背景:新生儿败血症是新生儿死亡率的主要决定因素。缺乏关于培养阳性脓毒症中抗生素使用持续时间的循证指南。
目的:本研究的目的是比较10天和14天抗生素治疗培养阳性新生儿败血症的疗效。
方法:这项随机对照试验在2023年1月至2023年5月期间,在三级护理中心的新生儿重症监护病房中,对患有培养阳性败血症(抗生素治疗第9天临床缓解迹象)的新生儿进行。有重大先天性异常的新生儿,深层感染,多器官功能障碍,相关的真菌感染/多生物感染和重度出生窒息被排除.将234名新生儿随机分为两组-研究(接受10天的抗生素治疗)和对照组(接受14天的抗生素治疗)。治疗失败,比较两组患者的住院时间和不良反应。p<0.05作为有统计学意义的极限。
结果:研究人群(53.8%的男孩)的出生体重和胎龄中位数为2.424kg(IQR:2.183-2.695)和37.3周(IQR:35.5-38.1),分别。不动杆菌是最常见的分离物种(56,23.9%)。两组的基线特征几乎相似。研究组和对照组的治疗失败相似(3.8%vs.1.7%,p=0.40),住院时间较短[中位数(IQR):14(13-16)与18(17-19)天,p<0.001]。
结论:10天抗生素治疗与14天抗生素治疗的疗效相当,住院时间较短,不良反应没有明显增加。
新生儿败血症是印度等发展中国家新生儿死亡的主要原因。教科书建议对培养阳性的新生儿败血症进行14天的抗生素治疗。然而,这些指南并非严格以证据为基础.长期的抗生素治疗可能与耐药性有关,继发感染和器官损伤。较短疗程的抗生素,如果发现有效,将是有益的,尤其是在像印度这样的资源受限的环境中。因此,本研究的目的是将较短持续时间的抗生素治疗(10天)与常规14天抗生素治疗进行比较.将234例培养阳性脓毒症新生儿随机分为研究组(接受10天的抗生素治疗)和对照组(接受14天的抗生素治疗)。社会人口特征,记录两组的临床和实验室特征以及细菌学特征.两组在基线特征方面具有可比性。其中三分之二患有革兰氏阴性脓毒症,不动杆菌是最常见的分离生物体。研究组和对照组的治疗失败发生率相似。研究组的住院时间明显低于对照组。无论胎龄和生物类型如何,这一观察都是正确的。两组之间的不良反应没有显着差异。然而,这项研究有一定的局限性,因此,在提出短期使用抗生素的一般性建议之前,应进行多中心研究。
Neonatal sepsis is a major determinant of neonatal mortality. There is a scarcity of evidence-based guidelines for the duration of antibiotics in culture-positive sepsis.
The aim of this study was to compare the efficacy of 10- and 14-day antibiotic therapies in the management of culture-positive neonatal sepsis.
This randomized controlled trial was conducted in the neonatal intensive care unit of a tertiary care center among the neonates suffering from culture-positive sepsis (with signs of clinical remission on day 9 of antibiotic) between January 2023 and May 2023. Newborns with major congenital anomaly, deep-seated infections, multi-organ dysfunction, associated fungal infections/infection by multiple organisms and severe birth asphyxia were excluded. Two hundred and thirty-four newborns were randomized into two groups-study (received 10 days of antibiotics) and control (received 14 days of antibiotics). Treatment failure, hospital stay and adverse effects were compared between the two groups. p < 0.05 was taken as the limit of statistical significance.
Median [interquartile range (IQR)] birth weight and gestational age of the study population (53.8% boys) were 2.424 kg (IQR: 2.183-2.695) and 37.3 weeks (IQR: 35.5-38.1), respectively. Acinetobacter was the most commonly isolated species (56, 23.9%). The baseline characteristics of both groups were almost similar. Treatment failure was similar in the study and control groups (3.8% vs. 1.7%, p = 0.40), with a shorter hospital stay [median (IQR): 14 (13-16) vs. 18 (17-19) days, p < 0.001].
Ten-day antibiotic therapy was comparable with 14-day antibiotic therapy in efficacy, with a shorter duration of hospital stay and without any significant increase in adverse effects.
Neonatal sepsis is a major cause of neonatal mortality in developing countries like India. Textbooks recommend 14-day antibiotic treatment for culture-positive neonatal sepsis. However, these guidelines are not strictly evidence based. Prolonged antibiotic treatment might be associated with drug resistance, secondary infections and organ damage. A shorter course of antibiotic, if found effective, would be beneficial especially in the resource-constrained settings like India. Hence, this study was undertaken to compare a shorter duration antibiotic treatment (10 days) with the conventional 14-day antibiotic therapy. Two hundred and thirty-four newborns with culture-positive sepsis were randomized into the study group (received 10 days of antibiotics) and the control group (received 14 days of antibiotics). Socio-demographic characters, clinical and laboratory features and bacteriological profile of both the groups were recorded. Both the groups were comparable in baseline features. Two-thirds of them were suffering from Gram-negative sepsis, Acinetobacter being the most commonly isolated organism. Incidence of treatment failure was similar in the study and control groups. Duration of hospital stay was significantly lower in the study group than in the control group. This observation was true irrespective of gestational age and type of organisms. There were no significant differences in adverse effects between the groups. However, there are certain limitations in the study, and hence, multi-centric research should be undertaken before making generalized recommendations of practising short duration of antibiotics.