国产非吸收可崩解肠道吻合器用于肠道吻合手术的研究  

The study on validation and safety of domestic non-absorbable disintegrating anastomat for entero- anastomosis

作　　者：吴小剑[1] 王磊[1] 何晓生[1] 王红军[2] 张洁[2] 兰平[1] 王利群[2] 汪建平[1] 

机构地区：[1]中山大学胃肠病学研究所 中山大学附属第六医院结直肠外科,广州510655 [2]浙江大学高分子科学与工程学系

出　　处：《中华实验外科杂志》2010年第9期1281-1282,F0003,共3页Chinese Journal of Experimental Surgery

基　　金：广东省科技厅产学研结合项目（2009B090300466）;广州市科技计划项目（2010J-E511）

摘　　要：目的 探讨国产非吸收可崩解肠道吻合器用于动物体内肠道吻合手术的确切性和安全性.方法 以进口Valtrac生物可降解吻合环为对照,通过噻唑蓝（MTT）实验检测国产非吸收可崩解肠道吻合器的体外细胞毒性;通过肠道吻合的动物实验比较其手术并发症发生、吻合环排出体外时间、吻合口愈合情况.结果 进口和国产吻合环的MTT实验A值分别为0.616±0.028和0.601±0.048（P＞0.05）;两组吻合环肠吻合术均无术后死亡、吻合口瘘、狭窄、出血和肠梗阻等并发症发生;国产吻合环和进口吻合环崩解时间分别为（14.1±1.4）d和（14.5±1.7）d（P＞0.05）;组织学检查吻合口愈合良好.结论 国产非吸收可崩解吻合器无明显的体外细胞毒性作用;与进口吻合环比较,在动物实验上有同样的确切性和安全性.Objective To investigate the validation and safety of domestic non-absorbable disintegrating anastomat for enteroanastomosis in vivo. Methods Compared with Valtrac biofragmentale anastomosis rings （ BARs）, cytotoxicity of domestic non-absorbable disintegrating anastomat in vitro was tested by MTT. Operative complications, time for anastomat discharging and anastomotic healing were also compared through zoopery. Results Optical density of domestic non-absorbable disintegrating anastomat and Valtrac BARs by MTT were 0.616±0.028 and 0.601 ± 0.048, respectively （ P 〉 0. 05 ）. No death, anastomotic leaks, anastomotic stricture, bleeding or ileus occurred in both groups. Domestic non-absorbable disintegrating anastomat fragmented at a mean time of （14.1 ± 1.4） days （ranged from 12 to 17 days） postoperatively, while BARs fragmented at a mean time of （ 14. 5 ± 1.7 ） days （ ranged from 12 to 16 days） （P〉0.05）. Favourable anastomotic healing was detected by histological examination. Conclusion Domestic non-absorbable disintegrating anastomat for enteroanastomosis had been proved the same validation and safety as Valtrac BARs in zoopery, without any significant cytotoxicity in vitro.

关 键 词：肠道吻合器 肠道吻合术 安全 

分 类 号：R735.37[医药卫生—肿瘤]