930 cases of adverse drug reactions induced by antibacterial drugs in children

doi:10.19803/j.1672-8629.2022.03.19

Abstract

Abstract: Objective To analyze the characteristics of adverse drug reactions induced by antibacterial drugs in children so as to provide reference for safe clinical drug use. Methods A total of 930 reports of ADR induced by antibacterial drugs in children submitted by our hospital to the National ADR Monitoring Center between 2017 to 2019 were analyzed retrospectively. Results Among the 930 cases of ADR reported, 565 (60.75%) were males and 365 (39.25%) were females. The incidence of ADR in patients aged 0 to 6 was the highest (88.07%). Most of the cases of ADR were induced by intravenous injection, accounting for 99.03%. 637 of these cases (68.49%) were induced by macrolides. The injury to the gastrointestinal system was the most common ADR, which accounted for 93.33% of the total. Most of these ADR were cured or improved after corresponding treatment. Conclusion The influencing factors of ADR induced by antibacterial drugs are complicated. The monitoring of ADR in children should be upgraded so as to promote rational use of drugs and ensure safe and effective drug use in clinic.

Key words: antibacterial drugs, children, adverse drug reaction, rational use of drugs

CLC Number:

R994.11

XU Zhe, JU Ping, LUO Qi, YANG Huan, WANG Yang. 930 cases of adverse drug reactions induced by antibacterial drugs in children[J]. Chinese Journal of Pharmacovigilance, 2022, 19(3): 317-321.

References

[1] National Medical Products Administration. Administrative Measures on Reporting and Monitoring of ADR (Order No. 81 of the Ministry of Health)[EB/OL]. (2011-05-04) [2020-05-17]. http://www.nmpa.gov.cn/WS04/CL2174/300642.html.
[2] WANG RQ,HUO YF,XIE YJ,et al.Retrospective analysis of 530 cases of new/severe pediatric ADR in Shandong Province during 2016-2017[J]. China Pharmacy(中国药房),2019,30(1):115-119.
[3] National Medical Products Administration. Notice on Issuing the Annual Report of National Adverse Drug Reaction Monitoring (2019)[EB/OL]. (2020-04-10) [2020-05-17]. http://www.cdr-adr.org.cn/tzgg_home/202004/t20200410_47300.html.
[4] China Food and Drug Administration. Technical Guidelines for Pharmacokinetic Studies in Pediatric Population[EB/OL]. (2014-07-11) [2020-05-17]. http://www.sda.gov.cn/WS01/CL0844/103095.html.
[5] ZHONG NS.Guiding Principles of Clinical Use of Antibiotics(2015)(抗菌药物临床应用指导原则(2015年版))[M]. Beijing:People's Medical Publishing House, 2015.
[6] Uppsala Monitoring Centre. What is WHO-ART[EB/OL]. (2019-04-25)[2019-04-25]. https://www.who-umc.org/vigibase/services/learn-more-about-who-art/.
[7] LIANG H, WEI FH, ZHONG LQ.Analysis of 233 cases of adr induced by antibacterials in our hospital[J].China Pharmacy(中国药房), 2016, 27(5):632-634.
[8] WANG YP, ZHONG W.Analysis on 687 reports of adverse drug reaction of children caused by antibacterial agents[J]. Anti Infect Pharm(抗感染药学), 2018, 15(10):1755-1757.
[9] ZHENG C.Analysis of Influencing factors of adverse reaction induced by antibacterial drugs in 222 children in a hospital[J]. China Licensed Pharmacist(中国执业药师), 2016, 13(11): 44-47.
[10] ZHOU LF, JIANG Y, ZHONG W, et al.Analysis of 332 cases of adverse drug reactions of children in our hospital[J]. Northwest Pharmaceutical Journal(西北药学杂志), 2019, 34(2): 272-275.
[11] Editorial board of Chinese National Formulary. Chinese National Formulary(Chemicals and Biological Products for Children)(中国国家处方集(化学药品与生物制品卷•儿童版))[M]. Beijing:People's Military Medical Press, 2013.
[12] ZHONG W, MAO CM, WANG M.Retrospective analysis of 562 cases of pediatric adverse drug reactions[J]. Journal of Pediatric Pharmacy(儿科药学杂志), 2018, 24(10): 39-42.
[13] MA J, MAO CM.Analysis of 408 pediatric cases with adverse drug Reaction[J]. Anhui Medical and Pharmaceutical Journal(安徽医药),2017, 21(6): 1150-1153.
[14] ZHOU L, SHI YP, HOU HL, et al.Adverse drug reactions in 108 children[J]. Journal of Pediatric Pharmacy(儿科药学杂志),2019, 25(4): 51-53.
[15] HIAMG CL, GUO DH, ZHU M, et al.Analysis on 9819 cases of ADR/ADE associated with quinolones in military hospitals[J]. Chinese Journal of Drug Application and Monitoring(中国药物应用与监测), 2017, 14(5): 293-296.
[16] ZHOU P, ZHU HY, CUI L.Investigation and analysis of adr reported and causes of missing reports by medical staff in a third grade class a hospital[J]. China Pharmacy(中国药房),2017, 28(36): 5056-5059.
[17] ZHANG Q.Retrospective analysis of 147 cases of adverse drug reactions[J]. Anhui Medical and Pharmaceutical Journal(安徽医药), 2019, 23(4): 846-848.
[18] WANG Y, XU Z.Analysis of 176 Pediatric ADR reports in our hospital[J]. China Pharmacy(中国药房), 2016, 27(26): 3649-3651.
[19] MENG XQ, ZHAO N, ZUO J, et al.Analysis of adverse drug reactions in reports of children and maternal in a hospital[J]. Anhui Medical and Pharmaceutical Journal(安徽医药),2017,21(10): 1938-1942.