Department of Pediatrics, Boston Children's Hospital, Boston, Massachusetts.
Harvard Medical School, Boston, Massachusetts.
Pediatrics. 2024 Aug 1;154(Suppl 1). doi: 10.1542/peds.2024-066588H.
Meningitis is associated with high mortality risk in young infants, yet the optimal treatment regimen is unclear.
To systematically evaluate the efficacy of antibiotic regimens to treat meningitis in young infants aged 0 to 59 days on critical clinical outcomes.
MEDLINE, Embase, CINAHL, WHO Global Index Medicus, and Cochrane Central Registry of Trials.
We included randomized controlled trials (RCTs) of young infants with meningitis (population) comparing the efficacy of antibiotic regimens (interventions) with alternate regimens (control) on clinical outcomes.
We extracted data on study characteristics and assessed risk of bias in duplicate. Grading of Recommendations Assessment, Development, and Evaluation was used to assess certainty of evidence.
Of 1088 studies screened, only 2 RCTs were identified. They included 168 infants from 5 countries and were conducted between 1976 and 2015. Neither study compared current World Health Organization-recommended regimens. One multisite trial from 4 countries compared intrathecal gentamicin plus systemic ampicillin/gentamicin to systemic ampicillin/gentamicin and found no difference in mortality (relative risk, 0.88; 95% confidence interval, 0.41-1.53; 1 trial, n = 98, very low certainty of evidence) or adverse events (no events in either trial arm). Another trial in India compared a 10-day versus 14-day course of antibiotics and found no difference in mortality (relative risk, 0.88; 95% confidence interval, 0.41-1.53; 1 trial, n = 98, very low certainty of evidence) or other outcomes.
Trial data on the efficacy of antibiotic regimens in young infant meningitis are scarce. Rigorous RCTs are needed to inform recommendations for optimal antibiotic regimens for meningitis treatment in this vulnerable population, particularly within the context of changing epidemiology and increasing antimicrobial resistance.
脑膜炎与 0 至 59 日龄婴儿的高死亡率风险相关，但最佳治疗方案仍不明确。
系统评估不同抗生素方案治疗 0 至 59 日龄婴儿脑膜炎的疗效，重点评估这些方案对关键临床结局的影响。
MEDLINE、Embase、CINAHL、世界卫生组织全球医学索引和 Cochrane 临床试验中心注册库。
我们纳入了比较抗生素方案（干预组）与其他方案（对照组）对临床结局影响的随机对照试验（RCT），纳入的研究对象为患有脑膜炎的 0 至 59 日龄婴儿（人群）。
我们提取了研究特征数据并进行了重复评估，采用推荐评估、制定与评估分级系统评估证据确定性。
在筛查的 1088 项研究中，仅确定了 2 项 RCT。这两项 RCT 共纳入了来自 5 个国家的 168 名婴儿，研究时间为 1976 年至 2015 年。这两项研究均未比较当前世界卫生组织推荐的方案。一项来自 4 个国家的多中心 RCT 比较了鞘内注射庆大霉素联合全身氨苄西林/庆大霉素与全身氨苄西林/庆大霉素，发现两组间死亡率（相对风险，0.88；95%置信区间，0.41-1.53；1 项试验，n = 98，极低确定性证据）或不良事件（在任何试验组均未发生不良事件）均无差异。另一项在印度开展的 RCT 比较了 10 天与 14 天疗程的抗生素治疗，发现两组间死亡率（相对风险，0.88；95%置信区间，0.41-1.53；1 项试验，n = 98，极低确定性证据）或其他结局也无差异。
目前关于婴儿脑膜炎抗生素方案疗效的试验数据十分有限。需要开展严格的 RCT 以明确最佳抗生素方案，为这一脆弱人群的脑膜炎治疗提供指导，尤其是在当前流行病学变化和抗菌药物耐药性不断增加的背景下。
