组织诱导性材料生物安全性评价研究策略与实践

Biosafety evaluation strategy and practice of tissue induced biomaterials

背景:组织诱导性生物材料种类复杂多样,评价标准缺乏及评价标准存在不足使得开展生物安全性评价是一个热点问题,也是一个难点问题。上述问题的存在导致生产商在开展组织诱导性医疗器械生物安全性试验研究时存在困惑。目的:在从事生物安全性实验评价的基础上,对研发阶段的材料样品应遵循的安全性评价策略,对拟上市注册的产品生物学实验项目的选择提供一些思路和借鉴。方法:对2016年度组织诱导性材料开展生物学实验项目进行了统计分析。统计结果表明,细胞毒性、刺激、致敏实验是开展最多的3大基本实验,同时仅选择刺激、致敏、细胞毒3个实验的样品有58种81批次。在文章中,其中17种材料开展了免疫毒性研究,部分样品还选择了生物降解实验。结果与结论:通过分析表明,在产品的研发及临床前评价阶段,可采取不同的实验方案或者评价策略。在研发初期,可用细胞毒性、刺激、致敏实验进行筛查;在研发后期,选择满足安全性评价要求的非常规实验,如亚慢性毒性、降解、免疫毒性等实验。

BACKGROUND:Due to the complexity of tissue induced biomaterials,the current biosafety evaluation standard is not available.For years,to choose an effective evaluation strategy and practice in tissue induced materials has been always a hot topic,but still with no conclusion.The existence of this problem results in numerous issues for manufactures when conducting the biosafety evaluation of tissue induced medical devices.OBJECTIVE:To formulate the biosafety evaluation strategy that should be followed by the material samples at the research and development stage and to provides some ideas and lessons for the selection of the product biology experimental items to be listed and registered.METHODS:In 2016,a statistical analysis was carried out for biological test items of tissue induced biomaterials.Cytotoxicity,irritation and sensitization tests were the most commonly used tests for biomaterials and medical devices.A biosafety evaluation only via the above three tests had been applied in 58 kinds of materials with 81 batches of samples.In this study,immune toxicity tests were performed in 17 kinds of materials and biodegradation tests were done in some samples.RESULTS AND CONCLUSION:It had been found that different test programs or evaluation strategies may be adopted in the product development or listing registration stage.At early stage of development,cytotoxicity,irritation and sensitization tests are suitable for sample screening.In the later stage of research and development,more in-depth tests,such as subchronic toxicity,degradation and immunity toxicity,should be employed to meet the safety evaluation requirements.