椎体成形术结合唑来膦酸治疗骨质疏松性胸腰椎压缩骨折的临床研究

Clinical study on vertebroplasty combined with zoledronic acid for osteoporotic thoracolumbar vertebral compression fractures

目的观察经皮椎体成形术结合唑来膦酸治疗骨质疏松性胸腰椎压缩骨折的临床疗效和安全性。方法将56例骨质疏松性胸腰椎压缩骨折患者以数字表法随机分为两组，每组28例。所有患者人院后均卧硬板床，腰部垫高进行复位。治疗组接受经皮椎体成形术治疗，术后第3天静脉滴注唑来膦酸100mL：对照组接受保守治疗，给予患者闭合复位，术后给予患者牵引悬吊，卧硬板床，将软枕垫在骨折处。比较两组患者治疗前、治疗后24h及治疗后6个月的伤椎前缘高度、脊柱后凸Cobb’s角、腰背部疼痛视觉模拟评分、Oswsetry功能障碍指数评分。结果（1）伤椎前缘高度。治疗前后不同时间伤椎前缘高度的差异有统计学意义，即存在时间效应[治疗组：（13．81±2．09）mm，（20．14±2．26）mm，（21．89±2．60）mm；对照组：（15．24±2．21）mm，（17．39±2．57）mm，（17．40±1．81）]，除治疗前外（t=0．278，P〉0．05），其余各时点对照组的伤椎前缘高度均小于治疗组（t=5．163，P〈0．01；t：7．491，P〈0．01）；两组患者伤椎前缘高度的组间差异总体上有统计学意义（F=60．721，P〈0．05），即存在分组效应。（2）脊柱后凸Cobb’s角。治疗前后不同时间脊柱后凸Cobb’s角的差异有统计学意义，即存在时间效应[治疗组：（26．18±2．03）°，（9．56±1．11）°，（9．57±1．08）°；对照组：（27．36±2．71）°，（14．59±1．28）°，（14．52±1．48）°]；除治疗前外（t=1．836，P〉0．05），其余各时点对照组的脊柱后凸Cobb’s角均大于治疗组（t=15．706，P〈0．01；t=14．300，P〈0．01）；两组患者脊柱后凸Cobb’s角的组间差异总体上有统计学意义（F=14．381，P〈0．05），即存在分组效应。（3）腰背部疼痛视觉模拟评分。治疗前后不同时间腰背部疼痛视觉模拟评分的差异有统计学意义，即存在时间效应[治疗组：（8．31±0．94）分，（1．86±0．74）分，（1．87±0．77）分；对照组：（8．12±0．95）分，（3．85±1．07）分，（3．824-1．08）分]；除治疗前外（t=0．752，P〉0．05），其余各时点对照组的腰背部疼痛视觉模拟评分均大于治疗组（t=8．095，P〈0．01；t=7．812，P〈0．01）；两组患者腰背部疼痛视觉模拟评分的组间差异总体上有统计学意义（F=23．330，P〈0．05），即存在分组效应。（4）Oswsetry功能障碍指数评分。治疗前后不同时间Oswsetry功能障碍指数评分的差异有统计学意义，即存在时间效应[治疗组：（73．27±4．55）分，（32．11±2．57）分，（29．14±3．60）分；对照组：（75．49±4．20）分，（43．83±2．98）分，（38．67±5．28）分]；除治疗前外（t=1．897，P〉0．05），其余各时点对照组的Oswsetry功能障碍指数评分均大于治疗组（t=14．413，P〈0．01；t=7．895，P〈0．01）；两组患者Oswsetry功能障碍指数评分的组间差异总体上有统计学意义（F=9．358，P〈0．05），即存在分组效应。结论椎体成形术结合唑来膦酸治疗骨质疏松性胸腰椎压缩骨折，能明显降低骨质疏松性椎体压缩性骨折所致的腰背部疼痛，提高骨密度，改善骨质量，提高生活质量，并能遏制骨质疏松症的进一步发展。

Objective To observe the clinical effects and safety of vertebroplasty combined with zoledronic acid for osteoporotic thoracolumbar vertebral compression fractures. Methods 56 osteoporotic thoracolumbar vertebral compression fractures patients were radomly divided into the two groups, each group had 25 cases. All patients had re- set treatment including lying on the hard bed and Padded waist. The treatment group had the surgery of vertebroplasty, 3 days after surgery these patients treated with 100mL Zoledronic acid by means of intravenous drip. The control group had the conservative treatment, these patients received the closed reduction, after operations the patients had the treat- ment of traction suspension, lying on the hard bed, padded the fractures. The two groups were compared at the time be- fore treatment,24h after treatment and 6 months after treatment. The anterior height of vertebral body, kyphosis Cobb＇s angle,low back pain visual analog scale, Oswsetry dysfunction index score and complications were included into the study. Results （ 1 ） The anterior height of vertebral body ： The difference of the anterior height of vertebral body at different time before or after the treatment was statistically significant, that showed the time effect [ the treatment group： （ 13.81±2.09）mm, （20.14 ±2.26） mm, （21.89 ±2.60ram;the control group： （ 15.24 ± 2.21 ） mm, （ 17.39 ± 2. 57） mm, （ 17.40 ± 1.81 ） mmJ. The difference of the overall anterior height of vertebral body between the two groups was statistically significant, which showed the grouping effect. （ 2 ） Kyphosis Cobb＇s angle ： The difference of Kyphosis Cobb＇s angle at different time was statistically significant, which showed the time effect[ the treatment group： （26.18 ± 2.03 ） °, （ 9.56 ± 1.11 ） ~, （ 9.57± 1.08 ）° ; the control group ： （ 27.36 ± 2.71 ）°, （ 14.59 ± 1.28 ） ° （ 14. 52 ± 1.48 ） ° ], the difference of the overall Kyphosis Cobb＇s angle between the two groups was statistically signifi- cant, which showed the grouping effect. （ 3 ） Low back pain visual analog scale ： The difference of low back pain visual analog scale at different time was statistically significant, which showed the time effect[ the treatment group：（ 8.31± 0. 94 ） points , （ 1.86 ± 0. 74 ） points, （ 1.87± 0. 77 ） points; the control group： （ 8. 12 ±0.95 ） points, （ 3.85 ± 1.07 ） points, （ 3.82 ± 1.08 ） points ]. The difference Of the overall low back pain visual analog scale between the two groups was statistically significant, which showed the grouping effect. （4）Oswsetry dysfunction index score： The difference of Oswsetry dysfunction index score at different time was statistically significant, which showed the time effect [ the treatment group： （ 73.27 ± 4.55 ） points, （ 32.11 ± 2.57 ） points, （ 29.14 ± 3.60） points ; the control group ： （ 75.49 ± 4.20） points, （43.83 ± 2.98 ） points, （ 38.67 ±5.28 ） points ]. The difference of the overall Oswsetry dys- function index score between the two groups was statistically significant ,which showed the grouping effect. Conclusion The treatment of vertebroplasty combined with zoledronic acid for osteoporotic thoracolumbar vertebral compression fractures was effective. It is able to relieve low back pain, improve bone density and quality, improve life quality, and prevent Osteoporosis from further development.