TruScreen检查用于子宫颈癌及癌前病变早期诊断的临床价值——以医院为基础的多中心研究  

Clinical value of TruScreen in early diagnosis of cervical cancer and precancerous lesions:a hospital-based multicenter study

作　　者：陈飞[1] 赵宇倩 李婷媛 陈汶 刘军[4] 王建东[5] 郭红燕[6] 张瑜[7] 郎景和[1] CHEN Fei;ZHAO Yu-qian;LI Ting-yuan;CHEN Wen;LIU Jun;WANG Jian-dong;GUO Hong-yan;ZHANG Yu;LANG Jing-he(Department of Obstetrics and Gynecology,Peking Union Medical College Hospital,Chinese Academy of Medwal Sciences and Peking Union Medual College,Beijing 100730,China;不详)

机构地区：[1]中国医学科学院北京协和医院妇产科,北京100730 [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附属肿瘤医院肿瘤预防研究中心,四川成都610041 [3]中国医学科学院肿瘤医院/国家癌症中心/国家癌症临床研究中心流行病室,北京100021 [4]首都医科大学附属北京朝阳医院妇产科,北京100020 [5]首都医科大学附属北京妇产医院妇瘤科,北京100006 [6]北京大学第三医院妇产科,北京100191 [7]中南大学湘雅医院妇科,湖南长沙410008

出　　处：《中国实用妇科与产科杂志》2021年第3期348-352,共5页Chinese Journal of Practical Gynecology and Obstetrics

基　　金：中国医学科学院创新医学计划(CAMS-I2M,2017-I2M-1-002)。

摘　　要：目的评估TruScreen检查作为子宫颈高级别病变早期诊断技术的准确性。方法于2017年5月至2018年8月,邀请在5家课题合作医院妇科就诊拟进行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人乳头瘤病毒(HPV)检测为阳性,或有可疑临床症状。入选的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和(或)子宫颈管搔刮,以组织学诊断为金标准,比较TruScreen检查的准确性。结果共纳入974名女性,其中62.8%细胞学为意义未明的不典型鳞状细胞(ASC-US)及以上病变,91.8%高危HPV阳性,TruScreen阳性率为41.7%。共检出153例子宫颈上皮内瘤变(CIN)2、99例CIN3+。HPV阳性女性中,与细胞学未见上皮内病变或恶性肿瘤(NILM)相比,TruScreen阴性女性中的CIN2+和CIN3+的检出率显著较低(CIN2+:4.4%vs. 13.4%;CIN3+:1.0%vs. 4.0%,P<0.05)。HPV检测和TruScreen检查联合筛查CIN2+的灵敏度、特异度分别为99.6%和9.4%,筛查CIN3+的灵敏度和特异度分别为100%和7.9%。HPV阳性女性TruScreen分流检出CIN2+或CIN3+的灵敏度分别为89.3%或91.9%。结论 TruScreen检查是一种准确的子宫颈高级别病变早期诊断技术。ObjectiveTo evaluate the accuracy of TruScreen as a test in the early diagnosis of high-grade cervicallesions.MethodsFrom May 2017 to August 2018,the women who visited the gynecology clinics at 5 hospitals forcolposcopy examination were invited to take part in the study. The enrolled women had either positive screening resultsof cytology or HPV,or were suspected to have clinical symptoms. Tru Screen was performed before colposcopy. Biopsyand/or ECC was then performed. Histopathology diagnosis was the golden standard. The accuracy of Tru Screen wascompared.ResultsIn total,974 women were included for data analysis. About 62.8% of them were cytological ASC-US+,91.8% were high-risk HPV positive. TruScreen waspositive in 41.7% of them. Among the 974 women,153 women were diagnosed as CIN2,and 99 were diagnosedas CIN3 + lesions. The CIN2 + and CIN3 + yields weremuch lower for positive HPV with negative Tru Screen,compared with NILM cytology(CIN2+:4.4% vs.13.4%;CIN3 + :1.0% vs.4.0%,P<0.05). The sensitivity andspecificity for HPV combined with Tru Screen testing forCIN2 + was 99.6% and 9.4%;for CIN3 + they were100.0% and 7.9%,respectively. The sensitivity ofTru Screen triage test for HPV positive women indetecting CIN2 + or CIN3 + was 89.3% or 91.9%.ConclusionThe Tru Screen is an accurate test for earlydiagnosis of high-grade cervical lesions.

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：R711.74[医药卫生—妇产科学]