唑来膦酸联合椎体后凸成形治疗骨质疏松性压缩骨折：提高骨密度、预防椎体再骨折、远期疗效评价的Meta分析

文题释义：椎体后凸成形：采用椎体内置入气囊的方法通过扩张使椎体复位，在椎体内部形成空隙，减小骨水泥注入所需的推力，使骨水泥在椎体内不易流动，可有效解除或缓解疼痛、恢复病椎高度，但临床发现仍存在骨水泥渗漏等风险。 唑来膦酸：椎体后凸成形已被广泛应用于骨质疏松性压缩骨折的治疗，临床疗效显著，然而如何有效改善骨质疏松状况成为临床面临的重要问题。唑来膦酸是双膦酸盐类药物，可有效抑制骨吸收，降低再发骨折风险，改善骨折患者的功能评分。 背景：临床应用唑来膦酸治疗骨质疏松症缺乏系统的科学评价和循证学依据，因此目前对于唑来膦酸联合椎体后凸成形治疗骨质疏松性椎体压缩骨折的临床疗效尚无明确定论。 目的：系统评价唑来膦酸联合椎体后凸成形治疗骨质疏松性椎体压缩骨折的临床疗效。 方法：应用计算机检索公开发表在CNKI、万方、维普等中文数据库及CBM、PubMed、Cochrane等英文数据库中，有关唑来膦酸联合椎体后凸成形治疗骨质疏松性椎体压缩骨折的随机对照试验，试验组治疗方式为唑来膦酸联合椎体后凸成形，对照组治疗方式为椎体后凸成形，时间截止至2019年9月。由2位研究员独立进行文献筛选、数据提取，按Cochrane协作网标准对纳入随机对照试验逐个进行质量评价，采用RevMan 5.3软件对符合纳入标准的研究进行统计分析。 结果与结论：①最终纳入5篇文献，均为随机对照研究，试验组患者175例，对照组患者184例；②统计分析结果显示：试验组治疗后12个月的骨密度高于对照组MD=0.12，95%CI(0.08，0.17)，P < 0.000 01]，治疗后6，12个月的目测类比评分低于对照组MD=0.46，95%CI(0.18，0.75)，P=0.002；MD=0.85，95%CI(0.20，1.50)，P=0.01]，治疗后1年的Oswestry功能障碍指数评分低于对照组MD=6.59，95%CI(4.77，8.41)，P < 0.000 01]，骨水泥渗漏率、椎体骨折再发率低于对照组OR=0.22，95%CI(0.08，0.59)，P=0.003；OR=0.18，95%CI(0.07，0.50)，P=0.000 8]；两组椎体高度恢复、椎体后凸Cobb角比较差异无显著性意义MD=0.65，95%CI(-0.27，1.56)，P=0.16；MD=-0.60，95%CI(-2.45，1.25)，P=0.53]；③结果表明与单独应用椎体后凸成形相比，唑来膦酸联合椎体后凸成形在提高骨密度值、减少椎体骨折再发率、改善患者远期临床症状、预防骨水泥骨水泥渗漏等并发症方面具有显著优势，但后期仍需大量高质量的多中心随机对照研究提供更充足的证据。 ORCID: 0000-0001-8871-3539(李凯明) 中国组织工程研究杂志出版内容重点：人工关节；骨植入物；脊柱；骨折；内固定；数字化骨科；组织工程

Zolidronic acid combined with percutaneous kyphoplasty in the treatment of osteoporotic compression fractures:a meta-analysis of bone density improvement,recurrent vertebral fractures prevention,and long-term efficacy evaluation

BACKGROUND:The clinical application of zoledronic acid in the treatment of osteoporosis lacks systematic scientific evaluation and evidence-based basis.Therefore,the clinical efficacy of zoledronic acid combined with percutaneous kyphoplasty in the treatment of osteoporotic vertebral compression fracture is still uncertain.OBJECTIVE:To systematically evaluate the efficacy of zoledronic acid combined with percutaneous kyphoplasty in the treatment of osteoporotic vertebral compression fracture.METHODS:A computer search of all randomized controlled studies and clinical trials of zolidronic acid combined with percutaneous kyphoplasty for the treatment of osteoporotic vertebral compression fracture published in CNKI,Wanfang,VIP,CBM,PubMed and Cochrane prior to September 2019 was performed.The experimental group was treated with zoledronic acid and percutaneous kyphoplasty,while the control group was treated with percutaneous kyphoplasty.Literature screening and data extraction were conducted by the two researchers independently.The quality of the included randomized controlled trials was evaluated one by one according to the Cochrane collaboration standards.Meta-analysis was performed on RevMan 5.3 for those that met the inclusion criteria.RESULTS AND CONCLUSION:(1)Five randomized controlled trials were included,including 175 in the experimental group and 184 in the control group.(2)Meta-analysis results showed that the bone mineral density was higher in the experimental group than in the control groupMD=0.12,95%CI(0.08,0.17),P<0.00001].The visual analogue scale score was lower in the experimental group than that of the control group 6 and 12 months after treatmentMD=0.46,95%CI(0.18,0.75),P=0.002;MD=0.85,95%CI(0.20,1.50),P=0.01].At 1 year after treatment,Oswestry disability index was lower in the experimental group than in the control groupMD=6.59,95%CI(4.77,8.41),P<0.00001].Bone cement leakage rate and recurrence rate of vertebral fractures were lower in the experimental group than in the control groupOR=0.22,95%CI(0.08,0.59),P=0.003;OR=0.18,95%CI(0.07,0.50),P=0.0008].Vertebral height recovery and kyphotic Cobb angle were not significantly different between the two groupsMD=0.65,95%CI(-0.27,1.56),P=0.16;MD=-0.60,95%CI(-2.45,1.25),P=0.53].(3)Results showed that compared with percutaneous kyphoplasty alone,zoledronic acid combined with percutaneous kyphoplasty has significant advantages in improving bone mineral density,reducing the recurrence rate of vertebral fracture,improving the long-term clinical symptoms of patients,preventing the bone cement leakage,but a large number of high-quality multi-center randomized controlled studies are still needed to provide more sufficient evidence in the later stage.