关键词: 纳米羟基磷灰石, 聚酰胺66, 人工椎体, 人工假体, 生物相容性

Abstract:

OBJECTIVE: To compare the safety and clinical efficacy of nano-hydroxyapatite/polyamide 66 composite bioactive artificial vertebral body versus vertebral body reconstructed with autologous bone in spinal disease treatment.
METHODS: Using “nano-hydroxyapatite/polyamide 66 artificial vertebral body, vertebral body reconstructed with autologous bone, spinal disease” in Chinese and “bioactive artificial vertebral body, spine disease" in English as the keywords, a computer search was performed for articles between January 1969 and December 2009. Articles associated with the artificial vertebral body were included; repeated study or Meta analysis articles were excluded. Thirteen articles were mainly discussed. Clinical validation was made in 36 patients with vertebral plate and body defects, who were admitted in Chongqing City Second People’s Hospital, according to the replacement, they were divided into two groups: observation group was treated with nano-hydroxyapatite/polyamide 66 bioactive artificial vertebral body, produced by Sichuan Guona Technology Co., Ltd; control group was treated with vertebral body reconstructed using autogenous iliac. At 3 days, 1 week, 2 weeks post-operation, the leukocyte count, C-reactive protein, erythrocyte sedimentation rate and other inflammatory markers were determined. At 1 and 2 weeks post-operation, the liver and kidney functions were detected. At 0, 1, 3, 6 months, the patients were rechecked using X-ray film, and using CT at 8 and 16 weeks.
RESULTS AND CONCLUSION: The artificial vertebral body can be divided into two kinds: metallic materials and composite materials; currently developed composite materials include polyether alkyl biological glass compounds, hydroxyapatite collagen hybrid materials and magnetic bio-ceramic artificial vertebral body. Clinical test results showed that, no patients appeared incision exudation, fever, rash and other immune rejections, Ⅰ stage wound healing was observed. Postoperative leukocyte count, C-reactive protein, erythrocyte sedimentation rate and other inflammatory markers, as well as liver and renal functions showed no significant differences (P > 0.05). At 8 weeks, CT showed bone conduction properties and bone formation property had no significant differences between the two groups. At 6 months, X-ray recheck demonstrated no absorption sign of artificial vertebral body, vertebral plate and surrounding sclerotin. The nano-hydroxyapatite/polyamide 66 bioactive artificial vertebral body is safe and effective in the treatment of spinal diseases, its short-term effect is similar to that of autologous iliac bone reconstructed vertebrae.