新型国产聚丙烯网塞与同类进口产品在腹股沟疝无张力修补术中的临床对比研究

Randomized controlled trial comparing a new domestic polypropylene mesh plug and imported similar product in tension-free repair of inguinal hernia

目的通过两个中心参与的一项随机对照临床试验研究,将一种国产聚丙烯补片和同类进口产品对比,以初步验证前者在无张力疝修补术中作为腹股沟疝修补材料的安全性及有效性。方法采用前瞻性随机分组对照研究分析2013年5月至2014年3月,符合要求的首都医科大学附属北京朝阳医院腹股沟患者60例和首都医科大学附属北京同仁医院患者40例。随机平均分为二组,试验组应用303(4.5 cm×9.0 cm)型聚丙烯补片(中国日照天一生物医疗科技有限公司),对照组使用Perfix plug mesh(美国Bard公司),同期由各研究中心医师按照相同的无张力疝修补术实施手术。对二组手术前后临床参数、近期临床疗效及术后并发症发生情况等方面进行统计学分析,并对异常情况及不良事件进行观察、记录及评价。结果试验组与对照组在一般资料、手术时间、术后住院时间、手术前后实验室检查等方面差异无统计学意义。术后随访6个月,二组均无术后感染和复发患者,并且在术后异物感、腹股沟区疼痛、阴囊血肿、血清肿等方面差异无统计学意义。结论国产聚丙烯补片在腹股沟疝无张力修补术中安全有效,在综合临床疗效上,优良率等效于进口同类产品。国产补片具有价格低、易于推广的优点,可满足我国广大患者的需要。

Objective A two-center randomized controlled clinical was performed to pediminarily assess the security and effectiveness of a new domestic polypropylene mesh plug as prosthesis in tension-free repair for inguinal hernia, with compared to a widely used imported similar product. Methods From May 2013 to Mareh 2014, a total of 100 cases of inguinal hernia （ineluding 60 eases in Beijing Chao-yang hospital and 40 eases in Beijing Tongren hospital）, who agreed to be included in this prospective study, were divided into 2 groups randomly ： 50 patients were treated with the domestic pelypropylene mesh （ China Rizhao Tianyi） and the other 50 with the imported one （ Bard Perfix plug）. All tension-free operations were complied with the same prineiples by eaeh surgeons. Both perioporative and postoperative variables were collected, and short-term outcomes and complications were recorded and evaluated, and all above data were analyzed statistieally. Results There were no statistically signifieant differences between the groups in terms of demographic data, operation time, postoperative hospitalization and perioperative/postoperative laboratory examination. During a follow-up period of 6 months, no recurrence and infection were observed. No significant differences were noted between the two groups for foreign body reaction, groin pain, homatoma, serema, and etc. Conclusion This randomized prospective trial suggests that the Rizhao Tianyi mesh is equivalent to Bard Perfix plug mesh, regarding short-term outcomes as recurrence and complications. Domestic mesh usually has the advantages of low price and being easy to promote, which should be in conformity with national conditions in China.