摘要
目的:分析神经节苷脂钠注射液出现聚集性不良反应的影响因素。方法:调阅本院ADR/ADE监测系统内的7份神经节苷脂注射液聚集性不良反应记录及相关病历,对用药人群、使用环节、ADR症状等因素进行调查分析。结果:经质量检验,此次使用的神经节苷脂注射液为合格药品,此次聚集性不良反应表现为抽搐、寒战、发热等过敏样症状。7例聚集性不良反应的发生时间、溶媒选择、药物用量、滴速等因素基本相同,仅在溶媒用量、合并用药方面存在差异。结论:导致聚集性不良反应发生的影响因素很多,难以确定某个具体因素。聚集性ADR一旦发现,应立即停药,及时上报,寻找原因,推动药品质量不断提高和临床用药不断规范。
Objective： To analyze the influence factors in 7 aggressive cases of adverse reaction of monosialotetrahexosylganglioside sodium injection. Methods： 7 cases of patients treated with monosialotetrahexosylganglioside sodium injection and occurred adverse reaction were investigated in the ADR / ADE monitoring system in our hospital and the population treated with the drug,clinical using process,the symptoms of adverse reaction were comparatively analyzed in order to find the inductive factors of the aggressive adverse reaction. Results： By the state quality inspection,the monosialotetrahexosylganglioside sodium injection was qualified. The aggregation of adverse reactions leading by the monosialotetrahexosylganglioside sodium injection showed convulsions,chills,fever and other symptoms of allergy. The occurrence time,solvent selection,dosage,dropping speed and other factors of 7 cases aggregation adverse reaction were basically the same,only in the amount of solvent and combined use of drugs were difference. Conclusion： There were many factors that could cause the aggressive adverse reaction,and it was difficult to determine the specific factors. Therefore,once the aggressive adverse reaction were found,the drug should be stopped immediately,timely reporting and finding the reasons,to improve the drug quality and promote clinical drug regulation.
出处
《药物流行病学杂志》
CAS
2015年第11期671-674,共4页
Chinese Journal of Pharmacoepidemiology
关键词
神经节苷脂注射液
聚集性不良反应
影响因素
药物警戒
Monosialotetrahexosylganglioside sodium injection
Aggressive adverse reaction
Influence factors
Pharmacovigilance
