摘要
银杏叶提取物注射液为银杏叶制剂,临床使用广泛。通过采用回顾性研究方法对银杏叶提取物注射液国内文献报道中上市后安全性信息进行重点分析,梳理出其主要不良反应为过敏反应,特点为速发型,单独用药或联合用药均可引起用药风险;主要涉及消化系统损害、中枢及外周神经系统损害、皮肤及其附件损害、心血管系统损害等,包括胃肠道不适、恶心、稀便、腹泻、应激性溃疡、头痛、头晕、皮肤潮红、多汗、血压降低、心悸、眼结膜充血、脑出血、失眠等表现。进而提出符合药品本身特点的风险控制措施,为安全、合理使用该药提供建议。
Extract of Ginkgo biloba leaves injection is ginkgo preparation and is widely used in clinic. Retrospective research method is used in the article for key analysis on post-marketing safety information of domestic hterature reports. It is found that the main adverse reaction is allergy which is in a rapid reactive type. Using the drug alone or in combination may either cause risks. Serious adverse reactions mainly include digestive system damage, central and peripheral nerve systems damage, skin and its accessories damages, cardiovascular system damage, etc. Main symptoms include gastrointestinal discomfort, nausea, liquid stools, diarrhea, stress ulcer, headache, dizziness, erubescence, sweating, lower blood pressure, palpitation, conjunctival congestion, cerebral hemorrhage, insomnia, etc. Accordingly we propose recommendations on suitable risk control measure for a safer and more rational use of the drug.
出处
《中国药物警戒》
2014年第3期163-169,共7页
Chinese Journal of Pharmacovigilance
基金
"十二五"重大新药创制专项课题"大品种药物IV期临床试验及新药临床试验审评研究技术平台"项目号(2011ZX09304-08)
关键词
银杏叶提取物注射液
文献分析
风险控制
extract of Ginkgo biloba leaves injection
literature analysis
risk control
