万古霉素和利奈唑胺治疗新生儿革兰阳性菌败血症的临床疗效及安全性评价

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• 英文论文题名：Clinical efficacy and safety of Vancomycin compared with Linezolid for the treatment of neonatal gram-positive bacterial sepsis
• 论文作者：唐莲 ; 方洁 ; 王三南 ; 翁小红 ; 李静静 ; 尚尔宁
• 英文论文作者：Tang Lian ; Fang Jie ; Wang Sannan ; Weng Xiaohong ; Li Jingjing ; Shang Erning
• 年：2016
• 作者机构：苏州市立医院本部药学部;上海交通大学医学院附属瑞金医院药学部;苏州市立医院本部新生儿科;
• 论文关键词：万古霉素 ; 利奈唑胺 ; 新生儿 ; 败血症 ; 倾向匹配分析
• 英文论文关键词：Vancomycin ; Linezolid ; Neonate ; Bacterial sepsis ; Propensity score matching
• 会议召开时间：2016-09-27
• 会议录名称：中国药学会第十三届青年药学科研成果交流会论文集
• 语种：中文
• 分类号：R722.131
• 学会代码：YYWS
• 会议名称：中国药学会第十三届青年药学科研成果交流会
• 会议地点：中国江西南昌
• 主办单位：中国药学会
• 学会名称：中国药学会
• 页数：7
• 文件大小：484k
• 原文格式：O
• 会议级别：全国

摘要

目的:对比分析万古霉素和利奈唑胺治疗新生儿革兰阳性菌败血症的临床疗效,并评估其安全性。方法:回顾性收集苏州市立医院新生儿科诊断革兰阳性菌败血症的患儿,分为万古霉素组和利奈唑胺组,采用倾向匹配分析法平衡两组基线数据,将匹配后的两组采用卡方检验比较临床有效率、革兰阳性菌清除率、万古霉素谷浓度分布与临床有效率的相关性,采用秩和检验比较两组用药前后相关化验指标的变化。结果:共纳入有效病例万古霉素组108例、利奈唑胺组209例,成功匹配两组患儿各108例,万古霉素和利奈唑胺的临床有效率分别为86.1%和88.9%(P=0.537),革兰阳性菌清除率分别为91.7%和93.5%(P=0.603)。万古霉素组初始谷浓度为11.8±8.3um01/L,达标率为33.3%(36/108),46.3%(50/108)进行了剂量调整,谷浓度达标组(10-20mg/L)与低谷浓度组(<10mg/L)的临床有效率差异有统计学意义(93.9%vs 78.6%,P=0.031)。万古霉素组和利奈唑胺组用药后的总胆红素和血小板值相比差异有统计学意义[34.1(14.9,91.0)umol/L vs 53.0(27.0,121.6)umol/L,P=0.034;301.0(198.8,416.0)×10~/L vs195.5(94.0,283.2)×10~9/L,P=0.000)]。209例利奈唑胺组患儿评定利奈唑胺相关性血小板减少有28例(1 3.4%)。结论:万古霉素和利奈唑胺治疗新生儿革兰阳性菌败血症的疗效相当,万古霉素初始谷浓度达标率较低,临床疗效与谷浓度相关。利奈唑胺对血小板和胆红素水平有影响,宜加强用药监测。
Objective To evaluate the clinical efficacy and safety of Vancomycin and Linezolid in the treatment of gram-positive neonatal bacterial sepsis.Methods This study retrospectively collected neonates with diagnosed gram-positive bacterial sepsis in neonatology department of Suzhou Municipal Hospital.These neonates were divided into Vancomycin group and Linezolid group.Propensity score matching(PSM) on baseline variables was used to balance the two groups by identifying a comparable group of neonates who received Vancomycin and Linezolid therapy.Clinical and microbiologic success rates were compared by chi-square,and changes of laboratory indexes before and after treatment at the end of treatment were then directly compared by rank-sum test between the matched groups.In Vancomycin group,correlation between trough concentration of Vancomycin and clinical efficacy were evaluated.Results Totally 108 and 209 cases were respectively selected in Vancomycin and Linezolid groups.108 cases with well-matched baseline characteristics were included in matched Linezolid group.The clinical success rates of Vancomycin vs Linezolid therapy were 86.1%and 88.9%(P=0.537),and the microbiologic success rates were 91.7%and 93.5%(P=0.603).The average trough concentration of Vancomycin was 11.8+8.3umol/L.The rate of reaching the high trough concentration standard was only 33.3%.50(46.3%) cases adjusted the dose according to the initial concentration data.Compared to less than 10 mg/L,the clinical efficacy of trough concentration in10-20 mg/L was much higher(93.9%vs 78.6%,P=0.031).Total bilirubin and platelet count had significant difference between the two-matched groups[34.1(14.9,91.0) umol/L vs53.0(27.0,121.6) umol/L,P=0.034;301.0(198.8,416.0) × 10~9/L vs 195.5(94.0,283.2) ×10~9/L,P=0.000)].The incidence of linezolid related thrombocytopenia was 13.4%(28 cases).Conclusion The clinical effect of gram-positive bacterial sepsis in neonates with Vancomycin was correspond to Linezolid.The rate of trough concentration of Vancomycin reaching the high trough concentration standard was low,and the clinical efficacy was relative to trough concentration.Linezolid had an effect on bilirubin and platelet count,the risk of thrombocytopenia should be monitored closely during linezolid treatment.

引文

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