61例曲克芦丁制剂不良反应的文献分析

Literature Analysis of 61 Cases of Adverse Drug Reaction Induced by Troxerutin

目的探讨曲克芦丁制剂不良反应的发生原因与规律,为临床安全用药提供参考。方法对国内文献报道的61例曲克芦丁制剂不良反应病例进行统计和分析。结果 61例不良反应病例中,80%以上为45岁以上中老年人,55.7%存在超说明书适应证用药;57例静脉途径给药的病例报告中,68%以葡萄糖注射液为溶媒,不良反应发生风险高于其他溶媒;22%存在同瓶配伍输注现象,易发生不良反应;77%不良反应出现在用药30 min内;不良反应表现主要为过敏样及过敏反应。结论医务人员用药前应仔细阅读说明书,严格按照说明书的适应证和用法用量给药,谨慎联合用药,禁止同瓶配伍输注,用药过程中加强监护,将不良反应引起的伤害降到最低;药品生产企业应加强曲克芦丁制剂的质量控制研究和安全性研究,修改完善说明书中的安全性内容。

Objective To explore the causes and regularity of the adverse reactions （ADRs） oftroxerutin, in order to provide the scientific references for safe drug use in clinic. Methods 61 cases of the ADRs of troxerutin reported in domestic literature were analyzed. Results Among 61 cases of the ADRs of troxerutin, more than 80% occurred in the age group above 45 years and 55.7% happened after the drug was taken beyond indications showed in the instructions. Futherrnore, among 57 cases accepting intravenous drop infusion, 68% used glucose injection as solvent, and the ADRs of the solvent were more risky than that of other solvents. In addition, 22% occurred when troxerutin was used combining with other drugs in the same infusion bottle. 77% happened within 30 minutes after the drug was taken. Finally, the main ADRs were anaphylactic and anaphylactoid reactions. Conclusion Medical staff should well know instructions of the drugs, use it in accordance with the indications and doses labeled in the instructions strictly, and be cautious of drug combination. Furthermore, it is prohibited to use the drug combining with other drugs in the same infusion bottle. Meanwhile, the drug should be used under strict monitoring to reduce the damage caused by ADRs to a minimum.Pharmaceutical manufacturers should strengthen researches on preparation quality control and safety of troxerutin, so as to revise and improve the instructions on safety of the drugs.