含木糖醇注射剂临床应用现状及潜在风险分析  

Clinical Application and Potential Risk of Xylitol-containing Injections

作　　者：许先兴 杨静文[2] 吴桂芝[1] 董铎[1] 

机构地区：[1]国家食品药品监督管理总局药品评价中心,北京100045 [2]解放军总医院第一附属医院,北京100048

出　　处：《中国药物警戒》2017年第11期680-682,共3页Chinese Journal of Pharmacovigilance

基　　金：国家重大新药创制课题(2017ZX09101001-001-003):药品再评价政策法规及实施策略研究

摘　　要：目的探讨含木糖醇注射剂临床应用的潜在风险,为临床合理用药提供参考。方法检索国家药品不良反应监测数据库和国内外相关文献资料,分析我国含木糖醇注射剂临床应用特点及潜在风险。结果含木糖醇注射剂在我国临床广泛使用,尽管在适应证方面对此类产品进行了限制,但是超说明书使用现象比较普遍,而且有些含木糖醇复方注射剂未限制适用人群,增加了患者发生不良反应的风险。结论含木糖醇注射剂在临床上不仅应严格按照适应证使用,还应关注大量输液导致木糖醇过量摄入的潜在风险。Objective To investigate the potential risks of xylitol-containing injections so as to promote rational use of these products in clinical practice. Methods The valid data of xylitol-containing injections were retrieved from the national database of drug adverse reaction monitoring and literature at home and abroad, and the characteristics and potential risks were analyzed. Results Xylitol-containing injections were widely used as glucose substitutes in our country. Although there are strict restrictions in the indications for such products, off-label use is common, which may increase the incidence of adverse reactions in patients. Additionally, some of the xylitol-containing formulations are not restricted for use in diabetic patients, and substantial intake of xylitol may happen. Conclusion Xylitol-containing injections should be used in accordance with indications, meanwhile, the potential risk of excessive intake of xylitol must be concerned about.

关 键 词：木糖醇 安全性 药品不良反应 

分 类 号：R95[医药卫生—药学]