Chinese Journal of Tissue Engineering Research ›› 2020, Vol. 24 ›› Issue (3): 477-484.doi: 10.3969/j.issn.2095-4344.2422
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A meta-analysis of expandable intramedullary nail versus interlocking intramedullary nail for treatment of femoral shaft fracture
Wang Wei1, Xie Chengxin1, Zhou Haonan1, Zhang Yu1, Wang Chenglong1, Yin Dong2
- 1Graduate School, Guangxi University of Chinese Medicine, Nanning 530000, Guangxi Zhuang Autonomous Region, China; 2People’s Hospital of Guangxi Zhuang Autonomous Region, Nanning 530000, Guangxi Zhuang Autonomous Region, China
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Received:2019-05-28Revised:2019-06-04Accepted:2019-09-18Online:2020-01-28Published:2019-12-27 -
Contact:Yin Dong, MD, Professor, Chief physician, People’s Hospital of Guangxi Zhuang Autonomous Region, Nanning 530000, Guangxi Zhuang Autonomous Region, China -
About author:Wang Wei, Master candidate, Graduate School, Guangxi University of Chinese Medicine, Nanning 530000, Guangxi Zhuang Autonomous Region, China
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Cite this article
Wang Wei, Xie Chengxin, Zhou Haonan, Zhang Yu, Wang Chenglong, Yin Dong. A meta-analysis of expandable intramedullary nail versus interlocking intramedullary nail for treatment of femoral shaft fracture[J]. Chinese Journal of Tissue Engineering Research, 2020, 24(3): 477-484.
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2.1 文献检索结果及质量评价 根据检索策略共检索到相关文献581篇，采用EndnoteX7排除重复文献，阅读文题及摘要排除与文题不符、非对照试验、综述等。进一步阅读全文后排除不符合纳入标准的文献，最终纳入文献7篇[13-19]，其中3篇为随机对照研究，4篇为队列研究，共计492例患者，可膨胀髓内钉组、交锁髓内钉组各246例。纳入研究的基本特征见表1，纳入文献质量评价及风险评价结果见表2，3。"
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2.2 Meta分析结果 2.2.1 骨折愈合时间 共6篇文献报道了骨折愈合时 间[14-19]，共计样本量481例，其中可膨胀髓内钉组239例，交锁髓内钉组242例。其中1篇文献只报道了24例(共计31例)可膨胀髓内钉组和27例(共计31例)交锁髓内钉组的骨折愈合时间[14]。异质性检验提示各研究间存在中度异质性(I2=58.5%，P=0.034)，故采用随机效应模型。结果显示可膨胀髓内钉组术后骨折愈合时间明显少于交锁髓内钉组[SMD=-0.87，95%CI(-1.20，-0.54)，P=0]，见图2。按研究类型亚组分析，3篇非随机对照试验合并显示可膨胀髓内钉组的骨折愈合时间明显少于交锁髓内钉组[SMD=-0.98，95%CI(-1.46，-0.50)，P=0][14-16]。3篇随机对照试验合并显示可膨胀髓内钉组的骨折愈合时间明显少于交锁髓内钉组[SMD=-0.78，95%CI(-1.28，-0.28)，P=0.002][17-19]。 "
2.2.2 骨不连或延迟愈合 共有4篇文献报道了骨不连或延迟愈合[13-15，18]，共计样本量286例，两组样本量各143例，骨不连或延迟愈合在可膨胀髓内钉组和交锁髓内钉组分别为7例(4.8%)和14例(9.7%)。异质性检验提示各研究间存在中度异质性(I2=57.8%，P=0.074)，故采用随机效应模型。结果显示两组骨不连或延迟愈合比较差异无显著性意义[RR=0.38，95%CI(0.06，2.32)，P=0.294]，见图3。按研究类型亚组分析，3篇非随机对照试验合并显示两组骨不连或延迟愈合比较差异无显著性意义[RR=0.53，95%CI(0.07，4.02)，P=0.536][13-15]；1篇随机对照试验显示两组骨不连或延迟愈合比较差异无显著性意义[RR=0.11，95%CI(0.01，2.01)，P=0.137][18]。"
2.2.3 手术时间 共有7篇文献报道了手术时间[13-19]，共计样本量492例，两组各246例。异质性检验提示各研究间存在明显异质性(I2=92.6%，P=0)，故采用随机效应模型。结果显示可膨胀髓内钉组手术时间明显少于交锁髓内钉组[SMD=-2.45，95%CI(-3.33，-1.58)，P=0]，见图4。按研究类型亚组分析，4篇非随机对照试验合并显示可膨胀髓内钉组手术时间明显少于交锁髓内钉组[SMD=-1.69，95%CI(-2.30，-1.08)，P=0][13-16]；3篇随机对照试验合并均显示可膨胀髓内钉组手术时间明显少于交锁髓内钉组[SMD=-3.38，95%CI(-4.69，-2.07)，P=0][17-19]。"
2.2.4 术中失血量 共有6篇文献报道了术中失血量[13，15-19]，共计样本量430例，两组各215例。异质性检验提示各研究间存在明显异质性(I2=97.9%，P=0)，故采用随机效应模型。结果显示可膨胀髓内钉组术中失血量明显少于交锁髓内钉组[SMD=-4.12，95%CI(-6.38，-1.87)，P=0]，见图5。按研究类型亚组分析，3篇非随机对照试验合并显示两组术中失血量比较差异无显著性意义[SMD= -2.36，95%CI(-4.75，0.03)，P=0.053][13，15-16]；3篇随机对照试验合并均显示可膨胀髓内钉组术中失血量明显少于交锁髓内钉组[SMD=-5.87，95%CI(-8.23，-3.50)，P=0][17-19]。"
2.2.5 透视时间 共6篇文献报道了术中透视时间[13-16，18-19]，共计样本量422例，两组各211例。异质性检验提示各研究间存在明显异质性(I2=89.7%，P=0.000)，故采用随机效应模型。结果显示可膨胀髓内钉组透视时间明显少于交锁髓内钉组[SMD=-2.83，95%CI(-3.68，-1.97)，P=0]，见图6。按研究类型亚组分析，4篇非随机对照试验合并显示可膨胀髓内钉组透视时间明显少于交锁髓内钉组[SMD=-2.45，95%CI(-3.40，-1.50)，P=0][13-16]；2篇随机对照试验合并均显示可膨胀髓内钉组的透视时间明显少于交锁髓内钉组[SMD=-3.52，95%CI(-3.98，-3.06)，P=0][18-19]。"
2.2.6 住院时间 共有6篇文献报道了住院时间[13，15-19]，共计样本量430例，两组各215例。异质性检验提示，各研究间存在明显异质性(I2=92.8%，P=0)，故采用随机效应模型。结果显示可膨胀髓内钉组住院时间少于交锁髓内钉组[SMD=-0.96，95%CI(-1.73，-0.18)，P=0.016]，见图7。按研究类型亚组分析，3篇非随机对照试验合并显示两组住院时间比较差异无显著性意义[SMD=-0.58，95%CI (-1.84，0.68)，P=0.396][13，15-16]；3篇随机对照试验合并显示可膨胀髓内钉组住院时间明显少于交锁髓内钉组[SMD=-1.33，95%CI(-2.09，-0.56)，P=0.001][17-19]。 "
2.2.7 总体并发症 共有4篇文献报道了并发症[13-15，18]，包括伤口感染、松动、断钉等不同程度的并发症，共计样本量286例，两组各143例，其中总并发症可膨胀髓内钉组为7例(4.8%)，交锁髓内钉组34例(23.8%)。异质性检验提示各研究间存在明显异质性(I2=81%，P=0.001)，故采用随机效应模型。结果显示两组总体并发症比较差异无显著性意义[RR=0.15，95%CI(0.01，1.98)，P=0.148]，见图8。按研究类型亚组分析，3篇非随机对照试验合并显示两组并发症比较差异无显著性意义[RR=0.21，95%CI(0.01，4.48)，P=0.320][13-15]；只有1篇随机对照试验结果显示可膨胀髓内钉组的总体并发症发生率低于交锁髓内钉组[RR=0.04，95%CI(0.00，0.66)，P=0.024][18]。"
2.3 敏感性分析 对骨折愈合时间指标行敏感性分析，逐一剔除文献合并后发现，剔除“虞荣昌，2015年”研究后变为同质，但两组比较差异仍具有统计学意义，提示合并结果相对稳健。考虑该文献可能为异质性来源，详细阅读全文，考虑在记录骨折愈合时间的标准上存在差异(临床愈合时间和影像学愈合时间差异)。对于手术时间、术中失血量及透视时间指标，逐一剔除文献合并后分析发现异质性并未发生明显变化，但两组比较差异仍具有统计学意义，提示合并结果相对稳健。对于骨不连或延迟愈合率、总体并发症发生率指标，均剔除“Sipahioglu，2016年”研究后合并出现同质，且两组差异有统计学意义，可膨胀髓内钉组的骨不连或延迟愈合率及总体并发症发生率均低于交锁髓内钉组。敏感性分析提示合并结果不稳健，还需要更多的随机对照试验来证实。"
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