因卡膦酸二钠治疗恶性肿瘤引起的骨转移疼痛或/和高钙血症Ⅱ期临床试验报告  

PhaseⅡclinical trial of incadornate in patients of malignant tumors with bone matastatic pain or/and hypercalcinemia

作　　者：陈颖波[1] 陈凌翔[1] 陈嘉[1] 潘良熹[1] 

机构地区：[1]江苏省肿瘤医院内科,江苏南京210009

出　　处：《现代肿瘤医学》2006年第2期207-209,共3页Journal of Modern Oncology

摘　　要：目的评价国产注射用因卡膦酸二钠治疗恶性肿瘤引起的骨转移疼痛或／和高钙血症的疗效和安全性。方法骨转移疼痛：盲法随机阳性药平行对照试验。高钙血症：开放性试验。A组：注射用因卡膦酸二钠10mg＋NS500ml静滴2～4小时，d1；B组：注射用博宁90mg＋NS500ml静滴3小时以上，d1。每天同一时间记录临床症状、疼痛缓解程度。结果A组22例病人中，骨转移疼痛缓解显效者7例，有效者11例，有效率为81．82％。生活质量改善（KPS）显效者6例，有效者6例，有效率为54．55％。B组22例病人中，骨转移疼痛缓解显效者1例，有效者13例，有效率为63．64％。生活质量改善显效者5例，有效者6例，有效率50％。A组发热、恶心各1例，B组发热5例。组问比较无显著性差异。2例高钙血症病人应用因卡膦酸二钠后血钙均能降至正常。结论因卡膦酸二钠对于恶性肿瘤骨转移所引起的骨痛具有止痛作用，对肿瘤引起的高钙血症有效。Objective To evaluate the efficacy and safety of domestic - made incadronate in patients with malignant tumors with bone matastatic pain or/and hypercalcinemia. Methods The blind, randomized, parallel comparative trial using pamidronic acid as control was performed in patients with bone matastatic pain. The open trial was performed in patients with hypercalcinemia. Group A： Incadronate lOmg ＋ NS500ml Ⅳ 2 - 4 hours d1; group B： pamidronic acid 90mg ＋ NS500ml Ⅳ over 3 hours dl. Clirtical symptom and degree of pain relief were recorded in same time every day. Results In 22 cases of group A there were 7 cases significant pain alleviation and 11 cases pain alleviation. （response rate 81.82% ）. There were 6 cases KPS increase significant response and 6 cases response . （response rate 54.55% ）. In 22 cases of group B there was 1 case significant pain alleviation and 13 cases pain alleviation. （ response rate 63.64% ）. There were 5 cases KPS increase significant response and 6 cases response . （ respose rate 50% ）. There were no significant difference between the two groups. Adverse reaction was ferver Ⅰ case, nausea 1 in group A and ferver 5 in group B. Serum calciums were normal in the two hypercalcinemic cases after using incadornate. Conclusion Incadornate is an effective drug in the treatment of patients with malignant tumors with bone matastatic pain or/and hypercalcinemia.

关 键 词：Ⅱ期临床试验 因卡膦酸二钠 骨转移疼痛 高钙血症 恶性肿瘤 

分 类 号：R738[医药卫生—肿瘤]