前列腺癌骨转移病人唑来膦酸不同给药间期疗效比较

Efficacy of zoledronic acid dosing every 12 VS 4 weeks in patients with bone metastases of prostate cancer

目的比较唑来膦酸在前列腺癌骨转移病人不同给药间期(4周及12周)临床疗效的差异。方法前列腺癌骨转移病人52例,按治疗间期分为每4周1次组(A组)及每12周1次组(B组),给予4.0 mg唑来膦酸静滴1年。比较两组病人治疗后骨相关事件(SRE)发生率,首次SRE发生时间、骨发病率、肌酐纠正的尿N-末端肽、骨痛缓解、骨转移灶控制及不良反应相关情况。结果 A组中有64.0%、B组中有33.3%病人出现治疗拖延,两组间比较,差异有统计学意义(P<0.05)。A组中5例(20.0%)、B组中6例(22.2%)出现了至少1个SRE,两组间首次SRE时间均在30周左右出现,差异无统计学意义(P>0.05)。A、B组的平均骨发病率(SMR)值分别为0.46∶0.50,差异无统计学意义(P>0.05)。疼痛数字量表(NRS)评分及及止痛药用量各监测时间点均无明显差异(P>0.05)。肌酐纠正的尿N-末端肽(uNTX/Cr)率仅在48周时B组高于A组,其他时间两组未有明显差异。骨转移灶缓解:24周及48周时骨扫描显示两组骨转移灶控制情况无明显差异。A组消化道反应和低血钾发生率高于B组,但差异无统计学意义(P>0.05)。结论唑来膦酸每12周1次在缓解骨痛,控制骨进展效果不次于每4周1次,是前列腺骨转移病人可接受治疗方案。

Objective To observe the treatment effect of zoledronic acid dosing every 12 VS 4 weeks in patients with prostate cancer metastatic to bone.Methods 52 patients with prostate cancer and bone metastases were assigned to receive 4.0 mg of intravenous zoledronic acid every 4(group A)or every 12 weeks(group B)for 1 year.The clinical value about two-way therapy were evaluated on SRE rate、first SRE and skeletal morbidity rate、uNTX/Cr ratio、bone pain relief rate、number of bone metastases and ad-verse events.Results Treatment delay was observed in 64.0%of group A and 33.3%of group B,and the difference between the two groups was statistically significant(P<0.05).SREs occurred in 5 patients(20.0%)in group A and 6 patients(22.2%)in group B.The SREs rate and the time to first SRE(oc-cured about 30 weeks)between two groups were not significantly different(P>0.05).The mean SMR was 0.46 vs 0.50 events per year in in group A and group B(P>0.05).The uNTX/Cr ratio had no statistical difference between the 2 treatment groups in each time period(P>0.05),except at the 48 weeks.Bone pain relief rate of two groups was not statistically significant in each time point.Adverse events:In group A,the proportion of patients in digestive tract reaction and hypopotassemia was higher than another group.But all AEs in two groups had no statistical difference.Conclusion The every 12 weeks regimen of zole-dronic acid was noninferior to the every 4 weeks regimen for treatment of patients with bone metastasis from prostate cancer in relief bone pain and control the progression of bone lesions.This longer interval may be an acceptable treatment option.