Referral Neonatal Unit, Department of Pediatrics, Maulana Azad Medical College, New Delhi, 110002, India.
Indian J Pediatr. 2013 Feb;80(2):102-7. doi: 10.1007/s12098-012-0875-9. Epub 2012 Oct 6.
To evaluate the role of dexamethasone therapy in neonatal meningitis in a randomized placebo controlled trial.
The participants were eighty neonates with meningitis randomized to receive dexamethasone or saline placebo. Dexamethasone was started prior to the first dose of antibiotics in the dose of 0.15 mg/kg intravenous 6 hourly for 2 d. Primary outcome measure was mortality. Secondary outcome measures included progression of systemic inflammatory response syndrome (SIRS) up to 48 h, differences in cerebrospinal fluid (CSF) cytokines between baseline levels and 24 h after enrolment and brain stem auditory evoked response (BAER) after 4 to 6 wk of discharge.
Baseline variables were comparable in both the groups. Mortality was significantly decreased in dexamethasone group (p = 0.005) and the absolute risk difference was 27.5 % (95 % CI 9.5-45.8 %). There was a significant reduction in cells per mm(3) (62.5 vs. 100) and proteins (162 vs. 217.5 mg/dl) after 24 h of treatment in the dexamethasone group. IL-1β was significantly reduced after 24 h in dexamethasone group (290 vs 665 pg/ml). TNF- α was significantly lower (157.5 vs 427.5 pg/ml) and sugar significantly higher (50 vs 38 mg/dl) in the dexamethasone group after 24 h. Significant difference was noted between dexamethasone and saline groups in the progression of SIRS.
Dexamethasone significantly reduced fatality, progression of SIRS and CSF inflammatory indices.
在一项随机安慰剂对照试验中评估地塞米松治疗新生儿脑膜炎的作用。
80 例脑膜炎新生儿被随机分为接受地塞米松或生理盐水安慰剂组。地塞米松在首次抗生素治疗前开始,剂量为 0.15mg/kg,静脉内每 6 小时 1 次,共 2 天。主要结局指标为死亡率。次要结局指标包括 48 小时内全身炎症反应综合征(SIRS)的进展、基线水平与入组后 24 小时之间脑脊液(CSF)细胞因子的差异以及出院后 4 至 6 周时脑干听觉诱发电位(BAER)。
两组的基线变量无差异。地塞米松组死亡率显著降低(p=0.005),绝对风险差异为 27.5%(95%CI 9.5-45.8%)。地塞米松组在治疗 24 小时后,细胞数(62.5 与 100)和蛋白(162 与 217.5mg/dl)显著减少。地塞米松组治疗 24 小时后,IL-1β 显著降低(290 与 665pg/ml)。TNF-α 显著降低(157.5 与 427.5pg/ml),糖显著升高(50 与 38mg/dl)。地塞米松组和生理盐水组在 SIRS 的进展方面有显著差异。
地塞米松显著降低了死亡率、SIRS 进展和 CSF 炎症指标。