Faculty of Pharmacy, Cairo University, Giza, Egypt.
Med Oncol. 2011 Jun;28(2):584-90. doi: 10.1007/s12032-010-9461-z. Epub 2010 Mar 5.
The aim of this study is to conduct a comparison study between the efficacy and safety of zoledronic acid and clodronate in malignant hypercalcemia secondary to bone metastases in Egyptian adult patients. This is a prospective observational study conducted 80 patients (40 in each group), who were assigned to receive either zoledronic acid (4 mg over a 30 min infusion) every 3-4 weeks or clodronate (a single dose of 1,500 mg over a 4 h infusion) monthly for 3 months. The primary efficacy analysis was the proportion of patients with at least one skeletal-related event. The safety was assessed based on the frequencies of the reported adverse effects as nausea, vomiting, anemia, etc. The calcium level significantly decreased in both groups. At least one skeletal-related event occurred in 15 (37.5%) patients receiving zoledronic acid and 32 (80%) patients receiving clodronate. Radiotherapy and fractures represented the highest event observed in both groups. At least one adverse event was experienced by 20 (50%) patients treated with zoledronic acid, while 26 (65%) patients on clodronate recorded one or more adverse event. Pyrexia was the most commonly reported side effect and flare phenomena. Both treatment groups were comparable regarding the reported adverse events. Both medications did not show any significant nephrotoxicity detected by elevation in the creatinine level. Zoledronic acid and clodronate have demonstrated clinical utility in the treatment of hypercalcaemia in cancer patients. Zoledronic acid provides a more effective and convenient treatment than clodronate, while both maintaining a similar safety profile.
本研究旨在对唑来膦酸和氯膦酸治疗埃及成年骨转移癌相关高钙血症患者的疗效和安全性进行比较研究。这是一项前瞻性观察性研究，共纳入 80 例患者（每组 40 例），分别接受唑来膦酸（4 mg 静脉滴注 30 分钟）或氯膦酸（1500 mg 静脉滴注 4 小时），每 3-4 周或每月一次，持续 3 个月。主要疗效分析为至少发生一次骨骼相关事件的患者比例。安全性评估基于报告的不良反应（如恶心、呕吐、贫血等）的频率。两组患者的血钙水平均显著降低。接受唑来膦酸治疗的患者中，有 15 例（37.5%）至少发生一次骨骼相关事件，接受氯膦酸治疗的患者中，有 32 例（80%）至少发生一次骨骼相关事件。两组中放疗和骨折是最常见的骨骼相关事件。接受唑来膦酸治疗的患者中有 20 例（50%）至少发生一次不良反应，而接受氯膦酸治疗的患者中有 26 例（65%）至少发生一次不良反应。发热是最常见的不良反应，其次是 flare 现象。两组报告的不良反应发生率相似。两种药物均未引起明显的肾毒性，即肌酐水平升高。唑来膦酸和氯膦酸在治疗癌症患者高钙血症方面均具有临床应用价值。唑来膦酸比氯膦酸治疗更有效、更方便，同时安全性相似。
