基于医院数据库的中药注射剂致药品不良反应发生特点分析

Analysis on Occurrence Characteristics of Adverse Drug Reactions Induced by Traditional Chinese Medicine Injection Based on Hospital Database

目的:了解医院中药注射剂致药品不良反应(adverse drug reaction,ADR)的发生特点及规律。方法:收集北京中医药大学东直门医院2004年1月—2016年8月上报的ADR报告1 393例,对其中中药注射剂致ADR报告339例进行回顾性分析。结果:339例使用中药注射剂发生ADR的患者中,男性147例,女性192例;年龄1~111岁,平均59岁,以70~<80、50~<60岁为主。339例ADR涉及中药注射剂4大类,30个品种;活血类中药注射剂致ADR病例数最多,共190例(占56.05%),涉及14个品种;累及多个器官和(或)系统,主要为皮肤及其附件损害(108例,占31.86%)和神经系统损害(109例,占32.15%);用药后≤0.5 h发生的ADR病例数最多,为188例(占55.46%)。结论:医院中药注射剂引发的ADR较多,应规范、合理使用中药注射剂,并加强ADR的预防,保证用药安全。

OBJECTIVE： To investigate the occurrence characteristics and regularities of adverse drug reactions（ ADR） induced by traditional Chinese medicine（ TCM） injection. METHODS： 1 393 reports of ADR reported in Dongzhimen Hospital of Beijing University of Chinese Medicine from Jan. 2004 to Aug. 2016 were collected and retrospectively analyzed in terms of the 339 ADR reports induced by TCM injection. RESULTS： Among the 339 cases of ADR induced by TCM injection,147 cases were male and 192 cases were female; aged from 1 to 111,with an average age of 59,mostly were aged 70- 80 and 50- 60. The 339 cases of ADR involved 4 kinds of 30 categories of TCM injection; TCM injection of blood invigoration had induced the most ADR,with 190 cases（ 56. 05%） including14 categories; various organs and（ or） systems were involved,mainly were damages in skin and its accessory（ 108 cases,31. 86%） and nervous system（ 109 cases,32. 15%）; most ADR cases occurred ≤ 0. 5 h after medication,with 188 cases（ 55. 46%）. CONCLUSIONS： TCM injection has induced many ADR cases,which indicates that the application of TCM injection needs to be standardized and rationalize,prevention of ADR also needs reinforcement to ensure safe medication.