唑来膦酸注射液治疗肿瘤溶骨性转移所致骨痛的多中心随机双盲对照临床试验  

Randomized,multicenter,double-blind,double-imitative,comparative trial of zoledronic acid versus pamidronate disodium in the treatment of pain of skeletal metastases in cancer patients

作　　者：张文东[1] 张昕[1] 王秀问[1] 梁军[2] 陈振东[3] 秦凤展[4] 束永前[5] 潘良熹 张茂宏[1] 

机构地区：[1]山东大学齐鲁医院肿瘤中心,济南250012 [2]青岛大学医学院附属医院肿瘤科,山东青岛266003 [3]安徽医科大学第一附属医院肿瘤内科,合肥230022 [4]安徽省肿瘤医院内科,安徽蚌埠233004 [5]南京医科大学第一附属医院肿瘤科,南京210029 [6]江苏省肿瘤医,南京210009

出　　处：《中国临床药理学杂志》2007年第2期83-86,共4页The Chinese Journal of Clinical Pharmacology

摘　　要：目的评价唑来膦酸注射液(抗恶性肿瘤辅助治疗药)治疗肿瘤溶骨性转移所致骨痛的疗效及安全性。方法用随机双盲阳性药物平行对照方法,将210例肿瘤溶骨性转移所致骨痛患者随机分为唑来膦酸组(A组,105例)及帕米膦酸二钠组(B组,105例)。结果A组和B组治疗骨痛有效率分别为71.43%和65.72%,差异无统计学意义(P>0.05)。用药后第7天,ECOG评分A组优于B组,差异有统计学意义(P<0.05)。A组和B组药物不良反应发生率分别为46.67%和52.38%,差异无统计学意义(P>0.05)。结论唑来膦酸治疗肿瘤溶骨性转移引起的骨痛安全、有效。Objective To evaluate the efficacy and safety of zoledronic acid in the treatment of pain of skeletal metastases in cancer patients. Methods A randomized double- blind, multieenter, comparative trial was performed in 210 patients with osteolytie metastases and pains. One hundred and five patients were treated with both zoledronie acid （group A） , others were treated with pamidronate disodium （group B）. Results The efficacy of group A and B in relieves pain of osteolytie were 71.43% and 65.72% , respectively. There was no significant difference between the two groups （P 〉 0.05）. The performance status of group A is lower than that of group B on the 7th day after administration, There was significant difference between the two groups （P 〈 0.05）. The ad- verse reaction of the group A and B were 46.76% and 52.38% , respectively. No significant difference was found between the two groups （P 〉 0.05 ）. Conclusion Zoledronie acid was safe and effective in the treatment of pain patients caused by osteolytie metastases.

关 键 词：唑来膦酸注射液 骨痛 恶性肿瘤骨转移 

分 类 号：R683[医药卫生—骨科学] R977.9[医药卫生—外科学]