猪小肠黏膜下层生物补片应用于腹股沟疝修补术的远期疗效  

Long-term effects of porcine small intestinal submucosa biologic mesh in inguinal hernia repair

作　　者：李宝山 代金明 满艺[1] 张新[1] 翟晖 陈影 谢加东[1] 胡巍 黄皇[1] 王荫龙[1] 马宏光[3] Li Baoshan;Dai Jinming;Man Yi;Zhang Xin;Zhai Hui;Chen Ying;Xie Jiadong;Hu Wei;Huang Huang;Wang Yinlong;Ma Hongguang(Department of Hernia and Abdominal Wall Surgery,Tianjin People′s Hospital,Tianjin 300121,China;Beijing Datsing Bio-tech Co.,Ltd,Beijing 100085,China;Department of General Surgery,China-Japan Friendship Hospital,Beijing 100029,China)

机构地区：[1]天津市人民医院疝和腹壁外科,300121 [2]北京大清生物技术股份有限公司,100085 [3]北京中日友好医院普通外科,100029

出　　处：《中华消化外科杂志》2021年第7期810-814,共5页Chinese Journal of Digestive Surgery

基　　金：国家重点研发计划(2017YFC1104704)。

摘　　要：目的探讨猪小肠黏膜下层(SIS)生物补片应用于开放Lichtenstein无张力疝修补术的远期疗效。方法采用前瞻性随机对照研究方法。选取2013年8月至2014年3月2家医疗中心收治的76例(天津市人民医院52例、北京中日友好医院24例)单侧腹股沟疝行开放Lichtenstein无张力疝修补术病人的临床资料。按随机数字表法分为2组,使用Biodesign Surgisis补片为对照组,使用SIS生物补片为试验组。观察指标:(1)入组病人分组情况。(2)术后远期疗效。通过电话、短信或邮寄信件方式进行随访,病人因其他原因死亡或出现疝复发视为随访终点事件。随访时间截至2019年12月。正态分布的计量资料以x±s表示,组间比较采用t检验。偏态分布的计量资料以M(范围)表示,组间比较采用Mann-Whitney U检验。计数资料以绝对数表示,组间比较采用χ^(2)检验和Fisher确切概率法。结果(1)入组病人分组情况:筛选出符合条件的病人76例。76例病人中,对照组和试验组各38例。对照组病人性别(男、女),年龄,体质量指数,麻醉方式(椎管内麻醉、局部麻醉),手术部位(腹股沟左侧、腹股沟右侧),Gilbert分型(GilbertⅠ型、GilbertⅡ型、GilbertⅢ型、GilbertⅣ型、GilbertⅤ型),手术时间分别为35、3例,(56±15)岁,(23.0±2.0)kg/m^(2),22、16例,16、22例,9、16、0、11、2例,(49±15)min;试验组病人上述指标分别为34、4例,(54±13岁),(22.9±2.2)kg/m^(2),17、21例,14、24例,9、21、1、7、0例,(53±21)min。两组病人上述指标比较,差异均无统计学意义(χ^(2)=0.157,t=0.532、0.367,χ^(2)=1.317、0.220,Z=-0.315,t=-0.765,P>0.05)。(2)术后远期疗效:对照组35例病人获得随访,其中4例因其他疾病死亡,随访时间为(68.8±2.7)个月,疝复发、慢性疼痛各1例,无异物感、术后感染发生。试验组31例病人获得随访,无因其他疾病死亡病例,随访时间为(68.8±2.7)个月,无上述并发症发生。两组病人疝复发、术后�Original Article Long-term effects of porcine small intestinal submucosa biologic mesh in inguinal hernia repair Li Baoshan,Dai Jinming,Man Yi,Zhang Xin,Zhai Hui,Chen Ying,Xie Jiadong,Hu Wei,Huang Huang,Wang Yinlong,Ma Hongguang Published 2021-07-20 Cite as Chin J Dig Surg,2021,20(7):810-814.DOI:10.3760/cma.j.cn115610-20210603-00262 Abstract Objective To investigate the long-term effects of porcine small intestinal submucosa(SIS)biologic mesh in open Lichtenstein tension-free hernia repair.Methods The prospective randomized controlled study was conducted.The clinical data of 76 patients with unilateral inguinal hernia who underwent open Lichtenstein tension-free hernia repair in 2 medical centers(52 cases in Tianjin People′s Hospital and 24 cases in China-Japan Friendship Hospital)from August 2013 to March 2014 were selected.Based on random number method,patients were allocated into two groups.Patients undergoing Lichtenstein tension-free hernia repair using Biodesign Surgisis mesh were allocated into control group,and patients undergoing Lichtenstein tension-free hernia repair using SIS biologic mesh were allocated into experiment group.Observa-tion indicators:(1)grouping situations of the enrolled patients;(2)postoperative long-term effects.Follow-up was conducted using telephone interview,text message or mail to detect hernia recurrence or death due to other reasons as the end-point event of patients up to December 2019.Measurement data with normal distribution were represented as Mean±SD,and comparison between groups was conducted using the t test.Measurement data with skewed distribution were represented by M(range),and comparison between groups was conducted using the Mann-Whitney U test.Count data were described as absolute numbers,and comparison between groups was conducted using the chi-square test or Fisher exact probability.Results(1)Grouping situations of the enrolled patients:a total of 76 patients were selected for eligibility.There were 38 cases in the control group and the experiment group,resp

关 键 词：疝 腹股沟 LICHTENSTEIN 生物补片 猪小肠黏膜下层 复发 感染 慢性疼痛 

分 类 号：R656.21[医药卫生—外科学]