静电纺复合生物材料与SIS生物补片在成人腹股沟疝修补术中的多中心比较研究  

Multi-center study of electrospun composite biomaterial and SIS biological mesh in adult inguinal hernia surgery

作　　者：李绍杰 唐健雄 校红兵 华蕾[3] 黄磊 平定 司仙科[3] 胡星辰 蔡昭 Li Shaojie;Tang Jianxiong;Xiao Hongbing;Hua Lei;Huang Lei;Ping Ding;Si Xianke;Hu Xingchen;Cai Zhao(Department of General Surgery,Huadong Hosptial Affiliated to Fudan University,Shanghai 200040,China;Department of General Surgery,Shanghai Tenth People's Hospital of Tongji University,Shanghai 200072,China;Department of General Surgery,Putuo Hospital Affiliated to Shanghai University of traditional Chinese Medicine,Shanghai 200062,China)

机构地区：[1]复旦大学附属华东医院普外科,上海200040 [2]同济大学医学院附属第十人民医院普外科,上海200072 [3]上海中医药大学附属普陀医院普外科,200062

出　　处：《中华疝和腹壁外科杂志（电子版）》2020年第4期336-341,共6页Chinese Journal of Hernia and Abdominal Wall Surgery(Electronic Edition)

摘　　要：目的比较静电纺复合生物材料与猪小肠黏膜下层补片修补成人腹股沟疝的疗效评价。方法收集2014年7月至2015年2月,在复旦大学附属华东医院、上海同济大学医学院附属第十人民医院和上海中医药大学附属普陀医院等3医院,单侧原发性腹股沟疝患者172例,进行随机、单盲、对照、多中心试验。将患者随机分配至静电纺复合生物材料组(试验组)或猪小肠黏膜下层补片组(对照组),每组患者86例。患者均接受腹股沟疝补片修补术(t ARB术)治疗,并在干预后1、3、6个月接受评估。主要评估指标是腹股沟疝术后复发;次要评估指标包括腹股沟疼痛、舒适感、血清肿、手术部位感染及生殖系统等术后并发症。结果随访6个月,有3例丢失,其中2例(对照组)均失去随访,1例患者(试验组)在手术区域产生炎症(暂停)。随访期间,2组均未出现疝复发的病例,对照组和试验组出现了术后并发症患者,分别为5例(5/86,5.95%)和2例(2/86,2.35%),差异无统计学意义(P>0.05),在疼痛评分上2组间未出现显著差异。结论静电纺复合生物补片可以作为一种腹股沟疝补片的选择,具有复发率低、可吸收、远期舒适性好等特点,可在临床中进一步推广运用。Objective To compare the efficacy evaluation of electrospun composite biomaterials and a porcine small intestine submucosa mesh for hernia repair.Methods A randomized,single-blind,controlled multicenter trial was performed in 3 hospitals in Shanghai.Eligible adult patients with primary unilateral reducible groin hernias were randomly assigned(1∶1)to electrospun composite biomaterials(experimental group)or porcine small intestine submucosa(control group)mesh groups.Patients were treated with the tARB technique and assessed at 1,3 and 6 months after the surgery.The primary endpoint was hernia recurrence.The secondary endpoints were postoperative complications including groin pain and operative site infections.Results 172 patients were assigned to experimental(n=86)and control(n=86)groups.At 6 months follow-up,postoperative complications occurred in 5 patients(5/86,5.95%)and 2(2/86,2.35%)patients in the control and experimental groups,respectively(P>0.05).There was no significant difference in VAS or SVS score between the two groups.Conclusion We demonstrate that electrospun composite biomaterial mesh can be used as a ideal choice for inguinal hernia repair.Electrospun composite biomaterial has the characteristics of low recurrence rate,absorbability and long-term comfort.It can be further applied in clinical practice in the future.

关 键 词：静电纺复合生物材料 猪小肠黏膜下层 单侧原发性腹股沟疝 手术 

分 类 号：R656.21[医药卫生—外科学]