唑来膦酸注射液治疗骨质疏松的安全性研究

Safety of zoledronic acid injection in the treatment of osteoporosis

目的:探讨唑来膦酸注射液治疗骨质疏松症出现急性期不良反应(APR)情况及可能的影响因素。方法:调查2013—2014年我院使用唑来膦酸注射液(密固达)的住院患者共186例,应用SPSS 17.0软件进行统计分析。结果:186例次患者中38例出现APR,总发生率为20.43%。主要表现为发热、寒战、乏力、肌肉酸痛、头痛和胃肠不适等症状。Logistic回归分析显示,体重指数(BMI)和降钙素制剂与APR呈负相关(P<0.05)。结论:唑来膦酸注射液APR发生率较高,用药时需注意观察,及时对症处理,保证患者用药安全。APR相关影响因素还有待进一步的深入研究证实。

Objective： To investigate the characteristics of the acute phase response（ APR） after treatment of osteoporosis with intravenous zoledronic acid,and the potential factors of the APR development. Methods：Survey for using azole phosphonic acid injection was performed in our hospital from 2013 to 2014 in hospitalized patients（ n = 186）,and SPSS 17. 0 software was used for statistical analysis. Results： In the 186 patients,38 had APR,and the total incidence rate was 20. 43%. The main manifestations were fever,chills,fatigue,muscle pain,headache,gastrointestinal discomfort,and other symptoms. Logistic regression analysis showed that BMI and calcitonin formulation were negatively correlated with APR（ P 0. 05）. Conclusion： APR occurrence rate of zoledronic acid injection is higher. We need to pay attention when the drug is used to ensure drug safety. APR related factors have yet to be confirmed in further research.