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口服双膦酸盐的新型制剂在骨质疏松症治疗中的应用。

Novel formulations of oral bisphosphonates in the treatment of osteoporosis.

机构信息

MRC Lifecourse Epidemiology Centre, University of Southampton, Tremona Road, Southampton, SO16 6YD, UK.

Chair for Biomarkers of Chronic Diseases, Biochemistry Department, College of Science, King Saud University, Riyadh, Kingdom of Saudi Arabia.

出版信息

Aging Clin Exp Res. 2022 Nov;34(11):2625-2634. doi: 10.1007/s40520-022-02272-z. Epub 2022 Nov 4.

DOI:10.1007/s40520-022-02272-z
PMID:36331798
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9675642/
Abstract

Oral bisphosphonates are a key intervention in the treatment of osteoporosis and in reducing the risk of fragility fractures. Their use is supported by over 3 decades of evidence; however, patient adherence to oral bisphosphonates remains poor in part due to complex dosing instructions and adverse events, including upper gastrointestinal symptoms. This problem has led to the development of novel oral bisphosphonate formulations. Buffered, effervescent alendronate is dissolved in water and so seeks to reduce upper gastro-intestinal adverse events, and gastro-resistant risedronate aims to reduce the complexity of dosing procedure (e.g. fasting prior to consumption) whilst still maintaining the efficacy of fracture risk reduction. Clinical trials and real-world data have been employed to demonstrate some benefits in terms of reduced upper gastro-intestinal adverse events, adherence, persistence and health economic outcomes. This report describes the result of an ESCEO (European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis) expert working group, which explores where oral bisphosphonates sit in current clinical practice guidelines, review their risk-benefit profile and the consequences of poor adherence before exploring novel oral bisphosphonate formulations and their potential clinical and health economic impact. Further research is required but there are signs that these novel, oral bisphosphonate formulations may lead to improved tolerance of oral bisphosphonates and thus, improved adherence and fracture outcomes.

摘要

口服双膦酸盐是骨质疏松症治疗和降低脆性骨折风险的关键干预措施。它们的使用得到了超过 30 年的证据支持;然而,由于复杂的剂量说明和不良反应,包括上胃肠道症状,患者对口服双膦酸盐的依从性仍然很差。这个问题导致了新型口服双膦酸盐制剂的发展。缓冲、泡腾型阿伦膦酸盐可溶于水,旨在减少上胃肠道不良反应,而耐胃型利塞膦酸盐旨在减少剂量程序的复杂性(例如在服用前禁食),同时仍保持降低骨折风险的疗效。临床试验和真实世界数据已被用于证明在减少上胃肠道不良反应、依从性、持久性和健康经济效益方面的一些益处。本报告描述了 ESCEO(欧洲临床和经济骨质疏松症和骨关节炎学会)专家工作组的结果,该工作组探讨了口服双膦酸盐在当前临床实践指南中的位置,审查了它们的风险-效益概况以及依从性差的后果,然后探讨了新型口服双膦酸盐制剂及其潜在的临床和健康经济效益。还需要进一步的研究,但有迹象表明,这些新型口服双膦酸盐制剂可能会提高口服双膦酸盐的耐受性,从而提高依从性和骨折结局。