主动灌洗引流技术应用于高位复杂性肛瘘手术后创面的前瞻性、多中心、随机对照研究  

A prospective,multicentre and randomised controlled study of initiative irrigation and drainage treatment(IIDT)after high complex anal fistula operation

作　　者：张昊悦 朱慧婷 吴鸿浩 王业皇[1] 嵇灵[1] 王雅娴 章阳[1,2] Haoyue Zhang;Huiting Zhu;Honghao Wu;Yehuang Wang;Ling Ji;Yaxian Wang;Yang Zhang(Colon and Rectal Surgery,Nanjing Hospital of Chinese Medicine Affiliated to Nanjing University of Chinese Medicine,Nanjing 210000,China;Jiangsu Clinical Innovation Center For Anorectal Diseases of T.C.M.,Nanjing 210000,China;Department of Anorectal Surgery,Nanjing Pukou Hospital of Traditional Chinese Medicine,Nanjing 210000,China)

机构地区：[1]中医药大学附属南京中医院肛肠一科,210000 [2]江苏省中医肛肠疾病临床医学创新中心,210000 [3]浦口区中医院肛肠科,南京210000

出　　处：《中华结直肠疾病电子杂志》2025年第1期62-70,共9页Chinese Journal of Colorectal Diseases(Electronic Edition)

基　　金：全国名老中医药专家传承工作室建设项目(No.WYH-2022-GJ王业皇)江苏省中医药管理局中医药科技发展计划面上项目(No.MS2021034)南京市卫健委卫生科技发展专项重点项目(No.ZKX21059)。

摘　　要：目的探讨主动灌洗引流技术(IIDT)对高位复杂性肛瘘患者术后创面及细胞因子的影响。方法本研究是前瞻性、多中心、随机对照研究,纳入江苏省7家医院结直肠外科160例高位复杂性肛瘘患者资料。患者被随机分配到IIDT试验组(IIDT组)或凡士林纱布敷料换药组(对照组)。主要观察指标是7天内的疼痛评分。次要观察指标为生活质量评分、愈合时间、瘘管闭合率和细胞因子指标变化。结果每组共纳入72例患者统计数据。两组间瘘管闭合率差异无统计学意义(对照组93.1%,IIDT组91.7%;χ2=0.098,P=0.754)。在使用IIDT的第一天(Z=-10.533,P<0.001)、三天(Z=-10.548,P<0.001)、五天(Z=-10.594,P<0.001)和第七天(Z=-10.578,P<0.001)的疼痛评分和7天内最大疼痛评分(Z=-10.262,P<0.001)均低于对照组。在生活质量评分方面,IIDT组患者在身体功能(Z=-10.358,P<0.001)、身体疼痛(Z=-3.358,P<0.001)、一般健康(Z=-2.506,P=0.012)、活力(Z=-2.564,P=0.010)、社会功能(Z=-5.632,P<0.001)和心理健康(Z=-7.617,P<0.001)方面得分较高,差异具有统计学意义。到第五天,创面肉芽组织的HE和Masson染色显示IIDT组患者的炎症细胞更少,成纤维细胞更多,IIDT组中VEGF(t=2.576,P=0.011)、FGF-2(t=-2.268,P=0.025)和TGF-β(t=2.009,P=0.046)的表达较对照组显著升高,同时炎症因子TNF-α(t=22.891,P<0.001)、IL-1β(t=-3.320,P=0.001)、IL-6(t=2.037,P=0.044)水平显著降低。Western blot分析显示,IIDT患者肉芽组织中磷酸化的p38(p-p38)蛋白显著提高(t=-2.209,P<0.001)。结论IIDT应用于高位复杂性肛瘘患者术后创面,对减轻疼痛和伤口生长速度有积极的作用,减少了炎症细胞因子TNF-α、IL-1β、IL-6表达,促进了生长因子VEGF、FGF-2、TGF-β表达。Objective To explore the effect of initiative irrigation and drainage treatment on postoperative wounds and cytokines in patients with high complex anal fistula.Methods This study was a prospective multi-center randomized controlled trial involving 160 patients who were operated on high complex anal fistulas in the Colorectal Surgery Department of 7 hospitals in Jiangsu Province.Patients were randomly assigned to receive IIDT or standard gauze dressing(control group)at a 1:1 ratio.The primary outcome was pain scores within 7 days.Secondary outcomes were quality-of-life scores,healing time,fistula closure rate and the relevant cytokine indexes.Results A total of 72 patients were included in each group.Demographics,preoperative comorbidities,and fistula type were comparable between the two groups.Additionally,no significant difference in fistula closure rate was observed between the control and IIDT groups(93.1%vs.91.7%,χ2=0.098,P=0.754).During the 5 days of IIDT,the maximum pain score in 7 days(Z=-10.262,P<0.001)and the pain scores on the postoperative day1,3,5 and 7 were lower than those of the control group(Z=-10.533,P<0.001;Z=-10.548,P<0.001;Z=-10.594,P<0.001;Z=-10.578,P<0.001).In the case of QOL scores,patients in the IIDT group had significantly higher score in physical functioning,physical pain,general health,vitality,social functioning,and mental health(Z=-10.358,P<0.001;Z=-3.358,P<0.001;Z=-2.506,P=0.012;Z=-2.564,P=0.010;Z=-5.632,P<0.001;Z=-7.617,P<0.001).By day 5,HE and Masson staining revealed fewer inflammatory cells and more fibroblasts in the IIDT group,the expression levels of VEGF,FGF-2,and TGF-βin the IIDT group were significantly upregulated from baseline(t=2.576,P=0.011;t=-2.268,P=0.025;t=2.009,P=0.046),whereas a notable reduction was found in inflammatory cytokine concentrations(TNF-α、IL-1β、IL-6)(t=22.891,P<0.001;t=-3.320,P=0.001;t=2.037,P=0.044).Western blot analysis revealed that phosphorylated p38(p-p38)protein was significantly upregulated in the granulation tissue of patients receivi

关 键 词：主动灌洗引流技术 高位复杂性肛瘘 伤口愈合 

分 类 号：R657.1[医药卫生—外科学]