新型可吸收骨蜡在骨损伤修复中的动物实验研究

Research of animal experimental on a newly absorbable bone wax in the repair of bone injury

目的:研究新型可吸收骨蜡在骨损伤修复中的有效性、安全性,并分析其对骨愈合的影响。方法:选用24只实验羊(雌雄各半),将其行胸骨正中剖开制成骨表面损伤模型,按照随机数表法将每只实验羊的6节胸骨分别纳入试验组、对照组和空白组,每组2节,试验组使用可吸收骨蜡试验品、对照组使用骨蜡对照品进行骨损伤表面填塞止血,空白组仅使用纱布按压止血,对比分析3组的止血效果。术后2周、6周、12周及26周各分别随机处死24只实验羊中的6只实验羊(雌雄各半),取胸骨行组织学、影像学和力学分析。结果:试验组与对照组在骨损伤表面止血中的有效性无差异;试验组和空白组术后2周、6周和12周的植入物与周围组织的刺激等级均为无刺激,对照组术后6周、12周为中度刺激;试验组植入物12周完全降解;试验组与空白组相比,显微结构和力学性能各项指标的差异均无统计学意义。术后6周的显微结构中,试验组与对照组的骨体积分数(BV/TV)、骨小梁数量(Tb.N)、骨小梁分离度(Tb.Sp)及骨密度(BMD)比较,差异有统计意义(t=-3.387,t=-4.405,t=3.433,t=-3.316;P<0.05);术后12周两组的BV/TV、Tb.N比较,差异有统计意义(t=-2.822,t=-2.677;P<0.05);术后26周试验组与对照组的Tb.N、Tb.Sp比较,差异有统计意义(t=-3.957,t=3.056;P<0.05)。术后12周的力学性能中,试验组与对照组损伤胸骨力学性能的三点弯曲最大力及强度比较,差异有统计意义(t=-2.583,t=-2.767;P<0.05);术后26周试验组与对照组的弹性模量、强度的差异有统计意义(t=-2.186,t=-2.168;P<0.05)。结论:新型可吸收骨蜡止血效果与不可吸收骨蜡相同,且组织相容性更佳,可完全降解吸收,与空白组具有相同的骨愈合结果,具有重要的临床使用价值。

Objective:To study the effectiveness and safety of a newly absorbable bone wax in the repair of bone injury,and analyze the influence of that on the bone healing.Methods:24 experimental goats(fifty to fifty of male and female)were selected,and they underwent median sternotomy to make the model of bone surface injury.6 sternums of each experimental goat were randomly divided into the experimental group,the control group,and the blank group according to random number table,with 2 sternums in each group.The experimental group used absorbable bone wax as experimental product,and control group used bone wax of reference product to implement tamping and hemostasis on the surface of bone injury,and blank group only used gauze to implement compression for hemostasis.The hemostatic effects among three groups were compared and analyzed.6 experimental goats(fifty to fifty of male and female)of 24 experimental goats were randomly executed at the 2nd week,6th week,12th week and 26th week after surgery.The sternums of them were analyzed by histology,iconography and mechanics.Results:There was no difference in the validity of hemostasis on the surface of bone injury between experiment group and control group.The stimulation level of the implant and periphery tissue both experiment group and blank group were nonstimulation at the 2nd w,6th w and 12th w.The control group was middle stimulation at the 6th w and 12th w.The materials of experiment group completely degraded at the 12th w.The difference of each indicator of microstructure and mechanical property between experiment group and blank group was no significant.In the microstructure of the 6th w after surgery,the differences of bone volume fraction(BV/TV),the number of bone trabecula(Tb.N),the degree of separation of bone trabecula(Tb.Sp)and bone mineral density(BMD)between experiment group and control group were significant(t=-3.387,t=-4.405,t=3.433,t=-3.316,P<0.05).The differences of BV/TV and Tb.N at 12th w after surgery between experiment group and control group were significant(t=-2.822,t=-2.677,P<0.05).The Tb.N and Tb.Sp at the 26th w after surgery between experiment group and control group were significant(t=-3.957,t=3.056,P<0.05),respectively.In the comparison of mechanical property at the 12th w after surgery,the differences in maximum force and strength of three-point bending of mechanical property of injured sternum between experiment group and control group were significant(t=-2.583,t=-2.767,P<0.05),respectively.The difference of elastic modulus and strength at the 26th w after surgery between above two groups were significant(t=-2.186,t=-2.168,P<0.05),respectively.Conclusion:The new absorbable bone wax has same hemostatic effect with non-absorbable bone wax,and it has better histocompatibility.It could be completely degraded,and it has same bone healing results with the blank group,which has important value in clinical application.