Chinese Journal of Tissue Engineering Research ›› 2024, Vol. 28 ›› Issue (5): 813-820.doi: 10.12307/2023.980
Meta-analysis of cement-augmented pedicle screw for thoracolumbar degenerative diseases with osteoporosis
Yu Zhaoyu1, Tan Lixin2, Sun Kai3, Lu Yao1, Li Yong1
- 1Third Department of Orthopedics, Zhuhai Branch, Guangdong Provincial Hospital of Chinese Medicine, Zhuhai 519000, Guangdong Province, China; 2Second Clinical Medicine College, Guangzhou University of Chinese Medicine, Guangzhou 510080, Guangdong Province, China; 3Department of Orthopedics, Ezhou Hospital of Traditional Chinese Medicine, Ezhou 436000, Hubei Province, China
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Received:2022-11-26Accepted:2023-01-31Online:2024-02-18Published:2023-08-17 -
Contact:Li Yong, Chief physician, Third Department of Orthopedics, Zhuhai Branch, Guangdong Provincial Hospital of Chinese Medicine, Zhuhai 519000, Guangdong Province, China -
About author:Yu Zhaoyu, Doctoral candidate, Attending physician, Third Department of Orthopedics, Zhuhai Branch, Guangdong Provincial Hospital of Chinese Medicine, Zhuhai 519000, Guangdong Province, China -
Supported by:Zhuhai Science and Technology Plan Project, No. 2220004000345 (to YZY)
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Cite this article
Yu Zhaoyu, Tan Lixin, Sun Kai, Lu Yao, Li Yong. Meta-analysis of cement-augmented pedicle screw for thoracolumbar degenerative diseases with osteoporosis[J]. Chinese Journal of Tissue Engineering Research, 2024, 28(5): 813-820.
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2.1 文献检索结果及质量评价 初步检索到1 953篇文献，查重后获取文献971篇，阅读文献标题及摘要后，剔除明显不相符文献，剩余35篇文献，仔细阅读全文，按标准进行严格筛选，最终纳入20篇文献[10-29]，具体过程见图2。纳入文献的基本特征见表1。其中2篇为随机对照试验[10，22]，均未提及分配隐藏及盲法，文献质量评价结果见图3。18篇为回顾性队列研究[11-21，23-29]，质量评价结果见表2。所有研究共涉及1 566例患者，其中骨水泥强化螺钉组789例，常规螺钉组777例。15项研究提及了骨水泥强化螺钉组有不同程度骨水泥渗漏[10，12，14，16-19，21-24，26-29]，3项研究未出现骨水泥渗漏[13，15，25]，其他均未提及骨水泥渗漏情况。6项研究提及患者出现不同部位好转，治疗后均好转[15-16，18-20，29]。1项研究有3例患者术口不愈合，需行二期缝合[16]。1项研究未提及任何不良反应发生与否[11]，其他研究均未出现神经、脊髓损伤等重大不良反应。"
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2.2 Meta分析结果 2.2.1 住院时间 7项研究报告了417例患者的住院时间[10，14，19，21，23，28-29]，各研究有明显异质性(I2=98%，P < 0.000 01)，遂采用随机效应模型，结果显示两组住院时间比较差异无显著性意义(MD=0.11，95%CI：-2.57，2.79)，P=0.94)，如图4所示。按照不同骨水泥螺钉强化方式进行亚组分析，4项研究比较了空心钉骨水泥强化组与传统椎弓根螺钉的手术时间[14，19，23，29]，结果显示两组住院时间比较差异无显著性意义(MD=0.74，95%CI：-3.33，4.82，P=0.72)。3项研究比较了常规椎弓根螺钉强化组与传统椎弓根螺钉组的手术时间[10，21，28]，结果表显示两组手术时间比较差异无显著性意义(MD=-0.52，95%CI：-1.29，0.26，P=0.19)。 2.2.2 手术时间 16项研究报告了1 114例患者的手术时间[10，14-15，17-29]，各研究间异质性较大(I2=89%，P < 0.000 01)，故采用随机效应模型，采用SMD表示其效应量(各计量资料单位不一致)，结果表明两组手术时间比较差异有显著性意义(SMD=0.82，95%CI：0.42，1.23，P < 0.000 1)，骨水泥强化螺钉组手术时间相对更长。按照不同骨水泥强化方式进行亚组分析，10项研究比较了空心钉水泥强化组与传统椎弓根螺钉的手术时间[14，17-20，23-24，26-27，29]，结果显示空心钉骨水泥强化组手术时间要多于传统螺钉组(SMD=1.05，95%CI：0.45，1.65，P=0.000 6)。6项研究比较了常规椎弓根螺钉强化组与传统椎弓根螺钉组的手术时间[10，15，21-22，25，28]，结果显示常规椎弓根螺钉强化组手术时间要长于传统椎弓根螺钉组(SMD=0.49，95%CI：0.11，0.87，P=0.01)，见图5。 "
2.2.3 术中出血量 16项研究报告了1 114例患者的术中出血量[10，14-15，17-29]，各研究间异质性较大(I2=65%，P=0.000 1)，遂采用随机效应模型，结果显示两组术中出血量比较差异无显著性意义(MD=3.58，95%CI：-12.76，19.92，P=0.67)。按照不同骨水泥螺钉强化方式进行亚组分析，10项研究比较了空心钉骨水泥强化组与传统椎弓根螺钉组的术中出血量[14，17-20，23-24，26-27，29]，结果显示两亚组术中出血量比较差异无显著性意义(MD=9.60，95%CI：-4.19，23.39，P=0.17)；6项研究比较了空心钉骨水泥强化组与传统椎弓根螺钉组的术中出血量[10，15，21-22，25，28]，结果显示两亚组术中出血量比较差异无显著性意义(MD=-20.30，95%CI：-62.79，22.18，P=0.35)，见图6。"
2.2.4 术后引流量 4项研究报告了术后引流量[20，24，26-27]，强化方式均为空心钉骨水泥强化，共计459例患者，各研究间异质性较小(I2=28%，P=0.24)，故采用固定效应模型，结果显示两组术后引流量比较差异无显著性意义(MD=-5.32，95%CI：-12.41，1.76，P=0.14)，见图7。"
2.2.5 术后JOA评分 5项研究报告了末次随访JOA评分[10，17，20，25，28]，共计317例患者，各研究间无明显异质性(I2=0%，P=0.53)，故采用固定效应模型，结果显示骨水泥强化螺钉组末次随访JOA评分高于传统螺钉组(MD=1.60，95%CI：1.14，2.07，P < 0.000 01)。按照不同骨水泥螺钉强化方式进行亚组分析，2项研究比较了空心钉水泥强化组与传统椎弓根螺钉组的JOA评分[17，20]，结果显示空心钉骨水泥强化组末次随访JOA评分高于传统螺钉组(MD=1.74，95%CI：1.18，2.30，P < 0.000 01)；3项研究比较了常规椎弓根螺钉强化组与传统螺钉组的JOA评分[10，25，28]，结果显示常规椎弓根螺钉强化组末次随访JOA评分显著高于传统螺钉组(MD=1.29，95%CI：0.47，2.12，P=0.002)，见图8。"
2.2.6 术后目测类比评分 14项研究报告了1 239例患者的末次随访目测类比评分[10，16-20，22-29]，各研究间异质性较大(I2=92%，P < 0.000 01)，故采用随机效应模型，结果显示骨水泥强化螺钉组末次随访目测类比评分低于传统螺钉组(MD=-0.50，95%CI：-0.78，-0.21，P=0.000 7)。按照不同骨水泥螺钉强化方式进行亚组分析，9项研究比较了空心钉骨水泥强化组与传统螺钉组的目测类比评分[17-20，23-24，26-27，29]，结果显示空心钉骨水泥强化末次随访目测类比评分低于传统螺钉组(MD=-0.46，95%CI：-0.84，-0.07，P=0.02)；5项研究比较了常规椎弓根螺钉强化组与传统螺钉组的目测类比评分[10，16，22，25，28]， 结果显示常规椎弓根螺钉强化组末次随访目测类比评分低于传统螺钉组(MD=-0.56，95%CI：-0.96，-0.16，P=0.006)，见图9。"
2.2.7 术后Oswestry 功能障碍指数 15项研究报告了1 270例患者的末次随访Oswestry功能障碍指数[10，16-29]，各研究间异质性较大(I2=90%，P < 0.000 01)，采用随机效应模型，因单位不一致，故采用SMD作为效应量，结果显示骨水泥强化螺钉组末次随访Oswestry功能障碍指数低于传统螺钉组(SMD=-0.49，95%CI：-0.88，-0.10，P=0.01)。按照不同骨水泥螺钉强化方式进行亚组分析，9项研究比较了空心钉骨水泥强化组与传统螺钉组的Oswestry功能障碍指数[17-20，23-24，26-27，29]，结果显示空心钉骨水泥强化组末次随访Oswestry功能障碍指数低于传统螺钉组(SMD=-0.71，95%CI：-1.37，-0.04，P=0.04)；6项研究比较了常规椎弓根螺钉强化组与传统螺钉组的Oswestry功能障碍指数[10，16，21-22，25，28]，结果显示常规椎弓根螺钉强化组末次随访Oswestry功能障碍指数低于传统螺钉组(MD=-0.19，95%CI：-0.38，-0.01，P=0.04)，见图10。"
2.2.8 术后椎间隙高度 5项研究报告了末次随访椎间隙高度[10，20，25，28-29]，包含331例患者，各研究间异质性较大(I2=89%，P < 0.000 01)，故采用随机效应模型，结果显示两组术后椎间隙高度比较差异有显著性意义(MD=1.26，95%CI：0.62，1.90，P=0.000 1)。按照不同骨水泥螺钉强化方式进行亚组分析，2项研究比较了空心钉骨水泥强化组与传统螺钉固定组的椎间隙高度[20，29]，结果显示空心钉骨水泥强化组末次随访椎间隙高度大于传统螺钉组(MD=1.83，95%CI：1.50，2.17，P < 0.000 01)；3项研究比较了常规椎弓根螺钉强化组与传统螺钉组的椎间隙高度[10，25，28]，结果显示常规椎弓根螺钉强化组末次随访椎间隙高度高于传统螺钉组(MD=0.90，95%CI：0.20，1.60，P=0.01)，见图11。"
2.2.9 术后融合率 13项研究报告了1 187例患者的末次随访融合率[10，13-17，19-20，23-24，26，28-29]，各研究间异质性较大(I2=78%，P < 0.000 01)，故采用随机效应模型，分析结果OR=11.24，95%CI：2.86，44.14，P=0.000 5，表明骨水泥强化螺钉组患者末次随访融合率高于传统螺钉组。按照不同骨水泥螺钉强化方式进行亚组分析，8项研究比较了空心钉骨水泥强化组与传统椎弓根螺钉组的融合率[14，17，19-20，23-24，26，29]，分析结果表明空心钉骨水泥强化组末次随访融合率高于传统椎弓根螺钉组(OR=11.65，95%CI：1.76，77.29，P=0.01)；5项研究比较了常规椎弓根螺钉强化与传统椎弓根螺钉固定的融合率[10，13，15-16，28]，分析结果表明常规椎弓根螺钉强化组末次随访融合率高于传统椎弓根螺钉组(OR=10.46，95%CI：1.09，100.01，P=0.04)，见图12。"
2.2.10 螺钉松动率 18项研究报告了末次随访松钉率[10-19，22-29]，共计1 447例患者，各研究间异质性较小(I2=15%，P=0.28)，故采用固定效应模型，结果显示骨水泥强化螺钉组末次随访螺钉松动率低于传统螺钉组(OR=0.08，95%CI：0.05，0.12，P < 0.000 01)。按照不同骨水泥螺钉强化方式进行亚组分析，9项研究比较了空心钉骨水泥强化组与传统螺钉组的螺钉松动率[14，17-19，23-24，26-27，29]，结果显示空心钉骨水泥强化组末次随访松钉率低于传统螺钉组(OR=0.10，95%CI：0.04，0.20，P < 0.000 01)；7项研究比较了常规椎弓根螺钉强化组与传统螺钉组的螺钉松动率[10，13，15-16，22，25，28]，结果显示常规椎弓根螺钉强化组末次随访螺钉松动率低于传统螺钉组(OR=0.11，95%CI：0.05，0.26，P < 0.000 01)；2项研究比较了椎弓根螺钉混合强化组(包含空心钉强化与常规螺钉强化)与传统螺钉组的螺钉松动率[11-12]，结果显示椎弓根螺钉混合强化组末次随访松钉率低于传统螺钉组(OR=0.04，95%CI：0.02，0.08，P < 0.000 01)，见图13。"
2.3 敏感性分析 对于手术时间进行逐一剔除研究后重新合并分析，发现异质性无明显变化，且两组比较结果与之前一致，提示Meta分析结果相对可靠。考虑不同研究手术节段、手术难度及医生技术水平差异导致研究间异质性较大。 对于住院时间进行逐一剔除研究后重新合并分析，发现异质性无明显变化，且两组比较结果与之前一致，提示Meta分析结果相对可靠。考虑各研究术后干预措施不同、患者经济水平差异导致的研究间异质性较大。 对于目测类比评分、Oswestry 功 能 障 碍 指 数、融合率、椎间隙高度进行逐一剔除研究后重新合并分析，发现异质性无明显变化，且两组比较结果与之前一致，提示Meta分析结果相对可靠。考虑各研究术后随访时长不同导致各研究间异质性较大。 对于术中出血量，敏感性分析提示1项研究可能为异质性来源，剔除该项研究后重新进行合并分析发现异质性明显减少(I2=6%)，采用固定效应模型分析，结果表明两组患者术中出血量仍无统计学差异(MD=6.66，95%CI：-0.94，14.26，P=0.09)，提示Meta分析结果相对可靠。异质性可能是各研究手术难度不同造成的。 2.4 发表偏倚分析 研究中纳入的手术时间、术中出血量、目测类比评分、Oswestry 功能障碍指数评分、融合率及松钉率的文献均不少于10篇，一般认为10篇文献以上可做漏斗图分析，故对以上指标进行发表偏倚分析，结果显示，各指标均存在不同程度发表偏倚，见图14。"
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