176例中药注射剂不良反应报告分析

Adverse drug reactions reports of traditional Chinese medicine injections:Analysis of 176 cases

目的探讨中药注射剂不良反应(ADR)发生的一般规律及特点,为临床合理用药提供参考。方法选择我院2017年1月~2019年12月上报至国家ADR监测系统的中药注射剂ADR报告176例,对患者的性别、年龄、ADR发生时间、用药种类、临床表现、不良反应的分级及关联性评价等信息加以统计分析。结果176例报告中涉及22种中药注射剂,60岁以上患者ADR发生率最高(39.20%),中药注射剂ADR主要发生在用药开始30min内(56.82%),ADR主要表现为皮肤及附件损害(40.34%),活血类中药注射剂产生的ADR发生率最高(49.43%)。结论导致中药注射剂ADR产生的因素较多,临床应加强中药注射剂ADR监测,提高安全用药水平。

Objective To investigate the general rules and characteristics of the adverse drug reactions(ADR)of traditional Chinese medicine injections,and to provide a reference for clinical rational drug use.Methods A total of 176 ADR reports of Chinese medicine injections reported to our national ADR monitoring system from January 2017 to December 2019 in our hospital were selected.The gender and age of the patients,the time of ADR occurrence,the type of medication,clinical manifestations,the classification and association evaluation of ADR,and other information were statistically analyzed.Results In 176 cases,22 Chinese medicine injections were involved.The incidence of ADR was the highest in patients over 60 years of age(39.20%);The ADR of Chinese medicine injections occurred mainly within 30 minutes after administration(56.82%);The ADR mainly appeared as skin and accessory damage(40.34%);The incidence of ADR produced by Chinese activating blood herbal injection was the highest(49.43%).Conclusion There are many factors that cause ADR of traditional Chinese medicine injection.The clinical monitoring of ADR of traditional Chinese medicine injection should be strengthened to improve the safety level of drug use.