【目的】探究扶元复衡汤辅助化疗治疗结直肠癌 （CRC） 脾肾亏虚证患者的临床疗效及其对细胞免疫功能、不良反应及预 后的影响。【方法】对2021年1月～2023年1月陕西中医药大学第二附属医院收治的120例CRC脾肾亏虚证患者的临床资料开 展回顾性研究，根据治疗方案的不同将120例患者分为研究组和对照组，每组各60例。2组患者均予以CRC根治切除术治 疗，对照组术后给予mFOLFOX6化疗方案 （5-氟尿嘧啶+奥沙利铂+亚叶酸钙） 治疗，研究组在对照组的基础上联合扶元复衡 汤治疗。以14 d为1个周期，连续治疗12个周期。观察2组患者治疗前后中医证候积分、细胞免疫功能[T淋巴细胞亚群 CD3+ 、CD4+ 、CD4+ /CD8+ 和自然杀伤 （NK） 细胞]、欧洲癌症研究与治疗组织生活质量测定量表 （EORTCQLQ-C30） 评分、癌因 性疲乏程度Piper疲乏量表 （PFS） 评分、Karnofsky功能状态 （KPS） 评分、预后相关标志物[糖类抗原199 （CA199） 、癌胚抗原 （CEA） 、血管内皮生长因子 （VEGF） 、乳酸脱氢酶 （LDH） ]的变化情况，并比较2组患者的治疗效果、不良反应发生率与1年 生存率。【结果】（1） 治疗效果方面：治疗12个周期后，研究组的总缓解率为75.00% （45/60） ，明显高于对照组的53.33% （32/60） ， 差异有统计学意义 （χ2 =6.125，P < 0.05） 。 （2） 中医证候积分方面：治疗后，2组患者的神疲乏力、腰膝酸软、食欲不振、头晕 目眩、大便溏稀等证候积分均较治疗前明显降低 （P < 0.05） ，且研究组的降低幅度均明显优于对照组 （P < 0.01） 。 （3） 细胞免疫 功能方面：治疗后，2组患者的外周血T淋巴细胞亚群CD3+ 、CD4+ 、CD4+ /CD8+ 和NK细胞水平均较治疗前降低 （P < 0.05） ， 但研究组的降低幅度均明显小于对照组 （P < 0.01） 。 （4） 生活质量、癌因性疲乏程度和功能状态方面：治疗后，2组患者的 EORTCQLQ-C30评分、KPS评分均较治疗前升高 （P < 0.05） ，PFS评分均较治疗前降低 （P < 0.05） ，且研究组对EORTCQLQ-C30 评分和KPS评分的升高幅度及对PFS评分的降低幅度均明显优于对照组 （P < 0.01） 。 （5） 预后相关标志物方面：治疗后， 2组患者的血清CA199、CEA、VEGF、LDH水平均较治疗前明显降低 （P < 0.05） ，且研究组的降低幅度均明显优于对照组 （P < 0.01） 。 （6） 不良反应方面：研究组患者的恶心/呕吐、消化道反应、血小板减少、白细胞减少、红细胞减少等不良反应发 生率均明显低于对照组 （P < 0.05或P < 0.01） 。 （7） 生存率方面：治疗结束后随访1年，随访期间研究组脱落3例，对照组脱 落5例。在完成随访的患者中，研究组的生存率为96.49% （55/57） ，明显高于对照组的83.64% （46/55） ，差异有统计学意义 （χ2 =5.223，P=0.022） 。【结论】扶元复衡汤辅助mFOLFOX6化疗方案治疗CRC的总缓解率明显升高，可改善临床症状、免疫 功能及机体功能状态，提高生活质量，降低癌因性疲乏程度，并可提高生存率，减少不良反应发生，进而改善患者预后。

Objective To investigate the clinical efficacy of adjuvant intervention of Fuyuan Fuheng Decoction for chemotherapy in the treatment of patients with colorectal cancer（CRC）of spleen-kidney deficiency syndrome，and to observe its effects on cellular immune function， adverse reactions and the prognosis of CRC treated by chemotherapy. Methods From January 2021 to January 2023，a retrospective study was conducted on 120 patients with CRC of spleen-kidney deficiency syndrome admitted to the Second Affiliated Hospital of Shaanxi University of Chinese Medicine. The patients were divided into a study group and a control group according to the treatment protocols，with 60 patients in each group. The patients of the two groups were treated by radical resection of CRC， and then the control group was given mFOLFOX6 chemotherapy（5-Fluorouracil+Oxaliplatin+Calcium Folinate） while the study group was given Fuyuan Fuheng Decoction together with mFOLFOX6 chemotherapy after operation. Fourteen days constituted a cycle of treatment，and the two groups were given 12 consecutive cycles of treatment. Before and after treatment，the two groups were observed in the changes of traditional Chinese medicine（TCM） syndrome scores，cellular immune function indicators [T-lymphocyte subsets CD3+，CD4+，CD4+/CD8+ and natural killer（NK）cells]，European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30（EORTC QLQ-C30）scores，Piper􀆳s Fatigue Scale（PFS）scores of cancer-related fatigue，Karnofsky Performance Status（KPS） scores， and prognosis-related markers [carbohydrate antigen 199（CA199）， carcinoembryonic antigen（CEA），vascular endothelial growth factor（VEGF），and lactate dehydrogenase（LDH）] . After treatment， the therapeutic efficacy，the incidence of adverse reactions，and the one-year survival rate of the two groups were compared. Results（1）After 12 cycles of treatment， the overall response rate of the study group was 75.00% （45/60），which was significantly higher than that of the control group [53.33%（32/60）]，the difference being statistically significant（χ2=6.125，P < 0.05）.（2）After treatment，the scores of TCM symptoms of fatigue and weakness，soreness and weakness in the waist and knee，poor appetite，vertigo and dizziness，and loose stools in the two groups were significantly decreased compared with those before treatment（P < 0.05），and the decrease in the study group was significantly superior to that in the control group（P < 0.01）.（3）After treatment，the levels of cellular immune function indicators of peripheral T-lymphocyte subset CD3+，CD4+，CD4+/CD8+，and NK cells of the two groups were all decreased compared with those before treatment（P < 0.05），but the decrease in the study group was significantly milder than that in the control group（P < 0.01）.（4）After treatment，the EORTC QLQ-C30 score and KPS score in the two groups were increased compared with those before treatment（P < 0.05）， and the PFS score was decreased compared with that before treatment（P < 0.05）. The increase of the EORTC QLQ-C30 score and KPS score as well as the decrease of the PFS score in the study group were significantly superior to that in the control group（P < 0.01）.（5）After treatment，the serum levels of prognosis-related markers of CA199，CEA，VEGF，and LDH in the two groups were significantly decreased compared with those before treatment（P < 0.05），and the decrease in the study group was significantly superior to that in the control group （P < 0.01）. （6） The incidence of adverse reactions such as nausea / vomiting， gastrointestinal reactions， thrombocytopenia，leukopenia，and erythrocytopenia in the study group was significantly lower than that in the control group（P < 0.05 or P < 0.01）.（7）One year of follow-up after the completion of treatment showed that three cases in the study group and five cases in the control group fell off during the follow-up period. Among the patients who completed the follow-up，the survival rate of the study group was 96.49%（55/57），which was significantly higher than that of the control group [83.64%（46/55）]，the difference being statistically significant（χ2=5.223， P=0.022）. Conclusion Adjuvant intervention of Fuyuan Fuheng Decoction can enhance the overall response rate of the patients with CRC treated by mFOLFOX6 chemotherapy， and is effective on improving clinical symptoms， immune function，and performance status of the patients，enhancing the quality of life，alleviating cancer-related fatigue， increasing the survival rate， reducing the incidence of adverse reactions， and then improving the prognosis of the patients.

R273.353

陕西省自然科学基础研究计划项目 （编号：2023-JC-YB-667）