n-HA/PA66 Cage在腰椎融合术中的生物安全性研究

The Applied Biology Safety of Transforaminal Lumbar Interbody Fusion with n-HA/PA66 Cage

目的评价新型纳米羟基磷灰石/聚酰胺66融合器(nano-hydroxyapatite/polyamide66Cage,n-HA/PA66Cage)植入人体内可能引起的全身毒性反应及对人体局部组织的影响。方法 2012年2月至2012年4月将n-HA/PA66Cage通过腰椎后路经椎间孔进行腰椎椎体融合植入20例患者体内,通过对研究对象检查术前、术后4d、术后2个月等3个时期的血压、脉搏、体温、免疫球蛋白A、G、M、补体C3、C4、谷丙转氨酶、谷草转氨酶、肌酐、尿素、白细胞、红细胞、血红蛋白、血小板、C反应蛋白、血沉、局部反应等指标。结果 n-HA/PA66Cage植入人体后,除了术后4d白细胞、红细胞、血红蛋白、血小板等血常规、C反应蛋白、血沉等检查与术前相比,存在统计学差异(P<0.05);在不同时相,其他检查结果之间无统计学意义(P>0.05)。结论新型n-HA/PA66Cage具有良好的生物安全性。

Objective To investigate the toxic reaction on the whole body and the local tissue stimulation reaction induced by the nano hydroapatite crystals and polyamide composite（n-HA/PA66）. Methods n-HA/PA66 Cages were planted into twenty patients with transforaminal lumbar interbody fusion from February to April, 2012,blood press, pluse, temperature, IgA, IgG, IgM, C3, C4, ALT, AST, Cr, BUN, WBC, RBC, Hb, PLT, CRP, ESR and local reaction were measured from the twenty patients in preoperation,four days and two weeks after the operation. Results After n-HA/PA66 Cage implantation .there were the significant different between preoperation and four days after operation in the WBC,RBC,Hb,PLT,CRP,ESR. there were no significant different among the other observed data in the differ ent points（P〉0. 05）. Conclusion The new type n HA/PA66 Cage has the good biosecurity.