国产因卡膦酸二钠治疗骨转移癌疼痛的Ⅱ期临床试验  

Phase Ⅱ clinical study of incadronate for pain control in metastatic bone cancer

作　　者：王琳[1] 秦叔逵[1] 陈映霞[1] 何泽明[1] 钱军[1] 杨宁蓉[1] 廖世兵[1] 

机构地区：[1]解放军八一医院全军肿瘤中心内科

出　　处：《临床肿瘤学杂志》2003年第3期204-207,共4页Chinese Clinical Oncology

摘　　要：目的 :观察评价国产因卡膦酸二钠治疗恶性肿瘤骨转移疼痛的有效性和安全性。方法 :自 2 0 0 1年 1 2月至2 0 0 2年 1 0月 ,收治恶性肿瘤骨转移患者 4 3例 ,随机分配至试验组和对照组 ,分别给予国产因卡膦酸二钠 1 0mg与帕米膦酸二钠 90mg静滴 ,观察其疗效和毒副作用。结果 :试验组 2 3例止痛有效率 5 2 2 % ,生活质量改善有效率为 4 3 5 % ,与对照组 2 0例相比无显著性差异 (P >0 0 5 ) ,但毒副反应少见。结论 :国产因卡膦酸二钠治疗恶性肿瘤骨转移疼痛疗效显著 ,安全可靠 。Objective:To evaluate the response rate and safety of incadronate made in China treating the pain of metastatic bone cancer.Methods:From Dec. 2001 to Oct.2002, 43 cases of metastatic bone cancer were randomly divided into two groups (test group and control group) which were treated with incadronate made in China 10mg and pamidronate 90mg respectively.Results:There were 23 patients in test group and 20 patients in the control group. The total remission rate of the bone pain was 52 2% and the improving rate of quality of life was 43 5% which were no significant difference as compared with the control group ( P >0 05). The toxicity was mild.Conclusion:Incadronate made in China is effective, safe to metastatic bone cancer and worthy of clinical application.

关 键 词：因卡膦酸二钠 治疗 骨转移癌 疼痛 Ⅱ期临床试验 有效性 安全性 

分 类 号：R738.1[医药卫生—肿瘤] R441.1[医药卫生—临床医学]