Chinese Journal of Tissue Engineering Research ›› 2020, Vol. 24 ›› Issue (6): 947-955.doi: 10.3969/j.issn.2095-4344.2455
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Intramedullary fixation versus plate fixation in the treatment of displaced mid-shift clavicle fractures: a meta-analysis
Liang Jie1, Xiang Feifan1, Yang Kun2, Sun Yuanlin3, Zhou Wei1, Xiang Yong1, Yang Yunkang1
- 1Department of Bone and Joint Surgery, the Affiliated Hospital of Southwest Medical University, Luzhou 646000, Sichuan Province, China; 2Department of Orthopedics, Luzhou People’s Hospital, Luzhou 646000, Sichuan Province, China; 3the First People’s Hospital of Yibin, Yibin 644000, Sichuan Province, China
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Received:2019-06-11Revised:2019-06-12Accepted:2019-07-10Online:2020-02-28Published:2020-01-18 -
Contact:Yang Yunkang, MD, Professor, Department of Bone and Joint Surgery, the Affiliated Hospital of Southwest Medical University, Luzhou 646000, Sichuan Province, China -
About author:Liang Jie, Master candidate, Department of Bone and Joint Surgery, the Affiliated Hospital of Southwest Medical University, Luzhou 646000, Sichuan Province, China -
Supported by:the Project of the Affiliated Hospital of Southwest Medical University, No. 2017-PT-47; the Project of Southwest Medical University, No. 2017-ZRQN-129
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Cite this article
Liang Jie, Xiang Feifan, Yang Kun, Sun Yuanlin, Zhou Wei, Xiang Yong, Yang Yunkang. Intramedullary fixation versus plate fixation in the treatment of displaced mid-shift clavicle fractures: a meta-analysis[J]. Chinese Journal of Tissue Engineering Research, 2020, 24(6): 947-955.
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2.1 文献收集及文献特点 从前述数据库中获得416篇文献，去重后，留下文献共281篇；初筛阅读题目和摘要后，剔除236篇文献，剩下45篇；再次阅读全文后排除24篇，最后只有21篇满足Meta分析的纳入标准[15-35]。共纳入1 692例患者，其中髓内固定组859例，钢板组833例。满足纳入标准的文献中，12篇是随机对照试验，具体文献筛选流程及结果见图1，纳入研究的21篇文献的基本特征见表1，2，特征包括第一作者、发表时间、样本大小、平均年龄、男女比例、干预因素、随访时间、结局、内固定取出。"
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2.2 偏倚风险 在随机对照试验文献中详细介绍了序列生成方法。在这些文献中，大多数文献没有采用盲法，除了3份文献[15，26，33]。文献详细的偏倚风险见图2。"
2.3 Meta分析结果 2.3.1 关于手术的Meta分析结果 纳入研究的9篇文献报道了弹性髓内钉组和钢板组的手术时间[15-23]。把9篇文献行Meta分析，异质性检验提示纳入研究的文献具有异质性(I2=95%)，宜采用随机效应模型。进行敏感性分析减少异质性，3篇文献被剔除[18，22-23]。Meta分析结果显示2组手术方式的手术时间差异有显著性意义，弹性髓内钉组的手术时间明显短于钢板组[MD=-18.62，95%CI(-20.75，-16.49)，P < 0.000 01，I2=0%]，见图3A。 纳入研究的7篇文献报道了弹性髓内钉组和钢板组的术中失血情况[16-22]。进行Meta分析，异质性检验提示纳入研究的文献具有异质性(I2=53%)，采用随机效应模型。进行敏感性分析减少异质性，2篇文献被排除[19-20]。分析结果显示2组手术方式在术中失血量方面差异有显著性意义，且弹性髓内钉组的术中血液量丢失明显低于钢板组[MD=-65.23，95%CI(-68.02，-62.44)，P < 0.000 01，I2=0%]，见图3B。 "
纳入研究的7篇文献提到了弹性髓内钉组和钢板组的切口长度[17-19，21-24]。进行Meta分析时，异质性检验提示纳入研究的文献具有异质性(I2=98%)，此时I2数值较大，故按照随机对照试验和非随机对照试验进行伤口长度的亚组分析，得出的异质性较前明显下降(I2=3.2%)，且P < 0.000 01，故分析结果显示弹性髓内钉组和钢板组的切口长度差异有显著性意义，且弹性髓内钉组切口长度明显短于钢板组[MD=-5.53，95%CI(-6.56，-4.49)，P < 0.000 01，I2=98%]，见图3C及图4。 "
2.3.2 住院时间的分析 纳入研究的5篇文献报道了弹性髓内钉组和钢板组的住院时间[15，17-18，21-22]。同上步骤进行Meta分析，异质性检验提示纳入研究的文献具有异质性(I2= 51%)。进行灵敏度分析后，1篇文献被排除[17]，分析结果显示弹性髓内钉组和钢板组的住院日差异有显著性意义，且弹性髓内钉组的住院天数显著短于钢板组[MD=-1.01，95%CI(-1.13，-0.89)，P < 0.000 01，I2=0%]，见图5。"
2.3.3 上肢功能评分的分析 纳入研究的4篇文献报道了术后6个月的弹性髓内钉组和钢板组的上肢功能评分[20，25-27]。拿4篇文献进行Meta分析时，异质性检验提示纳入研究的文献具有异质性(I2=95%)。经过敏感性分析后，1篇文献被排除在外[20]，分析结果提示2组上肢功能评分比较差异有显著性意义，弹性髓内钉组的上肢功能评分明显好于钢板组[MD=2.59，95%CI(2.21，2.97)，P < 0.000 01，I2=0%]，见图6A。 纳入文献研究的6篇报道中提到了报道术后12个月的弹性髓内钉组和钢板组的上肢功能评分[15，22，24-27]。当6篇文献进行Meta分析时，异质性检验提示纳入研究的文章具有异质性(I2=58%)。经敏感性分析后，2篇文章被排除在外[15，27]，分析结果提示在术后12个月后两组的上肢功能评分差异无显著性意义，即2组上肢功能评分差异无显著性意义[MD=0.62，95%CI(-0.64，1.88)，P=0.33，I2=0%]，见图6B。 "
2.3.4 并发症的分析 纳入研究的17篇文献中报道了弹性髓内钉组和钢板组的术后主要并发症[15-24，28-34]。由于主要并发症统计资料属于分类资料，Meta分析结果显示，2组手术方式在主要并发症方面有显著性意义，且弹性髓内钉组并发症发生率明显少于钢板组[OR=0.61，95%CI (0.39，0.93)，P=0.02，I2=24%]，见图7。通过评估纳入研究文献的发表偏倚，术后主要并发症的漏斗图结果显示无发表偏倚，见图8。"
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纳入研究的21篇文献提到了弹性髓内钉组和钢板组的术后轻微并发症[15-35]。对文献中统计的数据进行Meta分析时，异质性检验提示纳入研究的文献具有异质性(I2= 63%，此数据在未进行亚组分析时由Revman软件得出的结果)。经过亚组分析后，结果显示，在弹性髓内钉组和钢板组中，关于轻微并发症的发生率差异有显著性意义。 在其亚组植入物刺激反应分析中，Meta分析结果为：OR=1.30，95%CI(0.96，1.77)，P=0.09，I2=66%。在其亚组感染中，Meta分析结果为：OR=0.46，95%CI(0.26，0.83)，P=0.01，I2=0%。在其亚组术后瘢痕麻木分析中，Meta分析结果为：OR=0.37，95%CI(0.19，0.72)，P=0.000 4，I2=0%，见图9。术后轻微并发症的漏斗图结果显示无发表偏倚，见图10。 "
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2.3.5 骨折愈合时间的分析 纳入研究的6篇文献报道了弹性髓内钉组和钢板组的骨折愈合时间[15-17，19，22，25]。统计数据进行Meta分析，结果显示，弹性髓内钉组和钢板组的骨折愈合时间差异有显著性意义，弹性髓内钉的愈合时间明显短于钢板组[MD=-1.39，95%CI(-1.98，-0.80)，P < 0.000 01，I2=24%]，见图11。"
2.3.6 植入物取出分析 纳入研究的7篇文献报道了弹性髓内钉组和钢板组植入物的取出[19，26- 27，29-30，34-35]。对7篇文献进行Meta分析时，异质性检验提示纳入研究的文献具有异质性(I2=90%)。经敏感性分析后，异质性没有明显降低，结果显示，从长远来看，弹性髓内钉组与钢板植入物取出率差异无显著性意义[OR=4.24，95%CI(0.95，19.03)，P=0.06，I2=90%]，见图12。"
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