Unilateral versus bilateral percutaneous kyphoplasty for osteoporotic vertebral fractures: a meta-analysis

doi:10.3969/j.issn.2095-4344.0130

Abstract

Abstract:

BACKGROUND: Minimally invasive surgery is the main method for senile osteoporotic vertebral fractures, and percutaneous kyphoplasty (PKP) has been rapidly popularized. As the conventional bilateral transpedicular puncture needs a longer operation time and higher costs, unilateral transpedicular puncture is gradually applied in clinic. However, the long-term clinical efficacy of unilateral and bilateral PKP remains controversial.

OBJECTIVE: To evaluate the effectiveness and safety of unilateral and bilateral PKP for osteoporotic vertebral fractures through a meta-analysis.

METHODS: A computer-based retrieval of PubMed, Cochrane Library, Embase, Engineering Village, Web of Science, Wiley, OVID, Google Scholar, WanFang, CNKI and VIP databases was performed for the randomized controlled trials of unilateral and bilateral PKP for osteoporotic vertebral fractures through meta-analysis. Date and language of studies were not limited. Two reviewers screened the retrieved studies in accordance with the inclusion and exclusion criteria. The quality of the studies was evaluated by a modified Jadad scale prior to the meta-analysis on Review Manager 5.2 software.

RESULTS AND CONCLUSION: (1) Finally, 956 patients from 11 randomized controlled trials were included and divided into two groups, unilateral group (n=483) and bilateral group (n=473) (1:1). (2) The meta-analysis results showed that the operation time in the unilateral group was significantly better than that in the bilateral group (MD=-20.38, 95%CI(-24.10, -16.65), P < 0.000 01); the dose and duration of intraoperative radiation exposure to the patients in the unilateral group were less than those in the bilateral group; the bone cement used in the unilateral group was significantly less than that in the bilateral group (P < 0.000 01); the incidence of bone cement leakage in the unilateral group was less than that in the bilateral group (P=0.005); there were no significant differences in the Visual Analogue Scale scores, vertebral height restoration, Cobb angle of the fractured vertebra and re-fracture rate of the adjacent vertebrae between two groups during long-term follow-up. (3) Compared with bilateral PKP, unilateral PKP exhibits a shorter operation time, less intraoperative radiation exposure and a lower incidence of bone cement leakage in the treatment of osteoporotic vertebral fractures, so it is a safer surgical method.

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

Key words: Osteoporotic Fractures, Vertebroplasty, Evidence-Based Medicine, Tissue Engineering

CLC Number:

R318

Gao Zhi-xiang, Li Chun, Li Lei, Huang Wei-min. Unilateral versus bilateral percutaneous kyphoplasty for osteoporotic vertebral fractures: a meta-analysis [J]. Chinese Journal of Tissue Engineering Research, 2018, 22(7): 1140-1148.

Figures/Tables 5

2.2.4 术后目测类比评分本篇文献通过Meta分析评价评价两种手术方式术后目测类比评分在早期、中期、远期的评分比较。共7篇文献研究后术后早期目测类比评分[14-16，18-19，22-23]，各研究组间无异质性(P=0.38，I²= 6%)，采用固定效应模式进行Meta分析示，单侧与双侧手术方式术后早期目测类比评分差异无显著性意义[MD=-0.06，95%CI(-0.20，0.08)，P=0.39]。6篇文献报道了目测类比评分中期比较[15，18-19，21-23 ]，各研究组间无异质性(P=0.44，I²= 0%)，采用固定效应模式进行Meta分析示，单侧与双侧手术方式术后中期随访目测类比评分差异无显著性意义[MD=-0.88，95%CI (-0.24，0.09)，P=0.36]。4篇文献报道了目测类比评分远期比较[14-15，19，21]，各研究组间无异质性(P=0.88，I²= 0%)，采用固定效应模式进行Meta分析示，两种手术方式术后远期随访目测类比评分差异无显著性意义[MD= 0.20，95%CI (-0.08，0.47)，P=0.16> 0.05]。综上单侧入路组与双侧入路组在术后早期、中期、远期疼痛缓解程度方面差异无显著性意义，见图7。 2.2.5 术后伤椎后凸角在最终纳入文献中有7篇文献研究了术后早期伤椎后凸角改善情况[14-15，18-19，22-24]，各研究组间存在异质性(P=0.006，I²=67%)，采用随机效应模式进行Meta分析示，单侧与双侧手术方式术后早期伤椎后凸角改变情况差异无显著性意义[MD=-0.76，95%CI (-1.62，0.09)，P=0.08，图8]。5篇文献研究了术后中期伤椎后凸角变化[15，17，19，23-24 ]，各研究组间无异质性(I²=29%)，采用固定效应模式进行Meta分析示，单侧与双侧手术方式术后中期伤椎后凸角改变情况差异无显著性意义[MD=-0.34，95%CI(-0.85，0.16)，P=0.18，图9]。3篇文献研究了术后远期伤椎后凸角变化[15，18-19]，各研究组间存在异质性 (I²=89%)，用随机效应模式进行Meta分析示，单侧与双侧手术方式术后远期伤椎后凸角改变情况差异无显著性意义[MD=-0.96，95%CI(-2.82，0.90)，P=0.31，图10]。 2.2.6 椎体恢复高度椎体恢复高度包括前柱和中柱。3篇文献报道了术后早期前柱恢复高度[14-15，23]，各研究结果之间无异质性(P=0.18，I²= 42%)，采用固定效应模式进行Meta分析示，两种手术方式术后早期椎体前柱恢复高度差异无显著性意义[MD=0.09，95%CI(-0.61，0.79)，P=0.80]。2篇文献分别报道了术后中期随访椎体前柱高度[15，23]，各研究结果间无异质性(P=0.74，I²=0%)，采用固定效应模式进行Meta分析示，两种手术方式术后中期椎体前柱恢复高度差异无显著性意义[MD=0.36，95%CI(-0.35，1.06)，P= 0.32]。2篇文献分别报道了术后远期随访椎体前柱高度[14-15]，各研究结果间无异质性(P=0.64，I²=0%)，采用固定效应模式进行Meta分析示，两种手术方式术后远期椎体前柱恢复高度差异无显著性意义[MD=0.20，95%CI(-1.30，1.69)，P=0.80]，见图11。2篇文献共同报道了术后早期、远期随访椎体中柱高度[14-15]，各研究结果之间无异质性分别是(P=0.81，I²=0%)，(P=0.85，I²= 0%)，采用固定效应模式进行Meta分析示，两种手术方式术后早期、远期椎体中柱恢复高度差异无显著性意义分别是[MD=-0.46，95%CI(-1.62，0.71)，P=0.44]、[MD=-1.24，95%CI(-2.52，0.05)，P=0.06]，见图12。 2.2.7 术后ODI 在最终纳入文献中有4篇问卷调查了患者术后ODI[15，19-20，22]，各研究组间无异质性(P=0.15，I²=44%)。采用固定效应模式进行Meta分析示，2组手术方式见差异无显著性意义[MD=-0.20，95%CI(-1.24，0.84)，P=0.70]，见图13。 2.2.8 手术并发症椎体后凸成形术的并发症主要包括术中骨水泥渗漏及术后邻近非手术椎体再骨折。8篇文献报道了骨水泥渗漏的研究情况[14-19，22-23]，各组间无异质性 (P=0.29，I=18%)，采用固定效应模式进行Meta分析示，单侧与双侧手术方式术中骨水泥渗漏分析差异有显著性意义[MD=0.51，95%CI(0.32，0.82)，P=0.00]，见图14。3篇文献报道了术后邻近椎体再骨折[15，18，2]，各组间无异质性(I²= 0%)，采用固定效应模式进行Meta分析示，单侧与双侧手术方式在术后随访中邻近椎体再骨折发生情况差异无显著性意义[MD= 0.98，95%CI(0.51，1.88)，P=0.95]，见图15。 2.2.9 敏感性分析纳入的11篇文献中有3篇属于低质量文献[19-20，23]，而在这3篇文献中有2篇详细比较了手术时间，故在手术时间方面去除该2篇低质量文献进行敏感性分析[19，23]，8篇文献的各研究组间仍存在异质性[14-18，21-22，24] (P=0.000 8，I²=63%)，采用随机效应模式。Meta分析结果显示，单侧与双侧经皮椎体后凸成形术相比，2组差异有显著性意义[MD=-22.46，95%CI(-24.80，-20.11)，P < 0.000 01，图16]，单侧组经皮椎体后凸成形术治疗骨质疏松性椎体骨折的手术时间比双侧组短，与详细报道了手术时间的10篇文献研究结果相同[14-19，21-24]；同时在手术时间方面将10篇文献的随机效应模式改成固定效应模式分析结果一致[14-19，21-24]；同样使用上述两种方法分别对各项观察指标进行分析均得到与之相对应的结果。说明本次Meta分析的结果比较稳定。 "

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