MacLean Catherine, Newberry Sydne, Maglione Margaret, McMahon Maureen, Ranganath Veena, Suttorp Marika, Mojica Walter, Timmer Martha, Alexander Alicia, McNamara Melissa, Desai Sheetal B, Zhou Annie, Chen Susan, Carter Jason, Tringale Carlo, Valentine Di, Johnsen Breanne, Grossman Jennifer
Southern California Evidence-based Practice Center, RAND, Santa Monica, CA 90401, USA.
Ann Intern Med. 2008 Feb 5;148(3):197-213. doi: 10.7326/0003-4819-148-3-200802050-00198. Epub 2007 Dec 17.
Although several agents are available to treat osteoporosis, the relative efficacy and toxicity of these agents when used to prevent fractures has not been well described.
To compare the benefits in fracture reduction and the harms from adverse events of various therapies for osteoporosis.
MEDLINE (1966 to November 2007) and other selected databases were searched for English-language studies.
For the efficacy analysis, investigators selected studies that reported the rate of or risk for fractures. For the adverse event analysis, they selected studies that reported the relationship between an agent and cardiovascular, thromboembolic, or upper gastrointestinal events; malignant conditions; and osteonecrosis.
Using a standardized protocol, investigators abstracted data on fractures and adverse events, agents and comparators, study design, and variables of methodological quality.
Good evidence suggests that alendronate, etidronate, ibandronate, risedronate, zoledronic acid, estrogen, parathyroid hormone (1-34), and raloxifene prevent vertebral fractures more than placebo; the evidence for calcitonin was fair. Good evidence suggests that alendronate, risedronate, and estrogen prevent hip fractures more than placebo; the evidence for zoledronic acid was fair. The effects of vitamin D varied with dose, analogue, and study population for both vertebral and hip fractures. Raloxifene, estrogen, and estrogen-progestin increased the risk for thromboembolic events, and etidronate increased the risk for esophageal ulcerations and gastrointestinal perforations, ulcerations, and bleeding.
Few studies have directly compared different agents or classes of agents used to treat osteoporosis.
Although good evidence suggests that many agents are effective in preventing osteoporotic fractures, the data are insufficient to determine the relative efficacy or safety of these agents.
尽管有多种药物可用于治疗骨质疏松症,但这些药物用于预防骨折时的相对疗效和毒性尚未得到充分描述。
比较各种骨质疏松症治疗方法在减少骨折方面的益处以及不良事件带来的危害。
检索MEDLINE(1966年至2007年11月)及其他选定数据库中的英文研究。
对于疗效分析,研究者选择报告骨折发生率或风险的研究。对于不良事件分析,他们选择报告药物与心血管、血栓栓塞或上消化道事件、恶性疾病以及骨坏死之间关系的研究。
研究者使用标准化方案提取有关骨折和不良事件、药物及对照、研究设计以及方法学质量变量的数据。
充分证据表明,阿仑膦酸盐、依替膦酸盐、伊班膦酸盐、利塞膦酸盐、唑来膦酸、雌激素、甲状旁腺激素(1-34)和雷洛昔芬预防椎体骨折的效果优于安慰剂;降钙素的证据为中等。充分证据表明,阿仑膦酸盐、利塞膦酸盐和雌激素预防髋部骨折的效果优于安慰剂;唑来膦酸的证据为中等。维生素D对椎体和髋部骨折的影响因剂量、类似物和研究人群而异。雷洛昔芬、雌激素和雌激素 - 孕激素会增加血栓栓塞事件的风险,依替膦酸盐会增加食管溃疡以及胃肠道穿孔、溃疡和出血的风险。
很少有研究直接比较用于治疗骨质疏松症的不同药物或药物类别。
尽管充分证据表明许多药物在预防骨质疏松性骨折方面有效,但数据不足以确定这些药物的相对疗效或安全性。