182例新生儿药品不良反应分析

doi:10.19803/j.1672-8629.2021.05.15

摘要/Abstract

摘要： 目的探讨新生儿药品不良反应(adverse drug reaction, ADR)发生的原因、特点及影响因素,以减少新生儿ADR的发生,促进新生儿临床合理用药。方法对2006年10月1日至2019年12月31日我院收集上报的182例新生儿ADR进行统计分析;计算各类药物ADR严重度指数（adverse drug reaction severity index, SIADR）,并对其进行评价。结果在182例新生儿ADR中,男孩∶女孩为2.57∶1。引起新生儿ADR的主要药物为抗菌药物、神经系统用药、中药制剂;但SIADR最高的3类药物分别为镇静催眠药、血液系统用药和电解质、酸碱平衡及营养药。皮肤及其附件损害是新生儿ADR最主要的临床表现。新生儿临床用药存在超说明书用药及不合理用药现象。结论新生儿ADR的发生与新生儿性别、新生儿药代动力学、超说明书用药及不合理用药等因素相关;在临床用药时应警惕SIADR较大的药物;应加强新生儿药代动力学研究、加强新生儿专用药品的研发、合理使用抗菌药物等措施以减少和避免新生儿ADR的发生。

关键词: 新生儿, 药品不良反应, 药品不良反应严重度指数, 合理用药

Abstract: Objective To explore the causes, characteristics and influencing factors of adverse drug reactions (ADR) in neonates in order to reduce neonatal ADR and promote rational clinical use of drugs in neonates. Methods The 182 cases of ADR in neonates reported by our hospital between October 1, 2006 and December 31, 2019 were statistically analyzed. The ADR severity index (SIADR)of various drugs was calculated. Results The ratio of boys and girls was 2.57∶1. The main drugs that caused ADR in newborns were antibacterial drugs, nervous system drugs, and traditional Chinese medicine preparations. However, the three drugs with the highest SIADR were sedative and hypnotic drugs, blood system drugs and electrolytes, acid-base balance and nutritional drugs. The most common ADR were injuries to the skin and its appendants. Off-label drug use and irrational drug use were found during clinical medication of neonates. Conclusion ADR among neonates are closely related to gender, neonatal pharmacokinetics, off-label drug use and irrational drug use. Drugs with a high severity index deserve attention in clinical use. The following measures are recommended to reduce the incidence of neonatal ADR and promote the rational use of drugs: investing more in the study on neonatal pharmacokinetics, boosting R&D of special drugs for newborns; and to promote rational antibacterial drugs use.

Key words: neonates, adverse drug reactions, adverse drug reaction severity index, （SIADR）, rational drug use

中图分类号:

R969.3

李静, 彭翠英, 罗芳梅, 张海霞. 182例新生儿药品不良反应分析[J]. 中国药物警戒, 2021, 18(5): 473-477.

LI Jing, PENG Cuiying, LUO Fangmei, ZHANG Haixia. Analysis of Adverse Drug Reactions in 182 Neonates[J]. Chinese Journal of Pharmacovigilance, 2021, 18(5): 473-477.

参考文献

[1] Kassure EG.Drug-reactions complications in infants and children[J].Am J Roentgen,1991,1(1):4-7.
[2] Li LJ,Hu JH,Wang Z,et al.Establishment of a new standard for evaluation of grade of adverse drug reaction severity and application of adverse drug reaction severity index[J].Pharmaceutical Care and Research(药学服务与研究),2008,8(1):9-13.
[3] Pharmacopoeia committee of ministry of health of people's republic of China.Chinese pharmacopoeia part I (中国药典一部)[S].Beijing:China Medical Science and Technology Press,2020:1097-1098.
[4] Expert committee on rational drug use,Ministry of health.guidelines for clinical drug use of Chinese pharmacists ( 中国医师临床用药指南)[M].2nd ed.Chongqing:Chongqing publishing house,2014:1-1674.
[5] Chen DY,Chen WB.Clinical pharmacotherapy[M].4th ed.Beijing:People's Medical Publishing house (临床药物治疗学),2012:l-710.
[6] Zhao X,Lin P,Guo J,et al.Pareto chart analysis of irrational drug use in outpatient and emergency of our hospital[J].Chinese Journal of Pharmacovigilance(中国药物警戒),2018,15(7):429-433.
[7] Trab C,Knowles SR,Liu BA,et al.Gender differences in adverse drug reaction[J].Clin Pharmacol,1998,38(11):1003-1009.
[8] Wang SF,Sun DR,Wang GL,et al.Adverse drug reactions (药物不良反应)[M].Beijing:People's Medical Publishing House,1988:17.
[9] Wang XY.Analysis of adverse drug reactions in 94 neonates in children's hospital[J].Pharmaceutical Research(药学研究),2019,38(10):615-620.
[10] Chen YW,Li ZP.Pharmacokinetics of antifungal agents in newborns and infants[J].Chinese Journal of New Drugs and Clinical Sciences,2014,33(2):90-96.
[11] Sherwin MT,Medlicott NJ,Reith DM,et al.Intravenous drug delivery in neonates:lessons lear[J].Archives of Disease in Childhood,2014,99(6):590-594.
[12] Li YX,Li SJ,Zhang Y,et al.Progress in the application and pharmacokinetic characteristics of tacrolimus in living donor liver transplantation in children[J].Tianjin Pharmacy(天津药学),2017,29(4):54-57.
[13] Wang F,Li YH,Guo RF,et al.Literature analysis of 376 cases of adverse drug reactions induced by ceftriaxone sodium for injection[J].Journal of Pharmacovigilance(中国药物警戒),2019,16(5):289-295.
[14] Miline CP,Bruss JB.The economics of pediatric formulation development for off-patent drugs[J].Clin Ther,2008,30(11):2133-2145.
[15] Zhang J.Pharmacokinetic characteristics of levetiracetam oral administration in neonates[J].Chinese Journal of Clinical Rational Drug Use(临床合理用药杂志),2016,9(19):112-113.
[16] Wu MZ.A population pharmacokinetic study of caffeine prevention and treatment of apnea in premature infants[D].Guangzhou:Guangzhou Medical University(广州医科大学),2017:4-7.
[17] Hu X,Liu X,Lang LJ,et al.The composition and rationality evaluation of drug use for pediatric emergency respiratory diseases in our hospital[J].Chinese Journal of Pharmacovigilance(中国药物警戒),2018,15(12):741-745.
[18] Wang XL,Zhang TH.Challenges and strategies in pediatric pharmacokinetic study[J].Journal of International Pharmaceutical Research(国际药学研究杂志),2016,43(4):621-631.
[19] Xiao Y,Wan JJ,Lai CH.Investigation and analysis on the information of the children in the 1132 drug instruction[J].China Modern Medicine(中国当代医药),2016,23(18):72-74.