唑来膦酸注射液治疗高龄老年性骨质疏松的药物不良反应发生情况研究

摘要

目的 了解唑来膦酸注射液治疗高龄老年性骨质疏松的药物不良反应发生情况,并探讨高龄与药物不良反应发生的相关性.方法 选取201 1年3月-2016年7月在扬州市第一人民医院就诊的老年性骨质疏松患者45例,根据年龄分为老年组(年龄60 ～74岁,n=26)和高龄组(年龄75～88岁,n=19).收集并比较两组患者的基线资料和药物不良反应发生情况,采用偏相关分析探讨高龄与药物不良反应发生的相关性.结果 两组患者性别、BMI、骨钙素、钙离子、磷离子、碱性磷酸酶(ALP)、甲状旁腺激素(PTH)、25-羟维生素D[25-(OH) D]、腰椎L1-4和股骨颈骨密度、骨吸收抑制剂使用率及合并高血压、糖尿病、心脏病发生率比较,差异无统计学意义(P＞0.05).高龄组患者药物不良反应发生率低于老年组,差异有统计学意义(P＜0.05).是否发生药物不良反应患者的年龄、骨吸收抑制剂使用率比较,差异有统计学意义(P＜0.05);控制骨吸收抑制剂使用情况因素后,高龄与药物不良反应发生呈负相关(P＜0.05).结论 唑来膦酸注射液治疗75岁及以上高龄老年性骨质疏松患者的急性期不良反应发生率低于75岁以下患者,高龄与不良反应发生呈负相关.%Objective To investigate the adverse reactions to zoledronic acid injection in Chinese elders with osteoporosis,and based on this,to evaluate the correlation between advanced age (≥75 years) and the occurrence of adverse drug reactions.Methods Forty-five consecutive elderly patients with osteoporosis who were treated with zoledronic acid injection in Yangzhou First People's Hospital from March 2011 to July 2016 were enrolled and divided into elderly group (aged 60-74 years,n =26) and very elderly group (aged 75-88 years,n =19).The baseline data and information about adverse reactions to zoledronic acid injection of both groups were collected.Partial correlation analysis was performed to find the correlation between advanced age and the incidence of adverse drug reactions.Results Sex distribution,values of BMI,osteocalcin,calcium ion,phosphorus ion,alkaline phosphatase (ALP),parathyroid hormone (PTH),25-hydroxyvitamin D [25-(OH) D] and bone mineral density of lumbar L1-4 and femoral neck,utilization rate of bone resorption inhibitors,incidence of hypertension,diabetes mellitus and heart disease did not differ significantly between the two groups (P ＞ 0.05).Adverse reactions to zoledronic acid injection occurred significantly less in very elderly group than in the elderly group (P ＜ 0.05).The age and utilization rate of bone resorption inhibitors differed significantly between patients with adverse reactions to zoledronic acid injection and those without (P ＜ 0.05).After adjusting for the use of bone resorption inhibitors,advanced age presented a negative correlation with the incidence of adverse drug reactions (P ＜ 0.05).Conclusion Patients aged 75 or over with acute exacerbation of osteoporosis are less likely to have adverse reactions to zoledronic acid injection compared with those less than 75 years old.Advanced age is negatively correlated with the incidence of adverse drug reactions.