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早期肺癌诊断中国专家共识（2023年版）
中华医学会呼吸病学分会 
作者及单位信息
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DOI： 10.3760/cma.j.cn112147-20220712-00592
Chinese expert consensus on diagnosis of early lung cancer (2023 Edition)
Chinese Thoracic Society
Chen Liang′an
Authors Info & Affiliations
Chinese Thoracic Society
Chen Liang′an
College of Pulmonary & Critical Care Medicine, Chinese PLA General Hospital, Beijng 100039, China
·
DOI： 10.3760/cma.j.cn112147-20220712-00592
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摘要
肺癌在我国居恶性肿瘤发病与死亡之首，严重危害到人民生命健康。近年来肺癌治疗取得了较大的进展，我国肺癌的5年生存率也从16.1%提高到19.7%，但仍有约75%的患者在诊断时处于肺癌晚期，错过了最佳根治性手术治疗时机。早期诊断可显著提高肺癌患者预后生存，从肺癌患者术后5年生存率可以看出，Ⅰ期患者术后5年生存率在77%~92%，而ⅢA~ⅣA期患者仅为10%~36%，5年生存率存在显著差异。研究显示早期诊断并完全切除的肺原位腺癌（AIS）及微浸润腺癌（MIA）术后5年疾病特异性生存率分别为100%和100%。早期诊断是提高肺癌预后的关键，为进一步提高我国早期肺癌诊断水平，尤其是肺结节暨早期肺癌诊断、评估中的准确性、规范性，中华医学会呼吸病学分会肺癌学组的专家针对国内肺癌早诊领域实际情况，参考国内外最新研究数据和相关指南，制定了《早期肺癌诊断中国专家共识（2023年版）》，共识围绕早期肺癌筛查人群、无创检查、有创检查、人工智能与大数据及机器人技术、物联网及多学科合作等在早期肺癌诊断中的应用、疑诊早期肺癌的肺结节管理及随访策略等7个方面分别给出推荐意见，为临床医生在早期肺癌诊断方面提供参考，以进一步推动我国早期肺癌诊断工作。
ABSTRACT
Lung cancer is the leading cause of the incidence and mortality of malignant tumors in our country, seriously endangering people′s lives and health. The treatment of lung cancer has made great progress in the past 10 years, and the 5-year survival rate of lung cancer in China has also increased from 16.1% to 19.7%, but about 75% of patients are still in advanced stages of lung cancer at the time of diagnosis, missing the best time for radical surgery. Early diagnosis can significantly improve the prognosis and survival of lung cancer patients. From the 5-year survival rate of lung cancer patients, it can be seen that the 5-year survival rate of stage Ⅰ patients was 77%-92%, while that of stage ⅢA-ⅣA patients was only 10%-36%, and there was a significant difference in the 5-year survival rate. Studies have shown that early-diagnosed and completely resected lung adenocarcinoma in situ (AIS) and minimally invasive adenocarcinoma (MIA) have 5-year disease-specific survival rates of 100% and 100%, respectively. Early diagnosis is the key to improving the prognosis of lung cancer. In order to further improve the level of early lung cancer diagnosis in China, especially the standardization in the diagnosis and evaluation of pulmonary nodules and early lung cancer, experts from the Lung Cancer Group of Chinese Thoracic Society formulated the " Chinese Expert Consensus on Diagnosis of Early Lung Cancer (2023 Edition)", on the basis of the actual situation in the field of diagnosis and treatment, with reference to the latest research data and relevant guidelines at home and abroad. Consensus on the application of artificial intelligence, big data and robotics, the Internet of Things and multidisciplinary cooperation in the diagnosis of early lung cancer, the management of pulmonary nodules and follow-up strategies for suspected early lung cancer, etc., were respectively recommended to provide references for clinicians in the diagnosis of early lung cancer, in order to further promote the early diagnosis of lung cancer in China.
Chen Liang′an, College of Pulmonary & Critical Care Medicine, Chinese PLA General Hospital, Beijng 100039, China, Email:
tendef.3ab62103nehcnagnail
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引用本文
中华医学会呼吸病学分会. 早期肺癌诊断中国专家共识（2023年版）[J]. 中华结核和呼吸杂志,2023,46(01)：1-18.
DOI:10.3760/cma.j.cn112147-20220712-00592PERMISSIONS
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在世界范围内，肺癌是发病率与病死率最高的恶性肿瘤
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1
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2
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。我国情况相似，最新癌症数据显示，2020年我国新发肺癌约82万例，死亡71万例，新发及死亡人数均居恶性肿瘤之首
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1
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。面对吸烟、空气污染、人口老龄化加剧等严峻形势，我国肺癌发病率和病死率呈上升趋势
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3
,
4
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。
近年来，肺癌治疗取得了较大进展，我国肺癌的5年生存率也从16.1%（2003—2005）提高到19.7%（2012—2015）
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6
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，但仍有约75%的患者在诊断时已处于肺癌晚期，错过了最佳根治性治疗时机
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7
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。因此早筛早诊尤为重要，早期肺癌，一般认为若发生于段支气管以上的大支气管者，即中央型早期肺癌，其癌组织仅局限于管壁内生长，包括腔内型和管壁浸润型，后者不突破外膜，未侵及肺实质，且无局部淋巴结转移。发生于小支气管者，又称周围型早期肺癌，在肺组织内呈结节状，直径<2 cm，无局部淋巴结转移
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8
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。我国开展的社区肺癌高危人群低剂量胸部CT（LDCT）筛查结果显示，肺结节阳性率高达22.9%（804/3 512），其中恶性结节患者比例达6.34%（51/804），肺癌检出率为1.5%（51/3 512）
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。研究显示早期诊断并且完全切除的原位腺癌（adenocarcinoma in situ，AIS）和微浸润腺癌（minimally invasive adenocarcinoma，MIA），10年疾病特异性生存率分别为100%和100%，总生存率分别为95.3%和97.8%
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，而Ⅰ期浸润性腺癌完全切除后的5年复发率高达10%~30%
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。综上，提高肺癌生存率的关键在于早期发现、早期诊断和早期治疗，而早期诊断又是重中之重。为了更好地指导我国肺癌的早期诊断工作，中华医学会呼吸病学分会肺癌学组的专家针对国内肺癌早诊领域实际情况，参考国内外最新研究数据和有关指南，制定了《早期肺癌诊断中国专家共识（2023年版）》，以供临床参考。
共识形成方法：（1）本共识由中华医学会呼吸病学分会肺癌学组专家委员会发起，启动时间为2021年7月，审稿时间为2022年6—9月，定稿时间为2022年10月。本共识已在国际实践指南注册平台（
http：//www.guidelines-registry.cn）进行注册（注册号：PREPARE-2022CN41），并完成共识撰写计划书，读者可联系共识发起组织或通过国际实践指南注册平台获取计划书。（2）共识工作组：包括撰写组和审核组，撰写组包括呼吸与危重症医学科、胸腔外科为主的多学科专家，由本专业早期肺癌诊治经验丰富的专家组成核心撰写组；审核组包括呼吸与危重症医学科、胸腔外科、放射科、病理科等专家组成。（3）共识适用人群：该共识适用呼吸与危重症医学科医师、胸腔外科医师在肺结节暨早期肺癌诊断时使用；目标人群为肺癌高危人群筛查发现的肺结节等疑诊早期肺癌患者。（4）证据检索：根据筛选出的临床问题，检索PubMed、MEDLINE、Cochrane Library、中国生物医学文献服务系统、万方数据库和中国知网数据库，检索时间为建库至2021年6月30日。主要纳入了Meta分析、随机对照研究、队列研究、大型回顾性研究、病例对照研究等，因本共识不是基于系统评价的循证指南，故不进行证据质量分级。（5）推荐意见形成过程：首先由共识专家组成员对收集的临床问题进行充分筛选，通过在线问卷与电子邮件沟通等方式最终筛选出7个方面的问题；随后在对证据进行充分评价的基础上，充分采纳专家组意见，形成共识推荐意见和推荐等级。参考了推荐分级的评估、制定与评价（GRADE）方法
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14
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，推荐等级根据专家投票分为强推荐、弱推荐和无共识3个级别：“非常同意”的票数超过2/3为强推荐；“部分同意”+“非常同意”的票数超过2/3为弱推荐；否则不达成共识。GRADE推荐强度分级系统见
表1
。经过专家组两轮在线问卷、电子邮件沟通及线上会议讨论，最终确定共识定稿。所有参与共识制定的专家组成员不存在与本指南撰写内容相关的利益冲突。
| 项目 | 内容 |
|---|---|
| 推荐强度 | |
|
强 |
明确显示干预措施利大于弊或弊大于利 |
|
弱 |
利弊不明确或无论质量高低的证据均显示利弊相当 |
展开表格
GRADE推荐强度分级系统
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备注信息
A
通信作者：陈良安，解放军总医院呼吸与危重症医学部，北京 100039，Email：
tendef.3ab62103nehcnagnail
B
所有作者声明无利益冲突
C
中华医学会呼吸病学分会. 早期肺癌诊断中国专家共识（2023年版）[J]. 中华结核和呼吸杂志, 2023, 46(1): 1-18. DOI: 10.3760/cma.j.cn112147-20220712-00592.
D
首都卫生发展科研专项 (2020-1-5011)
陕西省重点研发计划 (2017ZDXM-SF-044)
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