佳助结扎血管夹对胆囊切除术后兔的安全性研究

目的：观察佳助结扎血管夹对胆囊切除术兔机体的影响，为临床的研究应用提供参考。方法将36只日本大耳白兔随机分成3组，即正常对照组、试验组和同类产品对照（ Hem-o-lok）组，每组12只，除正常对照组外，试验组和同类产品对照组分别用佳助结扎血管夹和Hem-o-lok结扎夹，在开腹胆囊摘除术中夹闭胆囊管及胆囊动脉。观察术后12个月内实验兔的血液生化、电解质、血液学、凝血指标、结扎效果和脏器系数的变化。结果与正常对照组比，试验组兔体重在术后3 d时明显降低（P ＜0.01），ALT在术后1周时明显升高（P ＜0.05）， CREA和ALB水平均在术后1-2周时显著降低（ P ＜0.05，P ＜0.01），NEUT数目和TG含量在术后2周时明显升高（P ＜0.05），GLU在术后1周和1个月时明显降低（P ＜0.01）；LYM和RBC数目分别在术后1个月和1周时降低显著（P ＜0.05），PLT数目在术后1-2周时均明显升高（P ＜0.01）；同类产品对照组兔体重在术后3 d-1个月时明显降低（P ＜0.05，P ＜0.01），血浆ALT、NEUT和PLT数目在术后1周时亦明显升高（P ＜0.05，P ＜0.01），ALB和GLU含量在术后2周时均明显降低（P ＜0.01），TC含量在术后1-2周时则明显升高（P ＜0.05）；其它时间段，试验组和同类产品对照组兔体重、血液生化指标、血液学参数均与正常对照组比无明显影响（P ＞0.05）；术后各组电解质指标、凝血指标和脏器系数亦均无明显差异（P ＞0.05）。结论佳助结扎血管夹在兔夹闭胆囊管残端和血管中的应用是安全、可靠的，其安全性与Hem-o-lok结扎夹基本一致。

Safety study on jiazhu vascular ligating clips in rabbits after laparoscopic cholecystectomy

Objective To provide an experimental reference for clinic application of Jiazhu vascular ligating clips on ligation effects and the impact on the body in rabbits after laparoscopoic cholecystectomy.Methods 36 rabbits were randomly divided into 3 groups, normal control group, Jiazhu group and similar product control （ Hem-o-lok） group, 12 rabbits in each group.Except for normal control group, the rabbits were used gallbladder duct and gallbladder artery closed by vascular ligating clips and Hem-o-lok clips in Jiazhu group and similar product control group, respectively.The changes of blood biochemical, electrolytes, hematological parameters, coagulation, ligation effects and organ coefficients were observed at post-operation during 12 months.Results Compared with normal control group, the rabbit weight was reduced in the Jiazhu group at 3 days postoperatively （ P 〈0.01 ） , ALT level was increased at 1week postoperatively （ P 〈0.05）, CREA and ALB levels were all significant decreased at 1-2 weeks postoperatively （P 〈0.05, P 〈0.01）, NEUT numbers and TG content were significant increased at 2 weeks postoperatively （ P 〈0.05 ） , GLU content was significant decreased at 2 weeks and 1 month postoperatively （ P 〈0.01 ）; LYM and RBC numbers were significant decreased at 1 month and 1 week postoperatively （P 〈0.05）, respectively.PLT numbers were significant increased at 1-2 weeks postoperatively （ P 〈0.01） .While the rabbit weight was reduced in the Hem-o-lok group between 3 days and 1month postoperatively （P 〈0.05, P 〈0.01）, and ALT level, NEUT and PLT numbers were increased at 1 week postoperatively （P 〈0.05, P 〈0.01）, ALB and GLU contents were all significant decreased at 2 weeks postoperatively （P 〈0.01）, TC content was significant increased at 1-2 weeks postoperatively （P 〈0.05）.The rabbit weight, blood biochemical and hematological parameters in the Jiazhu group and Hem-o-lok group were all no significant differences with normal control group