高低黏度骨水泥椎体成形术治疗骨质疏松性椎体压缩性骨折:36项临床随机对照试验的系统评价研究  

High-and Low-viscosity Cement Vertebroplasty for Osteoporotic Vertebral Compression Fractures:a Systematic Review of 36 Randomized Controlled Clinical Trials

作　　者：赵金龙[1,2] 潘建科 黄和涛 韩燕鸿[1,2] 曾令烽 梁桂洪[2,3] 林炯同 李嘉晖 吴明 侯森荣 刘军 ZHAO Jinlong;PAN Jianke;HUANG Hetao;HAN Yanhong;ZENG Lingfeng;LIANG Guihong;LIN Jiongtong;LI Jiahui;WU Ming;HOU Senrong;LIU Jun(The Second Clinical Medical College,Guangzhou University of Chinese Medicine,Guangzhou 510405,China;Bone and Joint Degeneration and Injury Research Team,Guangdong Academy of Traditional Chinese Medicine,Guangzhou 510120,China;The Second Affiliated Hospital of Guangzhou University of Chinese Medicine/Guangdong Provincial Hospital of Traditional Chinese Medicine,Guangzhou 510120,China)

机构地区：[1]广州中医药大学第二临床医学院,广东省广州市510405 [2]广东省中医药科学院骨与关节退变及损伤研究团队,广东省广州市510120 [3]广州中医药大学第二附属医院广东省中医院,广东省广州市510120

出　　处：《中国全科医学》2020年第23期2944-2955,2963,共13页Chinese General Practice

基　　金：广东省财政厅项目(〔2014〕157,〔2018〕8);广东省中医院中医药科学技术研究专项(YK2013B2N19,YN2015MS15);广东省医学科学技术研究基金项目(B2019091);广东省普通高校重点科研平台和科研项目(2018KQNCX041)。

摘　　要：背景以经皮椎体成形术(PVP)和经皮后凸成形术(PKP)为代表的椎体成形术治疗骨质疏松性椎体压缩性骨折(OVCF)的疗效已被广泛认可,但骨水泥渗漏在临床上仍是一个难题。虽已有相关的系统回顾文献报道,高黏度骨水泥安全性高、临床疗效好,但仍缺乏大样本的临床随机对照试验系统评价提供有力的循证依据。目的采用Meta分析进一步评价椎体成形术中使用高、低黏度骨水泥治疗OVCF的疗效和安全性,对系统评价循证数据进行更新,并分析更为详细的术中、术后评价指标。方法计算机检索PubMed、Cochrane Library、OVID、中国知网(CNKI)、万方数据知识服务平台(Wanfang Data)、维普网(VIP)等数据库,搜集试验组采用高黏度骨水泥注射椎体成形术,对照组采用普通或低黏度骨水泥注射椎体成形术治疗OVCF的临床随机对照研究,检索时限为建库至2019年7月。提取资料,采用Cochrane协作网推荐的方法进行质量评价,使用Stata 12.0统计软件进行Meta分析。结果最终纳入36篇随机对照试验,共计纳入病例3216例,其中试验组1624例,对照组1592例。纳入文献的总体质量中等。Meta分析结果显示,试验组术后2 d、3 d、1周、1个月、3个月、12个月视觉模拟量表(VAS)评分低于对照组〔SMD=-0.43,95%CI(-0.64,-0.22),P=0.042;SMD=-0.53,95%CI(-0.80,-0.26),P<0.05;SMD=-0.26,95%CI(-0.49,-0.03),P=0.042;SMD=-0.66,95%CI(-0.86,-0.47),P<0.05;SMD=-1.27,95%CI(-2.02,-0.51),P=0.001;SMD=-0.73,95%CI(-1.20,-0.27),P=0.002〕。试验组术后2 d、3个月、12个月Oswestry功能障碍指数(ODI)低于对照组〔SMD=-0.28,95%CI(-0.51,-0.05),P=0.018;SMD=-1.18,95%CI(-1.98,-0.38),P=0.004;SMD=-0.47,95%CI(-0.86,-0.08),P=0.017〕;两组术后1周、1个月ODI比较,差异无统计学意义〔SMD=-0.23,95%CI(-0.77,0.32),P>0.05;SMD=-0.44,95%CI(-1.14,0.25),P=0.214〕。两组术后1个月Cobb角比较,差异无统计学意义〔SMD=-1.01,95%CI(-2.41,0.40),P=0.16〕;试验组术后3个月、12Background Vertebroplasty,represented by PVP and PKP,has been widely accepted for the treatment of osteoporotic vertebral compression fracture(OVCF),but bone cement leakage is still a problem in clinical practice.Although systematic reviews have pointed out that high-viscosity bone cement has high safety and good clinical efficacy,it still lacks a systematic evaluation of clinical randomized controlled trials(RCTs)with a large sample to provide a strong evidence-based basis.Objective To further evaluate the efficacy and safety of high-and low-viscosity bone cement in the treatment of OVCF by meta-analysis,update evidence-based data of systematic evaluation,and analyze more detailed intraoperative and postoperative evaluation indicators.Methods Six databases(PubMed,Cochrane Library,OVID,CNKI,Wanfang Data,VIP)were searched were searched for RCTs about OVCF treated with high-viscosity cement vertebroplasty(experimental group)and lowviscosity cement vertebroplasty(control group)included from inception to July 2019.Cochrane Collaboration's tool was used to make a quality assessment.Stata 12.0 was used to perform meta-analysis.Results 36 RCTs with a total of 3216 cases were included,including 1624 in the experimental group and 1592 in the control group.The overall quality was moderate.Metaanalysis showed that the mean visual analogue scale(VAS)scores of the experimental group were lower than those of the control group at 2 days,3 days,1 week,1,3,and 12 months after surgery〔SMD=-0.43,95%CI(-0.64,-0.22),P=0.042;SMD=-0.53,95%CI(-0.80,-0.26),P<0.05;SMD=-0.26,95%CI(-0.49,-0.03),P=0.042;SMD=-0.66,95%CI(-0.86,-0.47),P<0.05;SMD=-1.27,95%CI(-2.02,-0.51),P=0.001;SMD=-0.73,95%CI(-1.20,-0.27),P=0.002〕.The mean Oswestry Disability Index(ODI)was lower in the experimental group than in the control group at 2 days,3 months,and 12 months〔SMD=-0.28,95%CI(-0.51,-0.05),P=0.018;SMD=-1.18,95%CI(-1.98,-0.38),P=0.004;SMD=-0.47,95%CI(-0.86,-0.08),P=0.017〕.But the mean ODI showed no significant difference between the two groups at 1 wee

关 键 词：骨折 压缩性 骨质疏松性骨折 骨水泥成形术 高黏度骨水泥 低黏度骨水泥 系统评价 Meta分析 

分 类 号：R683[医药卫生—骨科学]