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载有甲氨蝶呤的肿瘤细胞来源的囊泡术中喷涂降低消化系统恶性肿瘤术后局部复发风险的临床疗效
隋晓军,李岩,孙向宇,张大鹏,张晖,李棣华,杨磊
天津医科大学附属南开医院天津 300100;天津市急腹症器官损伤与中西医修复重点实验室天津 300100;天津市中西医结合急腹症研究所天津 300100
摘要:
目的:探讨术野喷涂载有甲氨蝶呤的肿瘤细胞来源的囊泡(MTX-TMPs)在消化系统恶性肿瘤根治术中的安全性,探索其对术区局部残留病灶的清除作用及降低局部复发风险的潜在价值。方法:回顾性研究我院2022年4月—2023年3月术野喷涂MTX-TMPs的28例患者(载药囊泡组)与2021年4月—2022年3月未喷涂MTX-TMPs的46例患者(对照组)的临床资料。比较两组患者的一般情况、肝肾功能、术后并发症及生存时间等指标。结果:载药囊泡组术前、术后直接胆红素、谷丙转氨酶水平均低于对照组,术后血红蛋白水平高于对照组,差异有统计学意义(P <0.05)。两组肾功能比较差异无统计学意义(P >0.05)。两组术中出血量、手术时间、术后并发症发生率及术后住院时间比较差异均无统计学意义(P >0.05)。生存分析显示,载药囊泡组中位总生存时间及无复发生存时间均显著高于对照组(P <0.05)。进一步采用多因素Cox比例风险回归模型校正TNM分期后,组别对总生存时间(HR=0.383,95%CI 0.127~1.159,P =0.09)及无复发生存时间(HR=0.445,95%CI 0.153~1.297,P =0.138)均无独立预后影响,提示两组生存差异可能受基线特征不均衡影响。结论:载药囊泡在术区局部应用表现出良好的安全性,未对患者肝肾功能产生不良影响,亦未增加术中出血量、手术时间及术后并发症发生率。该治疗显示出一定的潜在疗效,对降低术区局部复发风险具有潜在价值。
关键词:  载药囊泡  恶性肿瘤  术中喷涂  局部复发  术区局部辅助治疗
DOI:10.3969/j.issn.1007-6948.2026.04.014
投稿时间:2025-11-08
基金项目:天津市教委科研计划项目(2024KJ243);河北省中医药管理局科研计划项目(T2025037)
Clinical efficacy of intraoperative spraying of methotrexate-loaded tumor cell-derived microparticles for reducing postoperative local recurrence risk of digestive system malignancies
SUI Xiao-jun,LI Yan,SUN Xiang-yu
Abstract:
Objective To investigate the safety of intraoperative topical spraying of methotrexate-loaded tumor cell-derived microparticles (MTX-TMPs) in radical surgery for digestive system malignancies and to explore their potential value in clearing residual local lesions and reducing the risk of local recurrence. Methods A retrospective study was conducted using clinical and follow-up data from patients who received intraoperative topical spraying of MTX-TMPs between April 2022 and March 2023(MTX-TMPs group, n=28), and those who did not receive MTX-TMPs between April 2021 and March 2022(control group, n=46). General conditions, liver and kidney function, postoperative complications, and survival outcomes were compared between the two groups. Results Preoperative and postoperative levels of direct bilirubin and alanine aminotransferase were significantly lower in the MTX-TMPs group than in the control group (P <0.05), while postoperative hemoglobin level was higher in the MTX-TMPs group (P <0.05). No statistically significant differences were observed in renal function between the two groups (P >0.05). Intraoperative blood loss, operative time, postoperative complication rate, and postoperative hospital stay were comparable between the two groups (P >0.05). Survival analysis showed that the median overall survival and recurrence-free survival were significantly longer in the MTX-TMPs group than in the control group (P <0.05). However, after adjusting for TNM stage using multivariate Cox proportional hazards regression model, the group variable was not an independent prognostic factor for overall survival (HR=0.383, 95%CI 0.127-1.159, P =0.09) or recurrence-free survival (HR=0.445, 95%CI 0.153-1.297, P =0.138), suggesting that the survival differences might be influenced by baseline imbalances. Conclusion Topical application of MTX-TMPs in the surgical field demonstrates favorable safety, with no adverse effects on liver or kidney function, and no increase in intraoperative blood loss, operative time, or postoperative complications. The treatment also shows potential efficacy in reducing the risk of local recurrence.
Key words:  Drug-loaded microparticles  malignant tumors  intraoperative spraying  local recurrence  local adjuvant treatment in surgical area

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