猪小肠黏膜下层生物补片在腹股沟疝修补术中的Ⅲ期临床试验  

Stage Ⅲ clinical trial on the application of porcine small intestine submucosa mesh in inguinal hernia repair

作　　者：张洁[1] 孙小亮[1] 王荫龙[2] 张新[2] 马宏光[1] 

机构地区：[1]中日友好医院普外科,北京100029 [2]天津市人民医院普外科,300121

出　　处：《中华疝和腹壁外科杂志（电子版）》2017年第5期344-347,共4页Chinese Journal of Hernia and Abdominal Wall Surgery(Electronic Edition)

摘　　要：目的对比北京大青生物技术有限公司生产的SIS补片与美国COOK公司生产的Surgisis补片的临床疗效,以期填补国产SIS生物补片的空白。方法前瞻性收集2013年8月至2014年3月,中日友好医院与天津市中心医院普外科住院单侧腹股沟疝患者临床资料。本研究使用非劣效试验设计,确定样本量为76例。按随机表入选试验组38例,对照组38例。腹股沟疝患者行李金斯坦平片无张力疝修补术,对试验组和对照组进行临床疗效和安全性评估。结果试验组和对照组患者在麻醉方式、手术部位、Gilbert分型及手术时间方面均无明显差异。2组的治愈率均为100%,术后随访1、4、24周及36个月患者在静息状态和咳嗽时均未出现复发。试验组未出现不良反应,对照组有5例出现不良反应,不良反应发生率13.9%。2组间不良反应发生率差比较,差异无统计学意义。结论北京大青生物技术有限公司生产的SIS补片在腹股沟疝修补术中是安全有效的。Objective To compare the clinical efficacy of small intestine submucosa（ SIS） mesh from Beijing Daqing biotechnology limited company and Surgisis mesh from American COOK Company,in order to fill the gap of domestic SIS biological mesh. Methods From August 2013 to March 2014,we conducted a multicenter,prospective single-blind randomized controlled clinical trial,in which all patients underwent Lichtenstein＇s hernioplasty. A non-inferiority test was used,and the sample size was determined to 76 patients. Patients were randomly divided into 2 groups： experimental group（ n = 38） and control group（ n = 38）. The clinical efficacy and safety were evaluated for both control group and experimental group.Results There were no significant differences between the experimental group and control group in anesthesia,surgical site,Gilbert classification and operation time. The cure rate was 100% in the two groups,and the patients were followed up at 1 week,4 weeks,24 weeks and 36 months. There was no adverse reaction in experimental group,but 5 cases in control group. The incidence of adverse reaction was13. 9%. Conclusion The clinical application of SIS mesh from Beijing Daqing biotechnology limited company is safe and effective.

关 键 词：疝 腹股沟 疝修补术 随机对照试验 

分 类 号：R656.21[医药卫生—外科学]