唑来膦酸钠应用近期安全性观察
The observation of short-term safety of zoledronic sodium application
  
DOI:10.3969/j.issn.1006-7108.2012.10.013
中文关键词:  骨质疏松  副反应  唑来膦酸钠
英文关键词:Osteoporosis  Side effects  Zoledronic sodium
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袁元杏 李青 张非 赵成毅 梅治 张爱明 姚海燕 528403广东中山中山市人民医院骨二科 
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中文摘要:
      目的 了解唑来膦酸钠用药后的近期副反应。方法 自2009年11月至2012年2月对156例骨质疏松症患者应用唑来膦酸钠治疗,观察患者自用药1个月以来的临床表现,重点包括疼痛、发热及其他不良事件。同期观察因脊柱骨折行椎体成形术而未应用唑来膦酸钠治疗的患者107例,比较两组相应事件发生的差异。结果 本组患者全部得到随访,结果显示唑来膦酸钠组疼痛发生率17.3%,发热发生率12.8%,对照组疼痛发生率1.87%,发热发生率0.93%,两组差异有显著性(P < 0.001)。另外唑来膦酸钠组出现1例皮肤过敏,1例心肌缺血、心绞痛。1例多发性骨髓瘤病情加重。1例出现肺炎呼吸衰竭死亡。结论 唑来膦酸钠在骨质疏松症的应用中,有疼痛加重,发热等副反应,甚至可能有致皮肤过敏,心绞痛、多发性骨髓瘤病情加重、肺炎呼吸衰竭等不良事件,建议在用药当天密切监护下使用,并加强用药后2w内的随访。
英文摘要:
      Objective To investigate the short-term side effects after the medication of zoledronic sodium. Methods One hundred and fifty-six osteoporosis patients from November 2009 to February 2012 were treated with zoledronic sodium. Clinical manifestations were observed in patients within 1 month after the medication, including pain, fever, and other adverse events. One hundred and seven patients with spinal fractures treated with vertebroplasty but without the medication of zoledronic sodium were observed simultaneously. The difference of the incidence of side effects between the two groups was compared. Results All the patients were followed up. The results revealed that in zoledronic sodium group, the incidence of pain and fever was 17.3% and 12.8%, respectively. In control group, the incidence of pain and fever was 1.87% and 0.93%, respectively. The difference between the two groups was significant (P<0.001). In addition, in zoledronic sodium group, one patient with skin allergy and one patient with myocardial ischemia and angina were observed. The situation of one patient with multiple myeloma was aggravated. And one patient had pneumonia and died of respiratory failure. Conclusion The application of zoledronic sodium in osteoporosis patients can cause pain, fever and other side effects, and may even cause skin allergy, angina, exacerbation of multiple myeloma, pneumonia, respiratory failure, and other adverse events. Close supervision after the medication at the same day is recommended, and the follow-up after the medication for the first 2 weeks should be strengthened.
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