摘要
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,对佛山市中医院2004年12月—2010年1月上报的中药注射剂不良反应报告139例进行分析,对其用药情况、年龄、不良反应级别、ADR累及系统-器官等临床相关因素进行汇总分析。结果 139例ADE中,用药环节存在不当86例(61.9%),包括不符合适应证或不辨证用药、不同输液瓶联合用药没有冲洗输液管、超量或每日给药次数过多等。正确用药情况下ADR53例(38.1%),涉及19种中药注射剂,其中清热解毒类占52%,补益类占23%,活血化瘀、改善微循环类占19%;ADR集中在21～40岁青壮年,占46%;一般的不良反应发生率为96%,以皮肤反应和寒战发热为主,2h内速发型过敏反应占76%。结论用药不当仍在中药注射剂不良事件中占较高比例,容易被临床所忽视,需重视临床用药环节的正确性和合理性。
AIM To analysis the relative clinical factors of adverse drug events （ADE） and adverse drug reactions （ADR） after Chinese herbal injection. METHODS One hundred and thirty-nine ADR reports on Chinese herbal injection collected in traditional Chinese hospital of Foshan from December 2004-January 2010 including medicine usage, patients＂ age, grades, types of adverse reactions and clinical manifestation etc. were statistically analyzed in the methods of retrospective study. RESULTS Among 139 ADE patients, 86 patients were believed to impropriety clinical usage （61.9%）, including in not according with indication, not washing perfusion tube in combination drugs, overdoses, longer treatment period, mistakes for solvent, and wrong administration approach. Fifty-three ADR patients （38.1%） were involved 19 kinds of traditional Chinese medicines, including drugs of clearing away heat and toxic material （52%）, tonic drugs （23%）, drugs of meliorating microcirculation （ 19% ）. Patients of 21 -40 years old were 46%. Most ADR patients were not severely, 76% occur in 2 hours and presenting on fever and hypersensitive reaction. CONCLUSION Impropriety clinical usage was highly incidented in using of Chinese herbal injection and was neglected clinically. Validity and rationality of clinical medicine usage needed to be attached.
出处
《中国新药与临床杂志》
CAS
CSCD
北大核心
2010年第8期632-635,共4页
Chinese Journal of New Drugs and Clinical Remedies
关键词
中草药
注射剂
药物副反应报告系统
不良事件
药物不良反应
用药不当
drugs, chinese herbal
injection
adverse drug reaction reporting systems
adverse drug events
adverse drug reactions
impropriety clinical usage
