艾地骨化醇治疗骨质疏松症的疗效和安全性：一项随机对照试验的荟萃分析。
Efficacy and Safety of Eldecalcitol for Osteoporosis: A Meta-Analysis of Randomized Controlled Trials.
机构信息
Department of Endocrinology, The First Medical Center of Chinese PLA General Hospital, Beijing, China.
Department of Pediatrics, The First Medical Center of Chinese PLA General Hospital, Beijing, China.
出版信息
Front Endocrinol (Lausanne). 2022 Apr 19;13:854439. doi: 10.3389/fendo.2022.854439. eCollection 2022.
OBJECT
Eldecalcitol (ED-71) is a vitamin D analog for the treatment of osteoporosis. However, inconsistent results have been reported in this regard. Hence, this meta-analysis of randomized controlled trials (RCTs) aimed to assess the efficacy and safety of ED-71 for osteoporosis.
METHODS
The PubMed, Embase, and the Cochrane Library databases were systematically searched to identify potential trials from inception until April 2021. The investigated outcomes included bone mineral density and fractures at various sites, and potential adverse events. The pooled effect estimates were calculated using weighted mean difference (WMD) and relative risk (RR) with 95% confidence interval (CI) using the random-effects model.
RESULTS
Eight RCTs involving 2368 patients were selected for the final meta-analysis. The pooled results showed that ED-71 were associated with a higher level of femoral neck (FN) bone mineral density (BMD) (WMD: 0.92; 95% CI: 0.24-1.60; = 0.008), while it had no significant effect on lumbar spine BMD (WMD: 1.09; 95% CI: -0.11 to 2.30; = 0.076) and hip BMD (WMD: 1.12; 95% CI: -0.16 to 2.40; = 0.088). Moreover, the use of ED-71 could protect against the risk of all osteoporotic fracture (RR: 0.70; 95% CI: 0.55-0.88; = 0.003) and vertebral fracture (RR: 0.74; 95% CI: 0.55-0.98; = 0.038), while it did not affect the risk of nonvertebral fracture (RR: 0.53; 95%CI: 0.23-1.23; = 0.140). The subgroup analyses found that the effects of ED-71 were superior to those of alfacalcidol on both BMD and fracture results. Moreover, the use of ED-71 plus bisphosphonate was associated with a greater improvement in BMD at various sites compared with bisphosphonate alone. Finally, ED-71 was associated with an increased risk of increased urine calcium level (RR: 1.69; 95% CI: 1.33-2.15; < 0.001).
CONCLUSION
This study found that the use of ED-71 could improve BMD and fractures at various sites, especially compared with alfacalcidol or a combination with bisphosphonate for patients with osteoporosis.
SYSTEMATIC REVIEW REGISTRATION
[http://www.crd.york.ac.uk/prospero], identifier [CRD42021270536].
目的
艾地骨化醇（ED-71）是一种用于治疗骨质疏松症的维生素 D 类似物。然而，在这方面的报告结果并不一致。因此，本项针对随机对照试验（RCT）的荟萃分析旨在评估 ED-71 治疗骨质疏松症的疗效和安全性。
方法
系统检索了 PubMed、Embase 和 Cochrane 图书馆数据库，以确定从开始到 2021 年 4 月期间潜在的试验。研究的结果包括各部位的骨密度和骨折情况，以及潜在的不良事件。使用加权均数差（WMD）和相对风险（RR），通过随机效应模型，计算合并效应估计值。95%置信区间（CI）。
结果
最终有 8 项 RCT 纳入了 2368 名患者，进行了最终的荟萃分析。合并结果表明，ED-71 与股骨颈（FN）骨密度（BMD）水平升高相关（WMD：0.92；95%CI：0.24-1.60； = 0.008），但对腰椎 BMD（WMD：1.09；95%CI：-0.11 至 2.30； = 0.076）和髋部 BMD（WMD：1.12；95%CI：-0.16 至 2.40； = 0.088）无显著影响。此外，ED-71 的使用可降低所有骨质疏松性骨折（RR：0.70；95%CI：0.55-0.88； = 0.003）和椎体骨折（RR：0.74；95%CI：0.55-0.98； = 0.038）的风险，但不影响非椎体骨折（RR：0.53；95%CI：0.23-1.23； = 0.140）的风险。亚组分析发现，ED-71 的效果优于阿尔法骨化醇在 BMD 和骨折结果方面。此外，ED-71 加双膦酸盐的使用与各部位的 BMD 改善程度优于单独使用双膦酸盐。最后，ED-71 与尿钙水平升高的风险增加相关（RR：1.69；95%CI：1.33-2.15； < 0.001）。
结论
本研究发现，ED-71 的使用可以改善各部位的 BMD 和骨折情况，特别是与阿尔法骨化醇或与双膦酸盐联合使用相比，对骨质疏松症患者更有效。
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