抗菌药物致儿童血小板减少症的真实世界研究

Antimicrobial-induced Thrombocytopenia in Children: A Real-world Study

关键词:  抗菌药物  儿童  药源性血小板减少症  中国医院药物警戒系统  真实世界研究

Key words:  antimicrobial  children  drug-induced thrombocytopenia  Chinese Hospital Pharmacovigilance System  real- world study

摘要:

目的 基于10年真实世界数据探索不同品类抗菌药物所致儿童药源性血小板减少症(drug-induced thrombocytopenia，DIT)的发生率及血小板计数下降特征。方法 采用回顾性队列研究方法，选取2013年1月—2022年12月厦门大学附属妇女儿童医院(厦门市妇幼保健院)使用抗菌药物的住院患儿(98 301例次)，基于中国医院药物警戒系统(Chinese Hospital Pharmacovigilance System，CHPS)筛选其中发生DIT的例次。以不同抗菌药物品类为暴露分组，比较不同分组DIT发生率、血小板计数开始下降时间、血小板计数下降至最低点时间以及严重程度的差异。结果 所有品类抗菌药物中，DIT发生率前3位为喹诺酮类(19.61‰)、碳青霉烯类(16.59‰)及糖肽类(14.34‰)。碳青霉烯类引起血小板计数开始下降的时间最短[0.59(0.18，1.27) d]，而硝基咪唑类时间最长[2.71(0.80，4.06) d]。血小板计数下降至最低点不同分组时间类似，但糖肽类和硝基咪唑类严重不良反应占比较高(>28%)。结论 儿童DIT为喹诺酮类、碳青霉烯类以及糖肽类抗菌药物的常见不良反应。不同品类抗菌药物血小板计数下降时间特征不同，将其转化为CHPS触发规则嵌入日常诊疗，对DIT的预防具有重要意义。

Abstract:

OBJECTIVE To explore the incidence and platelet count decline characteristics of drug-induced thrombocytopenia (DIT) in children caused by different categories of antibacterial drugs based on 10 years of real-world data. METHODS A retrospective cohort study was used to select pediatric inpatients(98 301 samples) who used antibiotics at Women's and Children's Hospital, Affiliated to Xiamen University, Xiamen Maternal and Child Health Hospital from January 2013 to December 2022. The DIT samples were screened by the Chinese Hospital Pharmacovigilance System(CHPS). The incidence of DIT, the onset time of platelet count decline, the time when platelet count drops to the bottom, and differences in the severity were compared among groups of different types of antibacterial drugs. RESULTS Among all categories of antibacterial drugs, the top three incidence rates of DIT were quinolones(19.61‰), carbapenems(16.59‰) and glycopeptides(14.34‰). The shortest time for the onset of platelet count decrease caused by carbapenems[0.59(0.18, 1.27) d], while the longest time for nitroimidazoles[2.71(0.80, 4.06) d]. The time of decrease in platelet count to the bottom was similar among different groups, but the proportion of severe adverse reactions was higher in glycopeptides and nitroimidazoles(>28%). CONCLUSION DIT is a common adverse reaction of quinolones, carbapenems, and glycopeptide antibiotics in children. The time characteristics of platelet count decrease vary among different antibacterial drugs converting this information into CHPS triggering rules and embedding that in daily clinical practice may be of great significance for the prevention of DIT.