【摘要】 目的分析刺五加注射液在四川省使用中的安全性,探讨其不良反应发生的一般规律及特点,为本品在临床安全合理使用提供参考。方法采取回顾性研究的方法,对四川省2014年1月1日至2019年8月31日收到的1 270例刺五加注射液不良反应报告进行统计分析。结果监测信息提示刺五加注射液不良反应发生人群以45岁以上的中老年患者为主,发生时间多集中在用药后前30 min,累及的器官-系统较为广泛,其不良反应主要涉及全身、皮肤及附件、呼吸系统、心血管系统、胃肠系统、神经系统、血管和凝血系统、用药部位、免疫系统。不良反应发生后及时干预,症状多能痊愈或缓解。结论关注刺五加注射液安全合理使用,加强临床监护及不良反应监测,避免超说明书适应证及剂量用药。更多还原

【Abstract】 Objective To analyze the safety of acanthopanax injection used in Sichuan Province, and explore the patterns and characteristics of adverse reactions induced by acanthopanax injection in order to provide technical support for safe and rational use of drugs in clinic. Methods A total of 1 270 cases of adverse reactions induced by acanthopanax injection collected between January 1, 2014 and August 31, 2019 were retrospectively studied and statistically analyzed. Results According to the information on monitoring, the ADRs of acanthopanax injection mostly occurred in middle-aged and elderly patients over 45 years old, and most of the ADRs occurred in the first 30 minutes after medication, involving a wide range of organs and systems. The main ADRs were skin and accessory lesions, systemic damage, respiratory damage, cardiovascular damage, gastrointestinal damage, nervous system damage, vascular damage and coagulopathy, damage to the injection site, immune dysfunction and infection. Prompt interventions in ADRs could help alleviate or cure the symptoms. Conclusion Attention should be paid to safe and rational use of acanthopanax injection. Clinical nursing and monitoring of adverse drug reactions have to be enhanced to prevent over-indications and over-dosage medication.更多还原