目的 分析南京地區(qū)2017年中藥注射劑藥品不良反應(yīng)/事件（ADR/ADE）的發(fā)生特點(diǎn)和規(guī)律。方法 提取2017年南京市藥品不良反應(yīng)中心接收的懷疑藥品為中藥注射劑的ADR/ADE報(bào)告，對(duì)相關(guān)信息進(jìn)行統(tǒng)計(jì)分析。結(jié)果 共搜集到386例中藥注射劑所致ADR/ADE報(bào)告，其中女性患者與男性的構(gòu)成比為1.23∶1，年齡段≤10歲和60～69歲發(fā)生ADR/ADE的例數(shù)和構(gòu)成比較高，分別為69例和61例。ADR/ADE構(gòu)成比較高的藥物種類(lèi)主要集中于清熱類(lèi)（192例）和活血類(lèi)（103例）；248例（64.25%）在使用第1天就發(fā)生ADR/ADE，83例（21.50%）小于30 min出現(xiàn)ADR/ADE；累及器官構(gòu)成比較高的為皮膚和附件損傷，共277例；新的ADR 176例，嚴(yán)重ADR 30例。結(jié)論 本次分析老年人和兒童發(fā)生ADR/ADE的構(gòu)成比較高，臨床使用中應(yīng)加強(qiáng)老年人和兒童的ADR/ADE監(jiān)測(cè)。調(diào)查中發(fā)現(xiàn)新的ADR/ADE較多，生產(chǎn)企業(yè)應(yīng)及時(shí)更新修訂說(shuō)明書(shū)中相關(guān)內(nèi)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.

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江蘇省藥學(xué)會(huì)—奧賽康醫(yī)院藥學(xué)基金（A201808），南京市藥學(xué)會(huì)—常州四藥醫(yī)院藥學(xué)科研基金（2018YX001）