银杏内酯注射液不良反应鉴定的试验研究

目的探索1例对银杏内酯注射液过敏受试者发生的不良事件是否为试验药物引起的过敏反应,并进一步明确该不良事件与试验药物之间的相关性。方法在充分有效的风险防范措施下,根据激发试验原理,采用变应原皮肤点刺、皮内注射过敏试验等方法,开展受试者不良事件与药物相关性的探索性试验研究。结果受试者免疫系统功能正常,为非过敏体质者,对银杏内酯注射液不引起过敏反应。结论表明点刺过敏原试验联合皮肤过敏试验是对中药注射剂过敏反应监测的有益尝试,可能会成为预警高致敏中药注射剂过敏反应和药物临床不良反应相关性分析判断的方法之一。

The Identified Study on Adverse Reactions of Ginkgolide Injection

Objective To explore whether the adverse events of one subject who was allergic to ginkgolide injection was related to the drug allergy and to clarify the correlation with drug. Methods Under the adequate and effective risk prevention, an exploratory was carried out to find the relation between adverse events and drug using allergen skin prick test methods. Results Research showed the participant had a normal immune system function and no allergic diathesis, there was no allergic reactions on ginkgolide. Conclusion It is an useful attempt to monitor allergic reactions of traditional Chinese medicine injection by prick allergen test and skin allergy test. It will become one of the methods which warn the relationships between highly sensitized traditional Chinese medicine injection and clinical adverse reactions of drugs.