关键词: 补肾壮骨丸, 椎体成形术, 椎体再塌陷, 前瞻性队列研究

Abstract:

Objective To study the effect of Bushen Zhuanggu Pill in patients with osteoporotic vertebral compression fractures treated with primary vertebroplasty and explore its clinical efficacy and safety in preventing the recollapses of cemented vertebrae. Methods A total of 120 patients hospitalized for primary percutaneous augmentation in our department，were assigned into control group（Group A，n = 60）and experiment group（Group B，n = 60）based on different treatment options. The former was treated with calcium carbonate D3 tablets，calcitriol capsules，and alendronate to prevent osteoporosis after the operation and the latter with Bushen Zhuanggu pills on the basis of treatment for the control group. Both groups were treated continuously for 6 months，followed by sequen⁃ tial treatment for osteoporosis prevention for another 6 months. Radiographic images in the osteolysis zone around the femoral prosthesis were adjudicated concerning the changes in the height of wounded vertebrae at 0，6 and 12 months after treatment. A total of 7 mL of venous blood was collected from each participant at 0，6 and 12 months after treatment for detections of the levels of osteocalcin，β⁃C⁃terminal telopeptide of type I collagen，N⁃terminal propeptide of type I collagen，inflammatory factors interleukin⁃6（IL⁃6），C⁃reactive protein（CRP）and tumor necrosis factor⁃ɑ（TNF⁃ɑ）. Results Totally，117 of the 120 patients completed the follow⁃ups，and 3 missed the follow⁃ups due to reoperation or unknown reasons. The experimental group was better than the control group in delaying the recollapse of cemented vertebrae. Bushen Zhuanggu Pills combined with calcium carbonate D3 tablets， calcitriol capsules，and alendronate to prevent osteoporosis delayed the recollapse of cemented vertebrae after primary percutaneous augmentation for the inhibition mechanism on the formation of osteoclasts by way of activating inflammatory factors such as IL⁃6，CRP，TNF⁃ɑ and ultimately delaying the recollapse of cemented vertebrae.Conclusion Bushen Zhuanggu Pill has a good clinical effect in preventing the recollapse of cemented vertebrae after primary percutaneous augmentation in patients with osteoporotic vertebral compression fractures. 

Key words:

Bushen Zhuanggu Pill, percutaneous augmentation, recollapse of cemented vertebrae, prospective cohort study