摘要
目的探讨复方脂溶性维生素注射制剂所致不良反应的特点,为临床安全合理用药提供参考。方法检索2000年-2017年7月中国生物医学文献服务系统(Sino Med)与中国知网(CNKI)中关于复方注射用脂溶性维生素所致不良反应案例,进行统计与分析。结果复方脂溶性维生素注射制剂存在超适应证用药现象,所致不良反应多为速发型,不良反应累及多个系统-器官,可导致严重过敏反应或过敏性休克。结论临床用药时应把握使用复方注射用脂溶性维生素的适应证,重视不良反应;生产企业应加强上市后药品不良反应监测,及时修订药品说明书。
Objective To explore the general characteristics of adverse drug reactions（ADRs） induced by compound fat-soluble vitamin for injection in order to provide references for rational and safe clinical drug use. Methods ADR cases induced by compound fat-soluble vitamin for injection reported in SinoMed and CNKI during 2000~Jul. 2017 were collected and analyzed statistically. Results Compound fat-soluble vitamin was used in clinic beyond the approved indications and immediate hypersensitivity occurred, which hurted multiple organs and systems including severe allergic reactions and anaphylactic shock. Conclusion Compound fat-soluble vitamin for injection should not be used with unreasonable indications. Medical staff should pay attention to the ADR induced by compound fat-soluble vitamin for injection. Drug manufacturers should strengthen the post-market monitoring of ADR. The domestic drug package inserts need to be further improved and revised.
出处
《中国药物警戒》
2017年第11期691-696,共6页
Chinese Journal of Pharmacovigilance
关键词
复方脂溶性维生素
药品不良反应
文献
分析
compound fat-soluble vitamin
adverse drug reactions
literature
analysis
