采用回顧性文獻(xiàn)計量分析的方法，對2007年1月到2012年5月CNKI數(shù)據(jù)庫中有關(guān)清熱解毒類中藥注射劑導(dǎo)致兒童不良反應(yīng)（ADR）的文獻(xiàn)進(jìn)行統(tǒng)計分析。清熱解毒類中藥注射劑導(dǎo)致兒童ADR的發(fā)生率較高，其中以清開靈和雙黃連注射液表現(xiàn)尤為突出。兒童ADR類型以皮膚及其附件損害最為常見，其次為全身反應(yīng)，再次為消化系統(tǒng)反應(yīng)。導(dǎo)致兒童ADR的相關(guān)因素有小兒特殊的生理病理特點、中藥注射劑的質(zhì)量和制備工藝以及中藥注射劑的臨床不合理應(yīng)用。從藥品生產(chǎn)、國家監(jiān)測和臨床用藥過程等方面提出減少兒童ADR的措施。

By retrospective bibliometric analysis, statistical analysis for the literature of adverse drug reaction (ADR) of traditional Chinese medicine (TCM) injections with the heat clearing and detoxicating in pediatrics based on the CNKI database from January 2007 to May 2012 was carried out. The TCM injections with the heat clearing and detoxicating result in the higher incidence of ADR in children, particularly Qingkailing and Shuanghuanglian Injections. The most common type of ADR in children is skin and its accessories damage, followed by the whole body reaction and the digestive system reaction. ADR in children relates to the pediatric special physiological and pathological characteristics, quality and preparation technology of TCM injections, and unreasonable clinical use of. TCM injections. The measures to reduce ADR in the admininstration for the children have been put forward in pharmaceutical production, state monitoring, and clinical application process and other aspects.