Cao Guangna, Zhou Pengxiang, Zhang Hua, Sun Bangkai, Tong Xiaomei, Xing Yan
Department of Pediatrics, Peking University Third Hospital, Beijing 100191, China.
Department of Pharmacy, Peking University Third Hospital, Beijing 100191, China.
Antibiotics (Basel). 2022 Mar 4;11(3):341. doi: 10.3390/antibiotics11030341.
This single-center historical cohort study investigated the effectiveness and safety of extended infusion (EI) compared with short-term infusion (STI) of meropenem in neonatal sepsis. Patient electronic health records from Peking University Third Hospital (1 December 2011−1 April 2021) were screened. Neonates diagnosed with sepsis and treated with meropenem in the neonatal intensive care unit were included (256 patients) as STI (0.5 h, 129 patients) and EI (2−3 h, 127 patients) groups. Three-day clinical effectiveness and three-day microbial clearance were considered the main outcomes. Univariate and multivariate analyses were performed. Baseline characteristics were similar in both groups. EI of meropenem was associated with a significantly higher 3-day clinical effectiveness rate (0.335 (0.180, 0.623), p = 0.001) and 3-day microbial clearance (4.127 (1.235, 13.784), p = 0.021) than STI, with comparable safety. Subgroup analyses showed that neonates with very low birth weight benefited from EI in terms of 3-day clinical effectiveness rate (75.6% versus 56.6%, p = 0.007), with no significant difference in the 3-day clinical effectiveness (85.1% versus 78.3%, p = 0.325) and microbial clearance (6% versus 5%, p > 0.999) rates between 3 h and 2 h infusions. Thus, EI of meropenem may be associated with better effectiveness and comparable safety in treating neonatal sepsis than STI. Nonetheless, historically analyzed safety evaluation might be biased, and these findings need confirmation in randomized controlled trials of larger sample sizes.
这项单中心历史性队列研究调查了美罗培南延长输注（EI）与短期输注（STI）治疗新生儿败血症的有效性和安全性。对北京大学第三医院2011年12月1日至2021年4月1日的患者电子健康记录进行了筛查。纳入在新生儿重症监护病房被诊断为败血症并接受美罗培南治疗的新生儿（256例患者），分为STI组（0.5小时，129例患者）和EI组（2 - 3小时，127例患者）。将三日临床有效性和三日微生物清除率视为主要结局指标。进行了单因素和多因素分析。两组的基线特征相似。与STI相比，美罗培南EI的三日临床有效率（0.335（0.180，0.623），p = 0.001）和三日微生物清除率（4.127（1.235，13.784），p = 0.021）显著更高，安全性相当。亚组分析显示，极低出生体重的新生儿在三日临床有效率方面从EI中获益（75.6%对56.6%，p = 0.007），在2小时和3小时输注之间的三日临床有效率（85.1%对78.3%，p = 0.325）和微生物清除率（6%对5%，p > 0.999）无显著差异。因此，与STI相比，美罗培南EI在治疗新生儿败血症方面可能具有更好的有效性和相当的安全性。尽管如此，基于历史数据的安全性评估可能存在偏差，这些发现需要在更大样本量的随机对照试验中得到证实。
