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背景与目的:骨转移是引起恶性肿瘤患者疼痛的最常见原因,严重影响患者的生活质量。唑来膦酸是第三代的双膦酸盐类药物,能抑制破骨细胞活性,缓解疼痛。本研究观察注射用唑来膦酸单次静脉滴注治疗恶性肿瘤溶骨性骨转移疼痛的有效性和安全性。方法:采用随机双盲双模拟、阳性药平行对照、多中心的研究方法。试验组:唑来膦酸加甘露醇冻干粉针;对照组:甘露醇冻干粉针加帕米膦酸二钠。结果:2003年10月至2004年10月共随机入组216例,试验组109例,对照组107例。试验组和对照组患者用药前的疼痛强度(PI)分别为6.0±1.1和6.0±1.3(P=0.938);治疗后第7天疼痛强度分别为3.7±2.0和4.1±2.0(P=0.119);第14天分别为3.2±2.0和3.7±2.4(P=0.129)。两组完全缓解(completeresponse,CR)率10.4%和9.5%,部分缓解(partialresponse,PR)率69.8%和69.5%,总缓解率88.7%和85.7%(P>0.05);出现CR时间分别为(7.0±2.2)天和(9.5±2.6)天(P=0.033)、出现PR时间为(4.9±2.6)天和(5.0±2.5)天(P=0.908);CR的持续时间(13.2±1.8)天和(14.0±0.0)天(P=0.155),PR持续时间(13.4±1.9)天和(12.8±2.8)天(P=0.127)。试验组出现CR时间较对照组早,差异有显著性(P<0.05),其余指标两组间差异均无显著性(P>0.05)。不良反应主要是发热、恶心呕吐、乏力等,两组在不良反应发生率及程度等方面无显著性差异(P>0.05)。结论:注射用唑来膦酸治疗恶性肿瘤溶骨性骨转移疼痛的有效性和安全性与帕米膦酸二钠相似,但起效更快。
BACKGROUND & OBJECTIVE: Bone metastasis is the most common cause of pain in patients with malignant tumors and seriously affects the quality of life of patients. Zoledronic acid is the third generation of bisphosphonates that inhibit osteoclast activity and relieve pain. This study was to observe the efficacy and safety of single intravenous infusion of zoledronic acid for the treatment of osteolytic bone metastases of malignant tumors. Methods: Randomized double-blind double-dummy, positive drug parallel control, multi-center research methods. Test group: Zoledronic acid plus mannitol freeze-dried powder; Control group: Mannitol freeze-dried powder plus pamidronate disodium. Results: From October 2003 to October 2004, a total of 216 patients were enrolled into the study, 109 in the experimental group and 107 in the control group. The pain intensity (PI) before treatment was 6.0 ± 1.1 and 6.0 ± 1.3 (P = 0.938) in the test group and the control group, and pain intensity was 3.7 ± 2.0 and 4.1 ± 2.0 on the seventh day after treatment (P = 0.119) ; Day 14 were 3.2 ± 2.0 and 3.7 ± 2.4, respectively (P = 0.129). The complete response (CR) rates were 10.4% and 9.5%, partial response (PR) rates were 69.8% and 69.5%, and the total response rates were 88.7% and 85.7% (P> 0.05) 7.0 ± 2.2 days and 9.5 ± 2.6 days respectively (P = 0.033). The duration of PR was (4.9 ± 2.6) days and (5.0 ± 2.5) days Day and (14.0 ± 0.0) days (P = 0.155), PR duration (13.4 ± 1.9) days and (12.8 ± 2.8) days (P = 0.127) respectively. The CR time in the experimental group was earlier than that in the control group, with significant difference (P <0.05). There was no significant difference between the two other groups (P> 0.05). Adverse reactions were mainly fever, nausea and vomiting, fatigue and so on. There was no significant difference in the incidence and extent of adverse reactions between the two groups (P> 0.05). CONCLUSIONS: The efficacy and safety of zoledronic acid for the treatment of osteolytic bone metastases in malignant tumors is similar to that of pamidronate but works faster.