目的 探討中藥注射劑不良反應(yīng)（ADR）的發(fā)生特點(diǎn)與規(guī)律，為中藥注射劑的臨床合理使用，及時預(yù)防與處理ADR提供參考。方法 收集上海中醫(yī)藥大學(xué)附屬曙光醫(yī)院2015年1月—2019年12月報(bào)告國家不良反應(yīng)監(jiān)測系統(tǒng)的中藥注射劑引起的ADR報(bào)告206例，運(yùn)用回顧性分析方法進(jìn)行統(tǒng)計(jì)分析。結(jié)果 206例中藥注射劑ADR報(bào)告共涉及28個品種，男性88例，女性118例，年齡>60歲患者最多（62.62%）；ADR排名前3的注射劑分別是華蟾素注射液、刺五加注射液和復(fù)方苦參注射液，抗腫瘤類中藥注射劑ADR發(fā)生率最高；用藥30 min內(nèi)即發(fā)生的ADR最多（23.79%），中藥及2種以上中藥聯(lián)用致ADR占35.44%，ADR臨床表現(xiàn)以累及皮膚及附件損害為常見（35.83%）。結(jié)論 中藥注射劑ADR的發(fā)生可能與患者年齡、藥品種類、聯(lián)合用藥等多種因素相關(guān)。溝通、反饋藥品ADR發(fā)生特點(diǎn)和規(guī)律，有利于臨床醫(yī)生重視藥品ADR，確?；颊吆侠戆踩盟?。

Objective To explore the feature and regularity of adverse drug reactions (ADRs) caused by traditional Chinese medicine injection, so as to provide reference for the rational clinical use of traditional Chinese medicine injection and prevent adverse reactions as early as possible. Methods A retrospective analysis was performed on 206 traditional Chinese medicine injection cases with all ADR reports which were reported to the National Drug Adverse Reaction Monitoring System from January 2015 to December 2019. Results A total of 28 traditional Chinese medicine injection were involved among the 206 traditional Chinese medicine injection of ADR reports from Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, there were 88 males and 118 females, and the majority were patients aged over 60 years old (62.62%). The most of ADR occureed in Huachansu Injection, followed by Ciwujia Injection, and Compound Kushen Injection. The incidengce of ADR induced by anti-tumor traditional Chinese medicine injection took the lead. The most ADRs occurred within 30 min, accounting for 23.79%. The ADR induced by the combination of two or above two traditional Chinese medicine injection accounted for 35.44%. Skins and accessories were the major clinical manifestations (35.83%). Conclusion The occurrence of traditional Chinese medicine injection ADR may be associated with age, classes of drugs, and the combinations of drugs. Communicate and feedback the regularity and characteristics of ADR, which is beneficial for clinicians to strengthen their vigilance against ADR and ensure rational medication and safety of patient.

R969.3

上海市科學(xué)技術(shù)委員會科研項(xiàng)目（16DZ192010B）