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唑来膦酸对接受替诺福韦治疗的 HIV 感染成年人的骨密度和骨转换的长期影响:一项随机、开放标签研究。

Prolonged Effect of Zoledronic Acid on Bone Mineral Density and Turnover in HIV-Infected Adults on Tenofovir: A Randomized, Open-Label Study.

机构信息

Centre for Applied Medical Research, St Vincent's Hospital, Sydney, Australia.

Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.

出版信息

J Bone Miner Res. 2019 Dec;34(12):2192-2197. doi: 10.1002/jbmr.3834. Epub 2019 Oct 24.

DOI:10.1002/jbmr.3834
PMID:31361922
Abstract

Zoledronic acid (ZOL) 5 mg annually was more effective than tenofovir disoproxil fumarate (TDF) switching at increasing bone mineral density (BMD) over 24 months in HIV-infected, osteopenic adults. To determine whether the effects of ZOL would persist without further infusions, we compared changes in left hip and spine BMD over 36 months in participants randomized to ZOL 5 mg at baseline and month 12 (and to continue TDF) or to switch TDF (without receiving ZOL). We also compared changes in the plasma bone turnover markers (BTMs) C-terminal telopeptide of type 1 collagen (CTX; bone resorption), and procollagen type 1 N propeptide (P1NP; bone formation) and determined whether CTX and P1NP changes at month 3 predicted BMD changes at month 36. Changes were compared in the per-protocol populations, which included 32 (74%) of 43 participants randomized to ZOL and 37 (88%) of 42 participants who switched TDF. Despite not receiving ZOL after month 12, mean hip and spine BMD change from baseline were stable and remained greater with ZOL at month 36 than with TDF switching (spine: 7.5% versus 2.7%, mean difference 4.7%, p < 0.001; hip: 5.5% versus 1.5%, mean difference 4.0%, p < 0.001). CTX and P1NP levels declined in both groups but significantly more with ZOL. Only percent changes in P1NP at month 3 correlated inversely with BMD changes at month 36 (spine: rho = -0.442, p < 0.001; hip: rho = -0.373, p = 0.002). Two infusions of ZOL (in the presence of ongoing TDF) yielded sustained BMD increases through month 36 that remained greater than with TDF switching. © 2019 American Society for Bone and Mineral Research.

摘要

唑来膦酸(ZOL)5mg 每年比替诺福韦酯二吡呋酯(TDF)转换更有效,可在 24 个月内增加 HIV 感染、骨质疏松成年人的骨密度(BMD)。为了确定 ZOL 的作用是否会在没有进一步输注的情况下持续存在,我们比较了基线和第 12 个月(并继续接受 TDF)接受 ZOL 5mg 随机分组或转换 TDF(未接受 ZOL)的参与者左髋和脊柱 BMD 在 36 个月时的变化。我们还比较了血浆骨转换标志物(BTMs)I 型胶原 C 端肽(CTX;骨吸收)和前胶原 I 型 N 端前肽(P1NP;骨形成)的变化,并确定 CTX 和 P1NP 的变化在第 3 个月是否可以预测第 36 个月的 BMD 变化。比较了符合方案人群的变化,其中包括 43 名随机接受 ZOL 的参与者中的 32 名(74%)和 42 名转换 TDF 的参与者中的 37 名(88%)。尽管在第 12 个月后不再接受 ZOL,但与 TDF 转换相比,左髋和脊柱 BMD 从基线的平均变化保持稳定,并且在第 36 个月时仍保持更大(脊柱:7.5%对 2.7%,平均差异 4.7%,p<0.001;髋部:5.5%对 1.5%,平均差异 4.0%,p<0.001)。CTX 和 P1NP 水平在两组中均下降,但 ZOL 组下降更明显。只有第 3 个月的 P1NP 百分比变化与第 36 个月的 BMD 变化呈负相关(脊柱:rho=-0.442,p<0.001;髋部:rho=-0.373,p=0.002)。两次唑来膦酸输注(在持续 TDF 的情况下)可使 BMD 在第 36 个月持续增加,并且仍然大于 TDF 转换。©2019 美国骨骼与矿物质研究协会。

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