骨质疏松性椎体压缩骨折PKP与保守治疗的随机对照研究

The Randomized Controlled Study of Acute and Subacute Osteoporotic Vertebral Compression Fractures with Percutaneous Kyphoplasty and Conservative Treatment

目的比较经皮椎体后凸成形术 （pereutaneous kyphoplasty ,PKP）与保守疗法对骨质疏松性椎体压缩骨折患者的有效性和安全性的研究。方法本研究对象为2007年7月至2010年7月间的164例患者。骨质疏松性脊柱骨折发生2周以内的急性患者和发生在2～8周内的亚急性患者被随机分为保守治疗组和PKP治疗组。术后观察症状改善情况、椎体高度恢复率、后凸矫正率、骨水泥渗漏情况、疼痛、生理与心理结果。视觉模拟量表评定疼痛的程度，SF-36表和Dallas问卷调查表测试评估生理和心理变化。结果从初诊到3个月随访时两组的疼痛缓解程度相当（P〈0．05），在视觉模拟量表中从7．7分降至1．8分，组内差异显著（P〈0．05）。PKP组在术后12～24h内疼痛显著缓解（P〈0．05）。术前vAs疼痛评分（7．7±1．0）分，术后24hVAS评分（1．8±0．9）分（P〈0．05）。椎体前壁高度平均恢复27．9％（P〈0．05）。椎体后凸角平均矫正12．6°（P〈0．05）。结论PKP改善了急性和亚急性骨质疏松性椎体压缩骨折患者的生活质量，减轻了腰背痛和残障程度，且在术后不明显增加包括相邻节段骨折在内的不良事件发生率。

Objective To Comparison of percutaneous kyphoplasty and conservative treatment of osteoporotic vertebral compression fractures in patients with efficacy and safety study. Methods This study from July 2007 to July 2010 was used to treat 164 patients cases. Occurrence of osteoporotic fractures within 2 weeks of acute patients and in 2 to 8 weeks of sub-acute patients were randomly divided into the conservative treatment group and PKP group. Improvement of symptoms ,vertebral height restoration rate ,correction rate of kyphosis ,and bone cement leakage ,pain, physical and psychological results were observed. Visual analog scale assessment of the degree of pain; SF-36 form and the Dallas questionnaire evaluate the physiological and psychological changes. Results Comparison of initial and 3 month follow-up,a considerable degree of pain relief in both groups （P〈0.05）. Scale from 7.7 to 1.8,significant difference in the visual analogue （P〈0.05）. In PKP group after Within 12-24 h after surgery pain relief was significantly （P〈0. 05）. Preoperative VAS pain score is （7. 7±1. 0） ,after 24 h VAS score is （1.8±0.9）（P〈0.05）.The average anterior vertebral body height restore 27.9% （P〈0.05）. The average vertebral kyphosis correct 12.6°（P〈 0.05）. Conclusion Osteoporotic vertebral compression fracture could acquire rapidly pain release,restore height of vertebralbody and improve abnormality by means of PKP.