Varenna M, Bertoldo F, Di Monaco M, Giusti A, Martini G, Rossini M
Bone Diseases Unit, Department of Rheumatology, Gaetano Pini Institute, Milan.
Reumatismo. 2013 Oct 31;65(4):143-66. doi: 10.4081/reumatismo.2013.143.
The range of osteoporosis treatments is increasingly large and, like any disease, the pharmacological management of patients should involve a risk/benefit evaluation to attain the greatest reduction in risk of fracture with the lowest incidence of adverse events. The aim of this review is to critically appraise the literature about the safety issues of the main pharmacological treatments of osteoporosis. This document is the result of a consensus of experts based on a systematic review of regulatory documents, randomized controlled trials, metaanalyses, pharmacovigilance surveys and case series related to possible adverse drug reactions to osteoporosis treatment with calcium and vitamin D supplements, bisphosphonates, strontium ranelate, selective estrogen receptor modulators, denosumab, and teriparatide. As expected, randomized controlled trials showed only the most common adverse events due to the samples size and the short observation time. Case series and observational studies are able to provide data about uncommon side effects, but in some cases a sure cause-effect relationship needs still to be confirmed. Consistently with methodological limitations, the newer drugs have a tolerance profile that has not been fully explored yet. Osteoporosis treatments showed an overall good tolerance profile with rare serious adverse events that, however, must be well known by the clinician who prescribes these drugs. The concern about possible adverse events should be weighed against the reduction of morbidity and mortality associated with a significant fracture risk reduction.
骨质疏松症的治疗方法种类日益繁多，与任何疾病一样，对患者的药物治疗应进行风险/效益评估，以在不良事件发生率最低的情况下最大程度降低骨折风险。本综述的目的是对有关骨质疏松症主要药物治疗安全性问题的文献进行批判性评价。本文档是专家共识的结果，该共识基于对监管文件、随机对照试验、荟萃分析、药物警戒调查以及与钙和维生素D补充剂、双膦酸盐、雷奈酸锶、选择性雌激素受体调节剂、地诺单抗和特立帕肽治疗骨质疏松症可能的药物不良反应相关的病例系列的系统评价。正如预期的那样，由于样本量和观察时间较短，随机对照试验仅显示了最常见的不良事件。病例系列和观察性研究能够提供有关罕见副作用的数据，但在某些情况下，确切的因果关系仍需确认。与方法学局限性一致，新型药物的耐受性情况尚未得到充分探索。骨质疏松症治疗总体耐受性良好，严重不良事件罕见，但开这些药物的临床医生必须充分了解这些情况。对可能不良事件的担忧应与降低与显著降低骨折风险相关的发病率和死亡率相权衡。
