不同剂量唑来膦酸抑制骨吸收作用研究

The research on the effect of different doses of Zoledronic acid on bone resorption

目的 评估单次注射低剂量唑来膦酸的抑制骨吸收作用.方法 选取在我院治疗的绝经骨质疏松患者332例,根据随机数字表法将患者分为4组,分别为唑来膦酸1mg治疗组（1mg组）、2.5mg治疗组（2.5mg组）、5mg治疗组（5mg组）与安慰剂治疗组（对照组）,每组各83例患者.1mg组、2.5mg组与5mg组患者分别单次接受1mg、2.5mg与5mg唑来膦酸治疗.对照组患者静脉滴注安慰剂.评估4组患者在基线期、第6个月、第12个月、第18个月、第24个月的腰椎（L1-L4）骨密度（BMD）、全髋骨密度（BMD）及骨代谢标志物,骨代谢标志物包括I型胶原羟基端肽β降解产物（β-CTX）和I型前胶原氨基末端肽（P1NP）.结果 1 mg组第6个月、第12个月腰椎BMD、全髋BMD值与基线期、对照组同期值比较显著升高,差异有统计学意义（均P〈0.05）.而该值在第18个月、第24个月逐渐下降,与基线期比较显著降低（P〈0.05）,与对照组同期值比较差异无统计学意义.而2.5mg组和5mg组腰椎BMD、全髋BMD值,在整个试验期间均显著低于基线值,同时也显著低于对照组同期值（P〈0.05）.各组患者β-CTX和P1NP的变化趋势与BMD相似.结论 静脉注射1mg和2.5mg唑来膦酸产生的抗骨吸收作用可以至少持续1年.治疗1年后,单次注射2.5mg唑来膦酸对骨骼的影响和单次注射5mg唑来膦酸相似.1mg唑来膦酸产生的抗骨吸收作用可以持续12个月,而之后缓慢消失.

Objective To evaluate the effect of single injection of low dose zoledronic acid on bone resorption.Methods332 menopausal patients with bone deficiency treated in our hospital were selected.The patients were treated with zoledronic acid 1mg （1mg group）, 2.5mg treatment group （2.5mg group）, 5mg treatment group （5 mg group） and placebo treatment group （control group）, each group of 83 patients.The patients of 1mg group, 2.5mg group and 5 mg group were treated with 1mg, 2.5mg and 5mg zoledronic acid alone.The patients in the control group were given intravenous infusion of placebo.Evaluated the lumbar spine （L1-L4） and total hip bone mineral density （BMD） and bone metabolic markers at baseline, 6, 12, 18, and 24 months in the four groups.The bone metabolic criteria included t β-Cterminal-telopeptide of type I collagen （β-CTX） and procollagen type-I N-terminal propeptide （P1NP）.ResultsThe Lumbar spine BMD and the Total hip BMD were significantly higher in 1mg group than baseline value and Simultaneous valueand in the control group （P〈0.05）, The difference were statistically significant （all P〈0.05）.The values at 8 and 24 months decreased gradually.The value was significantly lower （P〈0.05） compared with the control group, There were no statistically significant difference compared with the simultaneous value in control group.The lumbar BMD and the total hip BMD in 2.5mg and 5mg groups were significantly lower than the baseline values during the whole trial period （all P〈0.05）.The trend of β-CTX and P1NP was similar to that of BMD in each group.ConclusionIntravenous injection of 1 mg and 2.5 mg of zoledronic acid produces anti-bone resorption that can last for at least 1 year.After one year of treatment, The effect of single injection of 2.5 mg of zoledronic acid on bone is similar to that of single injection of 5 mg zoledronic acid.1 mg zoledronic acid produced by anti-bone resorption can last for 12 months, and then slowly disappear.