柴胡注射液致药品不良反应/药品不良事件的分析及防治

Analysis and Prevention of Adverse Drug Reactions/Adverse Drug Events Induced by Bupleurum Injection

目的:了解柴胡注射液致药品不良反应(adverse drug reaction,ADR)/药品不良事件(adverse drug event,ADE)的可能原因,探讨柴胡注射液的安全性,为临床合理用药提供参考。方法:综合采用文献研究、回顾性分析的方法,检索中国学术期刊全文数据库(CNKI)及万方医学数据库,从第1篇关于柴胡注射液致ADR/ADE的报道开始,经过数据拣选与挖掘,筛选出55篇个案报道,对涉及的64例病例的有效信息进行整理、归纳和分析。结果:柴胡注射液致ADR/ADE的个案报道中,轻型病例构成比为59.38%(38/64),重型病例构成比为40.62%(26/64),其中死亡病例占4.69%(3/64);重型病例的主要临床表现为过敏性休克,轻型病例以虚脱症状为主;重型病例中,儿童及老年患者所占比例高于其他年龄段;54例ADR/ADE发生在肌内注射柴胡注射液后30 min内,占84.38%;超剂量静脉滴注用药的3例患者均出现了严重的ADR/ADE,但目前的证据并不足以证明柴胡注射液的超剂量使用与ADR/ADE严重程度的相关性。64例ADR/ADE中,联合用药30例(占46.88%);其中,二联用药24例,重症病例11例(占二联用药病例数的45.83%);三联用药6例,重症病例3例(占三联用药病例数的50.00%)。结论:柴胡注射液的不合理使用情况严重,应进一步加强对临床各级医务人员规范使用柴胡注射液的教育,坚持合理用药。

OBJECTIVE： To investigate the possible cause of adverse drug reactions（ ADR）/adverse drug events（ ADE）induced by bupleurum injection,and to probe into the safety of bupleurum injection,so as to provide reference for the rational drug application in clinic. METHODS： The methods of literature review and retrospective analysis were adopted.CNKI and Wanfang database were retrieved. Through data selection and mining,from the first report with ADR/ADE induced by bupleurum injection,55 case reports were selected,and the effective information of the 64 cases involved was sorted,summarized and analyzed. RESULTS： Studies of ADR/ADE induced by bupleurum injection showed that the proportion of mild cased were 59. 38%（ 38/64）,severe cases were 40. 62%（ 26/64）,and the death cases were 4. 69%（ 3/64）. The main clinical manifestations of severe cases were anaphylactic shock,and mild cases were mainly characterized by the collapse of symptoms. Of the severe cases,the proportion of children and elderly patients were higher than those of other age groups. 54 cases of ADR/ADE occurred after 30 min of intramuscular injection,accounting for 84. 38%. Severe ADR was found in 3 cases with overdose intravenous drip,yet present evidence was not sufficient to prove the correlation between the overdose of bupleurum injection and the severity of ADR/ADE. Of the 64 cases of ADR/ADE,there 30 cases（ 46. 88%）of drug combination,among which,24 cases had duplex medication,and 11 cases were severe cases（ 45. 83%）; and 6 cases had triple medications,and 3 cases were severe cases（ 50. 00%）. CONCLUSIONS： The irrational application of bupleurum injection is serious,and it is necessary to further strengthen the standard use of education for the medical staff at all levels of clinical practice and adhere to rational application of drugs.