国产英卡膦酸二钠治疗恶性肿瘤骨转移疼痛或/和高钙血症的Ⅱ期临床研究  

Phase Ⅱ clinical trial of home-made incadronate in patients with pain of bone metastasis of malignancy or/and hypercalcemia

作　　者：傅强[1] 王雅杰[1] 秦叔逵[2] 潘良熹[3] 束永前[4] 秦凤展[5] 

机构地区：[1]第二军医大学长海医院肿瘤科,上海200433 [2]解放军八一医院肿瘤科,南京210002 [3]江苏省肿瘤医院肿瘤内科,南京210009 [4]南京医科大学第一附属医院肿瘤生物治疗中心,南京210029 [5]蚌埠医学院附属医院肿瘤内科,蚌埠233004

出　　处：《药学服务与研究》2007年第3期180-183,共4页Pharmaceutical Care and Research

摘　　要：目的:评价国产英卡膦酸二钠治疗恶性肿瘤骨转移疼痛或/和高钙血症的疗效和安全性。方法:采用多中心、随机阳性药平行对照研究方法,将212例恶性肿瘤骨转移病人分为试验组和对照组,每组106例,分别给予国产英卡膦酸二钠10 mg与帕米膦酸钠90 mg,观察其疗效和毒副作用。高钙血症治疗采用非随机临床研究。结果:国产英卡膦酸二钠治疗骨转移疼痛的有效率为70.19%,生活质量改善有效率为50.96%。对照组骨转移疼痛治疗有效率为67.62%,生活质量改善有效率为51.43%。试验组在疼痛缓解率和生活质量改善上与对照组均无显著差异。试验组不良反应发生率明显低于对照组(26.42%vs46.23%),主要为Ⅰ、Ⅱ度发热,两组有非常显著差异(P<0.01)。6例肿瘤骨转移伴高钙血症的病人使用英卡膦酸二钠后,有3例第3天血钙降至正常,2例第5天血钙降至正常,1例第14天血钙降至正常。结论:国产英卡膦酸二钠治疗恶性肿瘤骨转移疼痛疗效显著,安全可靠,治疗高钙血症有效,值得临床推广使用。Objective： To evaluate the efficacy and safety of home-made incadronate in treatment of patients with pain of bone metastasis of malignancy or/and hypercalcemia. Methods： A randomized, parallel comparative trial was performed on 212 patients with pain of bone metastasis of malignancy. The patients were randomized into test group（incadronate 10 mg-0.9% sodium chloride injection 500 mL, iv, 2-4 h） and control group （pamidronate sodium 90 mg-0.9% sodium chloride injection 500 mL, iv, 3 h）. Each group had 106 patients. The efficacy and the toxicity of incadronate and pamidronate sodium were ohserved. The open trial was done in patients with malignancy-associated hypercalcemia. Results： The rate of pain relief was 70.19% and the response rate of Karnofsky performance status（KPS） improvement was 50.96% in the test group. There were no significant differences between the two groups in pain relief and KPS improvement. The levels of serum calcium of 6 patients with malignancy-associated hypercalcemia were decreased to the normal after using incadornate. The incidence of adverse events was 26.42% in the test group and 46.23% in control group （P〈0.01）. The main symptom was slight or moderate fever. The test group had a significantly lower incidence of fever. Conclusion： Home-made incadornate is a kind of effective drug in the treatment of patients with pain of bone metastasis of malignancy or/and hypercalcemia.

关 键 词：英卡膦酸二钠 肿瘤转移 疼痛 骨肿瘤 临床试验 Ⅱ期 高钙血症 

分 类 号：R969[医药卫生—药理学] R73[医药卫生—药学]