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综述","","肿瘤标志物在早期筛查、辅助诊断、疗效评估与预后判断中的作用持续强化，已成为肿瘤精准诊疗体系的关键组成。文章系统梳理肿瘤标志物近两个世纪的演进脉络，从蛋白类标志物到基因组学时代，归纳我国规范化应用的核心原则与实验室现状，并提出肺癌、肝癌等重点癌种的临床应用建议。重点讨论液体活检支撑的ctDNA基因标志物、DNA甲基化、外泌体与循环肿瘤细胞等前沿进展及临床转化挑战，为创新发展与规范应用提供参考，支撑精准防控。",{"@graph":69,"@context":123},[70,84,106],{"@type":71,"itemListElement":72},"BreadcrumbList",[73,77,79,82],{"item":74,"name":75,"@type":76,"position":8},"https://docshare.wps.com","Home","ListItem",{"item":78,"name":9,"@type":76,"position":14},"https://docshare.wps.com/document/",{"item":80,"name":35,"@type":76,"position":81},"https://docshare.wps.com/document/healthcare/",3,{"item":83,"name":65,"@type":76,"position":19},"https://docshare.wps.com/document/current-status-and-development-of-tumor-biomarker-applications-in-china-review/363079/",{"url":83,"name":65,"@type":85,"image":86,"author":91,"headline":65,"publisher":94,"fileFormat":97,"inLanguage":63,"description":67,"dateModified":98,"datePublished":99,"encodingFormat":97,"isAccessibleForFree":100,"interactionStatistic":101},"DigitalDocument",{"url":87,"@type":88,"width":89,"height":90},"https://docshare.wps.com/thumbnails/current-status-and-development-of-tumor-biomarker-applications-in-china-review/363079.png","ImageObject",300,407,{"name":92,"@type":93},"Đào","Person",{"url":74,"name":95,"@type":96},"DocShare","Organization","application/pdf","2026-10-30","2026-09-23",true,{"@type":102,"interactionType":103,"userInteractionCount":105},"InteractionCounter",{"@type":104},"ViewAction",14,{"@type":107,"mainEntity":108},"FAQPage",[109,115,119],{"name":110,"@type":111,"acceptedAnswer":112},"肿瘤标志物在肿瘤精准诊疗中主要发挥哪些作用？","Question",{"text":113,"@type":114},"用于早期筛查、辅助诊断、疗效评估和预后判断，并在动态监测中反映治疗反应与复发进展。","Answer",{"name":116,"@type":111,"acceptedAnswer":117},"文章如何概括肿瘤标志物的发展历程及其阶段划分？",{"text":118,"@type":114},"以检测技术革新为主线，划分为初步探索、免疫检测、单基因检测和基因组学四个关键阶段。",{"name":120,"@type":111,"acceptedAnswer":121},"在我国临床实验室应用肿瘤标志物应遵循哪些总体原则？",{"text":122,"@type":114},"应坚持科学审慎：将其用于辅助诊断而非确诊；重视疗效监测与动态评估；采用联合检测互补优势；并强化检测前与检测中的质量控制。","https://schema.org",{"og:url":83,"og:type":125,"og:title":65,"og:site_name":95,"og:description":67},"article",{"robots":127,"canonical":83},"index,follow",{"doc_id":129,"site_id":62},363079,1790293366,{"code":4,"msg":5,"data":132},{"doc_id":129,"user_id":133,"nickname":92,"user_avatar":134,"doc_module":4,"category_id":34,"category_name":35,"doc_title":65,"doc_description":67,"doc_content":135,"file_id":136,"file_url":137,"file_type":138,"file_size":139,"view_count":105,"is_deleted":4,"is_public":8,"is_downloadable":8,"audit_status":8,"page_count":29,"language":140,"language_code":63,"site_id":62,"html_lang":141,"table_of_contents":142,"faqs":143,"seo_title":144,"seo_description":67,"update_tm":145,"read_time":146},1374402968488,"https://ap-avatar.wpscdn.com/davatar_29158cc5080c5b710cf443261637dec0","四 川 大 学 学 报（医学版） J Sichuan Univ ( Med Sci )  \n2026， 57（ 2） : 307 − 312 doi: 10. 12182/20260360301  \n• 实验医学前沿技术•  \n中国肿瘤标志物应用现状与发展*  \n王传新△  \n山东大学齐鲁医院检验医学中心（济南250063）  \n【摘要】 肿瘤标志物在早期筛查、 辅助诊断、疗效评估和预后判断中的作用日益凸显，已成为肿瘤精准诊疗体系的重要组成部分。本文系统回顾了肿瘤标志物近两个世纪的发展历程，从早期蛋白类标志物演进至基因组学时代；重点阐述了我国肿瘤标志物规范化应用的基本原则、实验室应用现状，以及在肺癌、肝癌等重点癌种中的临床应用建议；并深入剖析了以液体活检技术为支撑的ctDNA基因标志物、 DNA甲基化、外泌体及循环肿瘤细胞等多维度标志物研究，以及人工智能模型构建等前沿领域的研究进展及临床转化挑战，以期为我国肿瘤标志物的创新发展与规范应用提供参考，助力提升肿瘤精准防控水平。  \n【关键词】 肿瘤标志物 精准诊疗 临床应用 综述  \nThe Clinical Application and Development of Tumor Biomarkers in China  \nWANG Chuanxin △ . Department of Clinical Laboratory, Qilu Hospital of Shandong University, Jinan 250063, China  \n△ Corresponding author, [E-mail: wcx6601@126.com](E-mail: wcx6601@126.com)  \nThis work was supported by the National Natural Science Foundation of China (No.82327802) .  \n[Abstract] Tumor biomarkers play an increasingly prominent role in early screening, auxiliary diagnosis, efficacy evaluation, and prognosis assessment, becoming an essential component of the precision oncology system. This article systematically reviews the nearly two-century development history of tumor markers, from early protein-based markers to the genomics era. It focuses on the fundamental principles of standardized application of tumor markers in China, the current laboratory application status, and clinical application recommendations for key cancer types such as lung cancer and liver cancer. Additionally, it delves into multidimensional marker research supported by liquid biopsy technologies, including ctDNA genetic markers, DNA methylation, exosomes, and circulating tumor cells, as well as cutting-edge advancements and clinical translation challenges in areas such as artificial intelligence model construction. This review aims to provide insights for the innovative development and standardized application of tumor markers in China, thereby enhancing the precision of cancer prevention and control.  \n[Key words] Tumor biomarkers Precision diagnosis and treatment Clinical application Review  \n恶性肿瘤是严重危害人类健康的重大公共卫生问题，给全球带来沉重的疾病负担。近年来，受人口老龄化、生活方式变化等多重因素影响，我国恶性肿瘤发病率持续上升，癌谱构成日趋复杂，整体防控形势十分严峻。最新数据显示， 2022年中国新发恶性肿瘤病例约482万，死亡病例约257万，发病与死亡人数均位居全球首位，对社会经济发展和医疗卫生系统构成严峻挑战[1]。在此背景下，加强恶性肿瘤的早期发现与精准治疗，已成为提高患者五年生存率、减轻全社会医疗负担的关键路径，也是落实“健康中国”国家战略的核心任务之一。  \n肿瘤标志物是指在恶性肿瘤的发生和增殖过程中，由肿瘤细胞本身产生，或由机体对肿瘤细胞反应而异常  \n* 国家自然科学基金（No. 82327802）资助  \n△通信作者，[E-mail](E-mail：wcx6601@126.com)[：](E-mail：wcx6601@126.com)[wcx6601@126.com](E-mail：wcx6601@126.com)  \n出版日期：2026-03-20  \n产生和（或）升高的，能够反映肿瘤存在和生长的一类物质，这些物质可存在于患者的血液、体液、细胞或组织中[2]。随着医学科技的快速发展，肿瘤标志物已成为肿瘤精准诊疗体系的重要组成部分，是恶性肿瘤早期筛查、辅助诊断、 疗效评估、 复发监测和预后判断的重要工具。其发展经历了从蛋白质到基因、从单一指标到多组学整合的深刻演变。在精准医学理念的推动下，肿瘤标志物的临床应用不断深化，正推动肿瘤诊疗模式从传统的组织病理学，迈向基于分子分型与液体活检的精准新范式。  \n1 肿瘤标志物发展历程  \n肿瘤标志物发展至今已有近180年的历史，其发展与检测技术的革新密不可分。自1846年本周蛋白首次被发现以来，该领域经历了长达百年的缓慢发展，直至20世纪中后期免疫学技术，尤其是单克隆抗体技术的突破，推动  \n了一系列蛋白类标志物在临床中规模化应用。进入20世纪80年代，分子生物学的兴起将肿瘤标志物的研究推进至基因层面。人类基因组计划完成后，高通量测序、 基因/蛋白芯片、液体活检等新技术不断涌现，极大地拓展了肿瘤标志物的范畴，循环肿瘤细胞、 循环肿瘤DNA （circulating tumor DNA, ctDNA）及外泌体等新型标志物不断涌现，展现出较传统指标更优的早期预警与动态监测能力[3]。纵观其演进历程，可划分为以下四个关键阶段。  \n1.1 初步探索阶段（ 1846–1962年）  \n1846年，Henry Bence-Jones在多发性骨髓瘤患者的尿液与血清中首次发现了本周蛋白[4]，开创了肿瘤标志物研究先河。 1927年， Zondek揭示了绒毛膜促性腺激素与妇科肿瘤有关；次年， Brown等报道了促肾上腺皮质激素与肺癌异位内分泌综合征相关。至1959年， Markert研究证实某些酶及其同工酶谱的异常变化与多种恶性肿瘤密切相关。该阶段的研究确立了体液中蛋白质、激素或酶活性改变与肿瘤状态之间的关联，为后续研究奠定了重要基础。  \n1.2 免疫检测时代（ 1963–1979年）  \n20世纪60至70年代，免疫学技术推动了肿瘤标志物的快速发展[ 5 ]。 1963年， Abelev发现甲胎蛋白（ alphafetoprotein, AFP）与原发性肝癌的相关性； 1965年，Freedman 和Gold在结直肠癌组织中发现癌胚抗原（carcinoembryonic antigen, CEA），推动了肿瘤相关抗原研究的深入。 1975 年， Köhler和Milstein建立了单克隆抗体技术并荣获诺贝尔奖，为肿瘤标志物的高特异性检测提供了革命性工具，促进了糖类抗原（carbohydrate antigen, CA）如糖类抗原 19-9（ CA19-9）、 糖类抗原125（ CA125 ）、 糖类抗原15- 3（ CA15-3）、 糖类抗原（ CA242 ）、 糖类抗原724（CA72-4）等的发现与应用。在此阶段，“肿瘤标志物”这一概念于 1978年由Herberman首次提出，并于次年获得国际学术界的正式确认，标志着该领域进入系统化发展的新阶段。  \n1.3 单基因检测时代（ 1980–2004年）  \n1980年，Sanger和Gilbert因发明DNA测序技术获诺贝尔奖，为从基因层面解析肿瘤奠定了基础。此后，一系列癌基因与抑癌基因相继被发现，如1982年，首个人类致癌基因RAS被确认[6]； 1986年，第一个抑癌基因Rb-1成功克隆；至今先后分离了100多种癌基因和30余种抑癌基因。随着分子生物学技术的兴起，以及在人类基因组计划的推动下，肿瘤标志物研究进入","cbCaicOybmIZeTQ8","https://ap.wps.com/l/cbCaicOybmIZeTQ8","pdf",1358360,"Chinese","en","# 肿瘤标志物发展历程\n## 初步探索阶段（1846–1962年）\n## 免疫检测时代（1963–1979年）\n## 单基因检测时代（1980–2004年）\n## 基因组学时代（2005年–至今）\n# 中国临床实验室的应用现状\n## 肿瘤标志物临床应用的总体原则\n### 辅助诊断，而非确诊依据\n### 疗效监测与动态评估\n### 联合检测，优势互补\n### 重视检测前与检测中的质量控制\n## 肿瘤标志物检测的开展状况\n## 常见癌种肿瘤标志物的应用","[{\"question\":\"肿瘤标志物在肿瘤精准诊疗中主要发挥哪些作用？\",\"answer\":\"用于早期筛查、辅助诊断、疗效评估和预后判断，并在动态监测中反映治疗反应与复发进展。\"},{\"question\":\"文章如何概括肿瘤标志物的发展历程及其阶段划分？\",\"answer\":\"以检测技术革新为主线，划分为初步探索、免疫检测、单基因检测和基因组学四个关键阶段。\"},{\"question\":\"在我国临床实验室应用肿瘤标志物应遵循哪些总体原则？\",\"answer\":\"应坚持科学审慎：将其用于辅助诊断而非确诊；重视疗效监测与动态评估；采用联合检测互补优势；并强化检测前与检测中的质量控制。\"}]","中国肿瘤标志物应用现状与发展 - 综述 | PDF",1790149926,15]