唑来膦酸注射液与帕米膦酸二钠注射液对照治疗恶性肿瘤溶骨性骨转移20例  

Efficacy and safety of zoledronic acid injection versus pamidronate for the treatment of metastatic bone cancer

作　　者：毕明宏[1] 秦凤展[1] 郑荣生[1] 丁永为[1] 孙惠娟[1] 吴穷[1] 

机构地区：[1]安徽省肿瘤医院,蚌埠233004

出　　处：《中国新药杂志》2005年第10期1209-1212,共4页Chinese Journal of New Drugs

摘　　要：目的:评价唑来膦酸注射液治疗溶骨性癌转移引起骨痛的疗效及安全性。方法:采用随机、双盲、双模拟、阳性药物平行对照的方法,共入组40例患者,试验组(n=20)用唑来膦酸二钠4 mg加入生理氯化钠溶液50 mL静脉注射给药15 min,对照组(n=20)用帕米膦酸二钠90 mg加入生理氯化钠溶液500 mL静滴6 h,两组均单次给药后观察28 d。结果:试验组和对照组治疗溶骨性癌转移引起骨痛d14的有效率分别为90%和70%;d28的有效率分别为80%和70%。用药后止痛中位起效时间两组分别为8.5和7 d;止痛中位维持时间分别为21和18.5 d。以上结果差异均无显著性(P>0.05)。试验组及对照组不良反应发生率分别为25%和55%,其中发热为10%和5%,低血钙为15%和10%;低血磷为20%和35%,差异均无显著性(P>0.05)。结论:唑来膦酸注射液治疗溶骨性癌转移引起骨痛安全有效。Objective ： To evaluate the efficacy and safety of zoledronic acid injection for the pain relief in patients with metastatic bone cancer. Methods： A randominzed, double blind and comparative control clinical trial recruited 40 patients, who were randomized 1 ： 1 to receive a single intravenous infusion of 4 mg zoledronic acid injection for 15 minutes or 90 mg pamidronate for 6 hours. The patients were followed up for 28 days to assess the efficacy and safety of the treatment. Results： The pain relief rate of zoledronic acid and pamidronate in day 14 was 90% and 70% , respectively, and in day 28 80% and 70% , respectively. The median pain relief onset at day 8.5 and 7, respectively, and the maintenance period of the median pain relief was 21 and 18.5 days, respectively; the P value for these rates showed no statistical difference. The total incidence of adverse reactions was 25 % and 55 %, respectively. The common adverse events of zoledronic acid and pamidronate included fever （10% versus 5 % ）, hypocalcemia （15 % versus 10% ） and hypophosphatemia （20% versus 35%）. Conclusion： Zoledronic acid injection provided a therapeutic alternative in the pain relief for patients with metastatic bone cancer.

关 键 词：唑来膦酸注射液 帕米膦酸二钠 骨转移疼痛 

分 类 号：R944.9[医药卫生—药剂学] R979.1[医药卫生—药学]