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每月连续两天服用利塞膦酸盐。

Risedronate on two consecutive days per month.

作者信息

Frampton James E

机构信息

Wolters Kluwer Health, Adis, Auckland, New Zealand.

出版信息

Drugs Aging. 2009;26(4):355-62. doi: 10.2165/00002512-200926040-00006.

DOI:10.2165/00002512-200926040-00006
PMID:19476402
Abstract

Risedronate, an orally administered pyridinal bisphosphonate, is effective in the treatment and prevention of postmenopausal osteoporosis. Efforts to optimize patient adherence and persistence with, and hence the effectiveness of, therapy have led to the development of a 75 mg tablet to be taken on two consecutive days each month (2CDM). After 1 year of treatment, risedronate 75 mg 2CDM was noninferior to risedronate 5 mg once daily in improving lumbar spine bone mineral density (BMD) in an ongoing (2-year) randomized, double-blind, parallel-group, multinational trial in 1229 postmenopausal women with osteoporosis. Mean percentage increases in BMD from baseline at 12 months were 3.4% and 3.6% in the 75 mg 2CDM and 5 mg once-daily groups; the upper limit of the 95% confidence interval for the treatment difference (5 mg once daily - 75 mg 2CDM; -0.19%, 0.62%) did not exceed the predefined noninferiority margin (1.5%). In general, improvements in hip BMD and reductions in bone turnover markers with the 75 mg 2CDM regimen were not significantly different from those with the 5 mg once-daily regimen; there was no significant between-group difference in the incidence of new vertebral fractures at 12 months. The tolerability profile (including the incidence of upper gastrointestinal tract adverse events) of risedronate 75 mg 2CDM in postmenopausal women with osteoporosis was similar to that of risedronate 5 mg once daily.

摘要

利塞膦酸盐是一种口服的吡啶双膦酸盐,在治疗和预防绝经后骨质疏松症方面有效。为了优化患者对治疗的依从性和持续性,从而提高治疗效果,已研发出一种每月连续两天服用的75毫克片剂(2CDM)。在一项针对1229名绝经后骨质疏松症女性进行的正在进行的(为期2年)随机、双盲、平行组、多国试验中,治疗1年后,75毫克2CDM利塞膦酸盐在改善腰椎骨密度(BMD)方面不劣于每日一次服用5毫克利塞膦酸盐。75毫克2CDM组和每日一次5毫克组在12个月时BMD较基线的平均百分比增加分别为3.4%和3.6%;治疗差异(每日一次5毫克 - 75毫克2CDM;-0.19%,0.62%)的95%置信区间上限未超过预先定义的非劣效性界值(1.5%)。总体而言,75毫克2CDM方案在髋部BMD改善和骨转换标志物降低方面与每日一次5毫克方案无显著差异;12个月时新椎体骨折发生率在组间无显著差异。75毫克2CDM利塞膦酸盐在绝经后骨质疏松症女性中的耐受性特征(包括上消化道不良事件的发生率)与每日一次5毫克利塞膦酸盐相似。

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本文引用的文献

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New dosing options in osteoporosis treatment: clinical evidence on Risedronate 75mg monthly treatment.骨质疏松症治疗的新给药方案:每月一次服用75毫克利塞膦酸盐治疗的临床证据
Clin Cases Miner Bone Metab. 2008 May;5(2):155-8.
2
Efficacy of bisphosphonates in reducing fracture risk in postmenopausal osteoporosis.双膦酸盐类药物在降低绝经后骨质疏松症骨折风险方面的疗效。
Am J Med. 2009 Feb;122(2 Suppl):S14-21. doi: 10.1016/j.amjmed.2008.12.003.
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Osteoporosis and skeletal fractures.骨质疏松症与骨骼骨折。
HSS J. 2006 Feb;2(1):62-9. doi: 10.1007/s11420-005-0137-8.
4
Bisphosphonates in the management of postmenopausal osteoporosis--optimizing efficacy in clinical practice.双膦酸盐在绝经后骨质疏松症管理中的应用——优化临床实践中的疗效
Clin Interv Aging. 2008;3(2):279-97. doi: 10.2147/cia.s2134.
5
Risedronate once monthly: a potential new regimen for the treatment of postmenopausal osteoporosis.每月一次利塞膦酸盐:一种治疗绝经后骨质疏松症的潜在新方案。
Clin Interv Aging. 2008;3(2):227-32. doi: 10.2147/cia.s2502.
6
Risedronate for the primary and secondary prevention of osteoporotic fractures in postmenopausal women.利塞膦酸盐用于绝经后妇女骨质疏松性骨折的一级和二级预防。
Cochrane Database Syst Rev. 2008 Jan 23(1):CD004523. doi: 10.1002/14651858.CD004523.pub3.
7
Mechanisms of action of bisphosphonates: similarities and differences and their potential influence on clinical efficacy.双膦酸盐的作用机制:异同及其对临床疗效的潜在影响。
Osteoporos Int. 2008 Jun;19(6):733-59. doi: 10.1007/s00198-007-0540-8.
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Monthly dosing of 75 mg risedronate on 2 consecutive days a month: efficacy and safety results.每月连续2天服用75毫克利塞膦酸盐的每月给药方案:疗效和安全性结果。
Osteoporos Int. 2008 Jul;19(7):1039-45. doi: 10.1007/s00198-007-0531-9. Epub 2007 Dec 18.
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Mechanism of action, pharmacokinetic and pharmacodynamic profile, and clinical applications of nitrogen-containing bisphosphonates.含氮双膦酸盐的作用机制、药代动力学和药效学特征以及临床应用
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