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抗骨质疏松药物预防全髋关节置换术后假体周围骨丢失的疗效:随机对照研究的网络荟萃分析。

Prophylactic efficacy on periprosthetic bone loss in calcar region after total hip arthroplasty of antiosteoporotic drugs: a network meta-analysis of randomised controlled studies.

机构信息

Department of Public Health, Zhejiang University, Hangzhou, China.

Department of Orthopedic Surgery, Zhejiang University, Hangzhou, China.

出版信息

Postgrad Med J. 2021 Mar;97(1145):150-155. doi: 10.1136/postgradmedj-2019-137120. Epub 2020 Feb 29.

DOI:10.1136/postgradmedj-2019-137120
PMID:32114493
Abstract

OBJECTIVES

The aim of this study was to evaluate the effect of antiosteoporotic drugs on preventing periprosthetic bone loss in calcar 6 and 12 months after total hip arthroplasty.

METHODS

The network meta-analysis was conducted guided by the Preferred Reporting Items for Systematic Reviews and Meta-analysis (PRISMA) guideline. A systematic literature search was conducted and 21 studies that enrolled a total of 955 patients with 9 antiosteoporotic drugs met the inclusion criteria. Network meta-analysis and conventional meta-analysis were carried out for calculating standard mean difference (SMD) and the surface under cumulative ranking curve (SUCRA) of the bone mineral density (BMD) in calcar (Gruen zone 7) as well as bone turnover markers (BTMs) including bone-specific alkaline phosphatase (BSAP) and collagen type I cross-linked N telopeptide (NTX) at 6 and 12 months between different antiosteoporotic drugs.

RESULTS

At 6 months after total hip arthroplasty, zoledronate (SUCRA=86.4%), risedronate (SUCRA=51.3%) and etidronate (SUCRA=44.5%) were effective in retaining BMD in calcar; zoledronate was significantly more effective than etidronate (SMD=0.65, 95% CI 0.03 to 1.27). Teriparatide (SUCRA=84.5%), denosumab (SUCRA=82.5%), zoledronate (SUCRA=69.2%), alendronate+alfacalcidol (SUCRA=66.2%) and etidronate (SUCRA=51.5%) were the top five drugs in retaining BMD in calcar at 12 months after total hip arthroplasty and the efficacy were comparable. After simultaneously excluding studies in which the prosthesis were cement and the drug dosages as well as treatment durations were inconsistent with those in treating osteoporosis, the above results were robust with the exception that alendronate showed significant efficacy compared with placebo (SMD=1.22, 95% CI 0.46 to 1.99) and was comparable with those effective drugs at 12 months. Long-term residual effect was corroborated only in etidronate, alendronate and zoledronate from previous studies. BTMs were significantly decreased as early as 6 months (SMD of BSAP -0.49, 95% CI -0.84 to -0.13; SMD of NTX -0.93, 95% CI -1.21 to -0.64) and sustained until 12 months (SMD of BSAP -0.27, 95% CI -0.50 to -0.03; SMD of NTX -0.84, 95% CI -1.11 to -0.56) during the prophylaxis.

CONCLUSIONS

Antiosteoporotic drugs showed prophylactic efficacy on periprosthetic bone loss after total hip arthroplasty in calcar, the effectiveness varied. Zoledronate was the best recommendation due to its optimal efficacy both within 6 and 12 months as well as its residual effect in the long term. BTMs could be used as indicators for monitoring through the treatment. More head-to-head clinical trials are needed to confirm those findings.

摘要

目的

本研究旨在评估抗骨质疏松药物对全髋关节置换术后 6 个月和 12 个月时假体周围骨丢失的预防作用。

方法

本研究遵循系统评价和荟萃分析的首选报告项目(PRISMA)指南进行网络荟萃分析。进行了系统的文献检索,共纳入了 21 项研究,总计 955 例患者,使用了 9 种抗骨质疏松药物。通过计算骨密度(Gruen 区 7)和骨转换标志物(BTM)的标准均数差(SMD)和累积排序曲线下面积(SUCRA),对不同抗骨质疏松药物在全髋关节置换术后 6 个月和 12 个月时的骨密度以及骨特异性碱性磷酸酶(BSAP)和 I 型胶原交联 N 末端肽(NTX)等 BTM 进行了网络荟萃分析和常规荟萃分析。

结果

全髋关节置换术后 6 个月时,唑来膦酸(SUCRA=86.4%)、利塞膦酸(SUCRA=51.3%)和依替膦酸(SUCRA=44.5%)在保留假体周围骨密度方面效果显著;唑来膦酸明显优于依替膦酸(SMD=0.65,95%置信区间 0.03 至 1.27)。特立帕肽(SUCRA=84.5%)、地舒单抗(SUCRA=82.5%)、唑来膦酸(SUCRA=69.2%)、阿仑膦酸钠+阿尔法骨化醇(SUCRA=66.2%)和依替膦酸(SUCRA=51.5%)在全髋关节置换术后 12 个月时是保留假体周围骨密度的前 5 种药物,且疗效相当。在同时排除了假体为水泥型、药物剂量以及治疗持续时间与治疗骨质疏松症不一致的研究后,除阿仑膦酸钠与安慰剂相比具有显著疗效(SMD=1.22,95%置信区间 0.46 至 1.99)且与 12 个月时的有效药物相当外,上述结果具有稳健性。仅从前瞻性研究中证实了依替膦酸、阿仑膦酸钠和唑来膦酸具有长期残留效应。BTM 早在 6 个月时就明显下降(BSAP 的 SMD-0.49,95%置信区间-0.84 至-0.13;NTX 的 SMD-0.93,95%置信区间-1.21 至-0.64),并持续至 12 个月(BSAP 的 SMD-0.27,95%置信区间-0.50 至-0.03;NTX 的 SMD-0.84,95%置信区间-1.11 至-0.56)。

结论

抗骨质疏松药物对全髋关节置换术后假体周围骨丢失具有预防作用,疗效存在差异。唑来膦酸是最佳推荐药物,因为它在 6 个月和 12 个月内的疗效以及长期的残留效应都很理想。BTM 可作为治疗期间监测的指标。需要更多的头对头临床试验来证实这些发现。

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