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中华老年骨科与康复电子杂志

中华老年骨科与康复电子杂志 ›› 2022, Vol. 08 ›› Issue (01) : 35 -43. doi: 10.3877/cma.j.issn.2096-0263.2022.01.007

Meta分析

抗骨吸收药对骨修复的影响：一项随机对照研究的系统综述和meta分析
付海瑞1, 杨露阳2, 梁斌3, 刘强4,†()   
  1. 1. 030032　山西省太原市山西医科大学附属白求恩医院骨科；032200　山西省吕梁市汾阳市山西医科大学附属汾阳医院骨科
    2. 030001　山西省太原市山西医科大学第一医院内分泌科
    3. 032200　山西省吕梁市汾阳市山西医科大学附属汾阳医院骨科
    4. 030032　山西省太原市山西医科大学附属白求恩医院骨科
  • 收稿日期:2020-08-25 出版日期:2022-02-05
  • 通信作者: 刘强

Effect of anti-resorptive agents affect on bone repair. A meta-analysis of randomized controlled studies

Hairui Fu1, Luyang Yang2, Bin Liang3, Qiang Liu4,†()   

  1. 1. Department of Orthopedics, Affiliated Bethune Hospital of Shanxi Medical University, Taiyuan 030032, China; Department of Orthopedics, Affiliated Fenyang Hospital of Shanxi Medical University, Fenyang 032200, China
    2. Endocrinology Department, The First Hospital of Shanxi Medical University, Taiyuan 030001, China
    3. Department of Orthopedics, Affiliated Fenyang Hospital of Shanxi Medical University, Fenyang 032200, China
    4. Department of Orthopedics, Affiliated Bethune Hospital of Shanxi Medical University, Taiyuan 030032, China
  • Received:2020-08-25 Published:2022-02-05
  • Corresponding author: Qiang Liu
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引用本文：

付海瑞, 杨露阳, 梁斌, 刘强. 抗骨吸收药对骨修复的影响：一项随机对照研究的系统综述和meta分析[J]. 中华老年骨科与康复电子杂志, 2022, 08(01): 35-43.

Hairui Fu, Luyang Yang, Bin Liang, Qiang Liu. Effect of anti-resorptive agents affect on bone repair. A meta-analysis of randomized controlled studies[J]. Chinese Journal of Geriatric Orthopaedics and Rehabilitation(Electronic Edition), 2022, 08(01): 35-43.

目的

旨在明确骨修复的炎症期或骨生成期使用抗骨吸收药是否会影响骨修复。

方法

检索MEDLINE，EMBASE，CENTRAL和中国生物医学文献数据库，检索时间为自建库至2020年12月19日。研究的纳入标准为使用抗骨吸收药与骨修复关系的所有相关临床随机对照研究。纳入研究的质量评价使用5.2版本的Cochrane偏倚风险评估工具，使用Review Manager 5.4.1软件进行数据合成。其中，使用风险比（RR）及其95%的置信区间（CI）作为效应量，使用Mantel-Haenszel法和固定效应模型进行分析。

结果

最终确认符合纳入标准的相关研究25个，有18个研究纳入meta分析，包含3 421例，合成的骨连接RR=1.013（95% CI：0.994，1.032，P=0.198）。敏感性分析中，排除11个非低风险研究后的骨连接RR=1.008（95% CI：0.987，1.029，P=0.475）。亚组分析中，四肢骨折愈合人群（9个研究，2 891例）的骨连接RR=1.009（95% CI：0.989，1.029，P=0.399）；脊柱融合人群（9个研究，530例）的骨连接RR=1.034（95% CI：0.979，1.091，P=0.230）；骨质疏松患者人群（13个研究，749例）的骨连接RR=1.038（95% CI：0.993，1.086，P=0.103）；内固定手术人群（15个研究，2 967例）的骨连接RR=1.005（95% CI：0.989，1.021，P=0.540）。各研究结果均包括无效值1，即骨修复早期使用抗骨吸收药不影响骨连接。

结论

通过该研究可见，在骨修复的炎症期或骨生成期应用抗骨吸收药并不影响骨连接。其中，无论四肢骨折患者或脊柱融合手术患者，无论骨质疏松患者，或经历内固定手术患者，在骨修复早期应用抗骨吸收药预防继发性骨质疏松性骨折均不影响骨连接。因此，对于适用抗骨质疏松治疗的患者，出现骨折后建议立即开始抗骨质疏松治疗。

关键词: 抗骨吸收药, 骨连接, 脊柱融合, 骨折愈合, meta分析
Objective

The meta-analysis was performed to determine whether the early use of the anti-resorptive drugs would affect bone union.

Methods

We searched MEDLINE, EMBASE, CENTRAL and CBM for the related studies from each database inception until December 19, 2020. The inclusion criteria were all relevant clinical randomized controlled studies that studied the relationship between the anti-resorptive drugs and bone union. We assessed the quality of the included studies with version 5.2 of the Cochrane risk-of-bias tool, and the software for data synthesis was Review Manager 5.4.1. The effect measure was risk ratio (RR) with 95% confidence interval (CI), the Mantel-Haenszel method and the fixed effect model were used to analyze data.

Results

25 studies met the inclusion criteria, 18 studies were included in the meta-analysis, including 3, 421 people, the total bone union RR=1.013(95% CI: 0.994, 1.032, P=0.198). In the sensitivity analysis of excluding 11 non-low-risk studies, RR=1.008 (95% CI: 0.987, 1.029, P=0.475). In the subgroup analysis, the limb fracture population(9 studies, 2, 891 persons), RR= 1.009 (95% CI: 0.989, 1.029, P=0.399); the spinal fusion population (9 studies, 530 persons), RR=1.034 (95% CI: 0.979, 1.091, P=0.230), the osteoporotic population (13 studies, 749 persons), RR=1.038 (95% CI: 0.993, 1.086, P=0.103); the internal fixation surgery population (15 studies, 2,967 persons), RR=1.005 (95% CI: 0.989, 1.021, P=0.540). The results of each analysis included an invalid value of 1, that is, the early use of the anti-resorptive drugs in bone repair did not affect bone union.

Conclusions

In general, the early application of the anti-resorptive drugs in bone repair does not affect bone union. Among them, no matter the limb fracture patients or the spinal fusion patients, whether the osteoporotic patients, or the patients undergoing internal fixation surgery, the use of the anti-resorptive drugs in the early stage of bone repair to prevent secondary osteoporosis fracture does not affect bone union. Therefore, for patients suitable for anti-osteoporosis treatment, it is recommended to start anti-osteoporosis treatment immediately after fracture.

Key words: The anti-resorptive drugs, Bone union, Spinal fusion, Fracture healing, Meta-analysis
图1 研究筛选流程图
表1 纳入研究特点表
研究编码 国家 OP 骨折部位 手术/方法 实验组（人） 对照组（人） 干预 对照
高勇2017[37] 中国 是 转子间 ORIF/PFNA 15 15 ALN 空白
Colón-Emeric 2011[33] 美国 否 髋部 手术方法由治疗医生决定 1 065 1 062 ZOL 安慰剂
Duckworth 2019[30] 英国 否 桡骨远端 由经治医生决定手术或保守 196 183 ALN 安慰剂
Gong 2012[36] 韩国 是 桡骨远端 ORIF/掌侧板 24 26 ALN ALN（术后3月执行）
Harding 2011[32] 瑞典 否 胫骨平台近端截骨 HCO/外固定架 25 21 ZOL 安慰剂
Kim 2012[35] 韩国 是 转子间 加压螺钉或髓内钉（由术者决定） 47 24 RIS RIS（术后3月执行）
Nagahama 2011[34] 日本 是 腰椎融合 PLIF/双Cage+椎间隙植骨/自体骨和磷酸三钙 19 17 ALN 维生素D
van der Poest 2000[46] 荷兰 是 桡骨远端 否 18 19 ALN 安慰剂
van der Poest 2002[31] 荷兰 否 下肢 由经治医生决定手术或保守 20 18 ALN 安慰剂
研究编码 干预执行时间 干预持续时间（月） 评估时间 实验组骨连接（人） 对照组骨连接（人）
高勇2017[37] 10~14天 12 3月 10 9
Colón-Emeric 2011[33] 90天内 36 至少6周 1031 1033
Duckworth 2019[30] 14天内 6 8周 121 103
Gong 2012[36] 14天 - 10周 24 26
Harding 2011[32] 4周 12 12周 24 20
Kim 2012[35] 1周或1月 12 12周 35 15
Nagahama 2011[34] 1周 12 12月 18 11
van der Poest 2000[46] 平均4~5周 12 - 18 18
van der Poest 2002[31] 2周 12 - 19 17
Yang 2018[38] 中国 是 拇外翻行近节趾骨截骨、跖跗关节融合 螺钉固定 56 57 ZOL
陈莹2019[43] 中国 是 腰椎融合 PLIF/Cage/自体骨 31 32人 ZOL
李辉南2016[41] 中国 是 腰椎融合 PLIF/自体骨 20 18 ZOL
刘汉辉2019[44] 中国 是 腰椎融合 TLIF 32 30 ZOL
潘晟2014[40] 中国 是 腰椎融合 PLIF 40 40 ZOL
尹自龙2020[45] 中国 是 颈椎融合 前路/异体骨 28 29 ZOL
Chen 2016[27] 中国 是 腰椎融合 PLIF/自体骨+异体骨 33 36 ZOL
Li 2012[39] 中国 否 腰椎融合 TLIF/Cage/自体骨 41人 41人 ZOL
Liu 2019[42] 中国 是 颈椎融合 ACDF/Cage/异体骨 21 22 ZOL
Yang 2018[38] 安慰剂 1周 6 12周 56 57
陈莹2019[43] 空白 1周 12 - 27* 28*
李辉南2016[41] 空白 1~2周 12 - 20 16
刘汉辉2019[44] 空白 第5天 12 12月 29 28
潘晟2014[40] 空白 第7天 12 - 40 39
尹自龙2020[45] 安慰剂 第2~3天 12 12月 28 29
Chen 2016[27] 安慰剂 3天 12 12月 27 30
Li 2012[39] 安慰剂 3天 12 12月 36 35
Liu 2019[42] 安慰剂 第5天 12 12月 21 22
图8 手术患者骨连接风险比
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