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肺炎支原体肺炎患儿药物治疗安全性的主动监测及影响因素研究
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| 篇名： | 肺炎支原体肺炎患儿药物治疗安全性的主动监测及影响因素研究 |
| TITLE： | Active surveillance of drug safety and influential factors in pediatric patients with Mycoplasma pneumoniae pneumonia |
| 摘要： | 目的 分析肺炎支原体肺炎（MPP）患儿药品不良反应（ADR）的发生情况，并探讨其影响因素。方法从医院信息系统提取2023年10月1日－2024年9月30日新乡市中心医院（简称“我院”）收治的MPP患儿的病历资料，使用全面触发工具（GTT）进行回顾性审查，对触发器阳性患儿进行ADR判定，并分析其ADR发生特点。将患儿分为发生ADR组和未发生ADR组，通过单因素分析、多因素Logistic回归分析探讨MPP患儿发生ADR的潜在影响因素。结果共纳入MPP患儿1325例；设计触发器条目24项，其中14项检出阳性，触发器阳性率为58.3%；触发器阳性1301例次，所涉患儿846例；经判定，372例患儿发生399例次ADR，触发器阳性预测值为30.7%。ADR以血细胞异常（230例次，57.6%）、皮肤及其附件损害（78例次，19.5%）和胃肠系统损害（42例次，10.5%）为主，分别多发生在用药后4d及以上、2～3d、2～3d；好发于＞3～10岁患儿（295例，79.3%）；与ADR发生相关的药品主要有静脉用激素药物（209频次）、头孢菌素类药物（180频次）、大环内酯类药物（38频次）、四环素类药物（28频次）和中药注射剂（28频次）。ADR类型中，严重的有1例次，一般的有394例次，新的有4例次；与药物的因果关系中，肯定的有1例次，很可能的有19例次，可能的有379例次；ADR结局中，痊愈的有151例次，不详的有248例次。单因素和多因素Logistic回归分析显示，过敏史[比值比＝5.231，95%置信区间（2.004，13.656），P＜0.05]、药物使用数量[比值比＝1.064，95%置信区间（1.027，1.103），P＜0.05]、静脉使用激素[比值比＝3.223，95%置信区间（2.341，4.437），P＜0.05]是MPP患儿ADR发生的独立危险因素，阿奇霉素的使用[比值比＝0.544，95%置信区间（0.376，0.786），P＜0.05]为MPP患儿ADR发生的独立保护因素。结论我院MPP患儿ADR发生率较高，主要包括血细胞异常、皮肤及其附件损害、胃肠系统损害；过敏史、药物使用数量、静脉使用激素、使用阿奇霉素与MPP患儿ADR的发生相关。 |
| ABSTRACT： | OBJECTIVE To analyze adverse drug reactions （ADRs） in pediatric patients with Mycoplasma pneumoniae pneumonia （MPP）， and investigate the influential factors associated with the occurrence of ADRs. METHODS Clinical records of pediatric patients with MPP in Xinxiang Central Hospital （hereinafter referred to as “our hospital”） from Oct. 1st， 2023 to Sept. 30th， 2024 collected from the Hospital Information System were retrospectively reviewed using the global trigger tool （GTT）. The positive triggers were further reviewed to confirm the occurrence of ADRs， and the characteristics of those ADRs were analyzed. The children were divided into the ADR group and the non-ADR group. Univariate analysis and multivariate Logistic regression analysis were performed to investigate the potential influential factors for ADRs in MPP children. RESULTS A total of 1 325 MPP children were included. Out of 24 designed triggers， 14 were positive， with a positive trigger rate of 58.3%. There were 1 301 positive trigger cases， involving 846 pediatric patients. After assessment， 399 cases of ADRs were identified in 372 pediatric patients， yielding a positive predictive value of triggers at 30.7%. The main types of ADRs were abnormal blood cells （230 cases， 57.6%）， skin and its appendages damage （78 cases， 19.5%）， and gastrointestinal system damage （42 cases， 10.5%）， which predominantly occurred 4 days or more， within 2-3 days and within 2-3 days after medication， respectively. They were more prevalent in pediatric patients aged＞3-10 years （295 cases， 79.3%）. The major categories of drugs associated with ADRs included intravenous corticosteroids （209 cases）， cephalosporins （180 cases）， macrolides （38 cases）， tetracyclines （28 cases） and traditional Chinese medicine （TCM） injections （28 cases）. These ADR reports were classified into 3 types： 1 serious case， 394 general cases and 4 new cases. In terms of causality assessment， 1 case was assessed as certain， 19 cases as probable， and 379 cases as possible. In terms of ADR outcomes， 151 cases fully recovered， while the outcomes for 248 cases remained unknown. Univariate analysis and multivariate Logistic regression analysis revealed that a history of allergies [OR＝5.231， 95%CI （2.004， 13.656）， P＜0.05]， the number of medications used [OR＝1.064， 95%CI （1.027， 1.103）， P＜0.05]， and intravenous corticosteroid administration [OR＝3.223， 95%CI （2.341， 4.437）， P＜0.05] were independent risk factors of ADRs in pediatric patients with MPP. The use of azithromycin [OR＝0.544， 95%CI （0.376， 0.786）， P＜0.05] was identified as an independent protective factor against the occurrence of ADRs in pediatric patients with MPP. CONCLUSIONS Children with MPP in our hospital exhibit a higher incidence of ADRs， primarily involving abnormal blood cells， skin and its appendages damage， and gastrointestinal system damage. A history of allergies， the number of medications used， intravenous corticosteroid administration， and the use of azithromycin are associated with the occurrence of ADR in MPP pediatric patients. |
| 期刊： | 2025年第36卷第22期 |
| 作者： | 王月峰；高强；秦柯 |
| AUTHORS： | WANG Yuefeng，GAO Qiang，QIN Ke |
| 关键字： | 肺炎支原体肺炎；儿童；药品不良反应；安全性；影响因素 |
| KEYWORDS： | Mycoplasma pneumoniae pneumonia； children； adverse drug reaction； safety； influential factors |
| 阅读数： | 2 次 |
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