我院87例中药注射剂临床运用的不良反应分析及对策探讨

目的:分析我院近5年87例中药注射剂药物不良反应发生的原因、特征、高危因素及用药规律,探讨减少不良反应发生的办法,提出应对措施,为临床安全、合理使用中药注射剂提供参考。方法:通过对我院2014—2018年上报国家药物不良反应监测中心平台的87例中药注射剂不良反应进行统计及分析,对导致不良反应的原因进行评价及总结。结果:发生不良反应的中药注射剂品种数占医院使用的中药注射剂的比例为52.70%。在87例不良反应中,痰热清不良反应发生率最高(17例,19.54%),其次为血塞通、丹参川芎嗪。不良反应发生的时间多分布在用药开始的10~30 min,占49.43%。70岁以上老人是不良反应的高发人群,发生率为29.89%。不良反应累及的器官主要是皮肤及其附件,占45.98%。结论:中药注射剂易发生ADR;其发生与年龄、性别、用药时间、药物种类、用药合理性等多种因素有关;不良反应累及多个器官,临床症状及表现多样化。应遵循中成药合理应用指导原则,严格中医辨证施治,实施用药全过程管理,强化药学监护及用药宣教。

Analysis of adverse reactions and countermeasures in clinical application of 87 Chinese medicine injections in our hospital

Objective:To analyze the causes,characteristics,high risk factors and medication rules of 87 cases of adverse drug reactions of traditional Chinese medicine injection in our hospital in the past 5 years;to explore the ways to reduce the adverse drug reactions;to propose countermeasures and provide reference for the clinical safety and rational use of TCM injections.Methods:the causes of adverse drug reactions were evaluated and summarized through statistical analysis and analysis of 87 cases of adverse drug reactions caused by TCM injections,in our hospital from 2014 to 2018,reported to the national adverse drug reactions monitoring center platform.Results:The number of traditional Chinese medicine injections with adverse drug reactions accounted for 52.70%of the all TCM injections used in the hospital;among the 87 cases of adverse drug reactions,the incidence of adverse drug reactions caused by Tanreqing was the highest(17 cases,19.54%),followed by ADRs of Xuesaitong and DanShen ligustrazine;the time of occurrence of adverse reactions was mostly distributed in the first 10~30 minutes after using the drug,accounting for 49.43%;old people over the age of 70 are high-risk groups for adverse drug reactions,with an incidence rate of 29.89%;the organs involved in adverse reactions were mainly skin and its attachments,accounting for 45.98%.Conclusions:Traditional Chinese medicine injection is prone to ADR;its occurrence is related to age,gender,medication time,drug type,rationality of medication,etc;adverse drug reactions involve multiple organs and diversified clinical symptoms and performances.Therefore,we should follow the guiding principle of rational application of proprietary Chinese medicine,strictly treat patients with TCM syndrome differentiation,carry out the whole process of medication management,strengthen pharmaceutical care and medication education.