目的 了解北京中醫(yī)藥大學(xué)東方醫(yī)院中藥注射劑不良反應(yīng)（ADR）發(fā)生情況，掌握ADR發(fā)生特點(diǎn)，為臨床安全合理用藥提供依據(jù)。方法 檢索該院上報(bào)至國(guó)家藥品不良反應(yīng)監(jiān)測(cè)系統(tǒng)、發(fā)生于2011年6月-2016年5月的中藥注射劑ADR，進(jìn)行回顧分析。結(jié)果 18種中藥注射劑導(dǎo)致135例ADR，其中男性50例、女性85例；主要為清熱解毒類和活血化瘀類中藥注射劑；存在與中藥注射劑、抗生素、生物制品等藥物聯(lián)用，超劑量使用和配液不當(dāng)?shù)炔缓侠碛盟帲慌R床表現(xiàn)以皮膚及其附件損害較多；所有ADR患者均痊愈。結(jié)論 審慎合理用藥，規(guī)范臨床使用操作，開展臨床再評(píng)價(jià)工作，是降低中藥注射劑ADR發(fā)生率、安全合理用藥的關(guān)鍵。

Objective To learn the adverse drug reaction (ADR) of traditional Chinese medicine injection (TCMI) in Dongfang Hospital of Beijing University of Chinese Medicine (BUCM), to master the characteristics of the occurrences of ADR, and to provide basis for safe and rational clinical drug use. Methods Locating all the reported ADR cases by Dongfang Hospital of BUCM to national ADR monitoring system from June 2011 to May 2016, and make retrospective analysis of them. Results Eighteen kinds of TCMI that caused the total 135 ADR cases, 50 out of all the 135 instances were male patients, whilst the rest 85 instances were female patients; The main kinds of TCMI that caused ADR problems were TCMI for relieving heat and toxic material and TCMI for promoting blood circulation to remove blood stasis; TCMI was used jointly with antibiotics and biological product etc.; And the circumstances of ultra-dose and improper infusion allocation existed. The clinical manifestation included many skin lesion cases. All the patients suffered from ADR were cure. Conclusion Prudent and rational use of drugs, standardized clinical use procedure, and clinical re-evaluation are key aspects to lower the incidence rate of ADR of TCMI and to safe and rational use of drugs.

國(guó)家自然科學(xué)基金面上項(xiàng)目“基于三維立體數(shù)據(jù)庫和多維數(shù)據(jù)挖掘的中藥注射劑致過敏反應(yīng)關(guān)鍵影響因素研究”（81473547）