Gennari C, Reginster J Y
Institute of Medical Pathology, University of Siena, Nuovo Policlinico Le Scotte, Italy.
Aging (Milano). 1998 Aug;10(4):284-94. doi: 10.1007/BF03339790.
A treatment against osteoporosis can be considered efficacious only when its beneficial effects on bone remodeling, bone mass, and osteoporotic fracture incidence are proven. As for any treatment, proven efficacy must be combined with proven safety. This review analyzes published data on efficacy and safety of alendronate, clodronate and etidronate, the bisphosphonates currently marketed in Italy for osteoporosis treatment. Different studies have shown that alendronate, clodronate and etidronate reduce bone turnover, and increase bone mineral density in postmenopausal osteoporotic patients. Prospective, double blind, multicenter studies reported a reduction in osteoporotic fracture incidence for alendronate and etidronate. Fracture incidence reduction by clodronate, on the other hand, was shown only in an open label study. Finally, a reduction in fracture incidence by etidronate was shown in a large retrospective postmarketing study. Postmarketing surveillance evidenced that osteomalacia, a suspected side effect of etidronate treatment, does not occur at the currently used dose regimens. Postmarketing surveillance of alendronate has recently raised some concern regarding possible severe esophageal damage during alendronate treatment, especially when the drug is not taken according to the manufacturer's instructions.
只有当一种抗骨质疏松症的治疗方法对骨重塑、骨量和骨质疏松性骨折发生率的有益作用得到证实时，才能认为其有效。对于任何治疗方法而言，已证实的疗效必须与已证实的安全性相结合。本综述分析了阿仑膦酸盐、氯膦酸盐和依替膦酸盐（目前在意大利上市用于治疗骨质疏松症的双膦酸盐）的疗效和安全性的已发表数据。不同研究表明，阿仑膦酸盐、氯膦酸盐和依替膦酸盐可降低绝经后骨质疏松症患者的骨转换，并增加骨矿物质密度。前瞻性、双盲、多中心研究报告称，阿仑膦酸盐和依替膦酸盐可降低骨质疏松性骨折的发生率。另一方面，氯膦酸盐降低骨折发生率仅在一项开放标签研究中得到证实。最后，在一项大型上市后回顾性研究中显示依替膦酸盐可降低骨折发生率。上市后监测表明，依替膦酸盐治疗疑似副作用的骨软化症，在目前使用的剂量方案下不会发生。阿仑膦酸盐的上市后监测最近引发了一些担忧，即阿仑膦酸盐治疗期间可能出现严重的食管损伤，尤其是在未按照制造商说明用药时。
