摘要
目的评价老年骨质疏松患者(>60岁)使用唑来膦酸注射液治疗骨质疏松症的安全性。方法结合国家药品不良反应报告/事件报告表设计唑来膦酸注射液使用情况调查表,调查5家医院。收集相关临床数据进行分析。结果共685例老年患者使用5 mg唑来膦酸注射液静脉滴注,其中男性患者106例,女性患者579例。入选患者年龄60~99岁,平均年龄为(73.82±8.50)岁。使用唑来膦酸注射液后,当日静脉输液量>500 mL 598例。与用药前数据相比,患者用药后的尿素氮、天冬氨酸氨基转移酶及丙氨酸氨基转移酶升高显著。可疑与不良反应相关临床表现共281例。药品不良反应发生率为41.02%。该药不良反应有全身性损害(46.13%)、胃肠系统损害(17.96%)、泌尿系统损害(17.65%)等。使用该药出现了严重不良反应。结论 5 mg唑来膦酸注射液在老年患者中使用较安全。临床上应警惕唑来膦酸注射液不良反应的发生,评估具有高危因素的患者并对其采用防护措施。
] Objective To evaluate the safety of 5 mg zoledronic acid infiusion for osteoporosis in the eldly （ over 60 years old）. Methods The schedule of the survey was based on the national adverse events and adverse drug reactions report table. The survey was conducted in 685 patients who received 5 mg zoledronic acid for osteoporosis in 5 hospitals. Clinical data were collected. Results There were 685 cases who received zoledronie acid infusion. There were 106 male patients and 579 female patients. The patients were aged 60-99 years, with an average age of 73.82±8.50 years. After infusion of zoledronie acid, there were 598 patients receiving volume of intravenous infusion more than 500 mL. The patients＇ blood urea nitrogen, aspartate aminotrunsferase, and alanine aminotransferase were significantly different after using zoledronic acid. Adverse drug reaction （ADR） incidence was 41.02%. The common ADR included a whole-general disorders （46. 13%）, gastro-intestinal disorders, and urinary disorders （17.65%）. There were serious adverse drug realtion reports. Conclusion Five mg zoledronie acid infusion demonstrated acceptable safety. The ADR of zoledronic acid infusion should be paid attention in clinic and the risk factors of ADR should be evaluated. We should focused the old patients who received zoledronic acid infusion.
作者
纪立伟
邢丽秋
王明飞
姜微哲
任晓蕾
刘琛
裴彤
温灵犀
JI Li-wei1 , XING Li-qiu2 , WANG Ming-fei3 , JIANG Wei-zhe4, REN Xiao-lei5 , LIU Chen6, PEI Tong6 , WEN Ling-xi7(1. Belting Hospital, National Center of Gerontology, Beijiag 100730, China; 2. Beifing Center for Drug Reevaluation, Beijing 100035, China ; 3. Department of Pharmacy, Jiangong Hospital, Beijing 100054, China ; 4. Department of Pharmacy, Peking Union Medical College Hospital, Chinese Academy of Medical Science ＆ Peking Union Medical College, Beijing 100730, China; 5. Department of Pharmacy, People Hospital, Beijing 100044, China; 6. Department of Pharmacy, Xuanwu Hospital, Capital Medical University, Beifing 100053, China; 7. Food and Drug Administration of Beijing, Beijing 100053, Chin)
出处
《中华骨质疏松和骨矿盐疾病杂志》
CSCD
北大核心
2018年第2期136-141,共6页
Chinese Journal Of Osteoporosis And Bone Mineral Research
