Anesthesiology and Critical Care Research Center, Isfahan University of Medical Sciences, Isfahan, Iran; Nosocomial Infection Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.
Anesthesiology and Critical Care Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.
Clin Nutr ESPEN. 2023 Jun;55:30-37. doi: 10.1016/j.clnesp.2023.02.025. Epub 2023 Mar 2.
To evaluate the effect of a one-week LactoCare® oral probiotic supplementation on prognostic scores (APACHE II: acute physiology and chronic health evaluation II; SAPS II: simplified acute physiology score II; SOFA: sequential organ failure assessment), C-reactive protein (CRP) levels, and other outcomes in multiple trauma (MT) patients requiring intensive care compared to placebo.
A randomized, double-blind, placebo-controlled clinical trial. The population included MT patients admitted to ICUs of two referral centers in Isfahan, Iran, from December 2021 to November 2022 (registered under IRCT. ir identifier no. IRCT20211006052684N1). LactoCare® and placebo were administered twice daily for one week. Prognostic scores and CRP levels were calculated/measured before and after the dedicated intervention.
There was not a significant difference in APACHE II (p-value = 0.62), SAPS II (p-value = 0.70), SOFA (p-value = 0.71) scores, CRP levels (p-value = 0.25), median hospital days [LactoCare® vs. placebo] (28.00 vs. 22.50, p-value = 0.06), median ICU days (21.00 vs. 18.00, p-value = 0.16), and median days under mechanical ventilation (14.00 vs. 14.50, p-value = 0.74) between the LactoCare® and placebo groups. Also, 28-day mortality and time to discharge did not significantly differ between the two groups.
Evidence from this trial does not support the use of oral probiotic supplementation for MT patients who are admitted to the ICU.
评估为期一周的 LactoCare®口服益生菌补充剂对需要重症监护的多发创伤（MT）患者的预后评分（APACHE II：急性生理学和慢性健康评估 II；SAPS II：简化急性生理学评分 II；SOFA：序贯器官衰竭评估）、C 反应蛋白（CRP）水平和其他结局的影响，与安慰剂相比。
一项随机、双盲、安慰剂对照的临床试验。该人群包括 2021 年 12 月至 2022 年 11 月期间入住伊朗伊斯法罕两个转诊中心 ICU 的 MT 患者（通过 IRCT.ir 标识符 no.IRCT20211006052684N1 注册）。LactoCare®和安慰剂每天两次给药，持续一周。在专门干预前后计算/测量预后评分和 CRP 水平。
APACHE II（p 值=0.62）、SAPS II（p 值=0.70）、SOFA（p 值=0.71）评分、CRP 水平（p 值=0.25）、中位数住院天数[LactoCare®与安慰剂]（28.00 与 22.50，p 值=0.06）、中位数 ICU 天数（21.00 与 18.00，p 值=0.16）和中位数机械通气天数（14.00 与 14.50，p 值=0.74）在 LactoCare®组和安慰剂组之间没有显著差异。此外，两组 28 天死亡率和出院时间也无显著差异。
本试验的证据不支持对入住 ICU 的 MT 患者使用口服益生菌补充剂。
