Tang L, Fang J, Wang S N, Weng X H, Li J J, Shang E N
Department of Pharmacy, Suzhou Municipal Hospital, Suzhou 215002, China.
Zhonghua Er Ke Za Zhi. 2016 Sep;54(9):686-91. doi: 10.3760/cma.j.issn.0578-1310.2016.09.011.
To evaluate the clinical efficacy and safety of vancomycin and linezolid for the treatment of gram-positive neonatal bacterial sepsis.
The data of neonates diagnosed as gram-positive bacterial sepsis in neonatology department of Suzhou Municipal Hospital from June 2009 to December 2015 were retrospectively collected. 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 test, and changes of laboratory parameters 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.
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%(93/108) and 88.9%(96/108)(P=0.681), and the microbiologic success rates were 91.7%(99/108) and 93.5%(101/108)(P=0.795). The average trough concentration of vancomycin was (12±8) mg/L. The rate of reaching the high trough concentration standard was only 33.3%(36/108). In 50 (46.3%) cases the dose was adjusted according to the initial concentration data. Compared to less than 10 mg/L, the clinical efficacy of trough concentration in 10-20 mg/L was much higher(93.9%(46/49) vs. 78.6%(33/42), P=0.031). Total bilirubin and platelet count had significant difference between the two-matched groups (34.1(14.9, 91.0)μmol/L vs. 53.0(27.0, 121.6)μmol/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).
The clinical effect of vancomycin and linezolid on gram-positive bacterial sepsis in neonates is comparable. The rate of trough concentration of vancomycin reaching the high trough concentration standard is low, and the clinical efficacy is related to trough concentration. Linezolid have an effect on bilirubin and platelet count, the risk of thrombocytopenia should be monitored closely during linezolid treatment.
评估万古霉素和利奈唑胺治疗革兰阳性菌所致新生儿败血症的临床疗效及安全性。
回顾性收集2009年6月至2015年12月苏州市立医院新生儿科诊断为革兰阳性菌败血症的新生儿资料。将这些新生儿分为万古霉素组和利奈唑胺组。采用倾向得分匹配法（PSM）对基线变量进行匹配，以平衡两组接受万古霉素和利奈唑胺治疗的新生儿。通过卡方检验比较临床和微生物学成功率，并在治疗结束时采用秩和检验直接比较匹配组治疗前后实验室参数的变化。在万古霉素组中，评估万古霉素谷浓度与临床疗效之间的相关性。
万古霉素组和利奈唑胺组分别入选108例和209例；匹配后的利奈唑胺组纳入108例基线特征匹配良好的病例。万古霉素与利奈唑胺治疗的临床成功率分别为86.1%（93/108）和88.9%（96/108）（P = 0.681），微生物学成功率分别为91.7%（99/108）和93.5%（101/108）（P = 0.795）。万古霉素的平均谷浓度为（12±8）mg/L。达到高谷浓度标准的比例仅为33.3%（36/108）。50例（46.3%）根据初始浓度数据调整了剂量。与低于10mg/L相比，谷浓度在10 - 20mg/L时的临床疗效更高（93.9%（46/49）对78.6%（33/42），P = 0.031）。两组匹配后总胆红素和血小板计数有显著差异（34.1（14.9，91.0）μmol/L对53.0（27.0，121.6）μmol/L，P = 0.034；301.0（198.8，416.0）×10⁹/L对195.5（94.0，283.2）×10⁹/L，P = 0.000）。利奈唑胺相关血小板减少症的发生率为13.4%（28例）。
万古霉素和利奈唑胺对新生儿革兰阳性菌败血症的临床疗效相当。万古霉素谷浓度达到高谷浓度标准的比例较低，且临床疗效与谷浓度有关。利奈唑胺对胆红素和血小板计数有影响，利奈唑胺治疗期间应密切监测血小板减少症的风险。
