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摘要: 中国人群的肝癌存在生存率低、死亡率高的情况，如何有效降低肝癌相关负担仍是中国公共卫生和慢性病防控领域亟待解决的重大问题，而肝癌人群筛查策略优化是值得持续探索的重要抓手和方向。中国人群肝癌筛查指南受国家卫生健康委员会疾病预防控制局委托，由国家癌症中心发起，联合多学科专家，根据世界卫生组织推荐的指南制定原则和方法，整合肝癌人群筛查领域的国内外研究新证据，兼顾中国国情及实践经验，针对肝癌筛查过程中的筛查人群、筛查技术、监测方案等呈现循证推荐，以期为中国人群肝癌筛查实践的规范提供参考。Abstract: In China, the survival rate of liver cancer remains low while the mortality rate is high. Effectively reducing the burden of liver cancer is still a major challenge in the field of public health and chronic disease prevention in the Chinese population. Optimizing screening strategies for liver cancer remains a profound approach to secondary prevention worthy of continuous exploration. To address this pressing issue, the Bureau of Disease Control and Prevention of the National Health Commission commissioned this guideline. The National Cancer Center of China initiated the guideline development and convened a multidisciplinary expert panel and working groups. Following the World Health Organization Handbook for Guideline Development, this guideline integrated the most up-to-date evidence of liver cancer screening, China's national conditions, and existing practical experience in liver cancer screening. Evidence-based recommendations on the target population, screening technologies, surveillance strategies, and other key points across the process of liver cancer screening and surveillance management were provided. This guideline would help standardize the practice of liver cancer screening in China.
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Key words:
- Liver Neoplasms /
- Screening /
- Surveillance /
- Guideline /
- China
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表 1 GRADE证据质量与推荐强度分级
Table 1. Quality of evidence and strength of recommendation in Grading of Recommendations Assessment, Development and Evaluation
项目 内容 证据质量分级 高(A) 非常有把握：观察值接近真实值 中(B) 对观察值有中等把握：观察值有可能接近真实值，但亦有可能差别很大 低(C) 对观察值的把握有限：观察值可能与真实值有较大差别 极低(D) 对观察值几乎无把握：观察值与真实值可能有极大差别 推荐强度分级 强(1) 明确显示干预措施利大于弊或弊大于利 弱(2) 利弊不确定或无论质量高低的证据均显示利弊相当 
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表 2 TNM肝癌临床分期
Table 2. Tumor-node-metastasis (TNM) classification for staging of liver cancer
分期 T分期 N分期 M分期 ⅠA T1a N0 M0 ⅠB T1b N0 M0 Ⅱ T2 N0 M0 ⅢA T3 N0 M0 ⅢB T4 N0 M0 ⅣA 任何T N1 M0 ⅣB 任何T 任何N M1
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表 3 中国肝癌分期
Table 3. China liver cancer staging (CNLC) system
分期 患者体力活动状态(分) 肝功能Child- Pugh分级(级) 肿瘤情况 有无影像学可见血管癌栓和肝外转移 Ⅰa 0~2 A/B 单个，≤5 cm 无 Ⅰb 0~2 A/B 单个，＞5 cm；或2~3个，最大肿瘤长径≤3 cm 无 Ⅱa 0~2 A/B 2~3个，最大肿瘤长径＞3 cm 无 Ⅱb 0~2 A/B ≥4个，长径不论 无 Ⅲa 0~2 A/B 肿瘤情况不论 有影像学可见血管癌栓、无肝外转移 Ⅲb 0~2 A/B 肿瘤情况不论 有无影像学可见血管癌栓不论、有肝外转移 Ⅳ 3~4 C 肿瘤情况不论 有无影像学可见血管癌栓不论、有无肝外转移不论
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表 4 巴塞罗那肝癌临床分期
Table 4. Barcelona clinic liver cancer staging system
分期 体力状态评分(分) 肿瘤状态 相关肝脏特征 治疗方式 肿瘤数量 肿瘤长径 血管侵犯和淋巴结及远处转移情况 极早期(0期) 0 单个病灶 ≤2 cm 无转移 胆红素正常，无门脉高压 肝切除，肝消融术，肝移植 早期(A期) 0 单个病灶 ＞2 cm 无大血管侵犯 Child-Pugh A级 肝切除，肝消融术，肝移植 ≤3个病灶 每个肿瘤长径≤3 cm 中期(B期) 0 多发 - 无血管侵犯和肝外扩散 Child-Pugh A级 肝移植，TACE，系统治疗 晚期(C期) 1~2 - - 血管侵犯或肝外扩散 Child-Pugh A-B级 系统治疗 终末期(D期) 3~4 任何肿瘤数量 - - Child-Pugh C级 最佳支持治疗 注：TACE，经导管动脉化学治疗栓塞术；-为无数据。
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表 5 全球筛查指南或共识对肝癌高风险人群的定义
Table 5. Summary of definitions of high-risk populations for liver cancer from global screening guidelines or consensus statements
题目 制定单位或团体 高风险人群定义 《中国肝癌早筛策略专家共识》[14] 全国多中心前瞻性肝癌极早期预警筛查项目(PreCar)专家组 (1)慢性肝病或肝癌家族史者；(2)40~75岁男性风险更大 《原发性肝癌二级预防共识(2021年版)》[13] 中华医学会肝病学分会 (1)各种原因导致的肝硬化；(2)年龄≥30岁的慢性乙型肝炎患者，有肝癌家族史或长期酗酒、吸烟、明确接触致癌毒物史、合并糖尿病或肥胖 《原发性肝癌的分层筛查与监测指南(2020版)》[12] 中华预防医学会肝胆胰疾病预防与控制专业委员会，中国研究型医院学会肝病专业委员会，中华医学会肝病学分会，等 肝硬化及未抗病毒治疗或未获得SVR的慢性HBV或HCV感染者a 《中国临床肿瘤学会(CSCO)原发性肝癌诊疗指南2020》[111] 中国临床肿瘤学会指南工作委员会 (1)乙型肝炎和(或)丙型肝炎；(2)长期酗酒、非酒精性脂肪性肝炎、长期食用被黄曲霉毒素污染的食物、血吸虫病等各种原因引起的肝硬化；(3)肝癌家族史；(4)年龄＞40岁、男性 《原发性肝癌诊疗指南(2022年版)》[76] 中华人民共和国国家卫生健康委员会医政医管局 (1)乙型肝炎和(或)丙型肝炎；(2)过度饮酒；(3)非酒精性脂肪性肝炎；(4)长期食用被黄曲霉毒素污染的食物；(5)各种原因引起的肝硬化；(6)肝癌家族史；(7)年龄＞40岁、男性 Management consensus guideline for hepatocellular carcinoma: 2020 update on surveillance, diagnosis, and systemic treatment by the Taiwan Liver Cancer Association and the Gastroenterological Society of Taiwan[112] 中国台湾地区肝癌协会 慢性乙型肝炎或丙型肝炎引起的肝硬化 2019 Update of Indian national association for study of the liver consensus on prevention, diagnosis, and management of hepatocellular carcinoma in India: the Puri Ⅱ recommendations[104] 印度国家肝脏研究协会 (1)乙型肝炎或丙型肝炎引起的肝硬化；(2)列入肝移植名单的任何病因的Child-Pugh C级肝硬化 Management of hepatocellular carcinoma in Japan: JSH consensus statements and recommendations 2021 update[105] 日本肝病协会 (1)超高危人群：既有病毒性肝炎也有肝硬化；(2)高危人群：肝硬化、慢性乙型肝炎和丙型肝炎 2018 Korean Liver Cancer Association-National Cancer Center Korea Practice Guidelines for the Management of Hepatocellular Carcinoma[113] 韩国肝癌协会，韩国高阳市国立癌症中心 (1)任何病因的肝硬化；(2)慢性乙型肝炎或丙型肝炎感染伴随肝硬化或肝高级别纤维化 Asia-Pacific clinical practice guidelines on the management of hepatocellular carcinoma: a 2017 update[114] 亚太肝脏研究协会 (1)肝硬化肝炎患者；(2)慢性乙型肝炎患者 Latin American Association for the Study of the Liver (LAASL) clinical practice guidelines: management of hepatocellular carcinoma[115] 拉丁美洲肝脏研究协会 NA Brazilian society of hepatology updated recommendations for diagnosis and treatment of hepatocellular carcinoma[116] 巴西肝病学会 NA EASL clinical practice guidelines: management of hepatocellular carcinoma[106] 欧洲肝脏研究协会 (1)Child-Pugh A级和B级肝硬化；(2)Child-Pugh C级等待肝移植的肝硬化患者 Hepatocellular carcinoma: ESMO clinical practice guidelines for diagnosis, treatment and follow-up[117] 欧洲肿瘤内科学会 肝硬化 Guidelines for the diagnosis and treatment of hepatocellular carcinoma (HCC) in adults[107] 英国胃肠病学会 (1)男性；(2)年龄＞45岁；(3)肝硬化；(4)HBV、HCV感染 BASL guidelines for the surveillance, diagnosis and treatment of hepatocellular carcinoma[118] 比利时肝脏研究协会 (1)肝硬化；(2)丙型肝炎伴晚期肝纤维化 Clinical guideline SEOM: hepatocellular carcinoma[119] 西班牙肿瘤医学会 (1)Child-Pugh A级和B级肝硬化；(2)等待肝移植的肝硬化患者；(3)高危HBV慢性肝炎患者(较高病毒载量、病毒基因型为亚洲或非洲来源)、慢性丙型肝炎和肝纤维化患者 Hepatocellular carcinoma: Dutch guideline for surveillance, diagnosis and therapy[120] 荷兰鹿特丹伊拉斯姆斯大学医学院癌症研究所 NA Position paper of the Italian Association for the Study of the Liver (AISF): the multidisciplinary clinical approach to hepatocellul[121] 意大利肝脏研究协会 NA Argentinian clinical practice guideline for surveillance, diagnosis, staging and treatment of hepatocellular carcinoma[122] 阿根廷肝病研究协会 (1)任何病因的肝硬化；(2)慢性HBV或HVC感染 Saudi association for the study of liver diseases and transplantation practice guidelines on the diagnosis and management of hepatocellular carcinoma[123] 沙特肝病研究和移植协会 (1)Child-Pugh-Turcotte A级和B级的肝硬化患者，不分病因；(2)等待肝移植的患者，不分病因；(3)HCV引起的晚期肝纤维化(F3)或肝硬化(F4)，即使达到SVR AGA clinical practice update on screening and surveillance for hepatocellular carcinoma in patients with nonalcoholic fatty liver disease: expert review[124] 美国胃肠病学会 NA Guidelines insights: hepatobiliary cancers, version 2.2019[125] 美国国家综合癌症网络 NA A practical guideline for hepatocellular carcinoma screening in patients at risk[126] 原发性肝癌专家联合 NA AASLD guidelines for the treatment of hepatocellular carcinoma[108] 美国肝病研究协会 肝硬化 注：SVR，持续病毒学应答；HBV，乙型肝炎病毒；HCV，丙型肝炎病毒；NA，不适用；a, 更多不同风险度细化信息详见表 6。
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表 6 肝癌筛查共识和指南推荐的肝癌辨识特征与风险分层模型
Table 6. Consensus- and guideline-recommended risk identification features and risk stratification models of liver cancer
指南共识 分层人群 危险分层辨识特征 风险分层模型 模型证据分级 《中国肝癌早筛策略专家共识》[14] 低危组 NA 推荐aMAP评分，评分范围标准化为1~100分，aMAP评分的计算规则：{[0.06×年龄+0.89×性别(男性：1，女性：0)]+0.48×[(log10总胆红素×0.66)+(白蛋白×(-0.085)]-0.01×血小板+7.4}/14.77×100，其中年龄以年为单位，其他检测指标的单位分别为总胆红素(μmol/L)、白蛋白(g/L)和血小板(103/mm3)；aMAP评分0~50分 NA 中危组 NA aMAP评分50~60分 高危组 NA aMAP评分60~100分 《原发性肝癌二级预防共识(2021年版)》[13] 低危人群 (1)年龄＜30岁；(2)慢性肝病早期及稳定期，无明显肝脏炎症和纤维化 具体参考《原发性肝癌的分层筛查与监测指南(2020版)》 NA 中危人群 (1)年龄＞30岁的慢性乙型肝炎患者(无肝癌家族史，无长期酗酒、吸烟、明确接触致癌毒物史，无合并糖尿病或肥胖)；(2)慢性丙型肝炎、ALD、NASH、自身免疫性肝病或Wilson病等慢性肝病活动期的患者 NA 高危人群 (1)各种原因导致的肝硬化；(2)年龄≥30岁的慢性乙型肝炎患者有肝癌家族史，或长期酗酒、吸烟、明确接触致癌毒物史、合并糖尿病或肥胖 NA 极高危人群 高危人群伴有下列1项或多项：(1)超声等影像学发现疑似癌前病变或非典型占位病变；(2)血清AFP≥20 ng/mL，伴或不伴DCP≥40 mAU/mL和(或)AFP-L3≥15%；(3)影像学或肝组织病理学证实的肝脏异型增生结节 NA 《原发性肝癌的分层筛查与监测指南(2020版)》[12] 低危人群 (1)免疫耐受期HBV感染者(A1)；(2)抗病毒治疗获得SVR的HBV或HCV相关慢性肝炎(A1)；(3)ALT、血小板正常非病毒性肝病(B1) HBsAg阳性，REACH-B评分≤5分(未接受抗病毒治疗)或PAGE-B评分≤9分(B2) B2 中危人群 (1)年龄＜40岁，未接受抗病毒治疗或抗病毒治疗后LLV的HBV或HCV相关慢性肝炎(B1)；(2)抗病毒治疗获得SVR的HBV或HCV相关肝硬化(B1)；(3)ALT正常非病毒性肝硬化或ALT异常慢性非病毒性肝炎(C2) (1)HBsAg阳性，REACH-B评分6~11分(未接受抗病毒治疗)或PAGE-B评分10~17分(B2)；(2)肝硬化患者THRI评分≤240分(B2) B2 高危人群 (1)未接受抗病毒治疗或抗病毒治疗后LLV的HBV或HCV相关肝硬化(A1)；(2)非病毒性肝硬化患者伴糖尿病或(和)一级亲属肝癌家族史(B1)；(3)男性，年龄＞40岁；女性，年龄＞50岁；未接受抗病毒治疗的HBV或HCV相关慢性肝炎(B1) (1)HBsAg阳性，REACH-B评分≥12分(未接受抗病毒治疗)或PAGE-B评分≥18分(B2)；(2)肝硬化患者THRI评分＞240分(B2) B2 极高危人群 (1)腹部超声检查肝脏结节(1~2 cm)或病理学为LGDN和HGDN(A1)；(2)HBV或HCV相关肝硬化结节(＜1 cm)(B1)；(3)未接受抗病毒药物治疗、治疗后LLV的HBV或HCV相关肝硬化伴糖尿病或一级亲属有肝癌家族史等协同危险因素(B1) NA NA Management of hepatocellular carcinoma in Japan: JSH consensus statements and recommendations 2021 update[105] 高危人群 肝硬化或慢性乙型肝炎或丙型肝炎 NA NA 超高危人群 既有病毒性肝炎也有肝硬化 NA NA 注: ALD，长期过量饮酒所致酒精性肝病; NASH，非酒精性脂肪性肝炎; AFP，甲胎蛋白; DCP，异常凝血酶原; ALT，丙氨酸转氨酶；LLV，低病毒血症; NA，不适用; A1，证据质量: 高, 推荐强度: 强; B1，证据质量: 高, 推荐强度: 强; B2，证据质量: 中, 推荐强度: 弱; C2，证据质量: 低, 推荐强度: 弱。
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表 7 肝癌筛查共识指南所涉肝癌风险评估模型的适用人群及具体指标
Table 7. Applicable populations and specific indicators of the liver cancer risk assessment models involved by the consensus statements and guidelines for liver cancer screening
模型名称 适用人群 具体指标 开发国家和地区 人群来源 THRI[127] 肝硬化人群 年龄、性别、肝硬化病因、血小板计数 英国多伦多，在我国得到验证 医院来源 REACH-B[41] HBV感染者 性别、年龄、ALT、HBeAg状态和HBV DNA水平 中国台湾 社区来源 PAGE-B[128] 抗病毒治疗后HBV感染者 性别、年龄、血小板计数 欧洲，韩国验证 医院来源 AGED[129] HBV感染者 性别、年龄、HBeAg状态和HBV DNA水平 中国启东 社区来源 GES[130] 肝硬化或高级别纤维化的HCV感染者 年龄、性别、白蛋白、AFP、肝纤维化分期 埃及 医院来源 aMAP[131] 多病因的慢性肝病患者 年龄、性别、白蛋白、胆红素、血小板 全球多中心 11个前瞻性队列或RCT 注：HBV，乙型肝炎病毒；HCV，丙型肝炎病毒；ALT，丙氨酸转氨酶；HBeAg，乙型肝炎e抗原；AFP，甲胎蛋白；RCT，随机对照试验。
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表 8 我国人群现行主要肝癌筛查与监测方案推荐
Table 8. Current recommended strategies for liver cancer screening and surveillance in populations in China
项目 筛查人群及方案推荐 启动时间(年) 地区定位 监测方案推荐 农村癌症早诊早治项目[4] 目标人群年龄：
男性：35~64岁；女性：
45~64岁；
初筛技术：HBsAg检测；
复筛技术：US联合AFP检测2005(2006年纳入肝癌筛查) 农村或肿瘤高发现场 (1)US和AFP复筛均阴性者：每6个月1次AFP联合US；
(2)US阴性、AFP阳性：＜200 μg/L者每2个月复查1次，≥200 μg/L者每个月复查1次；
(3)AFP阴性US阳性：及时复查；
(4)AFP和US均阳性：及时诊治淮河流域癌症早诊早治项目[5-7] 目标人群年龄：
男性：35~64岁；女性：
45~64岁；
初筛技术：问卷风险评估和HBsAg检测；
复筛技术：US联合AFP检测2007 淮河流域4个省份 (1)US和AFP复筛均阴性者：每6个月1次AFP联合US；
(2)US阴性、AFP阳性：＜200 μg/L者每2个月复查1次，≥200 μg/L者每个月复查1次；
(3)AFP阴性US阳性：及时复查；
(4)AFP和US均阳性：及时诊治城市癌症早诊早治项目[8-10] 目标人群年龄：45~74岁(立项之初为40~69岁)；
初筛技术：问卷风险评估(5癌联合，肝癌为其中之一)和HBsAg检测；
复筛技术：US联合AFP检测2012 城市人群 (1)US阴性、AFP阳性：＜200 μg/L者每2个月复查1次，≥200 μg/L者每个月复查1次；
(2)AFP阴性US阳性：及时复查；
(3)AFP和US均阳性：及时诊治；
(4)近年增加随访方案推荐：对未诊断为肝癌的高危个体行为期5年的重复筛查，5年后未患癌者进入被动随访注：HBsAg，乙型肝炎表面抗原；US，超声检查；AFP，甲胎蛋白。
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表 9 不同肝癌监测方案的早期肝癌检出率效果
Table 9. Comparison of the early detection rate of liver cancer among different surveillance strategies
第一作者 发表年份(年) 随访时间(年) 研究类型 研究地点 监测对象人群 监测方案和确诊人数 早期肝癌检出率RR(95%CI) 监测手段 例数 确诊例数 监测手段 例数 确诊例数 Pocha等[260] 2013 3 RCT 美国 肝硬化 US(6个月1次) 83 9 CT(12个月1次) 80 8 0.89(0.40~1.96) Rhee等[261] 2018 3 RCT 韩国 肝硬化 US(6个月1次) 188 10 MRI(6个月1次) 189 12 0.60(0.37~0.97) Kudo等[217] 2019 3 RCT 日本 肝硬化 CEUS (4个月1次) 309 28 B-mode US (4个月1次) 313 26 1.08(1.00~1.23) Kim等[263] 2020 5 队列研究 韩国 乙型肝炎 US(6个月1次) 825 96 US(6个月1次)+CT (12个月1次) 822 105 2.15(1.56~2.98) Kim等[262] 2020 10 队列研究 韩国 肝硬化 US(6个月1次) 659 90 US(6个月1次)+CT (12个月1次) 576 94 1.31(1.13~1.51) 注：RCT，随机对照试验；US，超声检查；MRI，磁共振成像；CEUS，超声造影。
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表 10 我国人群中开展的肝癌监测效果评价：以肝癌死亡率为指标
Table 10. Effectiveness of liver cancer surveillance in the Chinese population: taking mortality rate of liver cancer as an indicator
第一作者 发表年份(年) 研究设计 研究地点 开展时间(年) 研究人群 干预组(例) 对照组(例) 随访时间(年) 监测方案 肝癌死亡率RR(95%CI) Chen JG等[142] 2003 RCT 江苏省启东市 1989—1995 30~59岁男性HBsAg阳性者(5581例) 3712 1869 7 每6个月行AFP检测 0.83(0.68~1.03) Zhang BH等[143] 2004 RCT 上海市 1993—1997 35~59岁且HBV阳性或具慢性肝炎史的人群(18 816例) 9373 9443 5 每6个月行AFP检测和超声检查 0.63(0.41~0.98) Ji MF等[194] 2018 队列研究 广东省中山市 2012—2015 35~64岁常住居民(68 551人) 17 966a 50 544 4 每6个月对基线HBsAg阳性者行AFP检测和超声检查 1.04(0.68~1.58) Chen TH等[204] 2002 队列研究 中国台湾地区 1991—1998 基线经系列血清标志物等指标评为高危者(年龄未报道)；接受超声监测 4385 458 7 间隔3个月、6个月和1年的超声检查 0.59(0.29~1.20) Yeh YP等[212] 2014 队列研究 中国台湾地区 2008—2010 45~69岁基线经系列血清标志物等指标评为高危者；接受风险评分引导的超声监测 8962 2152 3 间隔3个月、6个月和1年的超声检查 0.69(0.56~0.84) 注：RCT，随机对照试验；HBsAg，乙型肝炎表面抗原；RR，相对风险；HBV，乙型肝炎病毒；AFP，甲胎蛋白；a，接受筛查及监测人数。
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