Rosen L S, Gordon D, Kaminski M, Howell A, Belch A, Mackey J, Apffelstaedt J, Hussein M, Coleman R E, Reitsma D J, Seaman J J, Chen B L, Ambros Y
Jonsson Cancer Center, University of California, Los Angeles 90095, USA.
Cancer J. 2001 Sep-Oct;7(5):377-87.
Zoledronic acid, a new and more potent bisphosphonate, was compared with pamidronate, the current standard treatment for patients with osteolytic or mixed bone metastases/lesions.
A total of 1,648 patients with either Durie-Salmon stage III multiple myeloma or advanced breast cancer and at least one bone lesion were randomly assigned to treatment with either 4 or 8 mg of zoledronic acid via 15-minute intravenous infusion or 90 mg of pamidronate via 2-hour intravenous infusion every 3 to 4 weeks for 12 months. The primary efficacy endpoint was the proportion of patients experiencing at least one skeletal-related event over 13 months.
The proportion of patients with at least one skeletal-related event was similar in all treatment groups. Median time to the first skeletal-related eventwas approximately 1 year in each treatment group. The skeletal morbidity rate was slightly lower in patients treated with zoledronic acid than in those treated with pamidronate, and zoledronic acid (4 mg) significantly decreased the incidence and event rate for radiation therapy to bone, both overall and in breast cancer patients receiving hormonal therapy. Pain scores decreased in all treatment groups in the presence of stable or decreased analgesic use. Zoledronic acid (4 mg) and pamidronate were equally well tolerated; the most common adverse events were bone pain, nausea, fatigue, and fever and < 5% of serious adverse events were related to the study drug. The incidence of renal impairment among patients treated with 4 mg of zoledronic acid via 15-minute infusion was similar to that among patients treated with pamidronate.
Zoledronic acid (4 mg) via 15-minute intravenous infusion was as effective and well tolerated as 90 mg of pamidronate in the treatment of osteolytic and mixed bone metastases/lesions in patients with advanced breast cancer or multiple myeloma. (Can-
唑来膦酸是一种新型且效力更强的双膦酸盐，将其与帕米膦酸进行比较，帕米膦酸是目前治疗溶骨性或混合性骨转移/骨病变患者的标准疗法。
总共1648例患有Durie-Salmon III期多发性骨髓瘤或晚期乳腺癌且至少有一处骨病变的患者，被随机分配接受治疗，每3至4周通过15分钟静脉输注给予4毫克或8毫克唑来膦酸，或每3至4周通过2小时静脉输注给予90毫克帕米膦酸，持续12个月。主要疗效终点是在13个月内经历至少一次骨相关事件的患者比例。
所有治疗组中经历至少一次骨相关事件的患者比例相似。每个治疗组中首次骨相关事件的中位时间约为1年。接受唑来膦酸治疗的患者的骨发病率略低于接受帕米膦酸治疗的患者，并且唑来膦酸（4毫克）显著降低了总体以及接受激素治疗的乳腺癌患者的骨放射治疗的发生率和事件率。在镇痛药使用稳定或减少的情况下，所有治疗组的疼痛评分均降低。唑来膦酸（4毫克）和帕米膦酸的耐受性相当；最常见的不良事件是骨痛、恶心、疲劳和发热，且<5%的严重不良事件与研究药物有关。通过15分钟输注给予4毫克唑来膦酸治疗的患者中肾功能损害的发生率与接受帕米膦酸治疗的患者相似。
在治疗晚期乳腺癌或多发性骨髓瘤患者的溶骨性和混合性骨转移/骨病变方面，通过15分钟静脉输注给予的唑来膦酸（4毫克）与90毫克帕米膦酸一样有效且耐受性良好。
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