帕米膦酸二钠Ⅲ期临床试验报告  

A PHASE Ⅲ CLINICAL TRIAL OF PAMIDRONATE

作　　者：曹军宁[1,2] 许立功[1,2] 俞雄 张秀平[1,2] 张君玮 

机构地区：[1]上海医科大学肿瘤医院化疗科 [2]上海医药工业研究院

出　　处：《中国癌症杂志》1999年第1期77-80,共4页China Oncology

摘　　要：目的观察国产帕米膦酸二钠（ＡＰＤ）对恶性肿瘤溶骨转移疼痛的止痛作用，对恶性肿瘤并发高钙血症的治疗作用，合适的临床剂量及不良反应。方法对４４６例病理确诊的恶性肿瘤溶骨转移疼痛患者，给予ＡＰＤ６０ｍｇ或９０ｍｇ静脉点滴。结果治疗后止痛总有效率第７和第２８天分别为７７８％和８３９％，两剂量组比较，给药后第７天疗效无差别，第２８天９０ｍｇ组略优（Ｐ＜００１）。活动能力改善率第７和２８天分别为５０７％和５９０％，给药后第７天疗效无差别，第２８天９０ｍｇ组略优（Ｐ＜００５）。４７％患者血钙升高，治疗后血钙复常率５７１％。不良反应主要为发热，食欲减退、恶心、全身酸痛等。结论国产ＡＰＤ治疗恶性肿瘤溶骨转移疼痛及高钙血症疗效确实，不良反应轻微短暂，值得在临床上进一步推广使用。PURPOSE To evaluate the efficacy,convenient dosage and side effect of pamidronate for metastatic bone pain and hypercalcaemia of malignancy.METHODS 446 patients with metastatic bone pain were received intravenous pamidronate 60mg or 90mg.RESULTS 77.8% and 83.9% of patients had got pain relief separately on day 7 and 28. The response rate of patients with 90mg was higher than with 60mg on day 28( P <0.01). 50.7% and 59.0% of patients had improved moving ability separately on day 7 and 28. 4.7% of patients had hypercalcaemia.Serum calcium reduced to normal in 57.1% of patients. Side effects were fever,anorexia,nausea,general malaise.CONCLUSION This clinical trial confirmed that pamidronate was a effective drug for patients with metastatic bone pain and hypercalcaemia of malignancy.Side effect was slight and temporal.

关 键 词：帕米膦酸二钠 骨肿瘤 疼痛 高钙血症 药物疗法 

分 类 号：R738.106[医药卫生—肿瘤] R589.505[医药卫生—临床医学]