唑来膦酸延缓骨转移癌放射治疗的临床研究

A randomized controlled trial of Zoledronic acid in delaying the radiotherapy of patients with painful skeletal metastases

目的以帕米膦酸二钠为对照,研究唑来膦酸对延缓骨转移癌放射治疗事件发生的临床疗效。方法对118例骨转移癌患者,随机分为病例组60例,对照组58例,以疼痛持续加重,X线或CT证实骨转移病灶进展或有可能导致病理性骨折而行放射治疗为观察终点,研究唑来膦酸延缓骨转移癌放射治疗事件出现时间的临床疗效。结果近期止痛有效率和获益率在唑来膦酸组分别为55.36%,65.18%;帕米膦酸组为35.19%,44.44%,P<0.05;放疗事件发生率在唑来膦酸组为34.21%,帕米膦酸钠组为54.28%,P>0.05;发生放疗事件中位时间在唑来膦酸组为121天,帕米膦酸钠组为189天,P=0.041。结论唑来膦酸近期止痛的临床有效率、获益率和总体骨相关事件(SRE)危险性降低的比例均高于帕米膦酸二钠。

Objective To evaluate the effect of zoledronic acid versus pamidronate in delaying the radiotherapy of patients with painful skeletal metastases. Methods 220 patients with painful skeletal metastases were randomly divided into two groups, 112 in zoledironic acid group and 108 in pamidronate only. The clinic effect of zoledronic acid was evaluated. Pain assessment via VAS and progressed metastases especially pathological fracture were estimated by x-ray or CT scan, determining the necessity of radiotherapy. Results The short-term efficiency and clinical benefit in pain management was 55.36% ,65.18% separately in zoledronic acid group and 35.19% ,44.44% in pamidronate,P 〈 0.05; the incidence of radiotherapy cases was 34.21% in zoledronic acid group and 54.28% in pamidronate, P 〉 0.05 ; medium radiation-needed time was 121 days in zoledronic acid and 189 days in pamidronate, P = 0.041. Conclusions We reported that the short time efficiency, clinical benefit,the decrease of total skeletal related event （SRE） and the incidence of radiotherapy cases were improved in the group treated with zoledronic acid rather than in pamidronate acid group.