善释Ⅱ~组织修补片在腹股沟疝无张力修补术中的临床验证研究

目的通过应用善释Ⅱ(EasyProsthesis Ⅱ)部分可吸收材料疝修补片与强生公司的超普(Ultrapro)补片进行腹股沟疝无张力修补术的对比研究,初步验证国产部分可吸收材料疝补片的应用价值。方法试验组使用善释Ⅱ补片,对照组使用超普补片,每组各30例患者。记录二组患者手术前后的临床参数及术后各种并发症的发生例数,并对数据进行统计学分析。结果经统计分析,二组患者在手术时间、术后的最高体温、住院天数、术后CRP升高的例数以及术前术后24 h的血白细胞计数、中性粒细胞分类计数和生化的AST、ALT、BUN、Cr的数值等方面差异均无统计学意义。术后随访6个月,二组均未出现伤口感染、复发、慢性疼痛、男性患者的睾丸肿大或萎缩。试验组术后有2例出现阴囊积液,6例出现轻度伤口红肿;对照组术后有1例发生阴囊积液,5例出现轻度伤口红肿。经统计学分析,二组在术后并发症方面的差异无统计学意义。结论善释Ⅱ补片在腹股沟疝无张力修补术中的应用是安全有效的。

Application of EasyProsthesis Ⅱ~ mesh in tension-free herniorrhaphy for inguinal hernias

Objective To evaluate the effect of EasyProsthesis Ⅱ mesh in tension-free repair of inguinal hernias initially,by the controlled study of application with Ultrapro mesh in herniorrhaphy.Methods A total of 60 patients were divided into 2 groups to receive EasyProsthesis Ⅱ mesh(experiment group) or Ultrapro mesh(control group) repair procedure.Data collected included:operation time,postoperative highest temperature and the day of hospital stay;leucocyte count and differential count,the count of CRP,AST,ALT,BUN,Cr in preoperative and postoperative 24 hours;the cases of postoperative complications including wound infection,recurrence,testicular swelling or atrophy,scrotal hydrocele,chronic pain and foreign body feeling.The data were analyzed by statistical method.Results By the statistical analysis,no significant differences were found between the two groups in the operation time,postoperative highest temperature,the day of hospital stay,and the cases of elevated count in postoperative CRP;no significant differences in the leucocyte count,differential count,and the count of AST,ALT,BUN,Cr in preoperative and postoperative 24 hours.During the follow up period of 6 months,there was no wound infection,recurrence,chronic pain,testicular swelling or atrophy in the two groups;There were 2 cases of scrotal hydrocele and 6 case of postoperative red swelling of the skin in experiment group,there were 1 cases of scrotal hydrocele and 5 cases of postoperative red swelling of the skin in control group,by the statistical analysis,no significant differences were found between the two groups.Conclusions The application with EasyProsthesis Ⅱ mesh in tension-free herniorrhaphy is safety and available.