银杏叶提取物注射液不良反应报告分析

Analysis of ADR report of Ginkgo biloba extract injection

目的:探索银杏叶提取物注射液不良反应(ADR)的一般规律和特点,掌握其安全用药规律,为临床药品不良反应监测及合理用药提供参考。方法:通过向江门市药品不良反应监测中心申请,收集从2015年5月1日-2018年7月31日使用银杏叶提取物注射液出现不良反应的报告表共32例,对此报告表数据进行统计分析。结果:32例银杏叶提取物注射液药品引起的ADR报告中,男22例,占68.75%;女10例,占31.25%;60岁以上患者13例(占40.63%),其次是50~60岁患者7例(占21.88%);用药5~30min出现不良反应的病例13例(占比40.63%);累及系统的情况,循环系统损害为主,12例次,主要表现为静脉炎、心悸;其次是皮肤及其附件损害,共11例次,临床以皮疹、瘙痒等表现;全身性损害4例次,临床主要表现为过敏性反应等;消化系统损害(1例次)、神经系统损害(2例次),主要临床表现分别是腹部不适、头晕、胸闷;从本组研究数据看出,其主要用于脑血管疾病,具体用于脑梗死及其后遗症、头晕、脑伤、脑出血、脑萎缩、紧张性头疼、脑供血不足,跟适应症相符合。结论:临床应合理使用银杏叶提取物注射液,保证临床合理用药安全,减少不良反应的发生。

Objective: To explore the general law and characteristics of ADR of ginkgo biloba extract injection, grasp its safe drug use law, and provide reference for clinical adverse drug reaction monitoring and rational drug use. Methods: By applying to Jiangmen adverse drug reaction monitoring center, a total of 32 cases of adverse drug reactions caused by ginkgo biloba extract injection from May 1, 2015 to July 31, 2018 were collected and statistically analyzed. Results: Among 32 cases of ADR induced by ginkgo biloba extract injection, 22 cases (68.75%) were male. Ten cases were female, accounting for 31.25%. There were 13 cases (40.63%) of patients over 60 years old, followed by 7 cases (21.88%) between 50 and 60 years old. There were 13 cases (40.63%) with adverse reactions after 5-30 min of medication. As for the involving system, circulatory system damage was the main type, which was of 12 cases, mainly manifested as phlebitis, palpitation;Secondly, the skin and its accessories were damaged, which was of a total of 11 cases, included clinical rash, itching and other manifestations;Systemic damage occurred in 4 cases, and the main clinical manifestations were allergic reactions. There was digestive system damage (1 case) and nervous system damage (2 cases), the main clinical manifestations were abdominal discomfort, dizziness and chest tightness, respectively. From this group of research data, it was mainly used for cerebrovascular diseases, specifically for cerebral infarction and its sequelae, dizziness, brain injury, cerebral hemorrhage, cerebral atrophy, tension headache, insufficient cerebral blood supply, which was consistent with indications. Conclusion: Clinical use of ginkgo biloba extract injection should be reasonable to ensure the safety of clinical rational drug use, reduce the occurrence of adverse reactions.