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

doi:10.12114/j.issn.1007-9572.2020.00.041

Abstract

Abstract: Background　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 low-viscosity 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 3 216 cases were included，including 1 624 in the experimental group and 1 592 in the control group.The overall quality was moderate.Meta-analysis 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 week and 1 month postoperatively〔SMD=-0.23，95%CI（-0.77，0.32），P>0.05；SMD=-0.44，95%CI（-1.14，0.25），P=0.214〕.There was no significant difference in Cobb angle between the two groups at 1 month postoperatively 〔SMD
=-1.01，95%CI （-2.41，0.40），P=0.16〕.The mean Cobb angle at 3 months and 12 months after operation was smaller in the experimental group than in the control group 〔SMD=-1.78，95%CI （-2.90，-0.65），P=0.002；SMD=-0.70，95%CI （-1.15，-0.25），P=0.002〕.The mean JOA scores of the experimental group at 1 month and 3 months after operation were higher than those of the control group 〔SMD=1.15，95%CI （0.81，1.49），P<0.001；SMD=0.39，95%CI （0.08，0.71），P= 0.015〕.There was no significant difference between the two groups in the mean SF-36 score 〔SMD=1.13，95%CI （-0.19，2.82），P=0.088〕.The compression rate of the anterior margin of the injured vertebrae and the midline compression rate of the injured vertebra were lower than those of the control group 〔SMD=-2.31，95%CI （-3.71，-0.92），P=0.001；SMD=-1.27，95%CI （- 2.33，-0.20），P=0.02〕；but there was no significant difference in compression ratio of the posterior of the injured vertebrae between the two groups 〔SMD=-0.01，95%CI （-0.38，-0.36），P=0.956〕.There was no significant difference in the amount of postoperative bleeding between the two groups 〔SMD=-1.36，95%CI （-3.01，0.29），P=0.106〕.The mean operative time of the experimental group was shorter than that of the control group 〔SMD=-0.92，95%CI （-1.58，-0.26），P=0.006〕.There was no significant difference in the mean amount of bone cement injected between the two groups 〔SMD
=-0.44，95%CI （-0.93，0.06），P=0.082〕.The mean intraoperative fluoroscopy times of the experimental group was less than that of the control group 〔SMD=-0.86，95%CI （-1.32，0.39），P<0.001〕.The cement leakage rate of the experimental group was lower than that of the control group 〔RR=0.39，95%CI （0.33，0.47），P<0.001〕.Funnel plot of the cement leakage showed that the RCTs were basically in the confidence interval，and the left and right parts were basically symmetrical，indicating that there may be no publication bias.Conclusion　The meta-analysis shows that the use of high-viscosity bone cement for vertebroplasty in the treatment of OVCF can significantly shorten the operative time，reduce the times of intraoperative X-ray fluoroscopy，significantly alleviate postoperative pain and improve level of daily life activities.It has a better effect on improving the shape and function of the injured vertebrae.And there is sufficient evidence supporting that the leakage rate of high-viscosity cement is significantly lower than that of low-viscosity cement.

Key words: Fractures, compression；Osteoporotic fractures；Cementoplasty；High viscosity bone cement；Low viscosity bone cement；Systematic evaluation；Meta-analysis

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3 216例，其中试验组1 624例，对照组1 592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、12个月Cobb角小于对照组〔SMD=-1.78，95%CI（-2.90，-0.65），P=0.002；SMD=-0.70，95%CI（-1.15，-0.25），P=0.002〕。试验组术后1个月、3个月JOA评分高于对照组〔SMD=1.15，95%CI（0.81，1.49），P<0.001；SMD=0.39，95%CI（0.08，0.71），P=0.015〕。两组健康调查简表（SF-36）评分比较，差异无统计学意义〔SMD=1.13，95%CI（-0.19，2.82），P=0.088〕。试验组伤椎前缘压缩率、伤椎中线压缩率均低于对照组〔SMD=-2.31，95%CI（-3.71，-0.92），P=0.001；SMD=-1.27，95%CI（-2.33，-0.20），P=0.02〕；两组伤椎后缘压缩率比较，差异无统计学意义〔SMD
=-0.01，95%CI（-0.38，-0.36），P=0.956〕。两组术中出血量比较，差异无统计学意义〔SMD=-1.36，95%CI（-3.01，0.29），P=0.106〕。试验组手术时间短于对照组〔SMD=-0.92，95%CI（-1.58，-0.26），P=0.006〕。两组骨水泥注射量比较，差异无统计学意义〔SMD=-0.44，95%CI（-0.93，0.06），P=0.082〕。试验组术中X光透视次数少于对照组〔SMD=-0.86，95%CI（-1.32，0.39），P<0.001〕。试验组骨水泥渗漏率低于对照组〔RR=0.39，95%CI（0.33，0.47），P<0.001〕。绘制骨水泥渗漏文献发表偏倚漏斗图，结果表明文献基本处于可信区间，且左右基本对称，可能不存在发表偏倚。结论　本次Meta分析认为使用高黏度骨水泥椎体成形术治疗OVCF，可以缩短手术时间，减少医护人员进行X光透视的次数，缓解患者术后疼痛和提高患者日常生活能力，对于改善OVCF患者的伤椎形态、提高功能具有较好疗效，同时有充分证据证明高黏度骨水泥渗漏率低于低黏度骨水泥。

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

ZHAO Jinlong1,2,PAN Jianke2, et al. High- and Low-viscosity Cement Vertebroplasty for Osteoporotic Vertebral Compression Fractures：a Systematic Review of 36 Randomized Controlled Clinical Trials[J]. Chinese General Practice, 2020, 23(23): 2944-2955. DOI: 10.12114/j.issn.1007-9572.2020.00.041.
赵金龙1,2,潘建科2等. 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[J]. 中国全科医学, 2020, 23(23): 2944-2955. DOI: 10.12114/j.issn.1007-9572.2020.00.041.

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