摘要
目的:评价注射用唑来膦酸与伊班膦酸治疗癌性骨痛的临床疗效和安全性。方法:入选恶性肿瘤骨转移患者52例,其中唑来膦酸组26例,伊班膦酸组26例,采用平行对照研究方法。每组各用药2～4个周期。观察用药后患者临床获益率、起效时间、持续时间及骨扫描的变化。不良反应中注意观察发热、血钙及肾功能的变化。结果:12d时,唑来膦酸组临床获益率92.3%,伊班膦酸组临床获益率88.5%,P=0.015。56d时,唑来膦酸组临床获益率96.2%,伊班膦酸组临床获益率92.4%,P=0.065。两组止痛中位起效时间均为第5天,止痛持续整个周期,6个月后复查骨扫描均有改善。两组不良反应主要为低热和乏力。用药4d内骨转移部位疼痛有加重现象,严重程度与骨质损害一致。两组各有高血钙3例,用药2个周期后均恢复至正常范围。两组治疗前后血清肌酐均未见明显变化。结论:两者均是高效双膦酸类药,有良好的耐受性。止痛疗效唑来膦酸组略优于伊班膦酸组,且唑来膦酸静脉滴入时间短(15min),使用更方便。两者毒副反应均较轻,按推荐剂量使用均未见肾功能损害。
OBJECTIVE： To evaluate the clinical therapeutic effect and safeness of zoledronic acid and ibandronate in tumorous osteodynia. METHODS： Fifty-two patients of malignant tumor with osseous metastasis were enrolled in this study. The patients were randomized in a 1 ： 1 fasion to receive either zoledronic acid or ibandronate for 2 to 4 cylces. The clinical benefit rate, onset time, duration and the change in bone scanning in both the groups were observed. The adverse effects including fever, the change of blood calcium and the renal function were investigated. RESULTS： The clinical benefit rates in 12 days were 92.3% in the zoledronic acid group, and 88.5% in the ihandronate group （P = 0. 015）, and the clinical benefit rates in 56 days were 96.2% in the zoledronic acid group, and 92.4% in the ibandronate group （P=0. 065）. The median onset time of both the groups was the fifth day, the duration was both the whole cycle, and there were certain improvement in both the groups according to bone scanning after 6 months. The main adverse effects of both the groups were fever and hypodynamia. The pain of the tumorous osteodynia part aggravated in the initial 4 days after the administration, and there was a positive correlation between thedegree of pain and osteoclasia. Blood calcium was increased unconventionally in 3 patients in each group, which both rebounded to the normal range after 2 cycles. There was no significant change of creatinine in both the groups after the therapy. CONCLUSIONS： Both zoledronic acid and ibandronate are biophosphonate with good therapeutic effect and tolerance. Zoledronic acid has a slight advantage over ibandronate as far as the odynolysis effect is concerned, and is more convenient as the time of intravenous is short（15 minutes）. The adverse effect of both is light and no impact on renal function is found when both are administrated as recommended dose.
出处
《中华肿瘤防治杂志》
CAS
2007年第22期1725-1727,共3页
Chinese Journal of Cancer Prevention and Treatment
