Yao Renqi, Zhu Yibing, Yu Yue, Li Zhixuan, Wang Lixue, Zheng Liyu, Li Jingyan, Huang Huibin, Wu Guosheng, Zhu Feng, Xia Zhaofan, Ren Chao, Yao Yongming
Translational Medicine Research Center, Fourth Medical Center and Medical Innovation Research Division of the Chinese PLA General Hospital, Beijing 100048, China.
Medical Research and Biometrics Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100037, China.
Burns Trauma. 2021 Dec 6;9:tkab040. doi: 10.1093/burnst/tkab040. eCollection 2021.
The objective of this study was to evaluate the clinical efficacy of thiamine and vitamin C with or without hydrocortisone coadministration on the treatment of sepsis and septic shock.
MEDLINE, EMBASE and CENTRAL databases were searched for randomized controlled trials (RCTs) that made a comparative study between the combination therapy of vitamin C and thiamine with or without hydrocortisone and the administration of placebo in patients with sepsis or septic shock. Two reviewers independently performed study selection, data extraction and quality assessment. Both short-term mortality and change in the sequential organ failure assessment (SOFA) score from baseline (delta SOFA) were set as the primary outcomes. Secondary endpoints included intensive care unit (ICU) mortality, new onset of acute kidney injury, total adverse events, ICU and hospital length of stay, duration of vasopressor usage and ventilator-free days. Meanwhile, trial sequential analysis was conducted for primary outcomes.
Eight RCTs with 1428 patients were included in the current study. The results showed no significant reduction of short-term mortality in sepsis and septic shock patients who received combination therapy of vitamin C and thiamine with or without hydrocortisone compared to those with placebo {risk ratio (RR), 1.02 [95% confidence interval (CI), 0.87 to 1.20], = 0.81, = 0%; risk difference (RD), 0 [95% CI, -0.04 to 0.05]}. Nevertheless, the combination therapy was associated with significant reduction in SOFA score [mean difference (MD), -0.63, (95% CI, -0.96 to -0.29, < 0.001, = 0%] and vasopressors duration (MD, -22.11 [95% CI, -30.46 to -13.77], < 0.001, = 6%). Additionally, there were no statistical differences in the pooled estimate for other outcomes.
In the current meta-analysis, the combination therapy of vitamin C and thiamine, with or without hydrocortisone had no impact on short-term mortality when compared with placebo, but was associated with significant reduction in SOFA score among patients with sepsis and septic shock.
本研究的目的是评估硫胺素和维生素C联合或不联合氢化可的松治疗脓毒症和脓毒性休克的临床疗效。
检索MEDLINE、EMBASE和CENTRAL数据库，查找关于脓毒症或脓毒性休克患者中，维生素C和硫胺素联合或不联合氢化可的松的联合疗法与安慰剂给药进行对比研究的随机对照试验（RCT）。两名研究者独立进行研究筛选、数据提取和质量评估。将短期死亡率和序贯器官衰竭评估（SOFA）评分相对于基线的变化（SOFA差值）均设为主要结局指标。次要终点包括重症监护病房（ICU）死亡率、急性肾损伤的新发病例、总不良事件、ICU住院时间和住院时间、血管升压药使用持续时间和无呼吸机天数。同时，对主要结局指标进行试验序贯分析。
本研究纳入了8项RCT，共1428例患者。结果显示，与接受安慰剂治疗的脓毒症和脓毒性休克患者相比，接受维生素C和硫胺素联合或不联合氢化可的松联合疗法的患者短期死亡率没有显著降低{风险比（RR），1.02[95%置信区间（CI），0.87至1.20]，P = 0.81，I² = 0%；风险差（RD），0[95%CI，-0.04至0.05]}。然而，联合疗法与SOFA评分显著降低相关[平均差（MD），-0.63，（95%CI，-0.96至-0.29），P < 0.001，I² = 0%]以及血管升压药使用持续时间缩短相关（MD，-22.11[95%CI，-30.46至-13.77]，P < 0.001，I² = 6%）。此外，其他结局指标的合并估计值无统计学差异。
在当前的荟萃分析中，与安慰剂相比，维生素C和硫胺素联合或不联合氢化可的松的联合疗法对短期死亡率没有影响，但与脓毒症和脓毒性休克患者的SOFA评分显著降低相关。
