中药注射剂不良反应219例分析

Analysis on 219 cases with adverse drug reaction induced by TCM injection

目的了解中药注射剂不良反应的特点与规律,分析其原因,为临床安全用药提供依据。方法通过调取湖南省脑科医院2014-2016年中药注射剂的用药数据及不良反应报告单219份,进行回顾性分析和统计学处理。结果 219例不良反应,年龄<40岁占69.41%,高于其他年龄段,差异有统计学意义(P<0.05)。注射用血栓通、参麦注射液、生脉注射液等治疗心脑血管疾病的中药注射剂具有较高的不良反应发生率;不良反应发生在30 min以内占57.89%,皮肤及其附件是不良反应最常累及的器官占35.66%;不良反应的原因主要是注射剂为复方制剂或联合用药占49.8%。结论从中药注射剂的各个环节进行安全监测,合理用药,减少和避免不良反应的重复发生。

Objective To probe into the causes and characteristics of adverse drug reaction（ ADR） induced by traditional chinese medicine（ TCM）,and to provide reference for the clinical rational drug use. Methods Statistically retropective analysis was conducted on 219 cases reports of ADR induced by TCM injection. Results The rate ADR was 69. 41% in patients aged lower than 40,which was higher than that of other age groups,the differences were significant（ P 0. 05）; traditional Chinese medicine injection for cardiovascular disease,such as xueshuantong injection,shenmai injection and pulse-activating injection,has a high incidence of adverse reactions; the proportion of ADR occurrence at less than 30 min was 57. 89%; organs and systems were mainly involved in ADR and its proportion was 35. 66%; the main cause of ADR is the injection that is compound preparation or drug combination,which counted for 49. 8%. Conclusions In clinical practice,safety monitoring should be carried out in all aspects of traditional Chinese medicine injections,and rational use of TCM injection should be taken to reduce and avoid the repeated occurence of ADR.