骨化三醇治疗骨质疏松症的临床疗效和安全性概述。
Overview of the clinical efficacy and safety of eldecalcitol for the treatment of osteoporosis.
机构信息
Department of Endocrinology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100005, China.
Chugai Pharma China CO., LTD, Shanghai, 200021, China.
出版信息
Arch Osteoporos. 2022 May 5;17(1):74. doi: 10.1007/s11657-022-01071-3.
UNLABELLED
Eldecalcitol (ELD) is a new oral analog of the active form of vitamin D with anti-resorptive properties. We conducted a meta-analysis to investigate the efficacy and safety of ELD in osteoporosis. Compared with alfacalcidol, ELD significantly lowered vertebral facture risk, increased bone mineral density, but also had a higher risk of hypercalciuria.
PURPOSE
This study aimed to investigate the efficacy and safety of eldecalcitol (ELD) in osteoporosis by examining fracture rates, bone mineral density (BMD), bone turnover markers, and adverse events as outcomes.
METHODS
PubMed, EMBASE, and Cochrane Library were searched up to July 20, 2020, to identify eligible randomized controlled trials. The odds ratio (OR) or weighted mean difference (WMD) with 95% confidence interval was calculated by the random-effects model.
RESULTS
ELD significantly increased lumbar BMD (WMD: 2.80; 95% CI: 1.60, 4.00; P < 0.001, 2 studies involved), total hip BMD (WMD: 2.11; 95% CI: 0.68, 3.55; P = 0.004, 2 studies involved), and femoral neck BMD (WMD: 1.78; 95% CI: 0.76, 2.79; P = 0.001, 1 study involved) compared with alfacalcidol. Moreover, ELD caused a significantly lower rate of vertebral fracture (OR: 0.52; 95% CI: 0.29-0.95; P = 0.034, 2 studies involved) than alfacalcidol, but did not lower the rate of non-vertebral facture (OR: 0.44; 95% CI: 0.06-3.05; P = 0.405, 2 studies involved) compared with alfacalcidol. ELD significantly reduced the percentage change in bone-specific alkaline phosphatase (WMD: - 15.40; 95% CI: - 20.30, - 10.60; P < 0.001, 1 study involved) and serum type I collagen C-telopeptide (WMD: - 38.50; 95% CI: - 50.00, - 27.10; P < 0.001, 1 study involved) as compared with alfacalcidol. ELD was also associated with higher risk of hypercalciuria compared with alfacalcidol (OR: 1.64; 95% CI: 1.22, 2.20; P = 0.001, 2 studies involved).
CONCLUSIONS
This systematic review indicated that ELD was superior than alfacalcidol for improving vertebral fracture risk and BMD. Further large-scale trials should be conducted to verify the long-term effects and safety of ELD in osteoporosis.
PROSPERO REGISTRATION NUMBER
CRD42020147518.
目的
本研究旨在通过检测骨折发生率、骨密度（BMD）、骨转换标志物和不良事件，评估口服维生素 D 类似物艾地骨化醇（ELD）治疗骨质疏松症的疗效和安全性。
方法
检索PubMed、EMBASE 和 Cochrane Library 数据库，检索时限截至 2020 年 7 月 20 日，以纳入评估 ELD 治疗骨质疏松症的随机对照试验。采用随机效应模型计算比值比（OR）或加权均数差（WMD）及其 95%置信区间。
结果
与骨化三醇相比，ELD 可显著增加腰椎 BMD（WMD：2.80；95%CI：1.60，4.00；P<0.001，2 项研究）、全髋 BMD（WMD：2.11；95%CI：0.68，3.55；P=0.004，2 项研究）和股骨颈 BMD（WMD：1.78；95%CI：0.76，2.79；P=0.001，1 项研究）。此外，ELD 可显著降低椎体骨折发生率（OR：0.52；95%CI：0.29-0.95；P=0.034，2 项研究），但与骨化三醇相比，非椎体骨折发生率（OR：0.44；95%CI：0.06-3.05；P=0.405，2 项研究）无显著降低。与骨化三醇相比，ELD 还可显著降低骨碱性磷酸酶（WMD：-15.40；95%CI：-20.30，-10.60；P<0.001，1 项研究）和 I 型胶原 C 端肽（WMD：-38.50；95%CI：-50.00，-27.10；P<0.001，1 项研究）的变化百分比。与骨化三醇相比，ELD 还可增加高钙血症的发生风险（OR：1.64；95%CI：1.22，2.20；P=0.001，2 项研究）。
结论
本系统评价表明，ELD 改善椎体骨折风险和 BMD 的效果优于骨化三醇。需要进一步开展大规模试验以验证 ELD 治疗骨质疏松症的长期疗效和安全性。
前瞻性注册
CRD42020147518。
Zotero 插件