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基于真实世界分析哌拉西林钠/ 他唑巴坦钠在儿童的用药安全性
高宇1,王立丹1,王伟美1,张媛媛1,脱鸣富2,张亚玲2
0
(1. 衡水市人民医院,河北衡水 053000;2. 甘肃医学院附属医院, 甘肃平凉 744000)
摘要:
目的:基于真实世界数据探讨儿童患者使用哌拉西林钠/ 他唑巴坦钠致药物不良反应(ADR)的发生率、临床表现及影响 因素,为临床安全用药提供参考。方法:收集儿童使用哌拉西林钠/ 他唑巴坦钠的病例资料,以发生ADR 的患者为病例组,描述 性分析ADR 发生率、临床表现及转归,以性别和感染部位1 ∶ 1 在未发生ADR 的患者中匹配对照组,采用单因素和多因素 Logistic 回归分析发生ADR 危险因素。结果:纳入5 212 例患儿,247 例患儿发生271 例次ADR,ADR 发生率为4. 74%。年 龄<3 岁、有基础疾病、联用万古霉素、联用中药注射剂、用药种类数>3 种的患儿和哌拉西林钠/ 他唑巴坦钠用药≤72 h 的ADR 发生率较高。ADR 主要涉及9 个器官(组织) 损害,以皮肤及其附件损害、胃肠道损害和泌尿系统损害常见,分别占21. 40%、 18. 08%和13. 65%,主要表现为局部皮疹、恶心呕吐和血清肌酐水平升高。多因素Logistic 回归显示,年龄<3 岁(OR= 2. 118)、 联用万古霉素(OR=3. 642)和用药种类数>3 种(OR=2. 516) 是发生ADR 的独立危险因素(P<0. 05)。结论:儿童使用哌拉西 林钠/ 他唑巴坦钠致不良反应发生率为4. 74%,年龄<3 岁、联用万古霉素和用药种类数>3 种的患儿应警惕ADR 发生。
关键词:  哌拉西林钠/ 他唑巴坦钠  儿童  用药安全  影响因素  真实世界数据
DOI:10.13407/j.cnki.jpp.1672-108X.2024.12.004
基金项目:甘肃省教育厅高校教师创新基金项目,编号2024B-216。
Midication Safety of Piperacillin / Tazobactam in Children Based on Real-World Data
Gao Yu1, Wang Lidan1, Wang Weimei1, Zhang Yuanyuan1, Tuo Mingfu2, Zhang Yaling2
(1. People’ s Hospital of Hengshui, Hebei Hengshui 053000, China; 2. Affiliated Hospital of Gansu Medical College, Gansu Pingliang 744000, China)
Abstract:
Objective: To probe into the incidence, clinical manifestations and influencing factors of adverse drug reactions (ADR) induced by piperacillin/ tazobactam in children based on real-world data, so as to provide reference for clinical medication safety. Methods: Clinical data of children with piperacillin/ tazobactam were collected. Patients with ADR were extracted as the case group, and the incidence, clinical manifestations and outcomes of ADR were analyzed descriptively. The control group were matched 1 ∶ 1 for gender and site of infection in patients who did not develop ADR. Risk factors of ADR were analyzed by univariate and multivariate Logistic regression. Results: A total of 5,212 patients were enrolled. There were 271 cases of ADR in 247 patients, with an incidence of 4. 74%. The incidence of ADR was higher in patients with age < 3 years, underlying diseases, combined use of vancomycin, combined use of traditional Chinese medicine injections, more than 3 kinds of drugs and the duration of piperacillin/ tazobactam for ⩽72 h. ADR mainly involved 9 organs (tissues) , including skin and its appendages, gastrointestinal tract and urinary system, respectively accounting for 21. 40%, 18. 08% and 13. 65%. The main manifestations were local rash, nausea and vomiting, and increased serum creatinine level. Multivariate Logistic regression showed that age <3 years (OR=2. 118), combined use of vancomycin (OR=3. 642) and more than 3 kinds of drugs (OR=2. 516) were independent risk factors for ADR (P<0. 05). Conclusion:The incidence of ADR induced by piperacillin/ tazobactam in children was 4. 74%, children <3 years, with combined use of vancomycin and more than 3 kinds of drugs should be alert to ADR.
Key words:  piperacillin/ tazobactam  children  medication safety  influencing factors  real-world data

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