PLGA可吸收螺钉肌肉植入后的组织病理学观察  

Histopathological examination of PLGA absorbable screw after muscle implantation

作　　者：王涵[1] 雷昊[1] 王召旭[1] 周小婷[1] 王春仁[1] 

机构地区：[1]中国食品药品检定研究院,北京100050

出　　处：《药物分析杂志》2014年第9期1654-1659,共6页Chinese Journal of Pharmaceutical Analysis

基　　金：国家科技支撑计划项目:医疗器械质量评价;标准研究与医疗安全产品开发(2012BAI22B01)

摘　　要：目的:对聚丙交酯-乙交酯(PLGA)可吸收螺钉进行肌肉植入试验,以评价其植入后的组织学反应,提供PLGA螺钉安全性的相关信息,为可吸收钉固定器在临床上的应用提供依据。方法:采用Wistar大鼠脊柱旁肌植入方式,左侧植入2个对照材料(美国药典高密度聚乙烯),右侧植入2个样品(PLGA螺钉原材料),各时间点植入5只动物。植入后1、4、12、26、36周分别无痛处死动物,采用常规苏木精-伊红染色方法观察各时间点对照组与样品组的局部组织学反应。结果:植入后1、4、12、26周对照组与样品组组织学反应无显著差异,炎性反应分级分别为Ⅱ-Ⅲ级、Ⅱ级、Ⅰ级、Ⅰ级,纤维囊腔形成分级分别为Ⅱ-Ⅲ级、Ⅱ级、Ⅰ级、Ⅰ级。植入36周对照组与样品组纤维化程度无差异,均为Ⅰ级;对照组炎性反应分级为Ⅰ级;样品组10个材料中有1个材料完全降解、炎性反应分级为Ⅰ级,其余样品未完全降解、炎性反应分级为Ⅱ级。结论:PLGA可吸收螺钉肌肉植入后具有较好的组织相容性。Objective：To evaluate the histological responses after muscle implantation of PLGA absorbable screw and to provide safety information of the screw and reference for clinical application. Methods：The implants were inserted in the paravertebral muscles of the Wistar rats. Two reference materials（ high density polyethylene from USP） and two samples（ raw materials of PLGA absorbable screw） were implanted in the left and right paravertebral muscles respectively.Five animals were used for each implantation period. The animals were sacrificed at 1,4,12,26,36 weeks after surgery and then the histological responses was evaluated by hematoxylineosin staining. Results：There was no significant difference between the control group and the sample group in histological responses after 1,4,12,26 weeks of implantation. The grading wasⅡ-Ⅲ,Ⅱ,Ⅰ,Ⅰrespectively for the inflammatory reaction and for fibrous capsule of the tissue around the grafts in sample and control groups. After 36 weeks of implantation the control group was gradedⅠ for the inflammatory reaction and fibrous capsule. One out of the ten samples was degraded totally and was gradedⅠ for the inflammatory reaction; the remaining samples were not completely degraded and were graded Ⅱfor the inflammatory reaction. All the samples were gradedⅠ for fibrous capsule. Conclusion：The PLGA absorbable screw proves good tissue biocompatibility.

关 键 词：聚丙交酯-乙交酯 生物材料 可吸收钉 生物相容性 肌肉植入 炎症反应 组织学反应 

分 类 号：R917[医药卫生—药物分析学]