基于烟台市药品不良反应数据库对严重药品不良反应的分析与评价
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摘要
目的对烟台市药品不良反应数据库严重不良反应(SADR)进行分析与评价,为临床安全、有效、合理用药和进一步深化药品安全监测工作提供参考,减少或预防不良反应的产生,以保障公众用药安全。方法提取烟台市药品不良反应数据库中2015年1月～2017年12月上报的3985例SADR报告进行数据清洗。采用描述性分析对患者的性别、年龄、既往病史、既往药品不良反应、药品种类、给药途径、药物剂型、累及系统/器官与临床表现、转归及对原患疾病的影响、停药减药反应和再次使用等进行分析。结果获得数据库中有效的SADR报告3030例。其中新的严重的SADR 675例(22.3%);占比最大的年龄组为60岁以上的患者(44.9%);静脉滴注是引起SADR的主要途径,占70.3%;大多数患者发生SADR后经停药及对症处理后痊愈(47.7%)或好转(47.3%);引起SADR频次较高的药物为抗感染药(26.8%)和抗肿瘤药(15.4%);SADR报告中以皮肤及粘膜损害为最多(22.3%)。结论 SADR发生较多且危害严重。本研究对严重不良反应报告进行了分析,为临床安全用药提供了参考,以减少不良反应的发生。
Objective The analysis and evaluation of serious adverse drug reactions(SADR) in Yantai city adverse drug reaction database were carried out to provide reference for clinical safety, effective and rational drug use and further deepening drug safety monitoring, reduce or prevent the occurrence of adverse reactions, so as to ensure the safety of public medication. Methods From January 2015 to December 2017, 3985 SADR reports reported in Yantai city adverse drug reactions database were extracted for data cleaning. Descriptive analysis was used to analyze the gender, age, past medical history, past adverse drug reactions, drug types, drug delivery routes, drug dosage forms, involvement of system/organ and clinical manifestations, outcome and impact on the original disease, drug withdrawal and drug reduction reactions, and re-use of the patients. Results There were 3030 valid SADR reports in the database. Among them, there were 675 new serious SADR cases(22.3%). The age group with the largest proportion was patients over 60 years old(44.9%). Intravenous drip was the main cause of SADR, accounting for 70.3%. After SADR′s occurrence, most patients recovered(47.7%) or improved(47.3%) after drug withdrawal and symptomatic treatment. The drugs causing SADR′s high frequency were anti-infective drugs(26.8%) and anti-tumor drugs(15.4%). According to SADR, skin and mucosal lesions were the most common(22.3%). Conclusion SADR occurs more and is seriously harmful. This study analyzes the report of serious adverse reactions and provides a reference for clinical safe medication to reduce the occurrence of adverse reactions.
Objective The analysis and evaluation of serious adverse drug reactions(SADR) in Yantai city adverse drug reaction database were carried out to provide reference for clinical safety, effective and rational drug use and further deepening drug safety monitoring, reduce or prevent the occurrence of adverse reactions, so as to ensure the safety of public medication. Methods From January 2015 to December 2017, 3985 SADR reports reported in Yantai city adverse drug reactions database were extracted for data cleaning. Descriptive analysis was used to analyze the gender, age, past medical history, past adverse drug reactions, drug types, drug delivery routes, drug dosage forms, involvement of system/organ and clinical manifestations, outcome and impact on the original disease, drug withdrawal and drug reduction reactions, and re-use of the patients. Results There were 3030 valid SADR reports in the database. Among them, there were 675 new serious SADR cases(22.3%). The age group with the largest proportion was patients over 60 years old(44.9%). Intravenous drip was the main cause of SADR, accounting for 70.3%. After SADR′s occurrence, most patients recovered(47.7%) or improved(47.3%) after drug withdrawal and symptomatic treatment. The drugs causing SADR′s high frequency were anti-infective drugs(26.8%) and anti-tumor drugs(15.4%). According to SADR, skin and mucosal lesions were the most common(22.3%). Conclusion SADR occurs more and is seriously harmful. This study analyzes the report of serious adverse reactions and provides a reference for clinical safe medication to reduce the occurrence of adverse reactions.
引文
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[11]朱磊,黄萍,李颖.519例严重药品不良反应病例分析[J].中国医院药学杂志,2015,35(2):147-152.
[12]熊代琴,买吾丽旦·哈力木拉提,余文潇,等.抗肿瘤药物不良反应信息评价与分析[J].中国医院药学杂志,2018,38(4):407-411.
[13]杨春琳,卢浙文,章建华.2007~2010年105例严重药品不良反应/事件报告分析[J].海峡药学,2012,24(4):252-254.
[14]臧清策,靳洪涛,再帕尔·阿不力孜,等.注射剂中致敏成分分析方法研究进展[J].中国药物警戒,2018,15(4):216-220,225.
[15]王干一,闫梦青,连祎晓,等.河南省三甲医院药品不良反应分析[J].医药论坛杂志,2017,38(3):68-70.
[16]朱磊,黄萍,李颖.519例严重药品不良反应病例分析[J].中国医院药学杂志,2015,35(2):147-152.
[17]随何欢,苏强,朱丽莎,等.某三级甲等医院400例新的及严重的药品不良反应分析[J].中国药师,2018,21(6):1028-1031.
[18]周鹏,姜晓芹,崔岚.107例严重药品不良反应/事件报告分析[J].中国药物应用与监测,2016,13(6):356-359.
[2]彭谊.扬州市198例严重药品不良反应报告分析[J].海峡药学,2018,30(6):262-264.
[3]沈璐,刘巍,郭雪,等.我国药品不良反应监测模式的趋势探析[J].中国药物警戒,2017,14(5):295-297,308.
[4]李淼,徐辉,李秀丽.最新临床用药须知[M].2011版.北京:军事医学科学出版社,2011:1-320.
[5]陈新谦,金有豫,汤光.新编药物学[M].16版.北京:人民卫生出版社,2007:3-23.
[6]毛益辉.基层医院药品不良反应报告管理现状解析[J].中医药管理杂志,2017,25(13):83-84.
[7]陈思颖,尤海生,朱亚宁,等.134例严重药品不良反应/事件报告分析[J].药物流行病学杂志,2016,25(9):559-562.
[8]吴杰,方欢,唐辉.355例药品不良反应分析[J].中国医院用药评价与分析,2014,14(1):75-77.
[9]刘炜,彭丹梅,赖江丽.2014年度我院药物不良反应报告分析[J].齐齐哈尔医学院学报,2015(35):5397-5398.
[10]朱春梅,吴民.我院2007~2016年新的、严重的药品不良反应报告分析[J].药物流行病学杂志,2017,26(8):551-555.
[11]朱磊,黄萍,李颖.519例严重药品不良反应病例分析[J].中国医院药学杂志,2015,35(2):147-152.
[12]熊代琴,买吾丽旦·哈力木拉提,余文潇,等.抗肿瘤药物不良反应信息评价与分析[J].中国医院药学杂志,2018,38(4):407-411.
[13]杨春琳,卢浙文,章建华.2007~2010年105例严重药品不良反应/事件报告分析[J].海峡药学,2012,24(4):252-254.
[14]臧清策,靳洪涛,再帕尔·阿不力孜,等.注射剂中致敏成分分析方法研究进展[J].中国药物警戒,2018,15(4):216-220,225.
[15]王干一,闫梦青,连祎晓,等.河南省三甲医院药品不良反应分析[J].医药论坛杂志,2017,38(3):68-70.
[16]朱磊,黄萍,李颖.519例严重药品不良反应病例分析[J].中国医院药学杂志,2015,35(2):147-152.
[17]随何欢,苏强,朱丽莎,等.某三级甲等医院400例新的及严重的药品不良反应分析[J].中国药师,2018,21(6):1028-1031.
[18]周鹏,姜晓芹,崔岚.107例严重药品不良反应/事件报告分析[J].中国药物应用与监测,2016,13(6):356-359.