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中华关节外科杂志(电子版) ›› 2020, Vol. 14 ›› Issue (02) : 179 -188. doi: 10.3877/cma.j.issn.1674-134X.2020.02.009

所属专题： 文献；

荟萃研究

唑来膦酸对全髋置换术后假体周围骨密度的影响
刘小垒1, 周义钦2, 钱齐荣2,†()   
  1. 1. 200129　上海开元骨科医院关节外科
    2. 200003　上海长征医院关节外科
  • 收稿日期:2019-12-18 出版日期:2020-04-01
  • 通信作者: 钱齐荣

Effect of zoledronic acid on periprosthetic bone mineral density in osteoporotic patients following total hip replacement

Xiaolei Liu1, Yiqin Zhou2, Qirong Qian2,†()   

  1. 1. Department of joint surgery, Shanghai Kaiyuan Orthopaedic Hospital, Shanghai 200129, China
    2. Department of joint surgery, Shanghai changzheng hospital, Shanghai 200003, China
  • Received:2019-12-18 Published:2020-04-01
  • Corresponding author: Qirong Qian
  • About author:
    Corresponding author: Qian Qirong, Email:
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引用本文：

刘小垒, 周义钦, 钱齐荣. 唑来膦酸对全髋置换术后假体周围骨密度的影响[J/OL]. 中华关节外科杂志(电子版), 2020, 14(02): 179-188.

Xiaolei Liu, Yiqin Zhou, Qirong Qian. Effect of zoledronic acid on periprosthetic bone mineral density in osteoporotic patients following total hip replacement[J/OL]. Chinese Journal of Joint Surgery(Electronic Edition), 2020, 14(02): 179-188.

目的

评价唑来膦酸对骨质疏松患者全髋置换术后假体周围骨密度影响。

方法

检索主要数据库从建库至2019年11月10日唑来膦酸对骨质疏松患者全髋置换术后应用并评价假体周围骨密度结局指标的随机对照试验，筛选合格研究进行分析。偏倚风险评价应用Cochrane评价员手册，质量评价应用Jadad评分法。应用Rev Man 5.3软件对假体周围骨密度指标进行Meta分析。

结果

符合纳入标准的文献共5篇。Meta分析结果显示，术后3个月假体周围骨密度Gruen 2区均数差(MD)＝0.11，95%可信区间(CI)(0.01，0.21)，治疗组与对照组比较，假体周围骨密度Gruen 2区差异有统计学意义(Z ＝2.21，P＝0.03)；Gruen 3区MD＝0.11，95%CI (0.01，0.21)，治疗组与对照组比较，假体周围骨密度Gruen 3区差异有统计学意义(Z＝2.24，P＝0.03)；Gruen 6区MD＝0.12，95%CI(0.04，0.21)，治疗组与对照组比较，假体周围骨密度Gruen 6区差异有统计学意义(Z＝2.76，P＝0.006)。术后6个月假体周围骨密度Gruen 1区MD＝0.05，95%CI(0.01，0.09)，治疗组与对照组比较，假体周围骨密度Gruen 1区差异有统计学意义(Z＝2.20，P＝0.03)；Gruen 2区MD＝0.08，95%CI(0.03，0.14)，治疗组与对照组比较，假体周围骨密度Gruen 2区差异有统计学意义(Z＝3.03，P＝0.002)；Gruen 3区MD＝0.05，95%CI (0.00，0.10)，治疗组与对照组比较，假体周围骨密度Gruen 3区差异有统计学意义(Z＝2.10，P＝0.04)；Gruen 4区MD＝0.10，95%CI(0.04，0.15)，治疗组与对照组比较，假体周围骨密度Gruen 4区差异有统计学意义(Z＝3.46，P＝0.0005)；Gruen 5区MD＝0.08，95% CI(0.03，0.14)，治疗组与对照组比较，假体周围骨密度Gruen 5区差异有统计学意义(Z＝2.87，P＝0.004)。术后12个月假体周围骨密度Gruen 1区MD＝0.09，95%CI(0.05，0.14)，治疗组与对照组比较，假体周围骨密度Gruen 1区差异有统计学意义(Z＝4.22，P<0.0001)；Gruen 2区MD＝0.11，95%CI(0.05，0.16)，治疗组与对照组比较，假体周围骨密度Gruen 2区差异有统计学意义(Z＝3.91，P<0.0001)；Gruen 3区MD＝0.08，95%CI(0.03，0.13)，治疗组与对照组比较，假体周围骨密度Gruen 3区差异有统计学意义(Z＝3.42，P＝0.0006)；Gruen 4区MD＝0.15，95%CI(0.09，0.20)，治疗组与对照组比较，假体周围骨密度Gruen 4区差异有统计学意义(Z＝5.01，P<0.00001)；Gruen 5区MD＝0.10，95%CI(0.05，0.16)，治疗组与对照组比较，假体周围骨密度Gruen 5区差异有统计学意义(Z＝3.77，P＝0.0002)。纳入研究均无重大不良反应发生。

结论

唑来膦酸能有效延缓全髋置换术后假体周围骨密度的降低，增加假体生物学稳定性，且临床应用安全，但需要更多高质量、多中心严格设计的随机对照试验进一步验证。

关键词: 唑来膦酸, 骨质疏松, 关节成形术, 置换, 髋, 骨密度, Meta分析
Objective

To evaluate the effect of zoledronic acid on bone mineral density after total hip arthroplasty in the patients with osteoporosis.

Methods

Main databases from the inception of each database up to 10 November 2019 were electronically searched. Randomized clinical trials (RCTs) of zoledronic acid on bone mineral density after total hip arthroplasty in patients with osteoporosis were included. The Cochrane risk of bias tool was used to assess the risk of bias. The quality of included studies was assessed using the Jadad rating scale. The Cochrane Collaboration’s RevMan5.3 software was used for meta-analysis.

Results

Five studies were included and made a meta-analysis. The meta-analysis results showed that three months after operation, the bone mineral density of Gruen 2 area [mean difference (MD)=0.11, 95% confidence interval (CI) (0.01, 0.21), Z=2.21, P=0.03], Gruen 3 area [MD=0.11, 95% CI (0.01, 0.21), Z=2.24, P=0.03], and Gruen 6 area [MD=0.12, 95% CI (0.04, 0.21), Z=2.76, P=0.006] in the treatment group were significantly higher than those in the control group; six months after operation, the bone mineral density of Gruen 1 area [MD=0.05, 95% CI(0.01, 0.09), Z=2.20, P=0.03], Gruen 2 area [MD=0.08, 95% CI(0.03, 0.14), Z=3.03, P=0.002], Gruen 3 area [MD=0.05, 95% CI (0.00, 0.10), Z=2.10, P=0.04], Gruen 4 area [MD=0.10, 95% CI(0.04, 0.15), Z=3.46, P=0.0005] and Gruen 5 area [MD=0.08, 95% CI (0.03, 0.14), Z=2.87, P=0.004] were significantly higher than those in the control group; 12 months after operation, the bone mineral density of Gruen 1 area [MD=0.09, 95% CI (0.05, 0.14), Z=4.22, P<0.0001], Gruen 2 area [MD=0.11, 95% CI(0.05, 0.16), Z=3.91, P<0.0001], Gruen 3 area [MD=0.08, 95% CI (0.03, 0.13), Z=3.42, P=0.0006], Gruen 4 area [MD=0.15, 95% CI(0.09, 0.20), Z =5.01, P<0.00001] and Gruen 5 area [MD=0.10, 95% CI (0.05, 0.16), Z=3.77, P=0.0002] were significantly higher than those in the control group. No significant adverse reactions occurred in the studies included.

Conclusion

Zoledronic acid can effectively delay the decrease of bone mineral density after total hip arthroplasty, increase the biological stability of the prosthesis, and the clinical application is safe, yet more high quality, multi-center strictly designed RCTs are needed to further verify.

Key words: Zoledronic acid, Osteoporosis, Arthroplasty, replacement, hip, Bone density, Meta-analysis
图1 文献筛选流程图
表1 纳入研究的基本特征
纳入研究 发表时间 例数(治疗组/对照组) 年龄(岁) 诊断 假体情况 治疗组 对照组 不良反应
袁宏等[7] 2014 31(16/15) [70～83，(73.8± 4.21)]/[70～81，(74.1±4.16)] 骨质疏松髋部骨折并行THA 生物型假体 钙尔奇＋阿尔法D3＋唑来膦酸 钙尔奇＋阿尔法D3 治疗组3例出现发热、头痛及流感样症状，对症治疗后好转
王利等[12] 2014 108(54/54) (61±1.2)/(62±1.3) 原发性骨质疏松症接受THA 生物型假体 术后使用唑来膦酸 术后不使用唑来膦酸 未报道
倪小青等[13] 2015 34(17/17) (83.32±2.33)/(82.98±2.99) 原发性骨质疏松症实施THA LINK陶对陶、陶对聚乙烯产品 THA术后加用唑来膦酸 THA术后不加用唑来膦酸 治疗组8例出现发热，乏力、肌肉酸痛等类感冒样症状，对症治疗后好转
Tsan-Wen Huang等[14] 2017 54(27/27) (60.1±11.7)/(59.4±13.3) 骨质疏松症实施THA 生物性假体 使用唑来膦酸 使用生理盐水安慰剂 治疗组3例发热、1例低钙血症
周伟等[15] 2018 32(16/16) (73.3±6.6)/(74.4± 5.7) 绝经后骨质疏松合并髋部骨折行THA 生物性假体 碳酸钙D3片＋骨化三醇胶囊＋唑来膦酸 碳酸钙D3片＋骨化三醇胶囊 治疗组2例出现低热反应
图2 纳入研究的偏倚风险图
图3 纳入研究的偏倚风险概况图
表2 纳入研究的偏倚风险及Jadad评分
纳入研究 发表时间 随机序列的产生 分配隐藏 参与者盲法 评估者盲法 结局数据完整性 选择报告 其他偏倚 Jadad评分
袁宏等[7] 2014 L U H U L U L 3
王利等[12] 2014 L U H U L U L 2
倪小青等[13] 2015 L U H U L U L 2
Tsan-Wen Huang等[14] 2017 L U L L L U L 5
周伟等[15] 2018 L U H L L U L 3
图4 治疗组与对照组术后3个月假体周围骨密度对比森林图
图5 治疗组与对照组术后6个月假体周围骨密度对比森林图
图6 治疗组与对照组术后12个月假体周围骨密度对比森林图
图7 治疗组与对照组术后12个月假体周围骨密度Gruen 1区对比漏斗图
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