128例中药注射剂不良反应报告分析

目的加深对中药不良反应的认识,促进合理用药。方法从医院2008年至2009年药品不良反应报表中筛选出中药注射剂不良反应128例,分别从患者年龄、性别,药品类别、名称,不良反应涉及器官/系统、临床表现,临床应用等进行分类统计、分析。结果 128例不良反应中老年患者较多,占50.78%;其次是儿童患者,占28.13%。药物共涉及6类24个品种,其中活血化瘀类药物较多(占44.53%),尤其是血塞通注射液(占13.28%)。不良反应临床表现以皮疹、瘙痒多见,累及器官/系统以皮肤及其附件最常见,其次为消化系统症状。较严重的不良反应有过敏性休克、呼吸困难等。中药注射剂临床应用中剂量过大、滴速过快、配伍不当等是引起不良反应的主要原因。结论中药注射剂临床应用较多,不良反应经常发生,应引起足够的重视。应加强中药注射剂质量管理,以及对中药注射剂不良反应的监测,保障患者用药安全。

Analysis on Adverse Reaction Reports of Traditional Chinese Medicine Injections in 128 Cases

Objective To deepen the cognition of adverse reactions of Chinese medicines for promoting rational drug use.Methods 128 cases of adverse reactions of Chinese medicine injections were screened out from ADR reports collected in our hospital during 2008 —2009 and performed the classified statistics and analysis in aspects of age,gender,drug category,name,involved organs/systems and clinical features.Results Among 128 cases of ADR,middle-aged and elderly cases were dominated,accounting for 50.8%,followed by pediatric cases,accounting for 28.13%.Drugs were involved in 24 varieties of 6 categories.Of which,the drugs promoting blood circulation and removing blood stasis accounted for 44.53%.In particular,Xuesaitong Injection accounted for 13.28%.In the clinical manifestations,rash and pruritus were common,the most common involved organs/systems were skin and its appendages,followed by gastrointestinal symptoms.More severe ADR were allergic shock,dyspnea,etc.Overdosage,dripping speed too fast and improper compatibility were the main causes leading to adverse reactions.Conclusion The clinical application of Chinese medicine injections is more common and ADR is of frequent occurrence,which should arouse enough attention to strengthen the quality control of TCM injections and ADR monitoring of traditional Chinese medicine injections for ensuring medication safety of patients.