目的 探討常州市兒童醫(yī)院2018—2020年中藥注射劑引起藥品不良反應(yīng)（ADR）發(fā)生規(guī)律及特點(diǎn)，為臨床合理使用中藥注射劑提供參考。方法 采用回顧性研究的方法，對(duì)常州市兒童醫(yī)院2018—2020年收集上報(bào)國(guó)家藥品不良反應(yīng)監(jiān)測(cè)中心的98份中藥注射劑ADR報(bào)告進(jìn)行統(tǒng)計(jì)分析。結(jié)果 98例ADR報(bào)告中，男性患兒58例（59.18%），女性患兒40例（40.82%），1～6歲年齡段患兒ADR構(gòu)成比最高，占86.7%。ADR涉及藥物均為清熱解毒類中藥注射劑，包括喜炎平注射液、熱毒寧注射液和痰熱清注射液，分別占74.49%、23.47%、2.04%；累及器官/系統(tǒng)以皮膚及其附件為主，占95.92%；不良反應(yīng)發(fā)生時(shí)間主要集中在用藥3 d之內(nèi)（55.10%）。ADR多為一般不良反應(yīng)（98.99%），且經(jīng)治療后大多痊愈。結(jié)論 臨床醫(yī)師和藥師應(yīng)重視兒童中藥注射劑的合理使用，加強(qiáng)ADR的監(jiān)測(cè)和上報(bào)工作，保證用藥安全。

Objective To analyze the occurrence and characteristics of adverse reactions (ADR) of traditional Chinese medicine (TCM) injections in Changzhou Children’s Hospital from 2018 to 2020, and to provide reference for the rational use of TCM injections. Methods A retrospective study was used to make statistical analysis of 98 ADR reports of TCM injections collected and reported to the National Center for Adverse Drug Reaction from 2018 to 2020.Results Among the 98 cases of ADR reported, there were 58 males (59.18%) and 40 females(40.82%). The proportion of ADR in children aged 1 — 6 years was the highest, accounting for 86.7%.The drugs involved in ADR were antipyretic and detoxifying TCM injection, including Xiyanping Injection, Reduning Injection and Tanreqing Injection, accounting for 74.49%, 23.47%, and 2.04%, respectively. Skin and its accessory reactions were the most prominent in the involved organs/systems, accounting for 95.92%. The occurrence time of ADR was mainly within 3 d (55.10%). Most ADRs were mostly general adverse reactions (98.99%), and most of them were cured. Conclusion Clinicians and pharmacists should pay attention to the rational use of TCM injections for children, strengthen the monitoring and reporting of ADR, and ensure the safety of medication.

R969.3

常州市第二十六批科技計(jì)劃項(xiàng)目（CJ20189013）