帕米膦酸二钠和唑来膦酸治疗非小细胞肺癌骨转移疗效和安全性比较

Comparison of the Efficacy and Safety between Pamidronate Disodium and Zoledronic Acid in Treating Non-small-cell Lung Cancer Patients with Bone Metastasis

目的评价伴骨转移的非小细胞肺癌(non-small cell lung cancer,NSCLC)患者在接受帕米膦酸二钠和唑来膦酸治疗后的有效性和安全性。方法 2007年6月2008年12月,74例伴骨转移的NSCLC,患者接受了双膦酸盐治疗,其中50例接受帕米膦酸二钠治疗,24例接受唑来膦酸治疗。帕米膦酸二钠90mg,静脉滴注3h,每4周重复1次;唑来膦酸4mg,静脉滴注15min,每4周重复1次。对可能影响其骨相关事件发生时间及生存率的各种临床﹑病理、治疗方法等因素进行分析,用Kaplan-Meier曲线及Log rank检验生存率差异,对不良反应的发生率等采用χ2检验。结果 18个月无骨相关事件生存率和总体生存率在帕米膦酸二钠及唑来膦酸组分别为19.3%、28.9%(P=0.253)和33.4%、38.2%(P=0.745),两组比较,差异均无统计学意义。两组患者不良反应中帕米膦酸二钠组8例(16.0%),唑来膦酸组6例(25.0%),两组比较差异无统计学意义(χ2=0.200,P=0.655)。7例患者用帕米膦酸二钠治疗失败后再用唑来膦酸治疗,其中位无骨相关事件生存时间为2个月(95%CI:0～4.6)。结论唑来膦酸和帕米膦酸二钠在缓解延迟骨相关事件发生时间疗效和不良反应发生率相当。用帕米膦酸二钠治疗失败后再用唑来膦酸可延缓骨相关事件发生时间。

Objective To retrospectively evaluate the efficacy and safety of pamidronate disoclium and zoledronic acid in treating non-small-cell lung cancer（NSCLC） patients with bone metastasis.Methods This study included 74 patients who were treated with bisphosphonate between June 2007 and December 2008.Fifty were treated with pamidronate disodium,and 24 with zoledronic acid.Pamidronate disodium was administered intravenously once for 3 hours every 4 weeks at a dose of 90 mg.Zoledronic acid was given intravenously once for 15 minutes every 4 weeks at a dose of 4 mg.Various clinical,pathological factors and treatment methods related to the occurring time of skeletal related events（SRE） and survival rate were analyzed.Kaplan-Meier curve and Log rank were adopted to detect the difference in survival rate between patients treated with different medicine,and we used χ^2 test to discover the rate of adverse events of the patients.Results Eighteen-month SRE-free survival and overall survival rate in the pamidronate disodium and zoledronic acid group were 19.3% vs.28.9%（P=0.253）,and 33.4% vs.38.2%（P=0.745） respectively.There were 8（8/50） cases of adverse events in the pamidronate disodium group,and 6（6/24） in the zoledronic acid group（χ^2=0.200,P=0.655）.The SRE-free survival time for seven patients who were treated with zoledronic acid after pamidronate disodium failed was 2 months（95%CI： 0-4.6）.Conclusion Compared with zoledronic acid,pamidronate has equal efficacy in delaying SRE and incidence of adverse effects.Administering zoledronic acid after pamidronate failed can also delay the occurring time of SRE.