新型静电纺丝聚乳酸-s-己内酯共聚物/纤维蛋白原复合生物补片在开放腹股沟疝术后的长期应用研究  

Long-term results of poly(L-lactic acid-co-e-caprolactone)/fibrinogen electrospun mesh in open repair of inguinal hernia

作　　者：李绍杰 唐健雄 校宏兵[2] 华蕾[3] 黄磊 平定[2] 司仙科[3] 蔡昭 LI Shaojie;TANG Jianxiong;XIAO Hongbing;HUA Lei;HUANG Lei;PING Ding;SI Xianke;CAI Zhao(Department of General Surgery,Huadong Hospital,Fudan University,Shanghai 200040,China;不详)

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

出　　处：《上海医学》2022年第4期239-244,共6页Shanghai Medical Journal

基　　金：国家自然科学基金(8217030297);上海市科学技术委员会科研项目(19DZ1930800)。

摘　　要：目的比较新型静电纺丝聚乳酸-s-己内酯共聚物[P(LLA-CL)]/纤维蛋白原(Fg)复合生物补片与猪小肠黏膜下层(SIS)补片用于开放腹股沟疝手术后的长期疗效及并发症。方法选择2014年7月—2015年2月间3家医院收治的单发侧腹股沟疝患者172例,按1∶1的比例将患者随机分为静电纺丝P(LLA-CL)/Fg复合生物补片组(试验组)、猪SIS补片组(对照组),每组各86例。两组患者均行开放腹股沟疝低张力修补+生物补片加强手术(tARB技术)治疗。分别于术后1周,术后1、3、6个月,以及术后3、6年随访时,记录主要终点(疝复发率)和次要终点(术后疼痛和并发症)。结果术后6个月,两组患者均无1例复发;术后第3年,试验组无1例复发,对照组有2例(2.53%,2/79)患者复发,两组间复发率的差异无统计学意义(P>0.05);术后第6年,试验组无1例复发,对照组有4例(5.97%,4/67)患者复发,对照组术后疝复发率显著高于试验组(P<0.05)。对照组术后1周咳嗽时疼痛VAS评分显著高于试验组同时间点(P<0.05),两组间其他时间点的疼痛VAS评分、各时间点静息时和咳嗽时简单量表评分(SVS)评估的各疼痛程度患者构成比的差异均无统计学意义(P值均>0.05)。术后1周,对照组、试验组并发症发生率分别为5.81%(5/86)、4.65%(4/86),两组间并发症发生率的差异无统计学意义(P>0.05);术后1个月,对照组并发症发生率(8.14%,7/86)显著高于试验组(1.16%,1/86,P<0.05);术后3个月,对照组并发症发生率(0)显著低于试验组(3.49%,3/86,P<0.05);术后6个月,对照组并发症发生率(5.81%,5/86)显著高于试验组(2.33%,2/86,P<0.05);术后3、6年,两组并发症发生率均为0。术后6个月,41例患者(试验组23例,对照组18例)超声检查见手术部位异常回声;术后3年,2例患者(试验组1例,对照组1例)超声检查见异常回声明显缩小;术后6年,无1例患者超声检查见异常回声。随访期间,共有11例患者(试验组5例,对照组6例)发Objective To compare the long-term efficacy and complications between poly(L-lactic acid-co-e-caprolactone)[P(LLA-CL)]/fibrinogen(Fg)composite biological mesh and porcine small intestinal submucosal mesh in open inguinal hernia surgery.Methods A prospective,randomized,single blind,controlled multicenter trial was conducted in 172 patients with unilateral inguinal hernia who were treated between July 2014 and February 2015 in three hospitals.They were randomly divided into experimental group and control group(n=86).New electrospun P(LLA-CL)/Fg composite mesh and porcine small intestinal submucosal mesh were applied in the two groups,respectively.Both groups were treated with abdominal wall reinforcement of biological technology(tARB).The patients were followed up one week,1 month,3 months,6 months,3 years and 6 years postoperatively.The primary end point was the hernia recurrence rate and secondary end point was postoperative inguinal pain and complications,including inguinal pain,surgical site infection and other complications.Results There was no recurrence in the two groups 6 months postoperatively.In the third year after operation,there was no recurrence in the experimental group and 2 cases(2.53%,2/79)of recurrence in the control group(P>0.05).In the sixth year after operation,there was no recurrence in the experimental group and 4 cases(5.97%,4/67)of recurrence in the control group,and the recurrence rate of hernia in the control group was significantly higher than that in the experimental group(P<0.05).The visual analogue scale(VAS)score when coughing one week after operation in the control group was significantly higher than that in the experimental group(P<0.05).There were no significant differences in the VAS score at other time points or SVS score at any time points between the two groups(P>0.05).One week after operation,the incidence of complications was 5.81%(5/86)in the control group and 4.65%(4/86)in the experimental group(P>0.05).One month after operation,the incidence of complications in the contr

关 键 词：复合生物材料 疝 腹股沟 开放手术 复发 并发症 

分 类 号：R656.21[医药卫生—外科学]