指南与规范
ENGLISH ABSTRACT
中国女性乳腺癌筛查与早诊早治指南(2021,北京)
赫捷
陈万青
李霓
沈洪兵
李江
王勇
李静
田金徽
周宝森
中国女性乳腺癌筛查与早诊早治指南制定顾问组
中国女性乳腺癌筛查与早诊早治指南制定专家组
中国女性乳腺癌筛查与早诊早治指南制定工作组
作者及单位信息
·
DOI: 10.3760/cma.j.cn112152-20210119-00061
China guideline for the screening and early detection of female breast cancer(2021, Beijing)
He Jie
Chen Wanqing
Li Ni
Shen Hongbing
Li Jiang
Wang Yong
Li Jing
Tian Jinhui
Zhou Baosen
Consulting Group of China Guideline for the Screening and Early Diagnosis and Treatment of Female Breast Cancer
Expert Group of China Guideline for the Screening and Early Diagnosis and Treatment of Female Breast Cancer
Working Group of China Guideline for the Screening and Early Diagnosis and Treatment of Female Breast Cancer
Authors Info & Affiliations
He Jie
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China
Chen Wanqing
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China
Li Ni
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China
Shen Hongbing
School of Public Health, Collaborative Innovation Center for Cancer Personalized Medicine, Nanjing Medical University, Nanjing 211166, China
Li Jiang
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China
Wang Yong
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China
Li Jing
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China
Tian Jinhui
Evidence Based Medicine Center of Lanzhou University, Lanzhou 730000, China
Zhou Baosen
School of Public Health, China Medical University, Shenyang 110122, China
Consulting Group of China Guideline for the Screening and Early Diagnosis and Treatment of Female Breast Cancer
Expert Group of China Guideline for the Screening and Early Diagnosis and Treatment of Female Breast Cancer
Working Group of China Guideline for the Screening and Early Diagnosis and Treatment of Female Breast Cancer
·
DOI: 10.3760/cma.j.cn112152-20210119-00061
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摘要

乳腺癌是中国女性最常见的恶性肿瘤,发病率位居中国女性恶性肿瘤首位。国家癌症中心受国家卫生健康委员会疾病预防控制局委托,根据《世界卫生组织指南制定手册》制定女性乳腺癌筛查与早诊早治指南。制作系统评价流程参考Cochrane协作网的方法,证据质量与推荐强度的分级采用推荐意见分级的评估、制定及评价方法,并根据国际实践指南报告规范条目进行报告。在系统评价结果的基础上,结合中国国情,综合考虑了证据的利弊、证据的质量、筛查经济成本、多学科临床调查对象的反馈和面对面的专家共识意见,针对乳腺癌筛查与早诊早治中适宜人群、技术流程等进行循证推荐,旨在规范女性乳腺癌筛查与早诊早治实践,提升中国女性乳腺癌防控效果。

乳腺肿瘤;女性;筛查;早诊早治;指南;中国
ABSTRACT

Breast cancer is the commonest malignant tumor among Chinese females, ranking first in terms of incidence of female cancers. Commissioned by the Disease Prevention and Control Bureau of National Health Commission of the People′s Republic of China, the National Cancer Center formulated the Guideline for Screening and Early Diagnosis and Treatment of Female Breast Cancer in China according to WHO Handbook for Guideline Development. The methods on Cochrane China were referred to for the formulation of the system evaluation procedures. The GRADE methods for assessment, formulation and evaluation were adopted for the classification of evidence quality and recommendation strength, and the items were reported according to Reporting Items for Practice Guidelines in Healthcare. Based on the results of evaluation, the guideline gives evidence-based recommendations for the appropriate population and technical procedures for breast cancer screening and early diagnosis and treatment after comprehensive consideration of China′s national conditions, the advantages and disadvantages of the evidence, the quality of the evidence, the economic cost of screening, the feedback of multidisciplinary clinical research respondents, and in-person expert consensus. It is aimed at regulating the practices of female breast cancer screening and early diagnosis and treatment and enhancing the effectiveness of the prevention and control of female breast cancer in China.

Breast neoplasms;Female;Screening;Early diagnosis and treatment;Guideline;China
He Jie, Department of Thoracic Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China, Email: nc.defcaab.smaciceijeh
引用本文

赫捷,陈万青,李霓,等. 中国女性乳腺癌筛查与早诊早治指南(2021,北京)[J]. 中华肿瘤杂志,2021,43(04):357-382.

DOI:10.3760/cma.j.cn112152-20210119-00061

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一、引言
乳腺癌是女性常见的恶性肿瘤,其发病率和死亡率分别位列我国女性恶性肿瘤的第1位和第4位。2015年我国女性乳腺癌新发病例约30.4万例,占女性全部恶性肿瘤发病的17.1%;死亡病例约7.0万例,占女性全部恶性肿瘤死亡的8.2% [ 1 , 2 ]。近年来,随着我国人口老龄化的加速,工业化、城市化以及生活方式的改变,女性乳腺癌疾病负担日益加重 [ 3 , 4 ]。提高早期乳腺癌的检出率并进行及时有效的治疗是降低乳腺癌死亡率的有效措施。多个国家(如美国、德国、日本和澳大利亚等)已陆续开展人群乳腺癌筛查。我国现已开展包括乳腺癌筛查在内的多个国家重大公共卫生服务项目,如城市癌症早诊早治项目、全国农村妇女"两癌筛查"项目等,均取得了较好的社会效益 [ 5 , 6 ]
美国医师协会、美国预防服务工作组(U.S. Preventive Services Task Force, USPSTF)、美国国立综合癌症网络(National Comprehensive Cancer Network, NCCN)、加拿大预防保健工作组等多个在世界上有影响力的学术组织和机构分别制定了各自的乳腺癌筛查指南 [ 7 , 8 , 9 , 10 ],中国抗癌协会在2019年发布了《中国女性乳腺癌筛查指南》和《乳腺癌诊治指南与规范(2019年版)》 [ 11 , 12 ]。作为当前医疗实践中最常用的指导性文件,指南的发布与更新对提高应用决策的科学性和规范性发挥着重要的推动作用。高质量的指南是降低医疗成本和经济负担、改善医疗资源分布不均的有效工具,是规范医疗行为和提高医疗服务整体水平的重要手段 [ 13 , 14 , 15 ]。为实现对潜在乳腺癌患者的早发现、早诊断、早治疗,提高筛查的科学性、可行性和适用性,制定符合我国国情的乳腺癌筛查与早诊早治指南是十分重要和必要的。
鉴于此,受国家卫生健康委员会疾病预防控制局的委托和指导,国家癌症中心按照循证实践指南制定的方法和步骤 [ 16 ],基于最新的研究证据,结合我国乳腺癌筛查实际情况,制定了《中国女性乳腺癌筛查与早诊早治指南(2021,北京)》(以下简称本指南)。
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附录
附件A
A.1 中文检索策略
中文检索策略
A.2 英文检索策略
英文检索策略
A.3 文献筛选流程图
文献筛选流程图
附录B
乳腺癌风险评估问卷

以下为乳腺癌风险评估可参考内容。

姓名:__________

出生日期:_______年______月_______日(请填写阳历生日)

籍贯:________省______市_______县(区)

民族:1.汉族 2.蒙古族 3.回族 4.满族 5.壮族 6.维吾尔族 7.哈萨克族 8.其他,请注明________

身份证号:_______________________________

本人联系电话:___________________(手机);_______________________(座机)

联系人1电话:____________________(手机);联系人2电话:____________________(手机)

常住地址:_______________________________ ;工作单位:_______________________________

1.生理和生育情况
1.1您的首次月经年龄是(周岁)?
1.2您是否已绝闭经? 0.否 1.是
1.2.1若是,停经年龄(周岁)
1.3您是否使用激素替代治疗?0.否 1.是,仅雌激素(如更宝芬、补佳乐、协坤、维尼安、更乐、倍美力、得美素、欧适可、松奇、康美华、尼尔雌醇等) 2.是,雌孕激素联合(如诺康律、诺更宁、克龄蒙、倍美安、倍美盈等)
1.3.1若是,使用月数
1.4您是否有活产史? 0.否(未生育、流产、死胎均包括) 1.是
1.4.1若是,初次活产年龄(周岁)
1.5您是否有哺乳史? 0.否 1.是
1.5.1若是,累计哺乳月数(不足1个月按1个月计)
2.乳腺相关疾病史
2.1您是否曾有乳腺活检史或乳腺良性疾病手术史? 0.否 1.是
2.1.1若是,请注明次数
2.2您是否曾进行过BRCA基因检测,结果显示携带有BRCA1/2基因致病性遗传突变 0.否 1.是
2.3您是否曾进行过乳腺X线检查,显示为乳腺实质(或乳房密度)类型为不均匀致密型或致密型 0.否 1.是
3.乳腺癌家族史
3.1您是否有一级亲属(母亲、姐妹及女儿)曾患乳腺癌? 0.否 1.是
3.2您是否有一级亲属(母亲、姐妹及女儿)曾患卵巢癌?  0.否 1.是
3.3您是否有二级亲属(祖母、外祖母及姑姨)50岁前曾患乳腺癌? 0.否 1.是
3.3.1若是,请注明人数
3.4您是否有二级亲属(祖母、外祖母及姑姨)50岁前曾患卵巢癌? 0.否 1.是
3.4.1若是,请注明人数
填写人签字:______________________________填写日期:______________________________
展开表格
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备注信息
A
赫捷,国家癌症中心 国家肿瘤临床医学研究中心 中国医学科学院北京协和医学院肿瘤医院胸外科 100021,Email: nc.defcaab.smaciceijeh
B
指南制定工作组感谢以下专家在本指南制定过程中提出的宝贵建议(按姓氏汉语拼音字母排序) 曹骥、曹素梅、董栋、董华、樊永祥、龚继勇、何美、黄立敏、黄焰、姜晶、姜文珍、雷林、李博、罗鹏飞、马洁、彭绩、史纪元、宋述名、孙喜斌、魏葆珺、魏东华、魏清风、王飞、王慜杰、王宁、王亚希、席云峰、许永杰、严俊、杨莉、于连政、张敏、张永贞、周金意、朱陈
C
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