Tripathy Debu, Body Jean-Jacques, Bergström Bengt
University of Texas, Southwestern Medical Center, 5323 Harry Hines Boulevard, Dallas, TX 75390-8852, USA.
Clin Ther. 2004 Dec;26(12):1947-59. doi: 10.1016/j.clinthera.2004.12.010.
Metastatic bone disease is a serious clinical problem in patients with advanced cancer. Bisphosphonates inhibit the activity of osteoclasts and are the treatment of choice for bone metastases.
This article reviews the efficacy and safety data from Phase III trials of ibandronate in metastatic bone disease.
Phase III data (available as of June 2004) for ibandronate were reviewed. Literature searches using the MEDLINE database and abstracts from scientific meetings were used to obtain data from Phase III trials of ibandronate.
Compared with placebo, patients with bone metastases from breast cancer receiving IV ibandronate (6 mg infused over 1-2 hours every 3-4 weeks) or oral ibandronate (50 mg/d for up to 96 weeks) had a statistically significant reduction in skeletal complications, as measured by the Skeletal Morbidity Period Rate (P = 0.004 vs placebo). Multivariate Poisson regression analysis of the data showed that the risk of a new bone event was reduced by 40% with IV ibandronate 6 mg and by 38% with oral ibandronate 50 mg, compared with placebo (P < or = 0.003). Both formulations also reduced bone pain below baseline levels over 2 years (P < or = 0.001 vs placebo). IV and oral ibandronate were well tolerated, with adverse-event profiles comparable to placebo and no significant renal toxicity.
IV and oral ibandronate provide meaningful clinical benefits in patients with bone metastases from breast cancer. Both formulations reduce the risk of skeletal events and provide sustained relief from metastatic bone pain. With its favorable efficacy and safety profile, and the added convenience of the oral formulation, ibandronate provides improved treatment options for managing metastatic bone disease.
转移性骨病是晚期癌症患者面临的一个严重临床问题。双膦酸盐可抑制破骨细胞活性，是骨转移的首选治疗药物。
本文综述了伊班膦酸钠治疗转移性骨病的III期试验的疗效和安全性数据。
对伊班膦酸钠的III期数据（截至2004年6月）进行综述。通过使用MEDLINE数据库进行文献检索以及从科学会议摘要中获取伊班膦酸钠III期试验的数据。
与安慰剂相比，接受静脉注射伊班膦酸钠（每3 - 4周1 - 2小时内输注6毫克）或口服伊班膦酸钠（每日50毫克，最长96周）的乳腺癌骨转移患者，其骨骼并发症有统计学意义的减少，以骨骼发病期发生率衡量（与安慰剂相比，P = 0.004）。对数据进行多变量泊松回归分析显示，与安慰剂相比，静脉注射6毫克伊班膦酸钠使新骨事件风险降低40%，口服50毫克伊班膦酸钠使风险降低38%（P≤0.003）。两种剂型在2年期间均将骨痛降至基线水平以下（与安慰剂相比，P≤0.001）。静脉注射和口服伊班膦酸钠耐受性良好，不良事件情况与安慰剂相当，且无显著肾毒性。
静脉注射和口服伊班膦酸钠为乳腺癌骨转移患者带来了有意义的临床益处。两种剂型均降低了骨骼事件风险，并持续缓解转移性骨痛。伊班膦酸钠具有良好的疗效和安全性，且口服剂型更加方便，为转移性骨病的治疗提供了更好的选择。
