机构：[1]Peking Union Medical College Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China[2]National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China[3]Institute of Medical Information,Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China[4]Sichuan Cancer Hospital & Institute, Sichuan Cancer Centre, School of Medicine, University of Electronic Science & Technology of China, Chengdu, China四川省肿瘤医院[5]Dalian Medical University, Dalian, China[6]West China School of Public Health,Sichuan University, Chengdu, China[7]Hua Xi Women and Children’s Hospital,Sichuan University, Chengdu, China[8]Peking University People’s Hospital, Beijing, China[9]China Medical University, Shenyang, China[10]Sun Yat-sen University Cancer Center, Guangzhou, China[11]Qingdao Municipal Hospital, Qingdao, China[12]Tongren Hospital, Capital Medical Hospital, Beijing, China首都医科大学附属同仁医院[13]The Eighth Affiliated Hospital, Sun Yat-sen University, Shenzhen, China深圳医学信息中心中国医学科学院阜外医院深圳医院[14]Affiliated Tumor Hospital of Xinjiang Medical University, Urumqi, China[15]Nanjing Drum Tower Hospital, Nanjing University Medical School, Nanjing, China[16]Beijing Chaoyang Hospital, China Capital Medical University, Beijing, China北京朝阳医院[17]Cancer Hospital, Chongqing University, Chongqing, China[18]Women’s Hospital School of Medicine Zhejiang University, Hangzhou, China浙江大学医学院附属妇产科医院[19]Tumor Hospital of Guangxi Zhuang Autonomous Region, Guangxi, China[20]People’s Hospital of Xinjiang Uygur Autonomous Region, Urumqi, China[21]Hangzhou Women’s Hospital, Hangzhou, China[22]Hubei Cancer Hospital, Wuhan, China[23]The Second Xiangya Hospital of Central South University, Changsha, China[24]Department of Maternal and Child Health, National Health Commission of China, Beijing, China
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摘要：
Background As part of China’s 2009 health-care system reform, a national cervical cancer screening programme
was launched, offering free screening by cytology or visuaI inspection with acetic acid and LugoI’s iodine (VIA/VILI).
We evaluated high-risk HPV (hrHPV) testing as a new screening modality for the national programme.
Methods This multicentre, open-label randomised trial was undertaken at nine urban and 11 rural primary-care
centres in mainland China. Women aged 35–64 years without history of cervical cancer or hysterectomy, no clinical
symptoms of pregnancy, who could understand the study procedures, and voluntarily participated were included.
At baseline, women in urban areas were randomly assigned (1:2) to primary screening by cytology or hrHPV,
and women in rural areas were randomly assigned (1:1:1) to cytology, hrHPV, or VIA/VILI. Women with baseline
hrHPV positive tests were randomly assigned to triage strategies using cytology, VIA/VILI (rural sites), or directly
refer to colposcopy. At 24-months, women in urban regions were rescreened with cytology and hrHPV co-testing;
rural women received combined hrHPV, cytology, and VIA/VILI screening. Women who showed positive in cytology
or VIA/VILI were referred to exams for further colposcopy, and biopsy was then required for participants with
abnormal colposcopy results. The primary outcome was cervical intraepithelial neoplasia 2 or worse (CIN2+)
and cervical intraepithelial neoplasia 3 or worse (CIN3+). Data analyses were done in the intention-to-screen
population (ie, all women assigned to screening). This trial is registered with Chinese Clinical Trial Registry,
number ChiCTR1900022530.
Findings Between May 18, 2015, and Sept 30, 2016, 61 484 women were assessed as eligible and 60 732 were randomly
assigned to screening. Among women in urban regions, 8 955 were assigned to cytology and 18 176 to hrHPVgenotyping;
among women in rural regions, 11 136 were assigned to VIA/VILI, 7080 to cytology, and 15 385 to hrHPVtesting.
Compared with cytology and VIA/VILI-based primary screening, hrHPV without triaging had 2·0–2·7 times
higher baseline CIN2+ or CIN3+ detection (risk ratios: urban hrHPV vs cytology CIN2+ 2·2 [95% CI 1·5–3·1], p<0·0001,
CIN3+ 2·0 [1·2–3·3], p=0·0084; rural hrHPV vs cytology CIN2+ 2·6 [1·7–4·0], p<0·0001, CIN3+ 2·7 [1·5–4·6],
p<0·0001; rural hrHPV vs VIA/VILI CIN2+ 2·0 [1·5–2·8], p<0·0001, CIN3+ 2·3 [1·5–3·6], p=0·00012). At the 24-month
follow-up, hrHPV without triage had lower new CIN2+ or CIN3+ than cytology in urban sites (risk ratio: CIN2+ 0·5
[0·3–0·97], p=0·038; CIN3+ 0·2 [0·03–0·8], p=0·026), and lower baseline false negative results in rural sites (risk ratio:
cytology CIN2+ 0·3 [0·2–0·6], p=0·00019 and CIN3+ 0·3 [ 0·1–0·6] p=0·0025; VIA/VILI CIN2+ 0·3 [0·2–0·6],
p=0·00012 and CIN3+ 0·4 [0·2–0·8], p=0·013).
Interpretation HrHPV-testing offered better performance than current cytology and VIA/VILI-based primary
screening and could be incorporated into China’s national programme, but with the longer screening intervals
recommended by WHO.
第一作者机构：[1]Peking Union Medical College Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China
共同第一作者：
通讯作者：
通讯机构：[1]Peking Union Medical College Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China[*1]Department of Obstetrics and Gynecology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing 100730, China
推荐引用方式(GB/T 7714)：
Junji Zhang,Yuqian Zhao,Yi Dai,et al.Cervical cancer screening strategies for evidence-based health care reform in China: a multicentre, open-label randomised trial[J].LANCET.2019,394:20-20.
APA：
Junji Zhang,Yuqian Zhao,Yi Dai,Le Dang,Li Ma...&Jinghe Lang.(2019).Cervical cancer screening strategies for evidence-based health care reform in China: a multicentre, open-label randomised trial.LANCET,394,
MLA：
Junji Zhang,et al."Cervical cancer screening strategies for evidence-based health care reform in China: a multicentre, open-label randomised trial".LANCET 394.(2019):20-20
医学