| 摘要: |
| 目的:收集2011-2020 年某院上报的<18 岁儿童的药品不良反应(ADR)报告,了解儿童发生ADR 的情况和特点,为儿童
ADR 监测与合理用药提供借鉴。方法:采用回顾性分析方法,统计分析ADR 报告类型、患儿性别、年龄、引发ADR 主要药品名
称、药品品种、给药途径、联合用药、ADR 累及器官等。结果:共收集到ADR 报告389 例,其中一般不良反应270 例(69. 41%),
新的一般不良反应78 例(20. 05%),严重不良反应32 例(8. 23%),新的严重不良反应9 例(2. 31%)。发生ADR 的患儿年龄主
要集中在28 d~7 岁。发生ADR 的给药途径以静脉用药为主,其中静脉滴注279 例(71. 72%)、静脉注射55 例(14. 14%)。引发
ADR 的药品种类前三位分别为抗菌药物193 例(38. 91%)、中成药136 例(27. 22%)、抗病毒药物33 例(6. 65%)。ADR 最高的
前三种抗菌药物分别为注射用头孢哌酮钠/ 舒巴坦钠33 例次、注射用头孢呋辛钠31 例次、注射用头孢曲松钠28 例次;前三种
中成药分别为注射用双黄连(冻干)34 例次、痰热清注射液29 例次、热毒宁注射液26 例次。引发ADR 累及系统/ 器最多的是皮
肤及其附件损害(343 例次,61. 58%),其次是胃肠道损害(78 例次,14. 00%)和心血管系统损害(31 例次,5. 57%)。结论:该院
患儿发生ADR 的情况、特点与国内报道相似,应加强医务工作者在静脉给药、联合用药、抗菌药物及中成药注射剂的监管,加强
临床药师对ADR 的监测,减少儿童ADR 的发生,保障儿童用药安全。 |
| 关键词: 儿童 药品不良反应 调查分析 |
| DOI：10.13407/j.cnki.jpp.1672-108X.2023.03.008 |
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| 基金项目: |
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| Investigation and Analysis of Adverse Drug Reactions of Children in a Hospital from 2011 to 2020 |
| Zhang Huan1, Lu YueXuan2 |
| (1. The People’s Hospital of Hezhou, Guangxi Hezhou 542899, China; 2. College of Pharmacy,Guangxi University of Chinese Medicine, Nanning 530200, China) |
| Abstract: |
| Objective: By collecting all adverse drug reaction (ADR) reports of patients under 18 years old reported by a hospital from
2011 to 2020, to investigate the situation and characteristics of ADR in juvenile patients, and to provide references for ADR monitoring
and rational drug use of children. Methods: A retrospective analysis was used to analyze the types of ADR reports, patients’ gender,
age, the names of main drugs causing ADR, drug varieties, routes of administration, drug combination, and involved organs. Results:
A total of 389 cases of qualified ADR were reported, of which 270 cases (69. 41%) were “normal”, 78 cases (20. 05%) were “new
normal”, 32 cases (8. 23%) were “severe” and 9 cases (2. 31%) were “new severe”. The age of the patients with ADR mainly
ranged from 28 days to 7 years old. The main routes of ADR were intravenous infusion in 279 cases (71. 72%), and intravenous
injection in 55 cases (14. 14%). The first three kinds of drugs causing ADR were antibacterial drugs in 193 cases (38. 91%), Chinese
patent medicine in 136 cases (27. 22%) and antiviral drugs in 33 cases (6. 65%). The highest number of the first three antibiotics were
33 cases of cefoperazone sodium and sulbactam sodium for injection, 31 cases of cefuroxime sodium for injection and 28 cases of
ceftriaxone sodium for injection. The first three kinds of Chinese patent medicines were Shuanghuanglian injection (lyophilized) in 34
cases, Tanreqing injection in 29 cases and Reduning injection in 26 cases. The most common system/ organ involvements caused by ADR
were damage of skin and its appendages (343 times, 61. 58%), and then the gastrointestinal (78 times, 14. 00%) and cardiovascular
system (31 times, 5. 57%). Conclusion: The situation and characteristics of ADR among children in this hospital are similar to those
reported in China. By strengthening the monitoring of ADR among children, the supervision of medical workers on intravenous
administration, combined use of drugs, antibacterial drugs and Chinese patent medicine injections, and the monitoring of ADR by
clinical pharmacists, the occurrence of ADR in children can be reduced, and the safety of drug use can also be ensured. |
| Key words: children adverse drug reaction investigation and analysis |
