基于目标导向的原发性肝癌中医药防治疗效评价体系的构建

张宁; 陆荫英

doi:10.12449/JCH260504

基于目标导向的原发性肝癌中医药防治疗效评价体系的构建

DOI: 10.12449/JCH260504

张宁^{1, 2},
陆荫英^1, , ,

1.
中国人民解放军总医院肝病医学部，北京 100039
2.
南方医科大学中医药学院，广州 510515

基金项目:

国家科技重大专项 (2024ZD0526200)

利益冲突声明：本文不存在任何利益冲突。

作者贡献声明：张宁负责撰写论文；陆荫英负责拟定写作思路、提出核心观点并指导论文撰写。

详细信息

通信作者:
陆荫英， luyinying1973@163.com （ORCID： 0000-0002-7737-2334）

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出版历程
- 收稿日期: 2026-03-22
- 录用日期: 2026-04-22
- 出版日期: 2026-05-20

Construction of a goal-oriented efficacy evaluation system for traditional Chinese medicine in the prevention and treatment of primary liver cancer

Ning ZHANG^{1, 2},
Yinying LU^{1
, ,
,}

1.
Senior Department of Hepatology，Chinese PLA General Hospital，Beijing 100039，China
2.
School of Traditional Chinese Medicine，Southern Medical University，Guangzhou 510515，China

Research funding:

National Science and Technology Major Project (2024ZD0526200)

More Information

Corresponding author: LU Yinying， luyinying1973@163.com （ORCID： 0000-0002-7737-2334）

摘要

摘要: 中医药在原发性肝癌全周期管理中发挥着重要作用，以肿瘤客观缓解为主要评价指标、以随机对照试验和系统评价/荟萃分析为核心的循证医学评价体系不能充分呈现中医药的特点与优势。本文在现有中医防治原发性肝癌疗效评价现状的基础上，提出构建以分期论治的阶段目标为导向、融合终点性指标与过程性指标的多维评价体系。前者包括总生存期、无复发生存期等现代医学终点指标；后者涵盖中医证候改善、患者报告结局、不良反应缓解率及主方案停药率等短期疗效内容。强调中医药方案的总结应遵循“理论内涵-验案积累-观察性评价-干预性评价”的递进顺序。同时，建议将人工智能方法融入该评价体系，以推动疗效评价的智能化与精准化。
- 肝肿瘤 /
- 中医药疗法 /
- 实体肿瘤疗效评价标准
Abstract: Traditional Chinese medicine （TCM） plays an important role in the full-cycle management of primary liver cancer； however， the current evidence-based evaluation system with the main assessment index of objective tumor remission is mainly centered on randomized controlled trials and systematic reviews/meta-analyses and cannot fully reflect the characteristics and advantages of TCM. Based on the current status of TCM efficacy evaluation in the prevention and treatment of liver cancer， this article proposes the construction of a multi-dimensional evaluation system that is oriented by stage-specific treatment goals and integrates outcome indicators with process indicators. Outcome indicators include modern medical endpoints such as overall survival and recurrence-free survival， and process indicators include short-term outcomes such as the improvement in TCM syndrome， patient-reported outcomes， the remission rate of adverse events， and the discontinuation rate of the core regimen. It is emphasized that the development of standardized TCM regimens should follow the order of theoretical connotation， accumulation of proven cases， observational evaluation， and interventional evaluation. Furthermore， it is recommended to incorporate artificial intelligence approaches into this evaluation system， so as to promote the intelligent and precise assessment of TCM efficacy.
- Liver Neoplasms /
- Traditional Chinese Medicine Therapy /
- Response Evaluation Criteria in Solid Tumors

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图 1 中西医结合肝癌全周期管理及不同阶段中西医结合的干预目标

Figure 1. Whole-cycle management of liver cancer with integrated traditional Chinese and Western medicine， and intervention goals of integrated Chinese and Western medicine at different stages

下载: 全尺寸图片幻灯片

表 1 基于目标导向的肝癌中医药防治疗效评价指标选择与研究设计

Table 1. Goal-oriented selection of evaluation indicators and research design for traditional Chinese medicine intervention in liver cancer prevention and treatment

指标类别	具体指标	癌前阶段	根治术后	中晚期	终末期
终点事件指标	总生存期		√	√	√
	无复发生存期		√
	无进展生存期		√	√
	肝癌发生率	√
	肝癌复发率		√
	死亡率			√	√
肿瘤缓解指标	客观缓解率			√
	疾病控制率			√
过程性指标	并发症改善			√	√
	不良反应缓解率			√
	主方案停药率			√
	依从性	√	√	√	√
无创评估模型	肝脏弹性检测	√
	肝纤维化4因子指数	√
	年龄-男性-白蛋白-胆红素-血小板肝癌风险评分		√
生物标志物	免疫功能指标	√	√	√	√
	肿瘤标志物		√	√	√
	肝功能指标	√	√	√	√
患者综合状态	疼痛评分				√
	营养评分				√
	心理评估				√
	EORTC QLQ-C30	√	√	√	√
	健康调查简表等	√	√	√	√
	ECOG体力状况评分	√	√	√	√
	KPS评分	√	√	√	√
中医特色评价	体质评分	√	√	√
	证候积分	√	√	√
	症状评分			√	√
	舌象改善	√	√	√	√
研究设计推荐		随机对照试验		真实世界研究
评价周期		长		短
注：EORTC QLQ-C30，欧洲癌症研究与治疗组织生活质量问卷核心量表；ECOG体力状况评分，美国东部肿瘤协作组体力状况评分；KPS评分，卡尔诺夫斯基体力状况评分。

下载: 导出CSV

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