医用聚丙烯酰胺水凝胶国内基础研究评析

目的：聚丙烯酰胺水凝胶产品虽经国家有关部门检测合格，但有无细胞毒性，注入体内后组织相容性如何，有无毒副作用需实验研究证实。方法：综合国内相关文献进行分析评价。结果：国内11篇相关此产品的研究通过对成纤维细胞L929及神经元细胞的细胞毒性实验，注入小白鼠、大白鼠、豚鼠、兔、香猪体内(皮下、肌肉、神经干周围、乳腺下)后，组织学、免疫学及排出试验等证实无细胞毒性，组织相容性好，较硅凝胶胶原蛋白反应轻微。结论：此产品符合国家标准，是当前较为安全的软组织充填材料，远期效果有待进一步观察。

REVIEW OF THE MEDICAL POLYACRYLAMIDE GEL (PAG)EXPERIMENTAL STUDY IN CHINA

Objective:Although polyacrylamide gel complies with the requirements of SDA in China,its cell toxicity,histocompatibility and side effects should be studied experimentally Methods:To review the references published in China and to analyse and evaluate it Results:There are 11 artical have been published in China about PAG cell toxicity on fibroblast L 929 and neuronal cell,histology and immunity reaction of PAG which was injected into mice,rats,guinea pigs,rabbits and pigs the results showed that there was no cell toxicity,good histocompatibility,less reaction than that of silicone gel,collagen protein Conclusion:PAG is coincidence with Chinese SDA standard It is a safe soft implanted material Long term follow up should be done in the future [