用7种医疗用品原料比较家兔肌肉植入试验两种评价方法的检测敏感性

Comparison of biocompatibility of two evaluation methods in rabbit muscle implantation test with seven kinds of medical raw materials

目的:采用兔组织反应分级法和半定量分值评价法检测7种医疗用品原料在短期和长期肌肉植入后的组织刺激反应,探讨两种方法用于生物相容性评价的敏感性。方法:采用兔同体左、右侧自身对比法。选择84只新西兰白兔,分别将同一检测样品和对照样品植入到左侧和右侧脊柱旁肌4个植入点,间隔距离2.5 cm。植入后第15、30、60和90天分别处死3只兔,取植入点含样品的背部肌肉组织1.0~1.5 cm^(3),按照GB/T 16886标准要求,进行大体观察是否存在出血、炎性变后,在显微镜下计数炎性细胞数量和观察组织增生反应指标,进行分级和半定量计分,根据左、右侧平均分值的差值确定分级或刺激程度。结果:组织反应分级法出现轻度刺激的检测样品分别为植入后第60天的3、5号,植入后第90天的3号;半定量分值评价法出现轻度刺激的检测样品分别为植入后第30天的5号,植入后第60天的3、4、6号,植入后第90天的3、5号。两种观察炎性反应和组织反应方法及时间点的敏感性有较大区别。结论:半定量分值评价方法优于组织反应分级方法;植入多个时间点优于一个时间点;样品植入≥60 d检出敏感性更高。

OBJECTIVE:To investigate sensitivities of two methods and four time points for detecting muscle implantation.Consequently,the rabbit tissue response grading method and semi quantitative score evaluation method were used to detect tissue stimulation responses to seven kinds of medical materials after shortterm and long-term muscle implantation.METHODS:The left and right sides of 84 New Zealand white rabbits were compared in this investigation.The same test and control samples were implanted into the left and right paraspinal muscles at 4 implantation points with an interval of 2.5 cm.On the 15th,30th,60th and 90th day after implantation,3 rabbits were killed respectively,and the 1.0-1.5 cm^(3) of back muscle tissues which contained the implanted samples were removed.The numbers of inflammatory cells were counted microscopically.Proliferative reaction indexes were graded and semi quantitative scorings were performed according to the GB/T 16886 standard.The gradings or stimulation degrees were determined according to the difference between the total average scores from the left and right sides.RESULTS:The samples which showed mild irritation by tissue response grading method were No.3,No.5(60 days after implantation)and No.3(90 days after implantation).The samples which showed mild irritation by the semi quantitative score evaluation method were No.5(30 days after implantation),No.3,No.4,No.6(60 days after implantation),No.3 and No.5(90 days after implantation).The sensitivity of the two methods and time points to observe inflammatory reactions and tissue reactions were different.CONCLUSION:The semi-quantitative score evaluation method was better than the tissue reaction grading method.In addition,multiple implantation time points were better than one time point and the detection sensitivities for sample implantation were better after 60 d.