【目的】 探讨下气汤（由茯苓、法半夏、炙甘草、杏仁、橘红、白芍、何首乌、牡丹皮等中药组成）对伴有癌因性疲乏 的Ⅲ-Ⅳ期结直肠癌化疗患者的临床疗效。【方法】 将2023年1月至2024年3月就诊于广东省第二中医院的60例伴有癌因性疲 乏的Ⅲ-Ⅳ期结直肠癌化疗的患者按随机数字表法随机分为化疗组和下气汤组，每组各 30 例。化疗组给予 Avastin+ mFOLFOX6/FOLFIRI 方案化疗，下气汤组在化疗组的基础上给予服用下气汤治疗，每 2周为 1个疗程，连续治疗 2个疗程。 观察2组患者治疗前后Piper 疲乏修订量表（PFS-R）评分、EORTC核心生活质量问卷（QLQ-C30）评分、患者主观整体营养评 估（PG-SGA）评分、Karnofsky功能状态量表（KPS）评分、食欲减退评分及血清白细胞介素6（IL-6）、肿瘤坏死因子α（TNF-α）、 白细胞介素1β（IL-1β）水平的变化情况，评价2组患者的临床疗效及用药安全性。【结果】（1）疗效方面，治疗2个疗程后，下 气汤组的总有效率为 86.21%（25/29），化疗组为 62.07%（18/29），组间比较（χ2检验），下气汤组的疗效明显优于化疗组 （P < 0.05）。（2）疲乏程度方面，化疗第2周和第4周，2组患者的PFS-R评分均较化疗前 1 d 升高（P < 0.05），但下气汤组化 疗后的 PFS-R 评分均明显低于化疗组（P < 0.01）。（3）生活质量方面，化疗第 2 周和第 4 周，化疗组的 QLQ-C30评分均较 化疗前1 d降低（P < 0.05），而下气汤组的QLQ-C30评分均较化疗前1 d无明显变化（P > 0.05）；组间比较，下气汤组化疗后 的 QLQ-C30评分均明显高于化疗组（P < 0.01）。（4）营养状况方面，化疗第 4周，2组患者的 PG-SGA 评分、食欲减退评分及 下气汤组的KPS评分均较化疗前1 d升高（P < 0.05），而化疗组的KPS评分较化疗前1 d降低（P < 0.05）；组间比较，下气汤组化 疗后的PG-SGA 评分、食欲减退评分低于化疗组，KPS评分高于化疗组，差异均有统计学意义（P < 0.05或P < 0.01）。（5）炎症 因子方面，化疗组化疗第 2周的血清 TNF-α、IL-6水平及化疗第 4周的血清 TNF-α、IL-1β、IL-6水平均较化疗前 1 d升高 （P < 0.05），而下气汤组的血清 TNF-α、IL-1β 、IL-6 水平均较化疗前 1 d 有所降低，其中化疗第 2 周的血清 IL-6 水平和化 疗第 4 周的血清 IL-1β、IL-6水平与化疗前 1 d比较，差异均有统计学意义（P < 0.05）；组间比较，下气汤组化疗后的血清 TNF-α、IL-1β、IL-6水平均明显低于化疗组（P < 0.05或P < 0.01）。【结论】 下气汤可以改善Ⅲ-Ⅳ期结直肠癌化疗患者临床 症状，提高治疗效果；同时可抑制炎症因子的表达，改善患者的癌因性疲乏和营养状况，提高患者的生活质量，且安全性 较好，可在临床中推广应用。

Objective To investigate the clinical efficacy of Xiaqi Decoction（mainly composed of Poria，Pinelliae Rhizoma Praeparatum，Glycyrrhizae Radix et Rhizoma Praeparata cum Melle，Armeniacae Semen Amarum，Citri Grandis Exocarpium， Paeoniae Radix Alba， Polygoni Multiflori Radix， and Moutan Cortex）on patients with stage Ⅲ-Ⅳ colorectal cancer accompanied by cancer-related fatigue（CRF）after chemotherapy. Methods Sixty patients with stage Ⅲ-Ⅳ colorectal cancer accompanied by CRF after chemotherapy who admitted to Guangdong Second Traditional Chinese Medicine Hospital from January 2023 to March 2024 were randomly divided into chemotherapy group and Xiaqi Decoction group according to the random number table method，with 30 patients in each group. The chemotherapy group was given chemotherapy regimen of Avastin + mFOLFOX6 / FOLFIRI， and Xiaqi Decoction group was given Xiaqi Decoction orally on the basis of treatment for the chemotherapy group. Two weeks constituted a course of treatment，and two consecutive courses of treatment were performed. Before and after treatment，the two groups were observed in the changes of Revised Piper Fatigue Scale（PFS-R）scores，EORTC Quality of Life Questionnaire-Core 30（QLQ-C30） scores， Patient-Generated Subjective Global Assessment （PG-SGA）scores， Karnofsky Performance Status（KPS）scores， poor appetite scores， and serum levels of interleukin 6（IL-6）， tumor necrosis factor α（TNF - α）， and interleukin 1β（IL-1β）were observed. After treatment，the clinical efficacy and safety between the two groups of patients were evaluated. Results（1）After two courses of treatment，the total effective rate of the Xiaqi Decoction group was 86.21%（25 / 29）and that of the chemotherapy group was 62.07%（18/29），and the intergroup comparison（tested by chi-square test）showed that the efficacy of Xiaqi Decoction group was significantly superior to that of chemotherapy group（P < 0.05）.（2）In the second and fourth weeks of chemotherapy，the PFS-R scores for evaluating the degree of fatigue of patients in the two groups were increased when compared with those in the day before chemotherapy（P < 0.05），but the PFSR scores in Xiaqi Decoction group were significantly lower than those in the chemotherapy group after chemotherapy （P < 0.01）.（3）In the second and fourth weeks of chemotherapy，the QLQ-C30 scores for evaluating the quality of life in the chemotherapy group was decreased when compared with that one day before chemotherapy（P < 0.05）， whereas the QLQ-C30 scores in the Xiaqi Decoction group showed no obvious changes when compared with that one day before chemotherapy（P > 0.05）. The intergroup comparison showed that the QLQ-C30 scores of the Xiaqi Decoction group were all significantly higher than those of the chemotherapy group after chemotherapy（P < 0.01）. （4）The evaluation of nutritional status showed that in the fourth week of chemotherapy，PG-SGA score and poor appetite score in the two groups as well as KPS score in Xiaqi Decoction group were increased when compared with those one day before chemotherapy（P < 0.05），while the KPS score in the chemotherapy group was decreased when compared with that one day before chemotherapy（P < 0.05）. The intergroup comparison showed that PGSGA score and poor appetite score of Xiaqi Decoction after chemotherapy were lower than those of the chemotherapy group， and the KPS score was higher than that of the chemotherapy group， the differences being statistically significant（P < 0.05 or P < 0.01）.（5）In the chemotherapy group，the serum inflammatory factor levels of TNF-α and IL-6 in the second week of chemotherapy and the serum TNF-α，IL-1β and IL-6 levels in the fourth week of chemotherapy were all increased when compared with those one day before chemotherapy（P < 0.05）. In the Xiaqi Decoction group，the serum TNF-α，IL-1β，and IL-6 levels were all decreased when compared with those one day before chemotherapy，and significant differences were shown in the serum IL-6 level in the second week of chemotherapy and in the serum levels of IL-1β and IL-6 in the fourth week of chemotherapy when compared with those one day before chemotherapy（P < 0.05）. The intergroup comparison showed that serum TNF- α，IL-1β， and IL-6 levels in the Xiaqi Decoction group after chemotherapy were significantly lower than those in the chemotherapy group（P < 0.05 or P < 0.01）. Conclusion Xiaqi Decoction is effective on relieving the clinical symptoms and enhancing the efficacy of patients receiving chemotherapy for stage Ⅲ-Ⅳ colorectal cancer. It can inhibit the expression of inflammatory factors，relieve the CRF and improve the nutritional status and the quality of life of the patients，with higher safety.

R273.353

广东省中医药局科研项目（编号：20231032）