论文部分内容阅读
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 evaluate the efficacy and safety of single injection of zoledronic acid for the treatment of osteolytic bone metastases caused by malignant tumors by injection of pamidronate disodium. Methods A prospective, randomized, double-blind, double-dummy, parallel-control, multicenter clinical trial of positive drugs was performed. Evaluable cases of 204 cases, 102 patients in the experimental group received intravenous infusion of 4 mg zoledronic acid, 102 patients in the control group received intravenous infusion of pamidronate 60 mg. Results The pain scores of experimental group and control group after treatment of bone metastases were significantly different from those before treatment (P <0.01). The effective rates of analgesia were 80.4% and 79.4% respectively, and the effective rates of activity improvement were 62.7 % And 61.8%, respectively, which were significantly different from those before treatment (P <0.01), but there was no significant difference between the two groups. There were no serious adverse events in both groups. The incidence of adverse events was 33.3% in the experimental group and 28.4% in the control group after treatment, which were mainly fever, headache, fatigue and nausea There was no significant difference between the two groups in the incidence of adverse events. Conclusion A single injection of zoledronic acid 4 mg for the treatment of osteolytic metastasis of malignant tumors pain curative effect is clear, the incidence of adverse events is low, and less dosage, medication time is short, worthy of clinical promotion.