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奥马环素治疗儿童大环内酯类药物无反应性肺炎支原体肺炎的疗效与安全性

Efficacy and safety of omadacycline in the treatment of macrolide-unresponsive Mycoplasma pneumoniae pneumonia in children
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摘要 目的探讨奥马环素治疗儿童大环内酯类药物无反应性肺炎支原体肺炎(MUMPP)的疗效与安全性。方法回顾性选取2022年1月至2025年6月于新疆医科大学第一附属医院儿内科住院的1~18岁MUMPP患儿作为研究对象,根据初始大环内酯类药物治疗72 h后二次抗生素的选择分为奥马环素组和多西环素组。在常规治疗基础上,奥马环素组患儿静脉输注注射用甲苯磺酸奥马环素2.4 mg/kg(每日1次),多西环素组患儿口服盐酸多西环素片2 mg/kg(每日2次)。比较两组患儿的疗效和安全性,对临床疗效进行单因素分析和多因素Logistic回归分析,并采用亚组分析与多重敏感性分析验证结论的稳健性。结果本研究共纳入284例MUMPP患儿,奥马环素组和多西环素组各142例。在疗效方面,虽然奥马环素组患儿住院时间长于多西环素组(P<0.05),但肺部病灶吸收率和临床疗效均显著高于或优于多西环素组(P<0.05)。多因素Logistic回归分析结果显示,药物(OR=5.300,95%CI:2.526~11.123)、住院时间(OR=1.348,95%CI:1.167~1.556)、用药时间(OR=1.422,95%CI:1.169~1.729)是临床疗效的影响因素(P<0.05)。亚组分析结果显示,在各亚组中,奥马环素的临床疗效均显著优于多西环素(P<0.05);多重敏感性分析结果显示,逆概率加权法校正前后及4个模型(逐步调整变量)的回归系数B均显著大于1(P<0.05)。在安全性方面,两组患儿的不良反应发生率比较,差异无统计学意义(χ^(2)=0.447,P=0.504)。结论在住院及用药时间较长的情况下,奥马环素治疗儿童MUMPP的疗效优于多西环素,且安全性良好。 OBJECTIVE To investigate the efficacy and safety of omadacycline in the treatment of macrolide-unresponsive Mycoplasma pneumoniae pneumonia(MUMPP)in children.METHODS A retrospective study was conducted on children aged 1-18 years old with MUMPP who were hospitalized in the Department of Pediatrics,the First Affiliated Hospital of Xinjiang Medical University from January 2022 to June 2025.According to the selection of secondary antibiotics after 72 h of initial treatment with macrolides,they were divided into the omadacycline group and the doxycycline group.Based on conventional treatment,children in the omadacycline group were given intravenous infusion of 2.4 mg/kg(once daily)of omadacycline tosylate,while children in the doxycycline group were given oral doxycycline hydrochloride tablets at 2 mg/kg(twice daily).The efficacy and safety were compared between the two groups of pediatric patients.Univariate analysis and multivariate Logistic regression analysis were performed on clinical efficacy,and subgroup analysis along with multiple sensitivity analyses were conducted to verify the robustness of the conclusions.RESULTS A total of 284 children with MUMPP were included in this study,with 142 in the omadacycline group and 142 in the doxycycline group.In terms of efficacy,although the hospitalization time of children in the omadacycline group was longer than that in the doxycycline group(P<0.05),the lung lesion absorption rate and clinical efficacy were significantly higher or better than those in the doxycycline group(P<0.05).The results of multivariate Logistic regression analysis showed that medication(OR=5.300,95%CI:2.526-11.123),length of hospital stay(OR=1.348,95%CI:1.167-1.556),and medication duration(OR=1.422,95%CI:1.169-1.729)were influencing factors of clinical efficacy(P<0.05).The subgroup analysis results showed that the clinical efficacy of omadacycline was significantly better than that of doxycycline in all subgroups(P<0.05).The results of multiple sensitivity analysis showed that the regression coefficients B of the four models(gradually adjust variables)before and after inverse probability of treatment weighting were significantly greater than 1(P<0.05).In terms of safety,there was no statistically significant difference in the incidence of adverse drug reactions between the two groups of patients(χ^(2)=0.447,P=0.504).CONCLUSIONS In the case of hospitalization and prolonged medication,the efficacy of omadacycline in treating childhood MUMPP is superior to that of doxycycline,and its safety is good.
作者 朱青梅 王菁 石莉莉 杨东亮 何家伟 沈静 杨建华 ZHU Qingmei;WANG Jing;SHI Lili;YANG Dongliang;HE Jiawei;SHEN Jing;YANG Jianhua(Dept.of Pharmacy/Key Laboratory of Clinical Drug Research in Xinjiang,the First Affiliated Hospital of Xinjiang Medical University,Urumqi 830054,China;Dept.of Public Health and Infection Management,Sixth People’s Hospital of Xinjiang Uygur Autonomous Region,Urumqi 830013,China;School of Pharmacy,Xinjiang Medical University,Urumqi 830054,China)
出处 《中国药房》 北大核心 2026年第4期480-485,共6页 China Pharmacy
基金 新疆维吾尔自治区卫生健康委员会“天山英才”医药卫生高层次人才培养计划(No.TSYC202401A024) 新疆药物临床研究重点实验室开放课题(No.2024XJYWY12)。
关键词 奥马环素 儿童 大环内酯类药物 耐药 肺炎支原体肺炎 临床疗效 安全性 omadacycline children macrolides drug resistance Mycoplasma pneumoniae pneumonia clinical efficacy safety
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