益气导滞方促进胃癌术后胃肠功能恢复随机对照研究  

Yiqi Daozhi Formula Promotes Gastrointestinal Function Recovery after Gastric Cancer Surgery:A Randomized Controlled Trial

作　　者：南海鸥 蔡雨玲 徐鹏演 李嘉宇 朱永康[1] 江志伟 王刚[1] NAN Hai-ou;CAI Yu-ling;XU Peng-yan;LI Jia-yu;ZHU Yong-kang;JIANG Zhi-wei;WANG Gang(Department of General Surgery,Affiliated Hospital of Nanjing University of Chinese Medicine,Nanjing,210029)

机构地区：[1]南京中医药大学附属医院普外科,南京210029

出　　处：《中国中西医结合杂志》2025年第1期25-31,共7页Chinese Journal of Integrated Traditional and Western Medicine

基　　金：江苏省重点学科项目(No.ZDXK202251);江苏省中医院人才引进项目(No.grjj0250)。

摘　　要：目的研究益气导滞方用于胃癌术后胃肠功能恢复的有效性及安全性。方法选择2023年4月—2024年4月行腹腔镜胃癌根治术患者67例,采用随机数字法分为治疗组(33例)和对照组(34例)。两组围手术期均采取加速康复外科模式管理,使用人工智能穿戴式心电记录仪、连续肠鸣音听诊记录仪采集数据。治疗组从术后第1—3日口服益气导滞方浓煎剂100 mL,对照组同时间每日口服100 mL清水。比较两组肠功能恢复指标(术后恢复通气时间、术后肠鸣音恢复时间,术后恢复半流质饮食时间、术后3日疼痛评分、术后住院时间),术后心率变异性指标[窦性心律RR间期标准差(SDNN)、NN间期总个数除以NN间期直方图的高度(SDANN)、相邻RR之差大于50 ms的个数占比(pNN50)、低频功率(LF)、高频功率(HF)],炎症指标[超敏C-反应蛋白(hs-CRP)、白细胞计数(WBC)、白细胞介素(IL)-1β、IL-2、IL-6、肿瘤坏死因子-α(TNF-α)、干扰素-γ(IFN-γ)]、术后并发症情况。结果与对照组比较,治疗组术后肠鸣音恢复时间、术后首次排气时间更短(P=0.001),治疗组术后第1日的hs-CRP、WBC、IL-1β、IL-2水平更低(P<0.001,P<0.05),治疗组术后第3日的hs-CRP、IL-1β、IL-2水平更低(P<0.001,P<0.05),治疗组术后第3日SDNN、SDANN、pNN50、LF水平更高(P<0.01,P<0.05)。结论益气导滞方在胃癌术后患者的应用中具有安全性,减轻了术后炎症反应,改善了自主神经功能,能够促进胃癌术后患者的早期胃肠功能恢复。(美国临床试验注册中心No.NCTO3121729)Objective To study efficacy and safety of Yiqi Daozhi Formula in the recovery of gastrointestinal function after gastric cancer surgery.Methods A total of 67 patients undergoing laparoscopic radical gastrectomy between April 2023 and April 2024 were selected and randomly assigned to a treatment group(33 cases)and a control group(34 cases)using a random number method.Both groups received perioperative management based on the Enhanced Recovery After Surgery(ERAS)protocol,with data collected using artificial intelligence-powered wearable electrocardiogram(ECG)recorders and continuous bowel sound auscultation recorders.The treatment group received 100 mL of concentrated Yiqi Daozhi Formula orally from the 1st to 3rd postoperative day,whereas the the control group reveived equal volume of plain water daily over the same period.Key indicators of gastrointestinal recovery encompassed the time to first flatus,bowel sound recovery,semi-liquid diet tolerance,pain scores on on the 3rd postoperative day,and length of hospital stay,which were compared between the groups.Additionally,postoperative heart rate variability(HRV)indices,including standard diviation of NN intervals(SDNN),standard deviation of the average NN intervals(SDANN),percentage of difference between adjacent normal R-R intervals exceeding 50 milliseconds(pNN50),low frequency(LF),and high frequency(HF)were evaluated.Inflammatory biomarkers such as high-sensitivity C-reactive protein(hs-CRP),white blood cell(WBC),interleukin(IL)-1β,IL-2,IL-6,tumor necrosis factor-α(TNF-α),interferon-γ(IFN-γ)were assessed,alongside the incidence of postoperative complications.Results Compared to the control group,the treatment group exhibited reduced bowel sound recovery time and earlier onset of first flatus(P=0.001).On the 1st postoperative day,the treatment group exhibited decreased levels of hs-CRP,WBC,IL-1β,and IL-2(P<0.001,P<0.05).By the 3rd postoperative day,the treatment group continued to show lower levels of hs-CRP,IL-1β,and IL-2(P<0.001,P<0.05).Furthermore,the

关 键 词：胃癌 益气导滞方 中药复方 胃肠功能 心率变异性 肠鸣音 人工智能 随机对照试验 中西医结合 

分 类 号：R273[医药卫生—中西医结合]