638例新的严重药品不良反应病例报告分析.docVIP

638例新的严重药品不良反应/事件（ADR/ADE）报告分析 丁长玲，丁召兴，高菲，成文娜，刘呈华 （滨州医学院附属医院 山东滨州256603） 摘要：目的 了解新的严重药品不良反应/ 事件（ADR/ADE）发生特点和规律，为临床安全用药提供参考。方法 采用回顾性研究方法，对我院2006-2014年收集上报的638例新的、严重ADR/ADE病例报告进行分类统计和分析评价。结果 新的严重ADR/ADE发生率较高的人群为≤10岁小儿（21.63%）和≥61岁老年人（23.67%）；有既往药物过敏史的患者占13.95%；ADR/ADE临床表现主要为皮肤及其附属器官的损害；涉及药物前十位以中药注射剂为主；用药途径主要为静脉滴注；近三年来新的、严重的ADR/ADE所占总报告数量的比例逐年下降；基层诊所用药出现的严重ADR/ADE可能与不合理用药有关，如选错药物、单次用量过大、用药途径不当、用药总量过大、溶媒错误、给药速度过快、联合用药不当等。结论 高度关注中药注射剂和特殊人群用药安全监测，加强基层诊所合理用药宣传，提高诊疗水平，能有效减少严重ADR/ADE发生，减少药物损害事件发生。 关键词：药品不良反应；回顾性研究；严重；分析 The Analysis of 638 New／Serious ADR Cases DING Chang-ling，Ding Zhao-xing ,Gao Fei，CHENG Wen-na ,LIuCeng-hua ( Affiliated Hospital Of Binzhou Medical College, Shandong Binzhou 256603) [ABSTRACT] OBJECTIVE：To research the Characteristics and laws on New／Serious adverse drug reaction(ADR) so as to promote clinical safe medication. Methods: A retrospective analysis was conducted on 638 reports of new/serious ADR during the period from 2006 to 2014 retrieved from our hospital. Results During the 638 ADRS, patients with previous history of drug allergy accounted for 13.95%; The ADRs occurred mainly in skin and appendage; involving drugs in the top ten are mostly caused by Chinese medicine injection; main route of administration is intravenous infusion ; nearly three years the proportion of the total number of reported new and serious ADR / ADE declining ; serious ADR / ADE may be irrational drug related, such as wrong medication , a single use of excessive , improper route of administration , the total medication excessive solvent wrong , administered too fast , improper drug combination. Conclusion It is important to pay attention to drug safety monitoring about traditional chinese medicine injections and special populations , to improve diagnosis and treatment can effectively reduce the serious ADR / ADE occurs and prevent drug harmful incidents . 滨州医学院科技计划课题：（BY2013KJ12） 药品不良反应监测是药品上市后安全监管的重要手段，新的、严重ADR/ADE是药品安全监管的重要参考依据。对新的、严重ADR报告进行分析、评价，结合临床用药情况，探讨其发生规律，有利于