610041 [2]四川肿瘤医院·研究所,四川省癌症防治中心,电子科技大学医学院妇科肿瘤中心,成都610041 [3]内江市第一人民医院妇产科,四川内江641099 [4]四川省人民医院妇科,成都610072 [5]攀枝花市中心医院妇产科,四川攀枝花617067 [6]乐山市人民医院妇产科,四川乐山614000 [7]广元市第一人民医院妇产科,四川广元628040 [8]雅安市人民医院妇产科,四川雅安625099 [9]四川大学华西第二医院妇科,成都610044 [10]成都妇女儿童中心医院妇产科,成都610073 [11]川北医学院附属医院妇产科,四川南充637002 [12]乐山市妇幼保健院妇科,四川乐山614000 [13]成都市第三人民医院妇产科,成都610014 [14]成都市第一人民医院妇产科,成都610095 [15]攀枝花学院附属医院妇产科,四川攀枝花617099 [16]宜宾市第二人民医院妇产科,四川宜宾644002

出　　处：《肿瘤预防与治疗》2022年第2期147-153,共7页Journal of Cancer Control And Treatment

摘　　要：目的:在四川省妇科门诊女性中评估TruScreen检查作为子宫颈高级别病变早期诊断技术的准确性。方法:2019年6月至2021年1月,邀请在四川省16家医院妇科就诊拟进行子宫颈阴道镜检查的女性参与研究。纳入标准为近期发现细胞学异常或高危型人乳头瘤病毒(humanpa pillomavirus,HPV)阳性,或有可疑临床症状。研究对象在阴道镜检查前先行TruScreen检查,然后在阴道镜下行活检。组织学诊断为金标准评价TruScreen的准确性。结果:纳入1319名女性,其中41.8%的女性TruScreen检查阳性。纳入分析的女性中,组织学高级别鳞状上皮内病变(high-grade squamous intraepithelial lesion,HSIL)阳性的检出率为25.5%。TruScreen用于初筛的灵敏度、特异度、AUC分别为87.2%、70.5%和0.789(0.761,0.816)。TruScreen的灵敏度显著高于细胞学(87.2%vs73.9%,P<0.001)。45岁以上的女性中,HPV检测与TruScreen的灵敏度接近(85.7%vs81.9%,P=0.481)。高危型HPV阳性女性中,用TruScreen分流后阳性患者中的HSIL+检出率显著高于用细胞学分流后ASC-US+患者中的HSIL+检出率(55.4%vs38.4%,P<0.001)。分流TruScreen检测的灵敏度和特异度均显著高于细胞学(89.7%vs730%,67.7%vs47.8%,P<0.001)。结论:TruScreen检查是一种灵敏度和特异度较高的子宫颈高级别病变早期诊断技术。Objective: To evaluate the accuracy of early diagnosis of high-grade cervical lesions by the TruScreen device in gynecological outpatients in Sichuan Province. Methods: From June 2019 to January 2021, women ready for colposcopy in 16 gynecological clinics in Sichuan Province were invited to participate in the study. Those with cytological abnormalities, positive results in tests for high-risk human papillomavirus(HPV) types, or suspicious clinical symptoms were included in, and were then examined by TruScreen before colposcopy for biopsy. Histological diagnosis was used as the gold standard to evaluate the accuracy of TruScreen. Results: A total of 1,319 women were enrolled, 41.8% of which were HPV-positive by TruScreen. The positive rate of high-grade squamous intraepithelial lesion(HSIL) was 25.5% by histological diagnosis. The sensitivity, specificity and AUC of TruScreen for primary screening were 87.2%, 70.5% and 0.789(0.761-0.816), respectively. The sensitivity of TruScreen was significantly higher than that of cytology(87.2% vs 73.9%, P<0.001). For women over 45 years, the HPV test resembled TruScreen in sensitivity(85.7% vs 81.9%, P=0.481). Among high-risk HPV-positive women, the detection rate of HSIL+ in positive patients triaged by TruScreen was significantly higher than that in ASC-US+-positive patients triaged by cytology(55.4% vs 38.4%, P<0.001). The sensitivity and specificity of triage by TruScreen were significantly higher than those of triage by cytology(89.7% vs 73.0%, 67.7% vs 47.8%, P<0.001). Conclusion: TruScreen examination is an early diagnosis technique for high-grade cervical lesions with high sensitivity and specificity.

关 键 词：子宫颈癌 癌前病变 TruScreen 早期诊断 筛查 分流 准确性 

分 类 号：R737.33[医药卫生—肿瘤] R443[医药卫生—临床医学]