唑来膦酸静脉滴注治疗骨质疏松症疗效观察。

Core Evidence Pub Date : 2010-06-15 DOI:10.2147/ce.s6011
E Michael Lewiecki
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引用次数: 17

摘要

引言:骨质疏松症是一种以骨密度低和骨质量差为特征的疾病,会导致骨强度降低和骨折风险增加。口服双磷酸盐是大多数骨质疏松症患者的一线治疗方法,由于一些患者复杂的给药方案和胃肠道不耐受等因素,口服双磷酸盐与治疗依从性不理想有关。静脉注射双磷酸盐通过不频繁的注射给药来解决这些限制,确保100%的生物利用度。唑来膦酸是最新被批准用于治疗骨质疏松症的双磷酸盐。目的:本综述评估静脉注射唑来膦酸治疗骨质疏松症的疗效。证据综述:在一项为期三年的随机、双盲、安慰剂对照试验中,唑来膦酸5mg,每年静脉滴注15分钟,已被证明可以降低绝经后骨质疏松症女性发生脊椎骨折、髋部骨折和其他骨折的风险。在一项随机、双盲、安慰剂对照的女性和男性试验中,它降低了新的临床骨折的风险,提高了生存率。在这两项研究中,唑来膦酸具有良好的安全性,通常耐受性良好。唑来膦酸有可能通过降低骨质疏松症患者骨折的风险来改善临床结果。临床价值:每12个月静脉注射5 mg唑来膦酸可降低绝经后骨质疏松症女性和近期低创伤髋部骨折女性和男性的骨折风险。
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Intravenous zoledronic acid for the treatment of osteoporosis: The evidence of its therapeutic effect.

Introduction: Osteoporosis is a disease characterized by low bone mineral density and poor bone quality resulting in reduced bone strength and increased risk of fracture. Oral bisphosphonates, first-line therapy for most patients with osteoporosis, are associated with suboptimal adherence to therapy due to factors that include a complex dosing regimen and gastrointestinal intolerance in some patients. Intravenous bisphosphonates address these limitations through infrequent injectable dosing that assures 100% bioavailability. Intravenous zoledronic acid is the newest bisphosphonate to be approved for the treatment of osteoporosis.

Aims: This review assesses the evidence for the therapeutic effects of intravenous zoledronic acid for the treatment of osteoporosis.

Evidence review: Zoledronic acid 5 mg administered as an annual 15-min intravenous infusion has been shown to reduce the risk of vertebral fractures, hip fractures, and other fractures in a three-year randomized, double-blind, placebo-controlled trial in women with postmenopausal osteoporosis. In a randomized, double-blind, placebo-controlled trial in women and men with a recent surgical repair of low-trauma hip fracture, it reduced the risk of new clinical fractures and improved survival. In both studies, zoledronic acid was associated with a good safety profile and was generally well tolerated. Zoledronic acid has the potential to improve clinical outcomes by reducing the risk of fracture in patients with osteoporosis.

Clinical value: Intravenous zoledronic acid 5 mg every 12 months reduces fracture risk in women with postmenopausal osteoporosis and in women and men with recent low-trauma hip fracture.

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Core Evidence
Core Evidence PHARMACOLOGY & PHARMACY-
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期刊介绍: Core Evidence evaluates the evidence underlying the potential place in therapy of drugs throughout their development lifecycle from preclinical to postlaunch. The focus of each review is to evaluate the case for a new drug or class in outcome terms in specific indications and patient groups The emerging evidence on new drugs is reviewed at key stages of development and evaluated against unmet needs
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