University of Liège, Department of Public Health and Health Economics, Liège, Belgium.
Expert Opin Drug Saf. 2013 Jul;12(4):507-22. doi: 10.1517/14740338.2013.793669. Epub 2013 Apr 24.
Postmenopausal osteoporosis is a chronic disease that exerts a significant burden on both individuals and the community. Hence, there is a requirement for long-term treatment to be associated with a positive benefit-risk balance.
In this descriptive review, the long-term safety of calcitonin, selective estrogen receptor modulators (SERMs), bisphosphonates, denosumab and strontium ranelate was reviewed based on randomized controlled trials of 3 years or longer supplemented by extension study data and data from large, observational studies.
Rare adverse events become apparent with all currently available treatments for osteoporosis with long-term therapy. Due to the rarity of these adverse events and to the worldwide burden of osteoporosis, the benefit-risk balance remains in favor of the beneficial effects of treatment on an outcome rather than the probability of an adverse effect. No single antiosteoporosis agent is appropriate for all patients. Treatment decisions should be made on an individual basis, taking into account the relative benefits and risks in different patient populations.
绝经后骨质疏松症是一种慢性病,给个人和社会都带来了巨大负担。因此,需要长期治疗,并保持积极的获益-风险平衡。
在本描述性综述中,根据 3 年或更长时间的随机对照试验,结合扩展研究数据和大型观察性研究的数据,对降钙素、选择性雌激素受体调节剂(SERMs)、双膦酸盐、地舒单抗和雷奈酸锶的长期安全性进行了回顾。
所有目前可用的骨质疏松症治疗药物在长期治疗中都可能出现罕见的不良反应。由于这些不良反应罕见,且骨质疏松症在全球范围内的负担沉重,因此治疗效果对预后的益处大于不良反应发生的概率,获益-风险平衡仍然对治疗有利。没有单一的抗骨质疏松药物适用于所有患者。治疗决策应根据个体情况做出,考虑不同患者人群的相对获益和风险。