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英国药物分析报告与麻醉药品不良反应

UK drug analysis prints and anaesthetic adverse drug reactions.

作者信息

Holdcroft Anita

机构信息

Imperial College London, Chelsea and Westminster Hospital, London, UK.

出版信息

Pharmacoepidemiol Drug Saf. 2007 Mar;16(3):316-28. doi: 10.1002/pds.1261.

Abstract

PURPOSE

Anaesthetic drugs were selected from the Medicines and Healthcare products Regulatory Agency Drug Analysis Prints in order to determine the number and types of reported reactions and associated mortality.

METHODS

The chosen drug groups were the intravenous induction agents, the neuromuscular blocking drugs and neostigmine, the inhalational anaesthetic agents and nitrous oxide, local anaesthetic agents and a selection of analgesics agents, naloxone and midazolam and its antagonist flumazenil. From each drug file, the number and type of reactions were analysed. Mortality was calculated as a percentage of the number of deaths against patient reports.

RESULTS

A total of 11,199 reactions were analysed from 6603 patients of whom 620 (9%) died. Few drug records reported reactions from multiple constituent formulations. The majority of reactions were not allergic. The highest mortality was in the inhalational anaesthetic group. Although the greatest number of fatal events was associated with halothane, this drug is no longer used. Nevertheless the percentage remains high because cardiovascular mortality is still being reported. Local anaesthetic use was associated with the smallest percentage mortality (3%). The highest reported number of reactions was associated with the intravenous induction agents and idiosyncratic neurological and peripheral vascular reactions were linked with the use of etomidate.

CONCLUSIONS

The reporting of allergic reactions was low. The data demonstrate that induction of anaesthesia presents the highest risk of adverse drug reaction; there is also mortality from newer drugs for example, desflurane, remifentanil as well as from drugs for which there is no alternative, for example, suxamethonium.

摘要

目的

从药品和保健品管理局的药品分析打印件中选取麻醉药物,以确定报告的反应数量和类型以及相关死亡率。

方法

所选药物组包括静脉诱导剂、神经肌肉阻滞剂和新斯的明、吸入麻醉剂和氧化亚氮、局部麻醉剂以及一些镇痛药、纳洛酮、咪达唑仑及其拮抗剂氟马西尼。对每个药物档案中的反应数量和类型进行分析。死亡率计算为死亡人数占患者报告数的百分比。

结果

共分析了6603例患者的11199例反应,其中620例(9%)死亡。很少有药物记录报告多种成分制剂的反应。大多数反应并非过敏反应。吸入麻醉剂组的死亡率最高。虽然致命事件数量最多的与氟烷有关,但该药物已不再使用。然而,由于仍有心血管死亡率的报告,其百分比仍然很高。局部麻醉剂的使用与最低死亡率百分比(3%)相关。报告反应数量最多的与静脉诱导剂有关,特异质性神经和外周血管反应与依托咪酯的使用有关。

结论

过敏反应的报告率较低。数据表明,麻醉诱导呈现出药物不良反应的最高风险;新药如地氟烷、瑞芬太尼以及无替代药物如琥珀胆碱也会导致死亡。

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