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奥那司他膦治疗绝经后骨质疏松症女性的疗效和安全性:一项荟萃分析。

Efficacy and safety of odanacatib in the treatment of postmenopausal women with osteoporosis: a meta-analysis.

机构信息

Deparment of Orthopedics, Xiangya Hospital, Central South University, Changsha, Hunan, 410008, China.

Five-year Clinical Medicine, Xiangya School of Medicine, Central South University, Changsha, Hunan, 410083, China.

出版信息

J Orthop Surg Res. 2024 Aug 29;19(1):521. doi: 10.1186/s13018-024-05008-z.

Abstract

BACKGROUND

Osteoporosis, a systemic skeletal disease, seriously affects the quality of life in postmenopausal women. As one type of cathepsin K (CatK) inhibitor, odanacatib (ODN) is a fresh medication for osteoporosis. Considering the potential of ODN, we further examined the effect and safety of ODN for postmenopausal osteoporosis (PMOP) with a meta-analysis.

METHODS

PubMed, EMBASE, Cochrane Library, and Web of Science were searched for eligible studies from inception to December 29th, 2023. After that, we conducted a comprehensive meta-analysis following PRISMA guidelines. Risk of bias was meticulously investigated with the Cochrane Collaboration's tool. Efficacy was assessed with bone mineral density (BMD) at different sites (lumbar spine, trochanter, radius, femoral neck) and biomarkers of bone turnover (P1NP, uNTx/Cr, s-CTx, BSAP). Safety was evaluated by analyzing total, serious, other, and skin adverse events (AEs).

RESULTS

Four random clinical trials (RCTs) were involved in our research. All trials were rated as having high quality and met the eligibility criteria. In the current research, ODN was found to elevate BMD at lumbar spine, femoral neck, total hip, trochanter and forearm, while it decreased the levels of serum C-telopeptides of type I collagen (s-CTx) as well as urinary N-telopeptide/creatinine ratio (uNTx/Cr). No significant differences were observed in AEs between the ODN group and the control group.

CONCLUSIONS

ODN is a promising alternative for the treatment of PMOP on account of its excellent efficacy and credible safety. Unclear links between ODN and cardiovascular AEs require further research to clarify.

摘要

背景

骨质疏松症是一种全身性骨骼疾病,严重影响绝经后妇女的生活质量。作为一种组织蛋白酶 K(CatK)抑制剂,odanacatib(ODN)是一种治疗骨质疏松症的新药。鉴于 ODN 的潜力,我们进一步通过荟萃分析研究了 ODN 治疗绝经后骨质疏松症(PMOP)的疗效和安全性。

方法

从建库至 2023 年 12 月 29 日,我们检索了 PubMed、EMBASE、Cochrane Library 和 Web of Science 中符合条件的研究。之后,我们按照 PRISMA 指南进行了全面的荟萃分析。使用 Cochrane 协作工具仔细评估了偏倚风险。通过分析不同部位(腰椎、股骨颈、桡骨、股骨颈)的骨密度(BMD)和骨转换标志物(P1NP、uNTx/Cr、s-CTX、BSAP)来评估疗效。通过分析总不良事件(AE)、严重不良事件(SAE)、其他不良事件和皮肤不良事件(AE)来评估安全性。

结果

本研究纳入了 4 项随机临床试验(RCT)。所有试验均被评为高质量,符合入选标准。在本研究中,ODN 可提高腰椎、股骨颈、全髋、股骨转子间和前臂的 BMD,同时降低血清Ⅰ型胶原 C 端肽(s-CTX)和尿 N 端肽/肌酐比(uNTx/Cr)水平。ODN 组和对照组的 AE 发生率无显著差异。

结论

由于 ODN 具有良好的疗效和可靠的安全性,因此它是治疗 PMOP 的一种有前途的选择。ODN 与心血管 AE 之间的关联尚不清楚,需要进一步研究以阐明。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7247/11361187/dea426908968/13018_2024_5008_Fig1_HTML.jpg

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