背景:骨质疏松症,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)是骨质疏松症的新鲜药物。考虑到ODN的潜力,我们通过荟萃分析进一步研究了ODN治疗绝经后骨质疏松症(PMOP)的疗效和安全性.
方法:PubMed,EMBASE,科克伦图书馆,从开始到12月29日,搜索了WebofScience的合格研究,2023年。之后,我们按照PRISMA指南进行了全面的荟萃分析.使用CochraneCollaboration的工具对偏倚风险进行了细致的调查。通过不同部位的骨密度(BMD)评估疗效(腰椎,转子,半径,股骨颈)和骨转换的生物标志物(P1NP,uNTx/Cr,s-CTx,BSAP)。通过分析总体来评估安全性,严肃,other,和皮肤不良事件(AE)。
结果:我们的研究涉及四个随机临床试验(RCT)。所有试验均被评为具有高质量并符合资格标准。在目前的研究中,发现ODN会升高腰椎的BMD,股骨颈,全髋关节,转子和前臂,同时降低了I型胶原的血清C端肽(s-CTx)水平以及尿N端肽/肌酐比(uNTx/Cr)。ODN组和对照组之间的AE没有观察到显著差异。
结论:ODN由于其优异的疗效和可靠的安全性,是治疗PMOP的一种有希望的替代方法。ODN和心血管不良事件之间不明确的联系需要进一步的研究来澄清。
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.