自制脊柱撑开复位器治疗骨质疏松性椎体压缩骨折临床对照试验

目的：探讨自制脊柱撑开复位器治疗骨质疏松性椎体压缩骨折的临床效果。方法：采用随机数字表法随机分组，治疗组42例共56椎体，男14例，女28例，年龄50～69岁；对照组54例共68椎体，男19例，女35例，年龄51—75岁。均摄X线片和CT扫描，其中27例加行MR以排除肿瘤继发性骨折和陈旧性骨折，均确诊为骨质疏松脊柱压缩性骨折。CT扫描椎体后壁完整无椎管占位，均无脊髓神经损害症状。骨质疏松程度以L3X线骨小梁变化分级。治疗组应用脊柱牵引复位器经椎弓根向椎体注入骨水泥，对照组采用椎体成形术。用视觉模拟疼痛评分（VAS），参照Lee方法测量椎体高度压缩率和恢复率，计算骨水泥渗漏率。结果：治疗组平均随访2．5年，VAS评分治疗组由术前的平均（8．6-＋0．8）分降至平均（1．7±0．5）分，对照组由平均（8．5±0．4）分降至平均（3．5±1．4）分，术后评分两组比较，差异有统计学意义P〈0．05。治疗组术前、术后椎体前壁和中间高度压缩率差异有统计学意义（P〈0．05）。治疗组后凸角度恢复率71．8％，对照组恢复率37．8％，差异有统计学意义（P〈0．05）。治疗组无骨水泥渗漏，对照组渗漏率47％。疗效评定治疗组36例完全缓解，4例部分缓解，对照组43例完全缓解，3例部分缓解。两组差异有统计学意义，P〈0．05。结论：自制脊柱撑开复位器是一种能替代进口球囊的微创技术，可迅速止痛，恢复椎体高度且无骨水泥渗漏。

A clinical trial on the treatment of compression fracture of osteoporotic vertebral body by self-made spinal expander

Objective：To observe the effects of self-made spinal expander in treatment of compression fracture of osteoporotic vertebral body. nethods：Ninty-six patients were randomly divided into two groups,treatment group included 42 cases with 56 centrums, 14 males and 28 females,aged from 50 to 69 years,and control group included 54 cases with 68 centrums, 19 males and 35 females,aged from 51 to 75 years. All cases were examined by X-ray and CT. MRI was taken in 27 patients to make sure the diagnosis which was compression fracture of vertebral body due to osteoporosis. The degree of osteoporosis was judged by X-ray of L3 bone trabecula. Fifty-six centrums in treatment group were treated with self-made spinal expander and bone cement. Sixty-eight centrums in control group were treated with PVP. Compression rate and recovery rate of vertebral height, and leakage rate of bone cement were measured according to the Lee standard. Results：（1） VAS between treatment group and control group had significant statistically difference （P〈0.05）. （2） In treatment group, compression rate of anterior and middle vertebal height were statistical difference before and after operation （P〈0.05）. In control group, the compression rate of pre-and post-operative vertebal height had no significant difference （P〉0.05）. （3） The recovery rate of kyphosis between treat- ment group （71.8%） and control group（37.8%） was significant statistically difference（P〈0.05）. （4） There was no cement leak- age in the treatment group,however the leakage rate in control group was 47%.（5） The curative effect was assessed based on the standard of WHO. In treatment group,36 cases was completely relieved,4 cases was partially relieved and the relief rate was 95.24%. In control group ,43 cases was completely relieved ,3 cases was partially relieved and the relief rate was 84.19%. There was no statistically significant difference between two groups （P〈0.05）. Conclusion：The self-made spinal expander is a minim