口服与静脉注射伊班膦酸：转移性骨病治疗方案比较
Oral versus intravenous ibandronic acid: a comparison of treatment options for metastatic bone disease.
作者信息
Mystakidou Kyriaki, Stathopoulou Evangelia, Parpa Efi, Kouloulias Vassilios, Kouskouni Evangelia, Vlahos Lambros
机构信息
Pain Relief and Palliative Care Unit, Department of Radiology, Areteion Hospital, University of Athens School of Medicine, 27 Korinthias St., 11526 Ampelokipi, Athens, Greece.
出版信息
J Cancer Res Clin Oncol. 2008 Dec;134(12):1303-10. doi: 10.1007/s00432-008-0419-x. Epub 2008 May 27.
PURPOSE
This trial is the first to compare directly the clinical response to and safety of oral and intravenous (IV) ibandronic acid for metastatic bone disease.
METHODS
Patients > or =18 years with breast, prostate, lung, urogenital or colon cancer received IV ibandronic acid 6 mg infused over 15 min every 28 days or oral ibandronic acid 50 mg/day. Clinical response was determined using bone scintigraphy, radiography and serum C-terminal telopeptide of type I collagen (S-CTX) at months 3-6. Adverse events and biochemical safety measures were recorded.
RESULTS
A total of 84.6 and 88.5% of patients had a complete/partial response to IV and oral ibandronic acid, respectively. Median percentage decreases in S-CTX were -39 and -35%, respectively. Bone pain scores decreased and analgesic use increased from month 0-3 and were stable from months 3-6. Both formulations improved physical and functioning scores.
CONCLUSION
Oral and IV ibandronic acid for bone metastases have similar efficacy and tolerability.
目的
本试验首次直接比较口服和静脉注射（IV）伊班膦酸治疗转移性骨病的临床反应和安全性。
方法
年龄≥18岁的乳腺癌、前列腺癌、肺癌、泌尿生殖系统癌或结肠癌患者，每28天接受一次静脉注射6毫克伊班膦酸，输注时间为15分钟，或口服伊班膦酸50毫克/天。在第3至6个月时，使用骨闪烁显像、X线摄影和血清I型胶原C端肽（S-CTX）来确定临床反应。记录不良事件和生化安全指标。
结果
分别有84.6%和88.5%的患者对静脉注射和口服伊班膦酸有完全/部分反应。S-CTX的中位数百分比下降分别为-39%和-35%。从第0至3个月，骨痛评分下降，镇痛药物使用增加，从第3至6个月保持稳定。两种剂型均改善了身体和功能评分。
结论
口服和静脉注射伊班膦酸治疗骨转移的疗效和耐受性相似。
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