Colorado Center for Bone Research, University of Colorado Health Sciences Center, Lakewood, CO, USA.
J Bone Miner Res. 2013 Oct;28(10):2049-59. doi: 10.1002/jbmr.2058.
Bisphosphonates are widely used for the treatment of osteoporosis and are generally well tolerated. However, the United States Food and Drug Administration safety reports have highlighted the issue of renal safety in bisphosphonate-treated patients. All bisphosphonates carry labeled "warnings" or a contraindication for use in patients with severe renal impairment (creatinine clearance <30 or <35 mL/min). Data from pivotal trials and their extension studies of bisphosphonates approved for the management of osteoporosis were obtained via PubMed, and were reviewed with support from published articles available on PubMed. Renal safety analyses of pivotal trials of oral alendronate, risedronate, and ibandronate for postmenopausal osteoporosis showed no short-term or long-term effects on renal function. Transient postinfusion increases in serum creatinine have been reported in patients receiving intravenous ibandronate and zoledronic acid; however, studies showed that treatment with these agents did not result in long-term renal function deterioration in clinical trial patients with osteoporosis. All bisphosphonate therapies have "warnings" for use in patients with severe renal impairment. Clinical trial results have shown that even in elderly, frail, osteoporotic patients with renal impairment, intravenous bisphosphonate therapy administration in accordance with the prescribing information did not result in long-term renal function decline. Physicians should follow guidelines for bisphosphonate therapies administration at all times.
双膦酸盐被广泛用于治疗骨质疏松症，通常具有良好的耐受性。然而，美国食品和药物管理局的安全报告强调了双膦酸盐治疗患者的肾脏安全性问题。所有双膦酸盐都带有“警告”标签，或在严重肾功能不全（肌酐清除率 <30 或 <35 mL/min）患者中禁用。通过 PubMed 获得了已批准用于骨质疏松症治疗的双膦酸盐的关键性试验及其扩展研究的数据，并在 PubMed 上可用的已发表文章的支持下进行了审查。对用于绝经后骨质疏松症的口服阿仑膦酸盐、利塞膦酸盐和伊班膦酸盐的关键性试验的肾脏安全性分析显示，它们对肾功能没有短期或长期影响。接受静脉伊班膦酸盐和唑来膦酸治疗的患者报告有短暂的输注后血清肌酐升高；然而，研究表明，在骨质疏松症临床试验患者中，这些药物的治疗并未导致肾功能长期恶化。所有双膦酸盐治疗都有“警告”，用于严重肾功能不全的患者。临床试验结果表明，即使在肾功能受损的老年、体弱的骨质疏松症患者中，按照说明书使用静脉双膦酸盐治疗也不会导致肾功能长期下降。医生应始终遵循双膦酸盐治疗管理指南。
