Abstract: Objective　To study the effect of the chemotherapy regimen of calcium folinate + fluorouracil + oxaliplatin (FOLFOX) combined with Jianpi Shengbai formula on patients with liver depression and spleen deficiency type advanced colorectal cancer (CRC). Methods　A prospective randomized controlled design was adopted. 108 patients with advanced liver depression and spleen deficiency type CRC who were admitted to the Affiliated Hospital of Shaanxi University of Chinese Medicine from February 2022 to February 2025 were selected. They were divided into two groups using the random number table method, with 54 cases in each group. There was no statistically significant difference in general data such as age, gender, and tumor stage between the two groups of patients (all P>0.05). The control group received the FOLFOX chemotherapy regimen, while the combined group was treated with the Jianpi Shengbai formula in addition to the regimen of the control group. Compare the TCM syndrome scores, Karnofsky Performance Status (KPS) score, immune function indicators [total T cell percentage in lymphocytes (CD3⁺), helper/inducer T cell percentage (CD4⁺), suppressor/cytotoxic T cell percentage (CD8⁺), CD4⁺/CD8⁺ ratio], hematological monitoring indicators [white blood cells (WBC), neutrophils (NEU), hemoglobin (Hb), platelets (PLT)], efficacy of solid tumors [disease control rate (DCR)], and the total incidence of adverse reactions between the two groups. The statistical methods employed were t-test, χ² test and rank sum test. Results　After treatment, the total symptom score of the combined group was lower than that of the control group [(11.1±2.3) points vs. (17.9±2.8) points], and the KPS score was higher than that of the control group [(92.6±2.2) points vs. (87.7±2.7) points], and the differences were statistically significant (t=13.790 and 10.339; both P<0.05). The immune function indicators of the combined group (CD3⁺, CD4⁺, CD4⁺/CD8⁺), WBC count, NEU count, Hb, and PLT count were all higher than those of the control group (all P<0.05). The DCR of the combined group was higher than that of the control group [83.33% (45/54) vs. 62.96% (34/54)], and the total incidence of adverse reactions was lower than that of the control group [35.19% (19/54) vs. 61.11% (33/54)], and the differences were statistically significant (χ²=5.704 and 7.269; both P<0.05). Conclusion　The FOLFOX chemotherapy regimen combined with the Jianpi Shengbai formula can increase the DCR of patients with liver depression and spleen deficiency type advanced colorectal cancer. It also has advantages in alleviating bone marrow suppression, enhancing immune function, and improving chemotherapy tolerance. It can be used as an adjuvant treatment for such patients receiving FOLFOX chemotherapy.

Key words: Colorectal cancer, Advanced stage, Stagnation of liver qi and spleen deficiency, Jianpi Shengbai , formula, Chemotherapy, Bone marrow suppression, Immune function

摘要： 目的　研究亚叶酸钙+氟尿嘧啶+奥沙利铂（FOLFOX）化疗方案联合健脾升白方对肝郁脾虚型晚期结直肠癌（CRC）患者的影响。方法　采用前瞻性随机对照设计，选取2022年2月至2025年2月陕西中医药大学附属医院收治的108例晚期肝郁脾虚型CRC患者，使用随机数字表法分为两组，每组54例。两组患者年龄、性别、肿瘤分期等一般资料比较，差异均无统计学意义（均P>0.05）。对照组采用FOLFOX化疗方案，联合组在对照组基础上联合健脾升白方治疗。比较两组中医证候积分、卡氏评分量表（KPS）、免疫功能指标［总T细胞占淋巴细胞百分比（CD3⁺）、辅助/诱导T细胞占比（CD4⁺）、抑制/细胞毒性T细胞占比（CD8⁺）、CD4⁺/CD8⁺比值］、血液学监测指标［白细胞（WBC）、中性粒细胞（NEU）、血红蛋白（Hb）、血小板（PLT）］、实体瘤疗效［疾病控制率（DCR）］，以及不良反应总发生率。统计学方法采用t检验、χ²检验、秩和检验。结果　治疗后，联合组中医症候积分低于对照组［（11.1±2.3）分比（17.9±2.8）分］，KPS评分高于对照组［（92.6±2.2）分比（87.7±2.7）分］，差异均有统计学意义（t=13.790、10.339，均P<0.05）；联合组免疫功能指标（CD3⁺、CD4⁺、CD4⁺/CD8⁺）、WBC计数、NEU计数、Hb、PLT计数均高于对照组（均P<0.05）；联合组DCR高于对照组［83.33%（45/54）比62.96%（34/54）］，不良反应总发生率低于对照组［35.19%（19/54）比61.11%（33/54）］，差异均有统计学意义（χ²=5.704、7.269，均P<0.05）。结论　FOLFOX化疗方案联合健脾升白方可提高肝郁脾虚型晚期结直肠癌患者DCR，且在减轻骨髓抑制、增强免疫功能、提高化疗耐受性方面具有优势，可作为该类患者接受FOLFOX化疗时的辅助治疗方案。

关键词: 结直肠癌, 晚期, 肝郁脾虚, 健脾升白方, 化疗, 骨髓抑制, 免疫功能