唑来膦酸预防芳香化酶抑制剂引起骨丢失的临床研究*

Clinical Trial on the Efficacy of Zoledronic Acid in Preventing Bone Loss Induced by Aromatase Inhibitor in Breast Cancer

  • 摘要: 目的:探讨唑来膦酸预防绝经后乳腺癌患者芳香化酶抑制剂内分泌治疗引起骨丢失的效果。方法:选取2005年6 月至2007年6 月天津医科大学附属肿瘤医院63例绝经后激素受体阳性乳腺癌患者,随机分为治疗组(唑来膦酸与芳香化酶抑制剂连用)和对照组(单用芳香化酶抑制剂)。 随访24个月,观察不同时期两组患者腰椎(L2~L4)前后位骨密度,骨量减少和骨质疏松发生率的变化。结果:治疗6 个月,唑来膦酸组腰椎的骨密度与单用芳香化酶抑制剂组相比有增高趋势,但差异无统计学意义(P=0.099)。 两组骨丢失事件的发生没有统计学差异(骨量减少:P=0.124,骨质疏松:P=0.573)。 12个月时,治疗组腰椎骨密度较对照组明显升高(P=0.008),治疗组骨量减少和骨质疏松的发生率低于对照组(骨量减少:P=0.048,骨质疏松:P=0.042)。 24个月时,治疗组的腰椎骨密度明显高于对照组(P=0.000)。 治疗组骨量减少和骨质疏松的发生率明显低于对照组(骨量减少:P=0.027,骨质疏松:P=0.011)。 治疗期间,除治疗组骨痛发生率与对照组相比较高外(P=0.039),两组的不良事件的发生率相似(P>0.05)。结论:唑来膦酸对芳香化酶抑制剂内分泌治疗引起的骨丢失有明显的预防作用,且不良反应轻微,安全有效,耐受性好。

     

    Abstract: g author: ZHANG Jin, E-mail: davidz9132002 @yahoo. com Third Department of Breast Cancer, Cancer Institute and Hospital of Tianjin Medical University, Tianjin 300060, China Grant support: The Key Program of Frontier Technology and Foundamentals of Its Application in Tianjin (08jczdjc 23800 ) Absract Objective:To evaluate the efficacy of zoledronic acid in preventing bone loss induced by aromatase inhibitor in postmenopausal women with breast cancer. Methods:A total of63postmenopausal breast cancer patients were recruit-ed in the clinical trial. The zoledronic acid plus aromatase inhinitor group included 31postmenopausal breast cancer pa-tients. There were 32patients in the aromatase inhibitor group (the control group). The lumbar spine bone mineral density (LS BMD) and the incidence of osteopenia and osteoporosis were compared between the two groups at different time points. Results: After6 months, the zoledronic acid group had a higher LS BMD than the control group, but the difference between them was not significant ( P=0.099 ). There was no significant difference in the incidence of osteopenia and osteo-prosis between the two groups (osteopenia: P=0.124 ; osteoporosis: P=0.573 ). At 12months after treatment, the zoledronic acid plus aromatase inhinitor group had higher LS BMD than the control group ( P=0.008 ); and the incidence of osteopenia and osteoporosis in the zoledronic acid plus aromatase inhinitor group was lower than that in the control group (osteope-nia: P=0.048 ; osteoporosis: P=0.042 ). At 24months after treatment, the LS BMD in the zoledronic acid group was higher than that in the control group ( P=0.000 ); and the incidence of osteopenia and osteoporosis in the zoledronic acid plus aro-matase inhinitor group was lower than that in the control group (osteopenia: P=0.027 ; osteoporosis: P=0.011 ). The inci -dence of adverse effects between the two groups was similar except for bone pain. Patients in the zoledronic acid plus aro-matase inhinitor group had a higher rate of bone pain (P=0.037 ). Conclusion:Zoledronic acid is effective for preventing bone loss induced by aromatase inhibitor in postmenopausal breast cancer patients, with slight adverse reactions.

     

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