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静脉注射阿仑膦酸钠和伊班膦酸钠治疗骨质疏松症的前瞻性对照研究。

A prospective comparative study of intravenous alendronate and ibandronate for the treatment of osteoporosis.

作者信息

Horikawa Akira, Miyakoshi Naohisa, Hongo Michio, Kasukawa Yuji, Kodama Hiroyuki, Shimada Yoichi

机构信息

Igarashi Memorial Hospital.

Department of Orthopedic Surgery, Akita University Graduate School of Medicine, Akita.

出版信息

Medicine (Baltimore). 2019 Feb;98(6):e14340. doi: 10.1097/MD.0000000000014340.

DOI:10.1097/MD.0000000000014340
PMID:30732159
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6380741/
Abstract

RATIONALE

Few comparative studies have evaluated the differences between intravenous alendronate (ALN) and ibandronate (IBN) in patients with osteoporosis. This study was to compare the effects of these 2 drugs on bone mineral density (BMD), bone metabolic markers, and adverse events in patients with osteoporosis.

PATIENT CONCERNS

Seventy-eight subjects were assigned to the ALN group and 66 to the IBN group.

DIAGNOSES

The diagnosis of osteoporosis was based on BMD values of the femoral neck or lumbar spine less than -2.5 SD below the reference values.

INTERVENTIONS

This study was designed as a 52-weeks, prospective, non-randomized study involving a parallel-group comparison between intravenous ALN and intravenous IBN in elderly women with osteoporosis.

OUTCOMES

The non-switched-IBN subgroup showed significant decrease in serum collagen type I cross-linked telopeptide (NTX) at 6 and 12 months compared with baseline, and the decrease in NTX were significantly greater in the non-switched-IBN subgroup than in the non-swithed-ALN subgroup. BMD in the lumbar spine in the non-switched-IBN subgroup showed a significant increase at 12 months and the increase in BMD were significantly larger than in the non-switched-ALN subgroup.

LESSONS

Intravenou IBN might result in a significantly greater increase of BMD and decrease in NTX, but it had a higher incidence of adverse drug reactions than ALN.

摘要

理论依据

很少有比较研究评估静脉注射阿仑膦酸钠(ALN)和伊班膦酸钠(IBN)在骨质疏松症患者中的差异。本研究旨在比较这两种药物对骨质疏松症患者骨密度(BMD)、骨代谢标志物和不良事件的影响。

患者情况

78名受试者被分配到ALN组,66名被分配到IBN组。

诊断

骨质疏松症的诊断基于股骨颈或腰椎的骨密度值低于参考值2.5个标准差。

干预措施

本研究设计为一项为期52周的前瞻性非随机研究,对老年骨质疏松症女性患者静脉注射ALN和静脉注射IBN进行平行组比较。

结果

未换药的IBN亚组在6个月和12个月时血清I型胶原交联末端肽(NTX)较基线显著降低,且未换药的IBN亚组NTX的降低幅度显著大于未换药的ALN亚组。未换药的IBN亚组腰椎骨密度在12个月时显著增加,且骨密度增加幅度显著大于未换药的ALN亚组。

经验教训

静脉注射IBN可能导致骨密度显著增加和NTX降低,但与ALN相比,其药物不良反应发生率更高。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4e30/6380741/af3267ab1559/medi-98-e14340-g007.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4e30/6380741/f43f80ecea78/medi-98-e14340-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4e30/6380741/cbc092f1d757/medi-98-e14340-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4e30/6380741/508569a96133/medi-98-e14340-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4e30/6380741/9b369606da55/medi-98-e14340-g006.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4e30/6380741/af3267ab1559/medi-98-e14340-g007.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4e30/6380741/f43f80ecea78/medi-98-e14340-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4e30/6380741/cbc092f1d757/medi-98-e14340-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4e30/6380741/508569a96133/medi-98-e14340-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4e30/6380741/9b369606da55/medi-98-e14340-g006.jpg
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