51例注射用脂溶性维生素(Ⅰ)严重不良反应回顾性分析

Retrospective analysis of 51 cases of serious adverse drug reactions induced by fat-soluble vitamin(Ⅰ) for injection

目的研究注射用脂溶性维生素(Ⅰ)严重不良反应的特点,为临床合理用药提供参考。方法收集国家药品不良反应中心反馈的本地企业全国范围内2014年1月—2016年8月注射用脂溶性维生素(Ⅰ)引起的严重不良反应51例,对其进行回顾性分析。结果发生严重不良反应的男女性别比为1∶0.96,发生时间多在用药后30 min内,累及系统-器官以循环系统和呼吸系统居多。结论脂溶性维生素(Ⅰ)的严重不良反应的发生有药品自身因素和临床使用不合理等人为因素。生产企业应提高药品质量;临床医师用药前详细询问过敏史,遵照说明书用药,加强不良反应监测,发生不良反应时及时采取措施,确保安全合理用药。

Objective To investigate the characteristics of serious adverse drug reactions （ ADRs） induced by fat-soluble vitamin （ Ⅰ） for injection and provide reference for rational clinical use of drugs. Methods A total of 51 cases of serious ADRs caused by fat-solu-ble vitamin （Ⅰ ） for injection from January 2014 to August 2016 in a manufacturer feedback by national center for ADR monitoring were collected for the retrospective analysis. Results The sex ratio of adverse reactions was 1-0.96. Most adverse reactions emerged in 30 min after drug treatment, and mostly in nervous and circulatory systems. Conclusions Serious ADRs of fat-soluble vitamin （Ⅰ ） for injection were caused by the factors both from drug and patients. Drug quality should be improved. The allergy history of pa-tients should be inquired before drug treatment and the instructions monitor adverse reaction should be followed. When adverse reac-tions occur, we should deal with problems in time to ensure the safe and effective drug were used.