Miller P D, Ward P, Pfister T, Leigh C, Body J J
Colorado Center for Bone Research, Lakewood, Colorado, USA.
Clin Exp Rheumatol. 2008 Nov-Dec;26(6):1125-33.
While intravenous (IV) bisphosphonates are well established in managing metastatic bone disease and hypercalcemia of malignancy, oral bisphosphonates are the primary treatment for postmenopausal osteoporosis. The availability of a well-tolerated, effective, IV bisphosphonate regimen for postmenopausal osteoporosis would increase physicians' options, allowing treatment of patients who cannot tolerate oral therapy, for whom oral bisphosphonates should be avoided or patients who are unable to comply with the oral dosing recommendations. Ibandronate is a potent, nitrogen-containing bisphosphonate, with proven efficacy and good tolerability when administered intermittently either orally or intravenously. Preclinical experience in animal models with IV ibandronate indicated that it had good renal tolerability. These data are supported by clinical pharmacology studies. Prolonged follow-up of patients receiving intermittent IV 15-30 second injections of 0.5-3 mg IV ibandronate has demonstrated no clinical evidence of renal toxicity in patients with postmenopausal osteoporosis. What is seen in controlled studies is not always the case in uncontrolled studies, however, no reports of renal failure have been received in post-marketing surveillance of >500,000 patients receiving IV ibandronate infusions in various indications including metastatic breast and prostate cancer. The good renal tolerability of IV ibandronate in patients with osteoporosis with glomerular filtration rates >30 mL/minute and without renal co-morbid conditions is reassuring.
虽然静脉注射双膦酸盐在治疗转移性骨病和恶性肿瘤高钙血症方面已得到广泛应用，但口服双膦酸盐是绝经后骨质疏松症的主要治疗方法。一种耐受性良好、有效的静脉注射双膦酸盐方案用于绝经后骨质疏松症，将增加医生的选择，使那些不能耐受口服治疗、应避免使用口服双膦酸盐或无法遵守口服给药建议的患者能够得到治疗。伊班膦酸钠是一种强效的含氮双膦酸盐，口服或静脉间歇给药时已证实具有疗效且耐受性良好。伊班膦酸钠静脉注射在动物模型中的临床前经验表明其对肾脏耐受性良好。这些数据得到了临床药理学研究的支持。对接受0.5 - 3mg伊班膦酸钠静脉注射15 - 30秒间歇给药的绝经后骨质疏松症患者进行长期随访，未发现肾脏毒性的临床证据。然而，在对照研究中观察到的情况在非对照研究中并非总是如此，在超过500,000例接受伊班膦酸钠静脉输注用于各种适应症（包括转移性乳腺癌和前列腺癌）的患者的上市后监测中，未收到肾衰竭报告。对于肾小球滤过率>30 mL/分钟且无肾脏合并症的骨质疏松症患者，伊班膦酸钠静脉注射具有良好的肾脏耐受性，这让人放心。
