目的 分析南京地区2017年中药注射剂药品不良反应/事件（ADR/ADE）的发生特点和规律。方法 提取2017年南京市药品不良反应中心接收的怀疑药品为中药注射剂的ADR/ADE报告，对相关信息进行统计分析。结果 共搜集到386例中药注射剂所致ADR/ADE报告，其中女性患者与男性的构成比为1.23∶1，年龄段≤10岁和60～69岁发生ADR/ADE的例数和构成比较高，分别为69例和61例。ADR/ADE构成比较高的药物种类主要集中于清热类（192例）和活血类（103例）；248例（64.25%）在使用第1天就发生ADR/ADE，83例（21.50%）小于30 min出现ADR/ADE；累及器官构成比较高的为皮肤和附件损伤，共277例；新的ADR 176例，严重ADR 30例。结论 本次分析老年人和儿童发生ADR/ADE的构成比较高，临床使用中应加强老年人和儿童的ADR/ADE监测。调查中发现新的ADR/ADE较多，生产企业应及时更新修订说明书中相关内容。
Objective To analyze the occurrence characteristics and general rules of adverse drug reactions/events of traditional Chinese medicine injections happened in Nanjing in 2017. Methods The adverse drug reaction/reports(ADR/ADE) occured in Nanjing in 2017 which was suspiciously induced by traditional Chinese medicine injections were collected and statistically analyzed. Results The ratio of female patients to male patients is 1.23:1 in 386 ADR/ADE reports in this study which was caused by traditional Chinese medicine injections. The incidence and composition of ADR/ADE at age less than 10 years and between 60 and 69 years were relatively high, which were 69 cases and 61 cases respectively. The types of drugs with high ADR/ADE composition are mainly heat clearing type (192 cases) and blood circulation promoting type (103 cases). There were 248 ADR/ADE cases (64.25%) which happened on the first day of usage and 83 cases (21.50%) occurred less than 30 min after usage; A total of 277 cases of skin and appendages injury were found in this analysis, which are the most common organs involved. There were 176 new cases and 30 severe cases. Conclusion The composition of ADR/ADE in elderly and children was relatively high in this analysis. The surveillance for them should be strengthened. There are some new ADR/ADEs and manufacturers should update and revise the manual contents.