唑来膦酸治疗癌症溶骨性骨转移疼痛的Ⅱ期临床试验  

Clinical Study of Zoledronic Acid in Treating Metastatic Bone Pain of Malignancy

作　　者：张弓[1] 戴静[1] 周云峰[1] 谢丛华[1] 粱辰[1] 高敏[1] 韩定芬[2] 

机构地区：[1]武汉大学中南医院肿瘤放化疗科,武汉430071 [2]武汉大学公共卫生学院,武汉430071

出　　处：《武汉大学学报（医学版）》2005年第5期612-615,共4页Medical Journal of Wuhan University

基　　金：国家食品药品监督管理局(2003L02441)

摘　　要：目的:观察唑来膦酸单次静脉滴注治疗恶性肿瘤溶骨性骨转移疼痛的有效性和安全性。方法:采用随机双盲双模拟、阳性药平行对照的研究方法。试验组:唑来膦酸+甘露醇冻干粉针;对照组:甘露醇冻干粉针+帕米膦酸二钠。结果:2003年10月至2004年10月共随机入组54例,试验组:27例,对照组:27例;两组用药前的疼痛强度(PI)分别为:6.7±1.25和6.2±1.17(P>0.05);治疗后第7d和第14d两组的疼痛强度分别为:4.1±1.36比3.5±1.44和4.0±1.31比3.4±1.68;两组部分缓解(PR)率:75.0%比92.0%(P>0.05),总缓解率:100%比96%(P>0.05);中位部分缓解时间(d):5.2±2.01比4.9±1.76(P>0.05),部分缓解持续时间(d):12.8±1.90比13.1±1.96(P>0.05),两组间差异无统计学意义。不良反应主要包括发热、恶心、呕吐、乏力等,两组在发生率及反应程度等方面组间差异无统计学意义。结论:单次静脉滴注唑来膦酸治疗恶性肿瘤溶骨性骨转移疼痛的有效性和安全性与帕米膦酸二钠相似,且使用更方便。Objective： To evaluate the efficacy and safety of zoledromic acid compared with pamidranate for metastatic bone pain of malignancy. Methods： The randomized, double blind and prospective trail was conducted in patients with metastatic bone pain. From October 2003 to October 2004, 54 patients with metastatic bone pain were randomly divided into either of two groups： the zoledromic acid treated group and the pamidranate treated group, with 27 patients in each group. Results： There was no apparent difference in pain relief on day 7 and 14 between the two groups; partial response rate was 75 % in the zoledromic acid treated group versus 92% in the pamidranate treated group （P=0. 135）, total response rate was 100% versus 96%（P=1.0）, median time of relief was （5.24-2.01）d versus （4.9±1.76）d of the control（P〉0.05）, and the lasting time of reliefwas（12.8±1.90）d versus （13.1±1.96）d （P〉0.05）. The main side effects were fever, nausea, vomiting and general malaise. The rate and severity of side effects were similar between the two groups. Conclusion： Zoledromic acid is effective and safe in the treatment of metastatic bone pain of malignancy that is similar to pamidranate and the use of zoledromic acid is more convenient than that of pamidranate.

关 键 词：唑来膦酸 帕米膦酸二钠 骨转移癌 疼痛 

分 类 号：R739[医药卫生—肿瘤]