Chinese Journal of Tissue Engineering Research ›› 2021, Vol. 25 ›› Issue (6): 970-976.doi: 10.3969/j.issn.2095-4344.2968
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Meta-analysis of clinical efficacy and safety of antibiotic artificial bone in the treatment of chronic osteomyelitis
Hua Haotian1, Zhao Wenyu1, Zhang Lei2, Bai Wenbo3, Wang Xinwei2
- 1Henan University of Chinese Medicine, Zhengzhou 450046, Henan Province, China; 2Henan Provincial Orthopedic Hospital, Luoyang 471002, Henan Province, China; 3Shaanxi University of Chinese Medicine, Xianyang 712046, Shaanxi Province, China
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Received:2020-04-03Revised:2020-04-14Accepted:2020-05-13Online:2021-02-28Published:2020-12-05 -
Contact:Wang Xinwei, Master’s supervisor, Chief physician, Henan Provincial Orthopedic Hospital, Luoyang 471002, Henan Province, China -
About author:Hua Haotian, Master candidate, Henan University of Chinese Medicine, Zhengzhou 450046, Henan Province, China -
Supported by:the Science and Technology Project of Henan Province, No. 182102310487
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Cite this article
Hua Haotian, Zhao Wenyu, Zhang Lei, Bai Wenbo, Wang Xinwei. Meta-analysis of clinical efficacy and safety of antibiotic artificial bone in the treatment of chronic osteomyelitis[J]. Chinese Journal of Tissue Engineering Research, 2021, 25(6): 970-976.
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2.1 文献筛选流程及结果 依据上述检索策略共检索到相关文献511篇，查重后获得329篇，阅读题目和摘要，排除动物实验类、护理方向、会议论文、综述、专家经验和病例报道类文献，共获得28篇文献，根据纳入、排除标准最终纳入文献13篇[6-18]，其中中文文献11篇，英文文献2篇，文献筛选流程见图1。"
2.2 纳入文献基本情况 纳入研究的13篇文献中包含2篇随机临床对照试验和11篇回顾性研究，共有744例患者，治疗组387例，对照组357例，治疗组使用抗生素人工骨(万古霉素硫酸钙)治疗或在此基础上联合骨水泥，对照组使用敏感抗生素、灌注冲洗及骨水泥等一种方法进行治疗，纳入文献的基本信息见表1。在纳入的13篇文献中，有6篇文献报道了感染清除率[7，9-10，14-16]，有2篇报道了骨折愈合率[7，9]，有4篇文献报道了再次手术率[7，9，13，16]，有6篇文献报道了骨折愈合时间[6-7，9，11-13]，有5篇文献报道了治疗有效率[8，11-12，17-18]， 有6篇文献报道了住院时间[8，10-12，14，17]，有8篇文献报道了复发率[8，12-18]，有3篇文献报道了切口愈合时间[8, 10, 17]，有2篇文献报道了并发症发生率[15-16]。"
2.3 纳入研究的质量评价 该研究纳入的13篇文献中包括2篇随机临床对照试验，有11篇回顾性研究。2篇随机临床对照试验的质量评价按照Cochrane评价手册进行，评价结果均为中等偏倚文献，见图2，3。"
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11篇回顾性研究的质量评价按照NOS量表进行，评价结果均为高质量文献，见表2。"
2.4 Meta分析结果 2.4.1 两组感染清除率比较 有6篇文献涉及了感染清除 率[7，9-10，14-16]，根据治疗方式的不同进行亚组分析，各研究间异质性较小(P=0.72，I2=0)，使用固定效应模型分析，Meta分析结果显示：抗生素人工骨组在感染清除率方面优于对照组(RR=1.27，95%CI：1.12-1.45，P < 0.05)，抗生素人工骨联合骨水泥组在感染清除率方面也优于对照组(RR=1.30，95%CI：1.09-1.55，P < 0.05)，见图4。"
2.4.2 两组骨折愈合率比较 有2篇文献涉及了骨折愈合时间[7，9]，经过异质性检验发现不存在异质性(P=0.90，I2=0)，采用固定效应模型分析，结果显示：抗生素人工骨组在骨折愈合率方面优于对照组(RR=1.24，95%CI：1.07-1.44，P < 0.05)，见图5。"
2.4.3 两组骨折愈合时间比较 有6篇文献涉及了骨折愈合时间[6-7，9，11-13]，经过异质性检验发现存在异质性(P < 0.01，I2=96%)，采用随机效应模型分析，逐一剔除纳入研究进行敏感性分析，结果并未发生改变，说明此次分析结果比较稳健。结果显示：抗生素人工骨组在骨折愈合时间方面优于对照组(SMD= -2.45，95%CI：-3.68至-1.23，P < 0.05)，见图6。"
2.4.4 两组再次手术率比较 有4篇文献涉及了再次手术率[7，9，13，16]，根据治疗方式的不同展开亚组分析，各研究间异质性较小，采用固定效应模型分析(P < 0.89，I2=0)，结果显示：抗生素人工骨组在再次手术率方面优于对照组(RR=0.33，95%CI：0.20-0.55，P < 0.05)，抗生素人工骨联合骨水泥组在再次手术率方面与对照组相比并未显示出优势(RR=0.41，95%CI：0.16-1.04，P=0.06)，见图7。"
2.4.5 两组有效率比较 有5篇文献涉及了治疗有效率[8，11-12，17-18]，经过异质性检验发现不存在异质性(P=0.61，I2=0)，采用固定效应模型分析，结果显示：抗生素人工骨在治疗有效率方面优于对照组(RR=1.29，95%CI：1.14-1.46，P < 0.05)，见图8。"
2.4.6 两组住院时间比较 有6篇文献涉及了住院时间[8, 10-12, 14, 17]，经过异质性检验发现存在异质性(P < 0.01，I2=89%)，对纳入文献逐一剔除进行敏感性分析，发现当剔除Qin等[14]后异质性显著下降(I2=0)，对剩余文献采用固定效应模型分析，结果显示：抗生素人工骨组在住院时间方面优于对照组(MD=-14.81，95%CI：-16.43至-13.20，P < 0.05)，见图9。"
2.4.7 两组复发率比较 有8篇文献涉及了复发率[8，12-18]，根据治疗方式的不同展开亚组分析，各研究间异质性较小(P=0.98，I2=0)，采用固定效应模型分析，结果显示；抗生素人工骨组在复发率方面优于对照组(RR=0.31，95%CI：0.17-0.57，P < 0.05)，抗生素人工骨联合骨水泥组在复发率方面优于对照组(RR=0.31，95%CI：0.13-0.72，P < 0.05)，见图10。"
2.4.8 两组切口愈合时间比较 有3篇文献涉及了切口愈合时间[8，10，17]，经过异质性检验发现存在异质性(P=0.09，I2=59%)，对纳入文献逐一剔除进行敏感性分析，当剔除时珂[10]文献后异质性显著下降(I2=0)，对剩余文献采用固定效应模型分析，结果显示：抗生素人工骨组在切口愈合时间方面优于对照组(MD=-1.61，95%CI：-2.72至-0.49，P < 0.05)，见图11。"
2.4.9 两组并发症比较 有2篇文献涉及了并发症[15-16]，经过异质性检验发现不存在异质性(P=0.41，I2=0)，采用固定效应模型分析，结果显示：抗生素人工骨组在并发症发生率方面优于对照组(RR=0.27，95%CI：0.11-0.68，P < 0.05)，见图12。 2.5 发表偏倚分析 使用RevMan 5.3软件进行发表偏倚分析原则上纳入文献应不少于10篇，否则漏斗图检验效能不足，因此未作漏斗图。该Meta分析共纳入13篇文献，但单个指标纳入文献最高为8篇，可能回因纳入研究较少而使结论存在发表偏倚。"
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