哌拉西林/他唑巴坦致血细胞减少的回顾性研究

目的:比较儿童及成人使用哌拉西林/他唑巴坦致血液系统不良反应(ADR)的发生情况及其影响因素,为儿童安全用药提供参考。方法:回顾性分析某三甲医院2017 年4 月至2018 年3 月使用哌拉西林/ 他唑巴坦的5 176 例患者的病例资料,根据年龄分为0 ~28 d,1 ~12 月,>1 ~12 岁,>12 ~18 岁,>18 ~65 岁,>65 岁6 组,分析不同年龄组患者血细胞减少的发生率、发生时间、严重程度及转归等,并对患者血细胞减少相关危险因素进行Logistic 回归分析,探讨儿童与成人使用该药的安全性差异。结果:血液系统ADR 总发生率为2.99%,1 ~ 12 月龄婴幼儿ADR 发生率最高,达14.48%,>65 岁的老年人最低,仅1.38%。898 例儿童中有88 例(9.80%)血细胞(NEU、WBC、PLT)减少,15 例(1.67%)3 ~ 4 级严重中性粒细胞减少。Logistic 多因素分析结果显示,年龄<1 岁(OR =5.399)是用药后血细胞(NEU、WBC、PLT)严重减少的独立危险因素。结论:哌拉西林/ 他唑巴坦在各年龄段儿童患者中血液系统ADR 发生率均明显高于成人和药品说明书的报道,尤其是新生儿及1 ~ 12 月龄的婴幼儿,应高度关注其血液系统ADR,加强监测血常规。

Retrospective Study of Hematocytopenia Induced by Piperacillin / Tazobactam

Objective: To compare the incidence and risk factors of adverse drug reactions (ADR) of blood system induced by piperacillin/ tazobactam, so as to provide reference for safe medication in children. Methods: From Apr. 2017 to Mar. 2018, totally 5,176 patients prescribed piperacillin/ tazobactam were collected and divided into six groups according to different age groups, including 0 to 28 days, 1 to 12 months, >1 to 12 years, >12 to 18 years, 18 to 65 years and >65 years. The incidence, time, severity and outcome of hemopenia in different age groups were analyzed. Logistic regression analysis were used for the related risk factors of hematocytopenia,and the safety differences between children and adults were investigated. Results: The overall incidence of ADR was 2.99%, in which the highest incidence was in infants and young children aged from 1 to 12 months (14.48%), and the lowest incidence was 1.38% in the elderly aged > 65 years. Among the 898 children, 88 cases (9.80%) developed hemocytopenia (NEU, WBC, PLT), and 15 cases (1.67%) developed 3 to 4 degree severe neutropenia. Logistic multivariate analysis showed that <1 years (OR = 5.399) was an independent risk factor for hematocytopenia (NEU, WBC, PLT) after administration. Conclusion: The incidence of ADR induced by piperacillin/ tazobactam in children is significantly higher than that in adults and reported in the drug instructions, especially in neonates and infants aged from 1 to 12 months. Therefore, close attention should be paid to blood system ADR, and blood routine monitoring should be strengthened.