国产新型生物补片的安全性及有效性研究

摘要

目的 应用国产生物补片用于修补腹股沟疝,评价其安全性及有效性.方法 本研究采用多中心、随机、开放、平行对照临床研究,分析2015年11月至2017年5月符合纳入标准的194例腹股沟疝患者资料,由首都医科大学附属北京朝阳医院(95例)、天津市人民医院(94例)、天津医科大学总医院(5例)共同完成.将腹股沟疝患者按1∶1的比例分为2组,每组97例.试验组应用国产生物疝修补片,对照组使用同类进口疝修补片.并由同组医师在同一时期行无张力疝修补术(Lichtenstein术式),比较两种补片在手术中的使用情况及临床疗效.结果 试验组与对照组在一般情况等方面比较,差异无统计学意义(P＞0.05).术后随访6个月,2组在腹股沟区不适感、血肿及血清肿、感染、疼痛、复发等方面比较,差异无统计学意义(P＞0.05).结论 国产生物补片在腹股沟疝无张力修补术中安全有效,其优良率等效于进口同类产品.国产补片价格低廉,便于推广,为我国腹股沟疝患者提供了更优选择.%Objective To evaluate the safety and effectiveness of a new biologic domestic mesh in inguinal hernia repairment.Methods A multicenter,randomized,parallel controlled clinical study was carried out,the patients with inguinal hernia were divided into control group using imported mesh and intervention group using domestic mesh,and they underwent Lichtenstein operation by the same group of surgeons during the same period to compare the clinical curative effect.Results A total of 194 patients firom 3 clinical hernia centers were included in this study.There was no significant difference in terms of demographic characteristics,general situation and medical history.During a follow-up period of 6 months,no significant differences were noted between the two groups for foreign body reaction,homatoma,seroma,infection,groin pain,recurrence and etc.Conclusions This study suggests that the domestic biologic mesh is equivalent to imported mesh,regarding long-term outcomes as recurrence and complications.Domestic mesh has the advantages of low price and beingeasy to promote,which could be a better choice for inguinal hernia patients in China.