Renal safety of ibandronate.
Renal safety of ibandronate.
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伊班膦酸钠的肾脏安全性。
DOI：
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发表时间：
2005
期刊：
影响因子：
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通讯作者：
G. Jackson
中科院分区：
文献类型：
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作者：
G. Jackson
尽管它们在治疗与转移性骨病相关的并发症方面有效，但仍有人担心某些静脉注射的潜在肾毒性。用于癌症患者长期治疗的双膦酸盐。然而，临床数据表明，静脉注射。伊班磷酸钠(Bondronat)；瑞士巴塞尔的F.Hoffman-La Roche Ltd.，与其他双膦酸盐不同，http://www.roche.com)，的肾脏安全性与安慰剂相当。在一项对乳腺癌骨转移患者进行的为期两年的III期研究中，静脉注射6 mg的患者发生了不良肾脏事件。伊班磷酸钠含量较低，与安慰剂相当(4%，安慰剂为4.5%)。对血清肌酐升高时间的两年评估也表明，肾脏的安全性与安慰剂相当(肌酐升高的患者：6%，而安慰剂为12%)。伊班磷酸钠的长期(4年)肾脏安全性在延长2年的试验中得到证实。第二阶段，开放标签研究表明，密集的伊班磷酸钠剂量不会影响各种肿瘤类型的转移性骨痛患者的肾脏安全性。此外，静脉注射。伊班磷酸钠耐受性良好，在存在肾损害的多发性骨髓瘤和泌尿系癌症患者中没有肾毒性的证据。一些双膦酸盐的潜在肾毒性促使在这些药物的产品标签中增加肾脏安全预防措施。然而，这些预防措施并没有包含在伊班磷酸钠的标签中，因此可以简化患者的管理。
Despite their efficacy in treating complications associated with metastatic bone disease, there are concerns about the potential nephrotoxicity of certain i.v. bisphosphonates for the long-term management of cancer patients. Clinical data suggest, however, that i.v. ibandronate (Bondronat); F. Hoffman-La Roche Ltd., Basel, Switzerland, http://www.roche.com), unlike other bisphosphonates, has a renal safety profile comparable with that of placebo. In a 2-year, phase III study of patients with breast cancer metastatic to bone, the incidence of adverse renal events in patients treated with 6 mg i.v. ibandronate was low and comparable with that of placebo (4% versus 4.5% with placebo). Two-year assessments of time to serum creatinine increase also demonstrated renal safety comparable with that of placebo (patients with creatinine increase: 6% versus 12% with placebo). Long-term (4-year) renal safety of ibandronate was demonstrated in a 2-year extension of the trial. Phase II, open-label studies show that intensive ibandronate dosing does not compromise renal safety in patients with metastatic bone pain from a variety of tumor types. In addition, i.v. ibandronate is well tolerated, with no evidence of renal toxicity in multiple myeloma and urologic cancer patients with existing renal impairment. The potential nephrotoxicity of some bisphosphonates has prompted additional renal safety precautions in product labeling for these agents. The precautions are not, however, contained in the label for ibandronate, which may thus simplify patient management.
短期服用双膦酸盐伊班膦酸盐可增加骨量并防止轻度实验性肾功能衰竭中甲状旁腺功能亢进性骨变化。
影响因子：
1.1
作者：
Geng,Z;Monier-Faugere,MC;Bauss,F;Malluche,HH
通讯作者：
Malluche,HH