原发性肝癌中西医结合介入诊疗专家共识(试行第一版)

2019年肝癌中西医临床协作专家委员会

doi:10.3969/j.issn.1001-5256.2022.01.010

原发性肝癌中西医结合介入诊疗专家共识(试行第一版)

DOI: 10.3969/j.issn.1001-5256.2022.01.010

2019年肝癌中西医临床协作专家委员会

利益冲突声明：所有作者均声明不存在利益冲突。

通信作者：郑加生，首都医科大学附属北京佑安医院，zhengjiasheng6@163.com；杨国旺，首都医科大学附属北京中医医院，guowangyang@sina.com

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出版历程
- 收稿日期: 2021-12-08
- 录用日期: 2021-12-08
- 出版日期: 2022-01-20

Interventional expert consensus on integrated traditional Chinese and Western medicine for the diagnosis and treatment of hepatocellular carcinoma(trial editionⅠ)

2019 Expert Committee on Clinical Coordination of Traditional Chinese and Western Medicine for Liver Cancer

摘要

摘要: 本共识由国家中医药管理局重大疑难疾病-中西医临床协作项目-肝癌项目组牵头撰写，该项目建立了早期肝癌微创根治性消融和中晚期肝癌TAE/TACE序贯微创介入消融，联合中医辨证整体施治，形成了介入栓塞标记肿瘤，序贯微创局部消融及解剖模式消融术，去除影像学可见肿瘤，建立了以肝段消融术为代表的肝脏消融体系；应用中医扶正去邪提升机体免疫功能，重塑不适合肿瘤生长的微环境，去除影像学不可见的微小肿瘤，探索出了“中西医结合临床协作治疗肝癌”的整体解决方案。本共识以中医药微环境调理和微创消融相结合为特色，充分发挥中医扶正、辨证施治的整体治疗优势与微创消融精准灭活肿瘤，同时保留正常解剖结构、生理功能和免疫功能的局部治疗特点，采用整体治疗与局部消融治疗相结合，中医药调理与微创消融相结合，开创了肝癌中西医结合微创诊疗新模式。该共识的实施使BCLC A期肝癌达到了与开放性手术相同的根治性治疗效果，使以往开放式手术不能治疗的BCLC B/C期肝癌也获得了根治性效果，使肝癌治疗进入到人文化诊疗新模式，是卫生经济学效应最大化实施方案。
- 癌, 肝细胞 /
- 中西医结合疗法 /
- 介入诊疗 /
- 共识
Abstract: This consensus is compiled by the experts of hepatocellular carcinoma(HCC) project team, which is under the "major and difficult diseases-the clinical cooperation project of traditional Chinese medicine and Western medicine" of the State Administration of Traditional Chinese Medicine of China. This HCC project team has established minimally-invasive radical ablation for early stage HCC and transcatheter arterial chemoembolization(TAE/TACE) sequential minimally-invasive interventional ablation for advanced HCC, and on the basis of traditional Chinese Medicine(TCM) theory of "determination of treatment based on differentiation of syndromes" the team has further developed a liver ablation system which is represented by hepatic segment ablation, including interventional embolization of labeled tumors, sequential minimally-invasive local ablation and anatomical mode ablation, and elimination of radiographically visible tumors, etc. Based on the TCM theory of "improving the general condition and eliminating the causative agents", reasonable and suitable therapeutic measures are adopted to improve the body's immune function, to remodel a micro-environment that is unsuitable for tumor growth, and to eliminate radiographically invisible tumors. After long-term efforts, the HCC project team has found out the overall solution of "integrated clinical cooperative treatment of HCC with traditional Chinese and Western medicine". This consensus is characterized by the combination of TCM micro-environment conditioning and micro-invasive ablation, it has fully played the TCM overall therapeutic advantages such as "improving the general condition and eliminating the causative agents", "determination of treatment based on differentiation of syndromes", accurately inactivating tumor with minimally-invasive ablation while effectively preserving the normal anatomical structure, physiological functions and immune functions, etc. The overall therapy combined with local ablation treatment and the TCM conditioning combined with minimally-invasive ablation have initiated a novel mode of minimally-invasive diagnosis and treatment of integrated traditional Chinese and Western medicine in treating HCC. After the implementation of this consensus, the treatment of BCLC stage A HCC can obtain the same radical effect as the open surgery. Moreover, the treatment of BCLC Stage B/C HCC that previously could not be treated with open surgery can also obtain radical effect. The above achievements have made the treatment of HCC entering a novel stage, in which a new mode of human cultural diagnosis and treatment becomes to be employed in clinical practice, and the implementation of this project can maximize the effect of health economics.
- Carcinoma, Hepatocellular /
- TCM WM Therapy /
- Interventional Diagnosis and Treatment /
- Consensus

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图 1 肝癌诊断路径

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图 2 肝癌分期及治疗路径

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表 1 Child-Pugh分级

指标	1分	2分	3分
肝性脑病	无	1~2期	3~4期
腹水	无	轻度	中度及以上
凝血酶原时间(s)	≤14	15~17	≥18
血清胆红素(μmol/L)	＜34.2	34.2~51.3	＞51.3
血清白蛋白(g/L)	≥35	28~34	＜28

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表 2 PS评分标准

级别	体力状况
0	活动能力完全正常，与起病前活动能力无任何差异
1	能自由走动及从事轻体力活动，包括一般家务或办公室工作，但不能从事较重的体力活动
2	能自由走动及生活自理，但已丧失工作能力，日间不少于一半时间可以起床活动
3	生活仅能部分自理，日间一半以上时间卧床或坐轮椅
4	卧床不起，生活不能自理
5	死亡

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表 3 BCLC分期标准

肿瘤分期	PS评分	肿瘤情况	Okuda分期	肝脏功能
0	0	单发，≤2 cm	Ⅰ	没有门静脉高压，胆红素正常
A1	0	单发，≤5 cm	Ⅰ	没有门静脉高压，胆红素正常
A2	0	单发，≤5 cm	Ⅰ	有门静脉高压，胆红素正常
A3	0	单发，≤5 cm	Ⅰ	有门静脉高压，胆红素不正常
A4	0	3个，≤3 cm	Ⅰ~Ⅱ	Child-Pugh A-B
B	0	单发＞5 cm，或＞3个	Ⅰ~Ⅱ	Child-Pugh A-B
C	1~2	侵犯血管或肝外转移	Ⅰ~Ⅱ	Child-Pugh A-B
D	3~4	任何情况	Ⅲ	Child-Pugh C
注：肿瘤分期A和B，所有标准都符合；C，至少一个标准，PS1~2，或侵犯血管或肝外转移；D，至少一个标准，PS3~4，或OkudaⅢ/Child-Pugh C；0为极早期肝癌，A为早期肝癌，B为中期肝癌，C为进展期肝癌，D为终末期肝癌。

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表 4 常用中成药及其功能

中成药	功能主治
华蟾素片或华蟾素注射液	用于中、晚期肿瘤，慢性乙型肝炎等症的解毒、消肿、止痛
复方斑蝥胶囊	用于原发性肝癌等的破血消瘀，攻毒蚀疮
槐耳颗粒	用于正气虚弱，瘀血阻滞，原发性肝癌不宜手术和化疗者辅助治疗，扶正固本，活血消癥
金龙胶囊	用于原发性肝癌血瘀郁结证，破瘀散结，解郁通络
康莱特注射液	适用于不宜手术的气阴两虚、脾虚湿困型原发性肝癌，对中晚期肿瘤患者具有一定的抗恶病质和止痛作用，益气养阴，消癥散结
艾迪注射液	用于原发性肝癌等，清热解毒，消瘀散结
复方苦参注射液	清热利湿，凉血解毒，散结止痛，用于癌肿疼痛、出血
康艾注射液	用于原发性肝癌，各种原因引起的白细胞低下及减少症，慢性乙型肝炎，益气扶正，增强机体免疫功能
消癌平注射液	用于肝癌，并可配合放疗、化疗的辅助治疗，清热解毒，化痰软坚
榄香烯注射液	逐瘀利水，合并放、化疗常规方案对肝癌、骨转移癌等恶性肿瘤可以增强疗效，降低放、化疗毒副作用，并可用于介入、腔内化疗及癌性胸腹水的治疗

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参考文献(28)

[1]	BRAY F, FERLAY J, SOERJOMATARAM I, et al. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries[J]. CA Cancer J Clin, 2018, 68(6): 394-424. DOI: 10.3322/caac.21492.
[2]	FERLAY J, COLOMBET M, SOERJOMATARAM I, et al. Estimating the global cancer incidence and mortality in 2018: GLOBOCAN sources and methods[J]. Int J Cancer, 2019, 144(8): 1941-1953. DOI: 10.1002/ijc.31937.
[3]	China Association of Chinese Medicine. Guidelines for diagnosis and treatment of cancer in traditional Chinese medicine[M]. Beijing: China Press of Traditional Chinese Medicine, 2008. 中华中医药学会. 肿瘤中医诊疗指南[M]. 北京: 中国中医药出版社, 2008.
[4]	ZHAO WJ, ZHU GQ, WU YM, et al. Comparative effectiveness of radiofrequency ablation, surgical resection and transplantation for early hepatocellular carcinoma by cancer risk groups: Results of propensity score-weighted analysis[J]. Onco Targets Ther, 2019, 12: 10389-10400. DOI: 10.2147/OTT.S224809.
[5]	LIN HS. Traditional Chinese medicine diagnosis and treatment guidelines for malignant tumors[M]. Beijing: People's Medical Publishing House, 2014. 林洪生. 恶性肿瘤中医诊疗指南[M]. 北京: 人民卫生出版社, 2014.
[6]	Chinese Societies of Liver Cancer and Clinical Oncology, Chinese Anti-Cancer Association; Liver Cancer Study Group, Chinese Society of Hepatology, Chinese Medical Association. Experts consensus on local ablation therapy for liver cancer[J]. Tumor, 2011, 31: 385-388. DOI: 10.3781/j.issn.1000-7431.2011.05.001. 中国抗癌协会肝癌专业委员会, 中国抗癌协会临床肿瘤学协作专业委员会, 中华医学会肝病学分会肝癌学组. 肝癌局部消融治疗规范的专家共识[J]. 肿瘤, 2011, 31: 385-388. DOI: 10.3781/j.issn.1000-7431.2011.05.001.
[7]	Interventional Group, Chinese Society of Radiology, Chinese Medical Association. Expert consensus on standard therapeutic procedures of percutaneous radiofrequency ablation for liver tumor[J]. Chin J Radiol, 2012, 46(7): 581-585. DOI: 10.3760/cma.j.issn.1005-1201.2012.07.001. 中华医学会放射学分会介入学组. 经皮肝脏肿瘤射频消融治疗操作规范专家共识[J]. 中华放射学杂志, 2012, 46(7): 581-585. DOI: 10.3760/cma.j.issn.1005-1201.2012.07.001.
[8]	MERKLE EM, ZECH CJ, BARTOLOZZI C, et al. Consensus report from the 7th International Forum for Liver Magnetic Resonance Imaging[J]. Eur Radiol, 2016, 26(3): 674-682. DOI: 10.1007/s00330-015-3873-2.
[9]	Panel on Technical Management Standards for Tumor Ablation Therapy, National Health and Family Planning Commission of the People's Republic of China. Technical management standards for tumor ablation therapy (2017 edition)[J/CD]. Electronic J Liver Tumor, 2017, 4(4): 6-7. DOI: 10.3969/j.issn.2095-7815.2017.04.004. 国家卫计委肿瘤消融治疗技术管理规范专家组. 肿瘤消融治疗技术管理规范(2017年版)[J/CD]. 肝癌电子杂志, 2017, 4(4): 6-7. DOI: 10.3969/j.issn.2095-7815.2017.04.004.
[10]	BOELLAARD R, DELGADO-BOLTON R, OYEN WJ, et al. FDG PET/CT: EANM procedure guidelines for tumour imaging: Version 2.0[J]. Eur J Nucl Med Mol Imaging, 2015, 42(2): 328-354. DOI: 10.1007/s00259-014-2961-x.
[11]	CHALIAN H, TORE HG, HOROWITZ JM, et al. Radiologic assessment of response to therapy: Comparison of RECIST versions 1.1 and 1.0[J]. Radiographics, 2011, 31(7): 2093-2105. DOI: 10.1148/rg.317115050.
[12]	Guidelines Working Committee of Chinese Society of Clinical Oncology. Chinese Society of Clinical Oncology (CSCO) Guidelines for the diagnosis and treatment of primary liver cancer (2020 edition)[M]. Beijing: People's Medical Publishing House, 2020. 中国临床肿瘤学会指南工作委员会. 中国临床肿瘤学会(CSCO)原发性肝癌诊疗指南2020[M]. 北京: 人民卫生出版社, 2020.
[13]	Bureau of Medical Administration, National Health Commission of the People's Republic of China. Guidelines for diagnosis and treatment of primary liver cancer in China (2019 edition)[J]. J Clin Hepatol, 2020, 36(2): 277-292. DOI: 10.3969/j.issn.1001-5256.2020.02.007. 中华人民共和国国家卫生健康委员会医政医管局. 原发性肝癌诊疗规范(2019年版)[J]. 临床肝胆病杂志, 2020, 36(2): 277-292. DOI: 10.3969/j.issn.1001-5256.2020.02.007.
[14]	ZHENG XY. Guidelines for clinical research of Chinese medicine (new drug) (trial)[M]. Beijing: China Medical Science Press, 2002: 208-213. 郑筱萸. 中药新药临床研究指导原则(试行)[M]. 北京: 中国医药科技出版社, 2002: 208-213.
[15]	SI T, NING XJ, FENG XB, et al. Study on traditional Chinese medicine syndrome of 312 cases of primary liver cancer patients before and after the interventional embolization chemotherapy[J]. J Tradit Chin Med, 2015, 56(19): 1678-1681. DOI: 10.13288/j.11-2166/r.2015.19.016. 斯韬, 宁雪坚, 冯献斌, 等. 312例原发性肝癌患者血管介入栓塞化疗前后中医证候研究[J]. 中医杂志, 2015, 56(19): 1678-1681. DOI: 10.13288/j.11-2166/r.2015.19.016.
[16]	ZHAO HJ, DU J, DONG BW, et al. Primary study on clinical TCM syndrome characteristics after microwave thermal ablation for hepatocellular carcinoma[J]. J Fujian Coll Tradit Chin Med, 2008, 18(3): 1-3. DOI: 10.3969/j.issn.1004-5627.2008.03.001. 赵红佳, 杜建, 董宝玮, 等. 肝癌患者微波热消融治疗术后中医证候特点[J]. 福建中医学院学报, 2008, 18(3): 1-3. DOI: 10.3969/j.issn.1004-5627.2008.03.001.
[17]	AYUSO C, RIMOLA J, VILANA R, et al. Diagnosis and staging of hepatocellular carcinoma (HCC): Current guidelines[J]. Eur J Radiol, 2018, 101: 72-81. DOI: 10.1016/j.ejrad.2018.01.025.
[18]	ZHENG JS, LI N, YUAN CW. CT-guided ablation therapy of liver tumor[M]. Beijing: People's Medical Publishing House, 2011: 1- 8. 郑加生, 李宁, 袁春旺. CT引导肝肿瘤消融治疗学[M]. 北京: 人民卫生出版社, 2011: 1- 8.
[19]	ZHENG JS, LI N, YUAN CW. Image-guided ablation therapy of tumor[M]. Beijing: People's Medical Publishing House, 2013: 14-16. 郑加生, 李宁, 袁春旺. 影像引导肿瘤消融治疗学[M]. 北京: 人民卫生出版社, 2013: 14-16.
[20]	LONG J, ZHENG JS, SUN B, et al. Microwave ablation of hepatocellular carcinoma with portal vein tumor thrombosis after transarterial chemoembolization: A prospective study[J]. Hepatol Int, 2016, 10(1): 175-184. DOI: 10.1007/s12072-015-9673-6.
[21]	YUAN C, YUAN Z, CUI X, et al. Efficacy of ultrasound-, computed tomography-, and magnetic resonance imaging-guided radiofrequency ablation for hepatocellular carcinoma[J]. J Cancer Res Ther, 2019, 15(4): 784-792. DOI: 10.4103/jcrt.JCRT_836_18.
[22]	ZHENG JS, LONG J, SUN B, et al. Transcatheter arterial chemoembolization combined with radiofrequency ablation can improve survival of patients with hepatocellular carcinoma with portal vein tumour thrombosis: Extending the indication for ablation?[J]. Clin Radiol, 2014, 69(6): e253-e263. DOI: 10.1016/j.crad.2014.01.015.
[23]	LI W, WANG Y, GAO W, et al. HCC with tumor thrombus entering the right atrium and inferior vena cava treated by percutaneous ablation[J]. BMC Surg, 2017, 17(1): 21. DOI: 10.1186/s12893-017-0217-y.
[24]	YUAN Z, WANG Y, HU C, et al. Efficacy of percutaneous thermal ablation combined with transarterial embolization for recurrent hepatocellular carcinoma after hepatectomy and a prognostic nomogram to predict survival[J]. Technol Cancer Res Treat, 2018, 17: 1533033818801362. DOI: 10.1177/1533033818801362.
[25]	Society of Interventional Physicians, Chinese Medical Doctor Association. Chinese clinical practice guidelines for transcatheter arterial chemoembolization (TACE) for hepatocellular carcinoma[J]. Natl Med J China, 2018, 98: 3811-3819. DOI: 10.3760/cma.j.issn.0376-2491.2018.47.002. 中国医师协会介入医师分会. 中国肝细胞癌经动脉化疗栓塞治疗(TACE)临床实践指南[J]. 中华医学杂志, 2018, 98: 3811-3819. DOI: 10.3760/cma.j.issn.0376-2491.2018.47.002.
[26]	HAN D, XU YM, YU J, et al. Clinical effect of Dachaihu decoction combined with modified Liujunzi decoction in prevention and treatment of post-embolization syndrome in liver cancer[J]. Beijing J Tradit Chin Med, 2011, 30(11): 842-843. https://www.cnki.com.cn/Article/CJFDTOTAL-BJZO201111017.htm 韩冬, 徐咏梅, 于洁, 等. 大柴胡汤合六君子汤加减防治肝癌栓塞后综合征的临床研究[J]. 北京中医药, 2011, 30(11): 842-843. https://www.cnki.com.cn/Article/CJFDTOTAL-BJZO201111017.htm
[27]	YANG HN, FAN QS, LIU FQ, et al. Effects of the traditional Chinese medicine Tiaogan Lipi granules on postembolization syndrome induced by transcatheter arterial chemoembolization for hepatocellular carcinoma[J/CD]. Chin J Inter Rad(Electronic Edition), 2021, 9(1): 20-24. DOI: 10.3877/cma.j.issn.2095-5782.2021.01.003. 杨海宁, 樊庆胜, 刘福全, 等. 中医调肝理脾法防治肝癌栓塞术后综合征的临床观察[J/CD]. 中华介入放射学电子杂志, 2021, 9(1): 20-24. DOI: 10.3877/cma.j.issn.2095-5782.2021.01.003.
[28]	HAN Y, HUANG Z, JIANG ZC, et al. Expert consensus on targeted therapy for liver cancer (draft)[J/CD]. Electronic J Liver Tumor, 2020, 7(2): 2-11. DOI: 10.3760/cma.j.cn112137-20210425-00991. 韩玥, 黄振, 姜志超, 等. 肝癌靶向治疗专家共识(草案)[J/CD]. 肝癌电子杂志, 2020, 7(2): 2-11. DOI: 10.3760/cma.j.cn112137-20210425-00991.