【摘要】 目的:通过对大株红景天注射液不良反应/事件的分析,得出药物不良反应/事件(ADR/ADE)发生的一般规律及临床特点。方法:采用描述性统计方法,对国家药品不良反应监测中心2009-2016年自发呈报系统(SRS)中1 029例大株红景天ADR/ADE进行预警分析。结果:大株红景天注射液病例报告以45岁中老年人为主要人群,不良反应/事件主要表现为皮疹、瘙痒、寒战、头晕等,以全身性损害、皮肤及附件损害为主;过敏反应患者病例报告主要ADR/ADE表现为过敏性紫癜、过敏性休克以及过敏样反应,主要涉及全身性损害。结论:大株红景天注射液引发的ADR/ADE在说明书中尚不明确,应采取进一步主动监测研究,完善相关ADR信息,重视中药注射剂临床用药安全问题。更多还原

【Abstract】 Objective: To conclude the general rules and clinical features through the analysis of adverse drug reactions or events(ADR/ADE) in Sofren Injection. Methods: Descriptive statistical methods were used to analyze the 1 029 Sofren Injection’s ADR cases, which were ranged from 2009 to 2016 of spontaneous reporting system from the National Center for Adverse Drug Reaction Monitoring. Results: In these Sofren Injection case reports, elderly people over 45 years-old were the main crowd. And main symptoms of ADR were rash, itching, chills, dizziness etc., which involved in systemic damage, damage to the skin and accessories. Allergic reaction included allergic purpura, anaphylaxis, anaphylactoid reaction, which mainly involved in systemic damage. Conclusion: ADR/ADE triggered by Sofren Injection is not clear in its instruction, and we should take more active monitoring to complete the relevant information about ADRs, and pay more attention to the safety of clinical traditional Chinese medicine injections.更多还原