【目的】 基于数据挖掘探讨晚期大肠癌（CRC）的中医证候、证型分布规律以及中医药治疗晚期 CRC的用药规律并挖掘 核心处方，同时回顾性分析该核心处方的临床疗效。【方法】 收集 2022年 1月至 2024年 3月南京中医药大学附属苏州市中医 医院肿瘤内科门诊及病房收治的晚期CRC首诊医案，录入中医传承辅助平台V2.5，分析其中医证候与证型、用药频次与中 药属性，通过关联规则和聚类分析形成核心处方（健脾化湿方）。对比经过该核心处方4周、8周和12周治疗后的疾病显愈率 和总有效率，并评估治疗前后中医证候积分、Karnofsky功能状态量表（KPS）评分及大肠癌患者生命质量测定量表（FACT-C） 评分的变化情况。【结果】（1）数据挖掘方面：本研究共纳入 143首方剂，涉及 214味中药，性味以甘温类为主，主归脾、肝 经。关联规则分析结果显示，以姜半夏→陈皮的支持度最高（94次），置信度为95.92%，并挖掘出14个核心药物组合，获得 7个新处方。频次分析结果显示，排前5位的中医证候为食欲不振、夜寐欠佳、乏力倦怠、大便稀溏、腹胀，排前3位的中 医证型为脾虚湿盛证、脾气虚证、脾肾阳虚证，以脾虚的辨证频次最高。经Apriori关联分析及熵聚类方法得到核心处方（健 脾化湿方）：陈皮、姜半夏、生黄芪、白术、薏苡仁、鸡内金、延胡索、鸡血藤、大血藤、茯神及合欢皮。（2）临床研究方 面：治疗 8、12 周后中医证候疗效的显愈率分别为 25.87%（37/143）、50.35%（72/143），总有效率分别为 60.14%（86/143）、 79.02%（113/143），均明显高于治疗4周后的13.99%（20/143）、41.96%（60/143），差异均有统计学意义（P＜0.05或P＜0.01）； 同时，患者治疗 12周后的各项中医证候积分、KPS评分以及FACT-C各领域评分均较治疗前明显改善，差异均有统计学意义 （P＜0.05或P＜0.01）。【结论】 晚期 CRC患者以脾虚为本，癌毒与痰、湿、瘀等病邪兼夹为标，健脾化湿方在ⅢB-Ⅳ期 CRC 治疗中能提升临床疗效，降低中医证候积分，改善患者体力状况和生活质量。

Objective To investigate the distribution of traditional Chinese medicine（TCM） syndrome manifestations and syndrome types in advanced colorectal cancer （CRC）， and to mine out the medication rules and the core prescriptions of traditional Chinese medicine in the treatment of advanced CRC as well as to observe the clinical efficacy of the core prescriptions. Methods From January 2022 to March 2024，the first-visit medical records of the outpatients and inpatients of advanced CRC admitted to the Department of Oncology， Suzhou Hospital of Traditional Chinese Medicine Affiliated to Nanjing University of Chinese Medicine were collected. The data of clinical information and prescriptions were input to the Traditional Chinese Medicine Inheritance Support System （TCMISS） V2.5. And then the TCM syndrome manifestations and syndrome types， medication frequency and attributes of Chinese herbal medicines were analyzed. A core prescription （Jianpi Huashi Prescription） was obtained after association rule analysis and cluster analysis. The core prescription was used for the treatment of CRC，and the cure rate and total effective rate after 4，8 and 12 weeks of treatment were compared. Moreover， the changes of TCM syndrome score，Karnofsky Performance Status （KPS） score and quality of life score evaluated with Functional Assessment of Cancer Therapy- Colorectal （FACT-C） were observed before and after treatment. Results （1） The data mining showed that a total of 143 prescriptions were included in this study，involving 214 Chinese herbal medicines. The medicines were usually sweet and warm in flavor and nature，and mainly had the meridian tropism of the spleen and liver meridians. The association rule analysis yielded 14 core drug combinations and 7 new candidate prescriptions，and the herbal combination of Pinelliae Rhizoma Praeparatum Cum Zingibere et Alumine and Citri Reticulatae Pericarpium had the highest support （94 times） with a confidence of 95.92%. The results of frequency analysis showed that the top five TCM syndrome manifestations were poor appetite，poor sleep at night，weakness and fatigue，loose stools，and abdominal distension. The top three TCM syndrome types were spleen deficiency with predominant dampness syndrome， spleen-qi deficiency syndrome， and spleen-kidney yang deficiency syndrome， and the syndrome element of spleen deficiency had the highest frequency. Apriori correlation analysis and entropy clustering yielded a core prescription （Jianpi Huashi Prescription），which was composed of Citri Reticulatae Pericarpium， Pinelliae Rhizoma Praeparatum Cum Zingibere et Alumine， crude Astragali Radix， Atractylodis Macrocephalae Rhizoma， Coicis Semen， Galli Gigerii Endothelium Corneum， Corydalis Rhizoma，Spatholobi Caulis，Sargentodoxae Caulis，Sclerotium Poriae Pararadicis and Albiziae Cortex. （2） Clinical research showed that after 8 and 12 weeks of treatment， the markedly effective rates for TCM syndromes were 25.87%（37/143） and 50.35%（72/143） respectively，and the total effective rates were 60.14% （86/143） and 79.02%（113/143） respectively，which were significantly higher than 13.99% （20/143） and 41.96% （60/143） after 4 weeks of treatment， and the differences were statistically significant （P＜0.05 or P＜0.01）. Moreover， the scores of TCM syndromes， KPS scores and FACT-C scores after 12 weeks of treatment were significantly improved compared with those before treatment，and the differences were statistically significant（P＜ 0.05 or P＜0.01）. Conclusion Patients with advanced CRC usually have the syndrome of spleen deficiency，often complicated with cancer-toxin，phlegm，dampness，blood-stasis and other pathogens. Jianpi Huashi Prescription can enhance the clinical efficacy of CRC in the treatment of stage IIIB-IV，decrease the TCM syndrome score， and improve the patient’s performance status and quality of life.

R273.353

国家自然科学基金资助项目（编号：82004136，82274257）；江苏省自然科学基金面上项目（编号：BK20221246）；苏州市科技 局科技计划项目（编号：SKY2022200）；苏州市姑苏区卫生人才项目（编号：GSWS2022083）