2016—2017年山东省530例新的/严重的儿童药品不良反应回顾性分析
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摘要
目的:分析山东省新的/严重的儿童药品不良反应(ADR)发生的特点及其规律,促进儿童临床安全用药。方法:对2016年1月1日-2017年12月31日山东省ADR数据库中已回报确定的新的/严重的儿童ADR报告进行回顾性分析,报告信息包括患儿的性别、年龄、原患疾病、既往史或家族ADR史,药品的剂型和给药途径、药品种类,ADR累及的系统/器官及临床表现、超药品说明书使用情况、药物联用情况、发生时间、对患儿原患疾病的影响及转归等。结果:在2016-2017年山东省ADR数据库中,儿童ADR共计发生44 742例,其中男性27 060例、女性17 664例、性别不详18例,530例被确定为新的/严重的儿童不良反应,其中男性334例、女性196例,男女比例为1.70∶1;≥1～3岁儿童新的/严重的ADR报告比例最高(158例,29.81%);原患疾病以呼吸系统疾病为主(190例,25.85%),既往有ADR史的患儿10例(1.89%),有家族ADR史患儿2例(0.38%);药品剂型以注射液为主(358例,67.55%);给药途径以静脉滴注为主(431例,81.32%);引起ADR的药品共包括20类162种,主要为水电解质酸碱平衡调节药(8种药品引起148例,27.92%)、抗菌药物(33种药品引起89例,16.79%)、中药及其提取物(24种药品引起80例,15.09%);在ADR累及的系统/器官中,以全身性损害为主(201例,37.92%,主要临床表现为寒战、发热等),其次为皮肤及其附件(99例,18.68%,主要临床表现为皮疹、瘙痒等),再次为呼吸系统(76例,14.34%,主要临床表现为呼吸困难、咳嗽等);41例(7.74%)存在超说明书用药,包括药品说明书中提示药物使用安全性尚不明确20例(3.77%)、药物未进行儿童用药试验且无可靠参考文献13例(2.45%)、药品说明书禁止儿童使用2例(0.38%);106例(20.00%)存在药物联用,包括两药、三药、四药联用(分别为62、36、8例);ADR主要发生在用药0～5 min内(140例,26.42%);在530例患儿中,ADR对原患疾病转归影响不明显的有457例(86.23%),导致病程延长的有57例(10.75%);278例(52.45%)痊愈,243例(45.85%)好转。结论:临床应加强儿童用药监测,相关部门应加紧制订儿童合理用药的国家标准和相关法规,完善药品使用说明书,提高医务人员对儿童ADR的认知,加强儿童安全用药相关知识的教育与宣传,促进儿童安全用药。
OBJECTIVE:To analyze the characteristics and regularity of new/severe pediatric ADR in Shandong province,and to promote the safe use of drugs in children. METHODS:A retrospective analysis of new/severe pediatric ADR in the Shandong Provincial ADR database 2016-2017 was conducted in respects of children's gender and age,primary disease,ADR history,family ADR history,dosage form,route of administration,drug type,systems/organs involved in ADR,clinical manifestations,off-label drug use,drug combination,occurrence time,effects of ADR on primary disease,outcome,etc. RESULTS:A total of 44 742 pediatric ADR cases were collected from Shandong province ADR database from 2016 to 2017,including 27 060 male,17664 female and 18 gender unknown. 530 cases were diagnosed as new/severe pediatric ADR,including 334 male and 196 female with ratio of male to female 1.70 ∶ 1. New/severe ADR reports of children aged 1-3 took up the highest proportion(158 cases,29.81%). Primary diseases were mainly respiratory disease(190 cases,25.85%);there were 10 children with ADR history(1.89%), 2 with family ADR history(0.38%). Dosage forms were mainly injection(358 cases, 67.55%). Route of administration were mainly intravenous drip(431 cases,81.32%). The drugs that caused ADR included 20 categories and 162 species,mainly including drug for regulating hydroelectric acid-base balance(148 cases caused by 8 kinds of drugs,27.92%),antibiotics(89 cases caused by 33 kinds of drugs,16.79%),traditional Chinese medicine and its extract(80 cases caused by 24 kinds of drugs,15.09%). The systems/organs involved in ADR were mainly systemic injury(201 cases,37.92%,main clinical manifestations included chills and fever, etc.), followed by skin and its appendants(99 cases, 18.68%, mainly clinical manifestations included rash and itching,etc.),respiratory system(76 cases,14.43%,main clinical manifestations included dyspnea and cough,etc.). Off-label drug use were found in 41 cases(7.74%),including the safety of drug use was not clear in drug instructions(20 cases,3.77%);no drug testing was carried out and no reliable references were available(13 cases,2.45%),that medicine was prohibited was stated in drug instructions(2 cases,0.38%). 106 cases(20.00%) had drug combination,including combined use of two drugs,three drugs and four drugs(62,36,8 cases). ADR occurred mainly within 0-5 min(140cases,26.42%). Among 530 children,ADR had no obvious effect on the outcome of the disease in 457 cases(86.23%);ADR caused longer course of disease in 57 cases(10.75%). 278 cases(52.45%)were cured and 243 cases(45.85%)were recovered.CONCLUSIONS:It is necessary to strengthen the monitoring of drug use in children,formulate national standards and relevant laws and regulations for children's rational drug use,improve the awareness of medical staff to children's ADR,strengthen the education and publicity of the knowledge about safe drug use in children,and to promote rational drug use.
OBJECTIVE:To analyze the characteristics and regularity of new/severe pediatric ADR in Shandong province,and to promote the safe use of drugs in children. METHODS:A retrospective analysis of new/severe pediatric ADR in the Shandong Provincial ADR database 2016-2017 was conducted in respects of children's gender and age,primary disease,ADR history,family ADR history,dosage form,route of administration,drug type,systems/organs involved in ADR,clinical manifestations,off-label drug use,drug combination,occurrence time,effects of ADR on primary disease,outcome,etc. RESULTS:A total of 44 742 pediatric ADR cases were collected from Shandong province ADR database from 2016 to 2017,including 27 060 male,17664 female and 18 gender unknown. 530 cases were diagnosed as new/severe pediatric ADR,including 334 male and 196 female with ratio of male to female 1.70 ∶ 1. New/severe ADR reports of children aged 1-3 took up the highest proportion(158 cases,29.81%). Primary diseases were mainly respiratory disease(190 cases,25.85%);there were 10 children with ADR history(1.89%), 2 with family ADR history(0.38%). Dosage forms were mainly injection(358 cases, 67.55%). Route of administration were mainly intravenous drip(431 cases,81.32%). The drugs that caused ADR included 20 categories and 162 species,mainly including drug for regulating hydroelectric acid-base balance(148 cases caused by 8 kinds of drugs,27.92%),antibiotics(89 cases caused by 33 kinds of drugs,16.79%),traditional Chinese medicine and its extract(80 cases caused by 24 kinds of drugs,15.09%). The systems/organs involved in ADR were mainly systemic injury(201 cases,37.92%,main clinical manifestations included chills and fever, etc.), followed by skin and its appendants(99 cases, 18.68%, mainly clinical manifestations included rash and itching,etc.),respiratory system(76 cases,14.43%,main clinical manifestations included dyspnea and cough,etc.). Off-label drug use were found in 41 cases(7.74%),including the safety of drug use was not clear in drug instructions(20 cases,3.77%);no drug testing was carried out and no reliable references were available(13 cases,2.45%),that medicine was prohibited was stated in drug instructions(2 cases,0.38%). 106 cases(20.00%) had drug combination,including combined use of two drugs,three drugs and four drugs(62,36,8 cases). ADR occurred mainly within 0-5 min(140cases,26.42%). Among 530 children,ADR had no obvious effect on the outcome of the disease in 457 cases(86.23%);ADR caused longer course of disease in 57 cases(10.75%). 278 cases(52.45%)were cured and 243 cases(45.85%)were recovered.CONCLUSIONS:It is necessary to strengthen the monitoring of drug use in children,formulate national standards and relevant laws and regulations for children's rational drug use,improve the awareness of medical staff to children's ADR,strengthen the education and publicity of the knowledge about safe drug use in children,and to promote rational drug use.
引文
[1]徐帆,张云玲.我院2013-2014年151例新的药品不良反应报告分析[J].中国药房,2015,26(32):4510-4512.
[2]刘洋,范峥,常馨予,等.我院祛瘀及清热类中药致新的和严重的不良反应298例分析[J].中国药房,2018,29(8):1091-1094.
[3]卫生部医政司,卫生部合理用药专家委员会.《抗菌药物临床应用管理办法》释义和抗菌药物临床应用培训教材[M].北京:人民卫生出版社,2012:257-260.
[4]国务院人口普查办公室,国家统计局,国家统计局人口和就业统计司.中国2010年人口普查资料[M].北京:中国统计出版社,2012:724.
[5]肖瑛,万瑾瑾,赖春花.1132份药品说明书之儿童用药信息的调查分析[J].中国当代医药,2016,18(23):72-83.
[6]陈新谦,金有豫,汤光.新编药物学[M].17版.北京:人民卫生出版社,2014:4.
[7]郭鹏飞,赵平.1019例门诊静脉输液儿童药物不良反应报告分析[J].儿科药学杂志,2012,18(1):31-33.
[8]谢婷婷,郭代红,赵粟裕,等.2009-2014年军队医院5099例儿童药品不良反应报告分析[J].中国药物应用与监测,2015,12(6):360-364.
[9]吴明钗,林洁,胡瑞颖.儿童药物不良反应报告136例分析[J].中国新药与临床杂志,2012,31(6):355-356.
[10]彭评志,蒙光义,莫金权,等.玉林市儿童新的/严重的药品不良反应报告分析[J].西北药学杂志,2017,32(4):518-521.
[11]唐高峰.儿童药品不良反应的分析与对策[J].医药前沿,2014,4(15):155-157.
[12]韦波.论儿童合理用药[J].大家健康,2013,7(2):129-130.
[13]穆菁.130例小儿药物不良反应分析及用药指导[J].中国当代医药,2016,23(32):150-152.
[14]中国药学会医院药学专业委员会儿科药学专业组.抗菌药物儿科临床合理应用指导意见(四)[J].儿科药学杂志,2006,12(3):48-50.
[15]赵志刚,费宇彤.药品超说明书使用循证评价[M].北京:中国协和医科大学出版社,2017:1.
[16]陈玉莹,褚淑贞.我国儿童用药不良反应/事件频发的原因与对策分析[J].中国执业药师杂志,2014,11(7):45-48.
[17]中华医学会儿科学分会临床药理学组,《中华儿科杂志》编辑委员会.中国儿科超说明书用药专家共识[J].中华儿科杂志,2016,54(2):101-103.
[2]刘洋,范峥,常馨予,等.我院祛瘀及清热类中药致新的和严重的不良反应298例分析[J].中国药房,2018,29(8):1091-1094.
[3]卫生部医政司,卫生部合理用药专家委员会.《抗菌药物临床应用管理办法》释义和抗菌药物临床应用培训教材[M].北京:人民卫生出版社,2012:257-260.
[4]国务院人口普查办公室,国家统计局,国家统计局人口和就业统计司.中国2010年人口普查资料[M].北京:中国统计出版社,2012:724.
[5]肖瑛,万瑾瑾,赖春花.1132份药品说明书之儿童用药信息的调查分析[J].中国当代医药,2016,18(23):72-83.
[6]陈新谦,金有豫,汤光.新编药物学[M].17版.北京:人民卫生出版社,2014:4.
[7]郭鹏飞,赵平.1019例门诊静脉输液儿童药物不良反应报告分析[J].儿科药学杂志,2012,18(1):31-33.
[8]谢婷婷,郭代红,赵粟裕,等.2009-2014年军队医院5099例儿童药品不良反应报告分析[J].中国药物应用与监测,2015,12(6):360-364.
[9]吴明钗,林洁,胡瑞颖.儿童药物不良反应报告136例分析[J].中国新药与临床杂志,2012,31(6):355-356.
[10]彭评志,蒙光义,莫金权,等.玉林市儿童新的/严重的药品不良反应报告分析[J].西北药学杂志,2017,32(4):518-521.
[11]唐高峰.儿童药品不良反应的分析与对策[J].医药前沿,2014,4(15):155-157.
[12]韦波.论儿童合理用药[J].大家健康,2013,7(2):129-130.
[13]穆菁.130例小儿药物不良反应分析及用药指导[J].中国当代医药,2016,23(32):150-152.
[14]中国药学会医院药学专业委员会儿科药学专业组.抗菌药物儿科临床合理应用指导意见(四)[J].儿科药学杂志,2006,12(3):48-50.
[15]赵志刚,费宇彤.药品超说明书使用循证评价[M].北京:中国协和医科大学出版社,2017:1.
[16]陈玉莹,褚淑贞.我国儿童用药不良反应/事件频发的原因与对策分析[J].中国执业药师杂志,2014,11(7):45-48.
[17]中华医学会儿科学分会临床药理学组,《中华儿科杂志》编辑委员会.中国儿科超说明书用药专家共识[J].中华儿科杂志,2016,54(2):101-103.