探讨参芪十一味颗粒联合FOLFOX4方案化疗对晚期结直肠癌患者的近期疗效及其对血清白细胞介素-35（IL-35）、IL-37和T淋巴细胞亚群的影响。

选择2018年1月至2021年3月上饶市人民医院收治的晚期结直肠癌患者80例，采用随机表字法分为观察组与对照组，各40例，年龄分别为（58.97±8.95）岁和（59.82±9.04）岁。对照组患者采用FOLFOX4化疗方案，观察组患者采用参芪十一味颗粒联合FOLFOX4化疗方案治疗。两组均以21 d为一个周期，治疗2个周期评价。比较两组近期疗效和生存质量改善情况，化疗前后血清IL-35和IL-37、T淋巴细胞亚群变化及毒副反应情况。

观察组患者治疗2个周期后的有效率（RR）为80.0%，对照组为60.0%，组间比较差异有统计学意义（P＜0.05）；观察组生活质量的有效率为100.00%，对照组为90.00%，组间比较差异有统计学意义（P＜0.05）；化疗后，观察组血清IL-35水平较化疗前降低，而IL-37、CD₃⁺、CD₄⁺和CD₄⁺/CD₈⁺均较化疗前升高（均P＜0.05）；化疗后，对照组血清IL-35、CD₃⁺、CD₄⁺和CD₄⁺/CD₈⁺水平均较化疗前降低，而IL-37较化疗前升高（均P＜0.05）；化疗后，观察组血清IL-35低于对照组，而IL-37、CD₃⁺、CD₄⁺和CD₄⁺/CD₈⁺均高于对照组，分别为［（48.31±7.49）ng/L vs（59.24±5.89）ng/L，P＜0.001］、［（58.97±2.97）% vs （47.89±3.71）%，P＜0.001］、［（39.54±3.05）% vs （30.91±2.08）%，P＜0.001］、（1.65±0.19 vs 1.02±0.14，P＜0.001）、［（508.15±28.78）μg/L vs （461.23±25.64）μg/L，P＜0.001］。观察组治疗期间胃肠道反应、乏力、肝功能异常、白细胞减少、血小板减少的发生率均低于对照组，差异均有统计学意义（均P＜0.05）。

参芪十一味颗粒联合FOLFOX4化疗方案可显著提高晚期结直肠癌患者近期疗效，下调IL-35水平，上调IL-37水平，提高免疫功能并减轻毒副反应。

To investigate the short-term curative effect of Shenqishiyiwei granules combined with FOLFOX4 chemotherapy in patients with advanced colorectal cancer and their effect on serum interleukin-35 (IL-35), interleukin-37 (IL-37), and T lymphocyte subsets.

A total of 80 patients with advanced colorectal cancer admitted to Shangrao People's Hospital from January 2018 to March 2021 were selected and divided into either an observation group or a control group using the random number table method, with 40 cases in each group. The mean age of the two groups was (58.97±8.95) years and (59.82±9.04) years, respectively. The control group was treated with FOLFOX4 chemotherapy alone. The observation group was treated with Shenqishiyiwei granules combined with FOLFOX4 chemotherapy. The two groups were treated for 21 days as a cycle, and the curative effect was calculated after two cycles of treatment. The short-term efficacy and improvement of quality of life were compared between the two groups. The changes of serum IL-35, IL-37, and T lymphocyte subsets and toxic reactions were also compared between the two groups.

The response rate (RR) of the observation group was 80.0% after two cycles of treatment, and it was 60.0% in the control group (P＜0.05). The improvement rate of quality of life in the observation group was 100.0%, and it was 90.0% in the control group (P＜0.05). After chemotherapy, the level of IL-35 in the observation group was lower than that before chemotherapy, while IL-37, CD3^＋ T cells, CD4^＋ T cells, and CD4^＋/CD8^＋ ratio were higher than those before chemotherapy (P＜0.05). After chemotherapy, the levels of IL-35, CD3^＋ T cells, CD4^＋ T cells, and CD4^＋/CD8^＋ T cell ratio in the control group were lower than those before chemotherapy, while the level of IL-37 was higher than that before chemotherapy (P＜0.05). After chemotherapy, serum IL-35 in the observation group was lower than that in the control group, while IL-37, CD3^＋ T cells, CD4^＋ T cells, and CD4^＋/CD8^＋ T cell ratio were higher than those in the control group [(48.31±7.49) ng/L vs (59.24±5.89) ng/L, P＜0.001; (58.97±2.97)% vs (47.89±3.71)%, P＜0.001; (39.54±3.05)% vs (30.91±2.08)%, P＜0.001; (1.65±0.19 vs 1.02±0.14, P＜0.001); and (508.15±28.78) μg/L vs (461.23±25.64) μg/L, P＜0.001, respectively]. The incidences of gastrointestinal reactions, fatigue, abnormal liver function, leucopenia, and thrombocytopenia in the observation group were all significantly lower than those in the control group (P＜0.05).

Shenqishiyiwei granules combined with FOLFOX4 chemotherapy can significantly improve the short-term curative effect in patients with advanced colorectal cancer, down-regulate the level of IL-35, up-regulate the level of IL-37, improve immune function, and reduce toxic and side effects.