经皮椎体后凸成形术与保守治疗骨质疏松性椎体压缩骨折的荟萃分析
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摘要
[目的]系统评价经皮椎体后凸成形术(PKP)与保守方法治疗骨质疏松性椎体压缩骨折(OVCF)的有效性和安全性。[方法]计算机检索CNKI、CBM、WanFang Data、VIP、PubMed、The Cochrane Library以及EMbase数据库,搜集关于PKP对比保守方法治疗OVCF的随机对照试验,检索时限均从建库至2017年7月。由两位评价员独立筛选文献、提取数据并评价纳入研究的偏倚风险后,采用RevMan 5.3软件进行荟萃分析。[结果]最终纳入9个RCT研究,共计1 156例患者,PVP治疗548例,保守治疗608例。短-中期随访PKP组在VAS评分、椎体后凸畸形、生活质量评分方面优于保守组,差异有统计学意义(P<0.05)。但长期随访两组VAS评分、椎体再骨折率、并发症发生率差异无统计学意义(P>0.05)。此外,PKP组在椎体高度、椎体高度丢失率和椎体后凸畸形角方面明显优于保守组,差异有统计学意义(P<0.05)。[结论]现有证据表明,PKP手术治疗OVCF短、中期疗效优于保留治疗,两种治疗方式在安全性方面无显著差异。受纳入研究质量和随访时间的限制,未来还需更多远期随访的大样本、高质量的RCT研究来进一步验证。
[Objective] To compare the efficacy and safety of percutaneous kyphoplasty(PKP) versus conservative treatment for osteoporotic vertebral compression fracture(OVCF) by a meta-analysis. [Methods] The CNKI, CBM, WanFang Data,VIP, PubMed, Cochrane Library, and EMbase database were searched for random control trials(RCT) on PKP versus conservative treatment for OVCF from the beginning to July 2017. The identified articles were screened and assessed for inclusion into this study by two independent reviewers. After that, a meta-analysis was carried out by using RevMan 5.3 software. [Results] A total of 9 RCT were included with a total of 1 156 patients, involving 548 patients treated by PKP and 608 patients treated conservatively. Regarding to short and medium term follow-up, the PKP group was significantly superior to the conservative group in the VAS scores, quality of life and kyphosis correction, which proved statistically significant(P<0.05). However, there were no statistically significant differences in VAS score, vertebral refracture rate and complication in long term follow-up between the two groups(P>0.05). In addition, the PKP group proved significantly superior to the conservative treatment in vertebral height restoration, loss of vertebral height correction and extent of kyphosis, which were statistically significant(P<0.05). [Conclusion] Compared with conservative treatment, PKP achieve improved short and medium outcomes for OVCF, although no significant difference in safety between the two treatments is evident. Limited by the quality and follow-up time of the studies included, more large samples and high-quality RCT studies with longer term follow-up are needed in the future to verify the conclusions further.
[Objective] To compare the efficacy and safety of percutaneous kyphoplasty(PKP) versus conservative treatment for osteoporotic vertebral compression fracture(OVCF) by a meta-analysis. [Methods] The CNKI, CBM, WanFang Data,VIP, PubMed, Cochrane Library, and EMbase database were searched for random control trials(RCT) on PKP versus conservative treatment for OVCF from the beginning to July 2017. The identified articles were screened and assessed for inclusion into this study by two independent reviewers. After that, a meta-analysis was carried out by using RevMan 5.3 software. [Results] A total of 9 RCT were included with a total of 1 156 patients, involving 548 patients treated by PKP and 608 patients treated conservatively. Regarding to short and medium term follow-up, the PKP group was significantly superior to the conservative group in the VAS scores, quality of life and kyphosis correction, which proved statistically significant(P<0.05). However, there were no statistically significant differences in VAS score, vertebral refracture rate and complication in long term follow-up between the two groups(P>0.05). In addition, the PKP group proved significantly superior to the conservative treatment in vertebral height restoration, loss of vertebral height correction and extent of kyphosis, which were statistically significant(P<0.05). [Conclusion] Compared with conservative treatment, PKP achieve improved short and medium outcomes for OVCF, although no significant difference in safety between the two treatments is evident. Limited by the quality and follow-up time of the studies included, more large samples and high-quality RCT studies with longer term follow-up are needed in the future to verify the conclusions further.
引文
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[3]Kan SL,Yuan ZF,Chen LX,et al.Which is best for osteoporotic vertebral compression fractures:balloon kyphoplasty,percutaneous vertebroplasty or non-surgical treatment?A study protocol for a Bayesian Network Meta-analysis[J].BMJ Open,2017,7(1):E012937.
[4]Cheng X,Long HQ,Xu JH,et al.Comparison of unilateral versus bilateral percutaneous kyphoplasty for the treatment of patients with osteoporosis vertebral compression fracture(OVCF):a systematic review and Meta-analysis[J].Eur Spine J,2016,25(11):3439-3449.
[5]李惠民,陈银河,申才良.经皮椎体后凸成形术治疗骨质疏松性椎体压缩骨折远期并发症的Meta分析[J].中国脊柱脊髓杂志,2017,27(7):592-598.
[6]Furlan AD,Malmivaara A,Chou R,et al.2015 Updated Method Guideline for Systematic Reviews in the Cochrane Back and Neck Group[J].Spine,2015,40(21):1660-1673.
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[9]Boonen S,Van Meirhaeghe J,Bastian L,et al.Balloon kyphoplasty for the treatment of acute vertebral compression fractures:2-year results from a randomized trial[J].J Bone Miner Res,2011,26(7):1627-1637.
[10]Ranstam J,Turkiewicz A,Boonen S,et al.Alternative analyses for handling incomplete follow-up in the intention-to-treat analysis:the randomized controlled trial of balloon kyphoplasty versus nonsurgical care for vertebral compression fracture(FREE)[J].BMCMed Res Methodol,2012,12:35.
[11]Van Meirhaeghe J,Bastian L,Boonen S,et al.A randomized trial of balloon kyphoplasty and nonsurgical management for treating acute vertebral compression fractures:vertebral body kyphosis correction and surgical parameters[J].Spine(Phila Pa 1976),2013,38(12):971-983.
[12]Fritzell P,Ohlin A,Borgstr?m F.Cost-effectiveness of balloon kyphoplasty versus standard medical treatment in patients with osteoporotic vertebral compression fracture:a Swedish multicenter randomized controlled trial with 2-year follow-up[J].Spine(Phila Pa 1976),2011,36(26):2243-2251.
[13]Yi X,Lu H,Tian F,et al.Recompression in new levels after percutaneous vertebroplasty and kyphoplasty compared with conservative treatment[J].Arch Orthop Trauma Surg,2014,134(1):21-30.
[14]张逸飞.椎体后凸成形术与保守疗法治疗老年骨质疏松性椎体压缩性骨折的比较研究[D].安徽医科大学,2010.
[15]谢恩,郝定均.经皮椎体后凸成形术与非手术治疗急性和亚急性骨质疏松性椎体压缩性骨折临床研究[J].创伤外科杂志,2011,13(6):510-514.
[16]徐汝峰,杨超群.经皮球囊扩张椎体后凸成形术治疗胸腰椎骨质疏松性骨折[J].中国实用医药,2013,8(14):100-101.
[17]娄玉健,王秀会,陆耀刚,李国庆.骨质疏松性椎体压缩骨折椎体后凸成形术与非手术治疗的临床对照研究[J].中国骨与关节损伤杂志,2014,29(1):15-17.
[18]罗建军,王冰.经皮椎体成形术治疗老年骨质疏松性胸腰椎压缩骨折的效果评价[J].颈腰痛杂志,2016,37(3):200-203.
[19]皮海菊,肖淼生,尚晖.经皮椎体后凸成形术治疗陈旧性骨质疏松椎体压缩性骨折疗效观察[J].中国临床研究,2017,30(1):27-30.
[20]Rao RD,Singrakhia MD.Painful osteoporotic vertebral fracture.Pathogenesis,evaluation,and roles of vertebroplasty and kyphoplasty in its management[J].J Bone Joint Surg Am,2003,85:2010-2022.
[21]Antonacci MD,Mody DR,Rutz K,et al.A histologic study of fractured human vertebral bodies[J].J Spinal Disord Tech,2002,15:118-126.
[22]Kim MJ,Lindsey DP,Hannibal M,et al.Vertebroplasty versus kyphoplasty:biomechanical behavior under repetitive loading conditions[J].Spine(Phila Pa 1976),2006,31:2079-2084.
[23]Kasperk C,Grafe IA,Schmitt S,et al.Three-year outcomes after kyphoplasty in patients with steoporosis with painful vertebral fractures[J].J Vasc Interv Radiol,2010,21(5):701-709.
[24]Berlemann U,Ferguson SJ,Nolte LP,et al.Adjacent vertebral failure after vertebroplasty:a biomechanical investigation[J].J Bone Joint Surg Br,2002,84(5):748-752.
[25]Yang S,Liu Y,Yang H,et al.Risk factors and correlation of secondary adjacent vertebral compression fracture in percutaneous kyphoplasty[J].Int J Surg,2016,36(A):138-142.
[2]Kim YM,Demissie S,Eisenber GR,et al.Intra-and inter-reader reliability of semi-automated quantitative morphometry measurements and vertebral fracture assessment using lateral scout views from computed tomography[J].Osteoporos Int,2011,22(10):10-12.
[3]Kan SL,Yuan ZF,Chen LX,et al.Which is best for osteoporotic vertebral compression fractures:balloon kyphoplasty,percutaneous vertebroplasty or non-surgical treatment?A study protocol for a Bayesian Network Meta-analysis[J].BMJ Open,2017,7(1):E012937.
[4]Cheng X,Long HQ,Xu JH,et al.Comparison of unilateral versus bilateral percutaneous kyphoplasty for the treatment of patients with osteoporosis vertebral compression fracture(OVCF):a systematic review and Meta-analysis[J].Eur Spine J,2016,25(11):3439-3449.
[5]李惠民,陈银河,申才良.经皮椎体后凸成形术治疗骨质疏松性椎体压缩骨折远期并发症的Meta分析[J].中国脊柱脊髓杂志,2017,27(7):592-598.
[6]Furlan AD,Malmivaara A,Chou R,et al.2015 Updated Method Guideline for Systematic Reviews in the Cochrane Back and Neck Group[J].Spine,2015,40(21):1660-1673.
[7]Furlan AD,Pennick V,Bombardier C,et al.2009 updated method guidelines for systematic reviews in the Cochrane Back Review Group[J].Spine(Phila Pa 1976),2009,34:1929-1941.
[8]Wardlaw D,Cummings SR,Van Meirhaeghe J,et al.Efficacy and safety of balloon kyphoplasty compared with non-surgical care for vertebral compression fracture(FREE):a randomised controlled trial[J].Lancet,2009,373(9668):1016-1024.
[9]Boonen S,Van Meirhaeghe J,Bastian L,et al.Balloon kyphoplasty for the treatment of acute vertebral compression fractures:2-year results from a randomized trial[J].J Bone Miner Res,2011,26(7):1627-1637.
[10]Ranstam J,Turkiewicz A,Boonen S,et al.Alternative analyses for handling incomplete follow-up in the intention-to-treat analysis:the randomized controlled trial of balloon kyphoplasty versus nonsurgical care for vertebral compression fracture(FREE)[J].BMCMed Res Methodol,2012,12:35.
[11]Van Meirhaeghe J,Bastian L,Boonen S,et al.A randomized trial of balloon kyphoplasty and nonsurgical management for treating acute vertebral compression fractures:vertebral body kyphosis correction and surgical parameters[J].Spine(Phila Pa 1976),2013,38(12):971-983.
[12]Fritzell P,Ohlin A,Borgstr?m F.Cost-effectiveness of balloon kyphoplasty versus standard medical treatment in patients with osteoporotic vertebral compression fracture:a Swedish multicenter randomized controlled trial with 2-year follow-up[J].Spine(Phila Pa 1976),2011,36(26):2243-2251.
[13]Yi X,Lu H,Tian F,et al.Recompression in new levels after percutaneous vertebroplasty and kyphoplasty compared with conservative treatment[J].Arch Orthop Trauma Surg,2014,134(1):21-30.
[14]张逸飞.椎体后凸成形术与保守疗法治疗老年骨质疏松性椎体压缩性骨折的比较研究[D].安徽医科大学,2010.
[15]谢恩,郝定均.经皮椎体后凸成形术与非手术治疗急性和亚急性骨质疏松性椎体压缩性骨折临床研究[J].创伤外科杂志,2011,13(6):510-514.
[16]徐汝峰,杨超群.经皮球囊扩张椎体后凸成形术治疗胸腰椎骨质疏松性骨折[J].中国实用医药,2013,8(14):100-101.
[17]娄玉健,王秀会,陆耀刚,李国庆.骨质疏松性椎体压缩骨折椎体后凸成形术与非手术治疗的临床对照研究[J].中国骨与关节损伤杂志,2014,29(1):15-17.
[18]罗建军,王冰.经皮椎体成形术治疗老年骨质疏松性胸腰椎压缩骨折的效果评价[J].颈腰痛杂志,2016,37(3):200-203.
[19]皮海菊,肖淼生,尚晖.经皮椎体后凸成形术治疗陈旧性骨质疏松椎体压缩性骨折疗效观察[J].中国临床研究,2017,30(1):27-30.
[20]Rao RD,Singrakhia MD.Painful osteoporotic vertebral fracture.Pathogenesis,evaluation,and roles of vertebroplasty and kyphoplasty in its management[J].J Bone Joint Surg Am,2003,85:2010-2022.
[21]Antonacci MD,Mody DR,Rutz K,et al.A histologic study of fractured human vertebral bodies[J].J Spinal Disord Tech,2002,15:118-126.
[22]Kim MJ,Lindsey DP,Hannibal M,et al.Vertebroplasty versus kyphoplasty:biomechanical behavior under repetitive loading conditions[J].Spine(Phila Pa 1976),2006,31:2079-2084.
[23]Kasperk C,Grafe IA,Schmitt S,et al.Three-year outcomes after kyphoplasty in patients with steoporosis with painful vertebral fractures[J].J Vasc Interv Radiol,2010,21(5):701-709.
[24]Berlemann U,Ferguson SJ,Nolte LP,et al.Adjacent vertebral failure after vertebroplasty:a biomechanical investigation[J].J Bone Joint Surg Br,2002,84(5):748-752.
[25]Yang S,Liu Y,Yang H,et al.Risk factors and correlation of secondary adjacent vertebral compression fracture in percutaneous kyphoplasty[J].Int J Surg,2016,36(A):138-142.