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  

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

作　　者：李凯明 朱立国[1] 张清[1] 李玲慧[2] 谢瑞 陈明[2] 梁龙 林承宇 侯晓宙 Li Kaiming;Zhu Liguo;Zhang Qing;Li Linghui;Xie Rui;Chen Ming;Liang Long;Lin Chengyu;Hou Xiaozhou(Second Department of Spine,2Comprehensive Department of Orthopedics,Wangjing Hospital of China Academy of Chinese Medical Sciences,Beijing 100102,China)

机构地区：[1]中国中医科学院望京医院,脊柱二科,北京市100102 [2]中国中医科学院望京医院骨伤综合科,北京市100102

出　　处：《中国组织工程研究》2020年第24期3911-3917,共7页Chinese Journal of Tissue Engineering Research

基　　金：首都卫生发展科研专项项目(2018-2-4162),项目负责人:张清;国家自然科学基金(81674005),项目负责人:朱立国;中央级公益性科研院所基本科研业务费专项资金资助(ZZ10-015),项目参与者:朱立国、李玲慧、陈明。

摘　　要：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、Pub Med、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Rev Man 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<0.00001],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<0.00001],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=0.0008];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。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 group[MD=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 treatment[MD=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 group[MD=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 group[OR=0.22,95%

关 键 词：唑来膦酸 骨质疏松性椎体压缩骨折 骨质疏松性压缩骨折 椎体后凸成形术 骨密度值 Cobb角 系统评价 有效性 安全性 META分析 

分 类 号：R459.9[医药卫生—治疗学] R318.01[医药卫生—临床医学]