2008—2011年中药制剂不良反应报告回顾性分析

目的:通过对中药制剂不良反应(ADR)报告的回顾性分析,加深对中药制剂ADR的认识,为临床安全合理用药提供参考。方法:利用Excel电子表和手工筛选,对医院2008年1月—2011年11月收集的273例中药制剂ADR报告进行分类统计并分析。结果:中药制剂ADR可以发生在任何年龄段,其中1～10岁儿童段发生ADR频率明显高于其他年龄段人群;涉及ADR的药品剂型以注射剂居首位,用药途径以静脉滴注为主;ADR累及器官和(或)系统及其临床表现主要为皮肤及其附件损害;中药注射剂双黄连(冻干)引发的ADR最多;严重的ADR有11例。结论:中药制剂ADR不容忽视,应合理使用中药注射剂,慎重选择静脉滴注给药治疗,降低临床使用风险,从而保障患者合理用药。

Adverse Drug Reactions Induced by Chinese Materia Medica Preparations During 2008-2011: A Retrospective Analysis

OBJECTIVE: To deepen understanding on induced by Chinese materia medica preparation-induced adverse drug reactions(ADRs) through retrospective analysis on ADRs induced by Chinese materia medica preparations for references of clinical safe and rational drug use.METHODS: Using Excel electronic table and by manual screening,273 ADRs cases induced by induced by Chinese materia medica preparations were collected during Jan.2008-Nov.2011 for statistical analysis.RESULTS: The Chinese materia medica preparation-induced ADRs occurred at any age,but more often in children aged 1 and 10 years;Chinese materia medica injections-induced ADRs showed the highest proportion in terms of dosage forms;the ADRs were predominantly induced via intravenous drip infusion and appeared mainly as lesions of skin and its appendages;Shuanghuanglian injection(lyophilized)-induced ADRs cases took the highest proportion;there were 11 serious ADRs cases.CONCLUSION: Great importance should be attached to Chinese materia medica preparation-induced ADRs;Chinese materia medica injections should be used rationally and intravenous drip infusion of which should be performed with caution to reduce the risk of its clinical use and ensure patients’ rational drug use.