某院2017-2020年中药注射剂不良反应分析报告

Analysis report of adverse reactions following administration of traditional Chinese medicine injections in a hospital from 2017 to 2020

目的了解中药注射剂不良反应(ADR)的发生情况、特点及规律,为临床合理用药提供参考。方法采用回顾性研究方法,对2017—2020年合肥市第二人民医院不良反应报告信息系统收集到的中药注射剂不良反应病例报告进行统计和分析。结果引起ADR发生例数最多的5个品种主要是理血剂中的活血化瘀药,其中以60岁以上人群发生较多,中药注射剂ADR45%以上的前5个品种发生总例数多达104例,本组中药注射剂的ADR发生时间范围较宽,在注射后立即至7 d后均有分布,ADR累及的系统/器官主要为皮肤及附件和心血管系统,其中有95例痊愈,128例好转,以及4例未好转。结论应重视中药注射剂的ADR,加强中药注射剂的质量控制,规范临床使用,提高合理用药水平。

Objective To understand the occurrence,characteristics and regularity of adverse reactions following administration of traditional Chinese medicine injections(TCMIs),and to provide references for clinical rational use of drugs.Methods By retrospective research methods,a statistical analysis was conducted for the adverse reaction case reports related to TCMIs collected in the ADR report information system of the Second People's Hospital of Hefei from 2017 to 2020.Results The five varieties of TCMIs that caused the largest number of adverse reactions were mainly the blood-activating and stasis-removing Chinese drugs in blood regulating agents.Among them,the adverse reactions occurred more frequently in the population over 60 years old and there were up to 104 cases related to the top five varieties of TCMIs,accounting for more than 45%of the adverse reactions related to TCMIs.The adverse reactions related to TCMIs in the above-mentioned group had a wide range of onset time,and they developed immediately after injection or continued to develop 7 days after injection.The involved systems/organs for adverse reactions were mainly the skin,appendages and the cardiovascular system.Among them,95 cases were cured,128 cases were improved,and 4 cases were not improved.Conclusion We shall pay attention to the adverse reactions related to TCMIs,strengthen the quality control of TCMIs,standardize their clinical use,and improve the level of rational drug use.