重组改构人肿瘤坏死因子用于进展期结肠癌患者术中腹腔灌注治疗的近期安全性及可行性分析  

Recent safety and feasibility analysis of recombinant mutant human tumor necrosis factor for intraoperative intraperitoneal perfusion therapy in patients with advanced colon cancer

作　　者：陈亚军 姜玉娟 周思成 陈海鹏 王征 周海涛 毕建军 冯强 郑朝旭 姜争 刘正 梁建伟 裴炜 张海增 汤坚强 刘骞 王锡山 Yajun Chen;Yujuan Jiang;Sicheng Zhou;Haipeng Chen;Zheng Wang;Haitao Zhou;Jianjun Bi;Qiang Feng;Zhaoxu Zheng;Zheng Jiang;Zheng Liu;Jianwei Liang;Wei Pei;Haizeng Zhang;Jianqiang Tang;Qian Liu;Xishan Wang(Department of Gastrointestinal Surgery,Yichang Central People's Hospital/the First College of Clinical Medical Science,China Three Gorges University,Yichang 443000,China;Department of Colorectal Surgery,National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital,Chinese Academy of Medical Science and Peking Union Medical College,Beijing 100021,China)

机构地区：[1]湖北省宜昌市中心人民医院/三峡大学第一临床医学院胃肠外科,443000 [2]国家癌症中心/国家肿瘤临床医学研究中心/中国医学科学院北京协和医学院肿瘤医院结直肠外科,北京100021

出　　处：《中华结直肠疾病电子杂志》2024年第2期94-100,共7页Chinese Journal of Colorectal Diseases(Electronic Edition)

基　　金：国家自然科学基金(81441070);中国癌症基金会北京希望马拉松专项基金(LC2020A37)。

摘　　要：目的评估重组改构人肿瘤坏死因子(rmhTNF)用于进展期结肠癌患者术中腹腔灌注治疗的近期安全性及可行性。方法前瞻性纳入2022年1月至2023年4月期间就诊于国家癌症中心/中国医学科学院肿瘤医院结直肠外科并进行手术治疗的进展期结肠癌患者的50例病例资料,按照腹腔是否灌注rmhTNF分为研究组和对照组,每组各入组25例,研究组在关腹后经腹腔引流管行rmhTNF腹腔灌注治疗,对照组应用蒸馏水冲洗腹腔。分析两组患者术后临床指标的差异。结果两组患者在术后胃肠道功能恢复情况、并发症发生率、血液学毒性、肝肾功能、凝血功能、炎症指标方面比较差异均无统计学意义(均P>0.05)。结论rmhTNF用于进展期结肠癌患者术中腹腔灌注治疗具有良好的安全性及耐受性,不影响术后胃肠功能恢复,未增加近期术后并发症的发生率,无血液学毒性,对肝肾功能、凝血功能、炎症指标无影响。ObjectiveEvaluate the short-term safety and feasibility of recombinant mutant human tumor necrosis factor (rmhTNF) for intraoperative intraperitoneal perfusion therapy in patients with advanced colon cancer.MethodsProspective inclusion of case data from 50 patients with advanced colon cancer who underwent surgical treatment at the Colorectal Surgery Department of the National Cancer Center/Cancer Hospital of the Chinese Academy of Medical Sciences between January 2022 and April 2023. The study group was divided into a study group and a control group based on whether rmhTNF was infused into the abdominal cavity, with 25 cases in each group. The study group received rmhTNF intraperitoneal infusion treatment through a drainage tube after abdominal closure, The control group was rinsed with distilled water in the abdominal cavity. Analyze the differences in clinical indicators between two groups of patients.ResultsThere was no significant differences in the incidence of postoperative complications, time of gastrointestinal function recovery, blood toxicity, liver and kidney function, coagulation function, and inflammatory markers between the two groups (all P>0.05).ConclusionThe use of rmhTNF for intraoperative intraperitoneal perfusion therapy in advanced colon cancer patients has good safety and tolerability, does not affect postoperative gastrointestinal function recovery and increase the incidence of recent postoperative complications, has no effect on liver and kidney function, coagulation function, inflammatory indicators, and has no hematological toxicity.

关 键 词：结肠肿瘤 重组改构人肿瘤坏死因子 腹腔灌注治疗 安全性 

分 类 号：R735.34[医药卫生—肿瘤]