目的：观察扶正消积颗粒联合一线化疗干预瘀毒内阻证结直肠癌患者的临床疗效及对肠道菌群的影响。方法：选取2019年1月1日至2023年12月31日上海交通大学医学院附属瑞金医院收治的瘀毒内阻证结直肠癌Ⅳ期患者100例为研究对象，按照随机数字表法分为对照组和治疗组，每组50例。对照组采用西医标准化疗方案，治疗组在对照组的基础上给予扶正消积颗粒加减口服。6个月后比较2组患者治疗前、中、后中医证候积分和卡诺夫斯凯计分（Kanofsky performance score, KPS）评分，并比较2组的肠道菌群。结果：治疗前，2组各中医证候积分和KPS评分相似，差异无统计学意义（均P>0.05）。治疗后，治疗组抑郁焦虑、乏力症状均较治疗前减轻，差异有统计学意义（均P<0.05）；治疗组刺痛、痛有定处、拒按，抑郁焦虑，乏力与对照组比较，差异有统计学意义（均P<0.01）；对照组各症状改善不明显，差异无统计学意义（均P>0.05）。治疗后对照组较治疗组肠道菌群丰度稍有增加，2组线性判别分析（linear discriminant analysis，LDA）值>2的差异性菌群为对照组的放线菌门（Actinobacteria）、瘤胃球菌属（Ruminococcus）、梭菌属（Clostridium）、弯曲菌（Campylobacteris）、营养缺陷菌属（Abiotrophia）、叶绿体（Chlotoplast）、假单胞菌属（Pseudobutyrivibrio），治疗组的气单胞菌目(Aeromonadales)。结论：扶正消积颗粒联合一线化疗能够改善瘀毒内阻证结直肠癌患者的生活质量，调节肠道菌群，改善中医症状。

Objective To observe the clinical efficacy of Fuzheng Xiaoji granules combined with first-line chemotherapy in colorectal cancer patients with stasis toxin internal obstruction syndrome and the influence of gut microbiota in them. Methods A total of 100 stage Ⅳ colorectal cancer patients with stasis toxin internal obstruction syndrome admitted to Ruijin Hospital,Shanghai Jiao Tong University School of Medicine from January 1, 2019 to December 31, 2023 were selected as the study subjects. They were randomly divided into a control group and a treatment group using a random number table method, with 50 cases in each group. The control group received standard Western medicine chemotherapy, and the treatment group was given modified oral Fuzheng Xiaoji granules combined with chemotherapy. Six months later, the traditional Chinese medicine syndrome scores and Kanofsky performance score (KPS) of the two groups before, during, and after treatment were compared between the two groups, and the gut microbiota were compared between the two groups. Results Before treatment, the traditional Chinese medicine syndrome scores and KPS of the two groups were similar, and the difference was not statistically significant (both P>0.05). After treatment, the scores of depression, anxiety, and fatigue in the treatment group decreased compared to those before treatment (all P<0.05). Tingling, localized pain, refusal to press, depression and anxiety, and fatigue in the treatment group decreased compared with those in the control group (all P<0.01). The symptoms in the control group were similar, and the difference was not statistically significant (all P>0.05). The results of two groups of gut microbiota showed a slight increase in the abundance of gut microbiota in the control group compared to the treatment group. The differential microbiota with linear discriminant analysis (LDA) values>2 in the two groups were Actinobacteria, Ruminococcus, Clostridium, Campylobacter, Abiotrophya, Chloroplast, and Pseudomonas in the control group, and Aeromonas in the treatment group. Conclusions The combination of Fuzheng Xiaoji granules and first-line chemotherapy can improve the quality of life of colorectal cancer patients with stasis toxin internal obstruction syndrome, regulate the patient's gut microbiota, and improve traditional Chinese medicine symptoms.