加味葛根芩连汤联合mFOLFOX6新辅助化疗治疗低位直肠癌患者临床研究

Clinical study on modified Gegen Qinlian Decoction combined with mFOLFOX6 neoadjuvant chemotherapy for patients with low rectal cancer

关键词:  低位直肠癌  新辅助化疗  腹腔镜  中医

Key words:  low rectal cancer  neoadjuvant chemotherapy  laparoscopy  traditional Chinese medicine

摘要:

[目的] 本研究运用加味葛根芩连汤干预顺序行 mFOLFOX6 新辅助化疗、腹腔镜手术的低位直肠癌患者，观察分析患者的新辅助化疗毒副反应、手术效率及术后并发症发生率等，探究加味葛根芩连汤干预顺序行 mFOLFOX6 新辅助化疗、腹腔镜手术的低位直肠癌患者有效性和安全性。[方法] 选择天津市第四中心医院 2021 年 10 月—2023 年 2 月收治可切除的局部进展期低位直肠癌患者，随机分为治疗组和对照组。对照组 26 例给予 mFOLFOX6 新辅助化疗后行腹腔镜手术治疗，治疗组在对照组基础上给予加味葛根芩连汤治疗。比较两组患者新辅助化疗相关毒副作用、手术效率、术后并发症和免疫功能等。[结果] 1）新辅助化疗相关不良反应方面，治疗组骨髓抑制、恶心呕吐、腹泻以及周围神经毒性反应发生率均低于对照组（P＜0.05），治疗组患者化疗结束后 7 d CD3⁺及 CD4⁺/CD8⁺水平高于对照组（P＜0.01）；CD4⁺、CD8⁺水平低于对照组（P＜0.01）。2）在手术效率及手术质量方面，治疗组在手术时间、术中出血量、住院天数、尿潴留发生率方面明显低于对照组；且术后首次肛门排气时间早于对照组，差异具有统计学意义（P＜0.05 或 P＜0.01）。3）在术后机体免疫功能方面，治疗组患者术后 7 d CD3⁺、CD4⁺及 CD4⁺/CD8⁺水平高于对照组；CD8⁺水平低于对照组（P＜0.01）。[结论] 对于顺序行 mFOLFOX6 新辅助化疗、腹腔镜手术的低位直肠癌患者，加味葛根芩连汤能降低化疗药物毒副作用，减轻免疫功能损伤，为手术创造有利条件，缩短手术时间，减少出血量，促进术后胃肠道功能快速康复，并降低尿潴留发生率。

Abstract:

[Objective] To study the effects and safety of modified Gegen Qinlian Decoction in patients with low rectal cancer underwent mFOLFOX6 neoadjuvant chemotherapy and sequential laparoscopic surgery，to observe and analyze the incidence of neoadjuvant chemotherapy side effects，operative efficiency and post-operative complications. [Methods] Patients with resectable locally advanced low rectal cancer admitted to Tianjin Fourth Central Hospital from October 2021 to February 2023 were randomly divided into treatment group and control group. There were 26 patients in the control group，which underwent mFOLFOX6 neoadjuvant chemotherapy and laparoscopic surgery. The treatment group was given modified Gegen Qinlian Decoction on the basis of the control group. The side effects of neoadjuvant chemotherapy，surgical efficiency，immune function and post-operative complications were compared between these two groups. [Results] 1）The incidence of neoadjuvant chemotherapy side effects such as myelosuppression，nausea-vomiting，diarrhea and peripheral neurotoxicity in treatment group were significantly less than that of the control group（P＜0.05）. The level of CD3⁺，CD4⁺/CD8⁺ 7 days after chemotherapy in treatment group were significantly higher than that of the control group（P＜0.01）. The level of CD4⁺，CD8⁺ 7 days after chemotherapy in treatment group were significantly less than that of the control group（P＜0.01）. 2）For surgical efficiency and quality evaluation，operative time，volume of intraoperative hemorrhage，days of hospitalization，incidence of urinary retention were significantly less than that of control group. And first post-operative anal ventilation time was significantly less than that of control group （P＜0.05 or P＜0.01）. 3）All of them were statistically different. For post-operative immune function evaluation，the level of CD3⁺，CD4⁺ and CD4⁺/CD8⁺ 7 days after surgery in treatment group were statistically higher than that of control group. And the level of CD8⁺ in treatment group was statistically less than that of control group （P＜0.01）. [Conclusion] For patients with low rectal cancer undergoing mFOLFOX6 neoadjuvant chemotherapy and sequential laparoscopic surgery，adding Gegen Qinlian Decoction can reduce the toxic and side effects of chemotherapy drugs on the damage of immune function，which may help to create favorable conditions for surgery，shorten the operative time，reduce the amount of blood loss，promote the rapid recovery of gastrointestinal function after surgery，and reduce the incidence of urinary retention.