唑来膦酸治疗恶性肿瘤骨转移疼痛的临床研究

Phase Ⅱ clinical trail of zoledronic acid in the treatment of pain caused by malignant tumor osseous metastasis

目的以注射用帕米膦酸二钠为对照,评价注射用唑来膦酸单次静脉滴注治疗恶性肿瘤引起的溶骨性骨转移疼痛的有效性和安全性。方法采用前瞻性,随机双盲双模拟,阳性药平行对照,多中心临床研究。可评价病例204例,试验组102例患者接受唑来膦酸4 mg静脉滴注,对照组102例患者接受帕米膦酸二钠60 mg静脉滴注治疗。结果试验组与对照组患者骨转移疼痛治疗后骨痛评分变化与治疗前比较差异均有显著性(P<0.01);止痛有效率分别为80.4%和79.4%,活动能力改善有效率分别为62.7%和61.8%,与治疗前相比差异均有显著性(P<0.01),但两组间比较差异无显著性。两组患者均未发生严重不良事件,用药后试验组不良事件发生率为33.3%,对照组不良事件发生率28.4%,主要表现为发热、头痛、乏力、恶心,均为轻度,未做特殊处理,两组不良事件发生率比较差异无显著性。结论注射用唑来膦酸一次用药4 mg,对恶性肿瘤溶骨转移疼痛的止痛作用疗效确切,不良事件发生率较低,且用量少,用药时间短,值得临床推广使用。

Objective To observe the efficacy and security of zoledronic acid single intervenous drop infusion in the treatment of pain caused by malignant tumor osteolysis osseous metastasis compared with pamidronic acid. Methods The muhicentre prospective, random, double-blind and imitation, positive-drug parallel control clinical trails are used. Appraisable 204 patients were divided into two groups, One group were treated with zoledronic acid 4 mg intervenous drop infusion and the other with pamidronic acid 60rag as control. Results The bone pain score change in both groups before and after treatment have significant difference（ P 〈 0.01 ）. The effective rate of pain release in both groups were 80.4% and 79.4% , and the locomotor activity improvement rate were 62, 7% and 61.8% respectively. Both have significant difference（P 〈0.01 ）compared with prior treatment, But there were no significant difference between two groups. No severe adverse events were found. The main adverse reactions of therapy were fever, headache debilitation, nausea which were light and without special handling. The difference between two groups in adverse events rate have no statistical significance. Conclusion The regimen of zoledronic acid 4mg single intervenous drop infusion have precisely efficacy in the treatment of pain caused by malignant tumor osteolysis osseous metastasis which have low adverse events rate and convenient shorter using time. More clinical use and generalization should be taken.