超声辅助可吸收螺钉的体内生物安全性及组织相容性  

In vivo biosafety and histocompatibility of absorbable poly-D,L-lactic acid screws implanted with ultrasound-assisted technology

作　　者：雷森林 刘宏远 杨红胜[2] 熊燕[1] 段宏[1] Lei Senlin;Liu Hongyuan;Yang Hongsheng;Xiong Yan;Duan Hong(Department of Orthopedics,West China Hospital of Sichuan University,Chengdu 610041,Sichuan Province,China;The First Affiliated Hospital of Chengdu Medical College,Chengdu 610500,Sichuan Province,China)

机构地区：[1]四川大学华西医院骨科,四川省成都市610041 [2]成都医学院第一附属医院,四川省成都市610500

出　　处：《中国组织工程研究》2020年第34期5454-5460,共7页Chinese Journal of Tissue Engineering Research

基　　金：四川省卫生厅资助项目(18PJ469),项目负责人:段宏;四川省科技厅支撑计划项目(2018FZ0033),项目负责人:段宏。

摘　　要：背景:根据外消旋聚乳酸玻璃化温度低的特点,课题组研制了治疗肢体骨折的超声焊接装置和配套使用的外消旋聚乳酸可吸收螺钉,但超声作用下外消旋聚乳酸物理性状改变对材料安全性及高强度超声作用于可吸收螺钉时对周围局部组织的影响尚不清楚。目的:评估超声辅助外消旋聚乳酸可吸收螺钉在大鼠体内的生物安全性和组织相容性。方法:在24只成年SD大鼠右胫骨干前侧制造直径1.6 mm的骨缺损模型,随机分为2组,实验组在超声辅助下植入外消旋聚乳酸可吸收螺钉,对照组不植入任何材料。术后1,3,7,14d及2,4,6,8周时检测血常规、血生化及血清炎性指标;术后2周及1,3,6个月进行骨缺损大体标本、X射线片及组织学观察。实验已获得四川大学华西医院动物伦理审查中心批准。结果与结论:①两组大鼠术后伤口均恢复良好,无感染及排异征象,术后血常规、生化、炎性指标均未见异常波动;②大体观察显示,至术后1个月时,实验组螺钉开始降解,周围有少量软骨痂向中间爬行;至术后6个月时,螺钉植入区周围有较多新生骨质长入,周围组织无异常反应增生;③X射线片显示,实验组骨缺损范围逐渐缩小,至术后6个月时有大量新生骨长入,始终未见周围骨质异常反应;④组织学观察显示,术后2周时,螺钉与宿主骨界面清晰,未见周缘骨小梁向材料内部长入,可见纤维组织增生包裹材料表面;此后螺钉逐渐降解,新生骨组织逐渐增多并分化成熟;⑤结果表明,超声辅助外消旋聚乳酸可吸收螺钉具有良好的生物安全性和组织相容性,可在体内逐步降解。BACKGROUND:According to the characteristics of low glass transition temperature of poly-D,L-lactic acid,we developed a new ultrasonic welding device to treat limb fractures with restorable poly-D,L-lactic acid screws.But whether the physical properties of poly-D,L-lactic acid changed by ultrasound has impact on material safety is unknown.In addition,under high intensity ultrasound action,the effects of absorbable screws on tissues around the absorbable screws remain unclear.OBJECTIVE:To evaluate the biosafety and histocompatibility of ultrasound-assisted absorbable poly-D,L-lactic acid screws in rats.METHODS:Twenty-four adult SD rat models of 1.6 mm-sized bone defects were made in the anterior side of the right tibial shaft,and then randomly divided into two groups.Absorbable poly-D,L-lactic acid screws were implanted in the experimental group and nothing was implanted in the control group.At postoperative 1,3,7 and 14 days and 2,4,6,and 8 weeks,routine blood tests,blood biochemical and serum inflammatory indicators were detected.At postoperative 2 weeks and 1,3 and 6 months,gross observation,X-ray imaging,and histological observation of the bone defects were performed.This study was approved by the Animal Ethics Committee,West China Hospital of Sichuan University,China.RESULTS AND CONCLUSION:(1)In both experimental and control groups,after surgery,wounds healed well without signs of infection and rejection,and there were no abnormal fluctuations in routine blood tests,biochemical and inflammatory indicators.(2)Gross observation revealed that by 1 month after surgery,absorbable poly-D,L-lactic acid screws began to degrade with a small amount of cartilage callus crawling towards the center;by 6 months after surgery,there were a large amount of new bone around the screws,and no abnormal reactive hyperplasia was observed in the surrounding tissues.(3)X-ray showed that the bone defect area in the experimental group was gradually reduced,and by 6 months after surgery,there were a large amount of new bone,and no abnorm

关 键 词：超声辅助 超声焊接 可吸收材料 可吸收螺钉 外消旋聚乳酸 骨缺损模型 生物安全性 组织相容性 

分 类 号：R459.9[医药卫生—治疗学] R318.08[医药卫生—临床医学]