Grafe Ingo A, Da Fonseca Katharina, Hillmeier Jochen, Meeder Peter-Jürgen, Libicher Martin, Nöldge Gerd, Bardenheuer Hubert, Pyerin Walter, Basler Linus, Weiss Christel, Taylor Rod S, Nawroth Peter, Kasperk Christian
Department of Medicine I, Division of Osteology, Ruprecht-Karls-University of Heidelberg, Im Neuenheimer Feld 410, 69120, Heidelberg, Germany.
Osteoporos Int. 2005 Dec;16(12):2005-12. doi: 10.1007/s00198-005-1982-5. Epub 2005 Aug 3.
Previously, we reported significantly reduced pain and improved mobility persisting for 6 months after kyphoplasty of chronically painful osteoporotic vertebral fractures in the first prospective controlled trial. Since improvement of spinal biomechanics by restoration of vertebral morphology may affect the incidence of fracture, long-term clinical benefit and thereby cost-effectiveness, here we extend our previous work to assess occurrence of new vertebral fractures and clinical parameters 1 year after kyphoplasty compared with a conservatively treated control group. Sixty patients with osteoporotic vertebral fractures due to primary osteoporosis were included: 40 patients were treated with kyphoplasty, 20 served as controls. All patients received standard medical treatment. Morphological characteristics, new vertebral fractures, pain (visual analog scale), physical function [European Vertebral Osteoporosis Study (EVOS) score] (range 0-100 each) and back-pain-related doctors' visits were re-assessed 12 months after kyphoplasty. There were significantly fewer patients with new vertebral fractures of the thoracic and lumbar spine, after 12-months, in the kyphoplasty group than in the control group (P=0.0084). Pain scores improved from 26.2 to 44.4 in the kyphoplasty group and changed from 33.6 to 34.3 in the control group (P=0.008). Kyphoplasty treated patients required a mean of 5.3 back-pain-related doctors' visits per patient compared with 11.6 in the control group during 12 months follow-up (P=0.006). Kyphoplasty as an addition to medical treatment and when performed in appropriately selected patients by an interdisciplinary team persistently improves pain and reduces occurrence of new vertebral fractures and healthcare utilization for at least 12 months in individuals with primary osteoporosis.
此前，在第一项前瞻性对照试验中，我们报告了经球囊扩张椎体后凸成形术治疗慢性疼痛性骨质疏松性椎体骨折后，疼痛显著减轻且活动能力改善持续达6个月。由于通过恢复椎体形态改善脊柱生物力学可能会影响骨折发生率、长期临床获益以及成本效益，因此我们在此扩展之前的研究工作，以评估球囊扩张椎体后凸成形术1年后与保守治疗对照组相比新椎体骨折的发生情况及临床参数。纳入60例因原发性骨质疏松导致椎体骨折的患者：40例行球囊扩张椎体后凸成形术治疗，20例作为对照。所有患者均接受标准药物治疗。在球囊扩张椎体后凸成形术12个月后，重新评估形态学特征、新椎体骨折情况、疼痛（视觉模拟评分）、身体功能[欧洲椎体骨质疏松研究（EVOS）评分]（每项范围均为0 - 100）以及与背痛相关的医生诊疗次数。12个月后，球囊扩张椎体后凸成形术组胸腰椎新椎体骨折患者明显少于对照组（P = 0.0084）。球囊扩张椎体后凸成形术组疼痛评分从26.2改善至44.4，而对照组从33.6变为34.3（P = 0.008）。在12个月的随访期间，球囊扩张椎体后凸成形术治疗的患者每位患者与背痛相关的医生诊疗次数平均为5.3次相比，对照组为11.6次（P = 0.006）。对于原发性骨质疏松患者，球囊扩张椎体后凸成形术作为药物治疗的补充，由多学科团队在适当选择的患者中进行时，可持续改善疼痛，减少新椎体骨折的发生，并降低医疗保健利用率，至少持续12个月。
