常用中药注射剂不良反应96例分析

目的分析中药注射剂不良事件（ADE）以及产生药物不良反应（ADR）的临床相关因素。方法采用回顾性研究方法,对我院2006年6月～2010年1月中药注射剂不良反应报告96例进行分析,对其用药情况、年龄、ADR、累及系统-器官等临床相关因素进行汇总分析。结果 96例中用药环节存在不当58例（60.4%）,包括不符合适应证或不辨证用药、同一输液瓶续滴未冲洗输液管、超剂量应用和用药次数过多等。正确用药情况下ADR38例（39.6%）,其中清热解毒类占44.7%,活血化瘀、改善微循环类占44.7%,补益类占10.5%,一般的不良反应发生率为93.75%,以皮肤反应和胃肠道反应为主。结论用药不当是中药注射剂发生不良反应的主要原因,容易被临床忽视,需要医生遵循中药注射剂的适应证和用法正确合理使用。

Analysis of 96 adverse drug events of chinese herbal injection

Objective To analyse the relative clinical factors of adverse drug events（ADE） and adverse drugs reactions（ADR） after chinese herbal injection.Methods Ninty-six ADR reports on chinese herbal injections collected people＇s hospital of Hulunboir from June 2006～2010 including medicine usage,patients＇age,ADR,type of adverse reactions and clinical manifestation etc.were statistically analyzed retrospectively.Results Among 96 ADE patients,58 patients existed impropriety clinical usage（60.4%）,including in not according to indication,not washing perfusion tube in combination drugs,over doses,longer treatment period,mistakes for solvent and administration approach.Thirty-eight ADR patients（39.58%） were involved 11 kinds of traditional chinese medicines,including drugs of clearing away heat and toxic material（44.7%）,drugs of meliorating microcireulation（44.7%）,tonic drugs（10.5%）.Most ADR were not severe（93.75%） and presenting on fever and hypersensitive reaction.Conclusion Impropriety clinical usage is primary cause in using of chinese herbal injection and is neglected clinically,validity and rationality of clinical medicine usage needed to be attached.