School of Medical Sciences, Faculty of Medicine and Health, Örebro University, 70182, Örebro, Sweden.
Clinical Epidemiology and Biostatistics, School of Medical Sciences, Örebro University, 70182, Örebro, Sweden.
Crit Care. 2019 Jul 3;23(1):241. doi: 10.1186/s13054-019-2528-0.
Epidemiologic data have shown an increasing incidence and declining mortality rate in sepsis. However, confounding effects due to differences in disease classification might have contributed to these trends. To assess if a declining mortality over time could be supported by data derived from high-quality prospective studies, we performed a meta-analysis using data from randomised controlled trials (RCTs) on sepsis. The primary aim was to assess whether the mortality in sepsis trials has changed over time. The secondary aim was to investigate how many of the included trials could show efficacy of the studied intervention regarding 28-day mortality.
We searched PubMed for RCTs enrolling patients with severe sepsis and septic shock, published between 2002 and 2016. The included trials were assessed for quality and sorted by date of first inclusion. A meta-analysis was performed to synthesise data from the individual sepsis trials.
Of 418 eligible articles, 44 RCTs on sepsis were included in the analysis, enrolling 13,315 patients in the usual care arm between 1991 and 2013. In this time period, mortality decreased by 0.42% annually (p = 0.04) to give a total decline of 9.24%. In subgroup analyses with adjustments for APACHE II, SAPS II and SOFA scores, the observed time trend was not significant (p = 0.45, 0.23 and 0.98 respectively). Only four of the included trials showed any efficacy with regard to mortality.
Data from RCTs show a declining trend in 28-day mortality in severe sepsis and septic shock patients during the years from 1991 to 2013. However, when controlling for severity at study inclusion, there was no significant change in mortality over time. The number of trials presenting new treatment options was low.
PROSPERO CRD42018091100 . Registered 27 August 2018.
流行病学数据显示脓毒症的发病率不断增加，死亡率不断下降。然而，由于疾病分类的差异造成的混杂效应可能导致了这些趋势。为了评估随着时间的推移死亡率是否呈下降趋势，我们使用脓毒症随机对照试验（RCT）的数据进行了荟萃分析。主要目的是评估脓毒症试验中的死亡率是否随时间发生了变化。次要目的是调查有多少纳入的试验可以显示所研究干预措施对 28 天死亡率的疗效。
我们在 PubMed 上搜索了发表于 2002 年至 2016 年间的纳入严重脓毒症和脓毒性休克患者的 RCT。对纳入的试验进行了质量评估，并按首次纳入的日期进行了分类。对个体脓毒症试验的数据进行了荟萃分析。
在 418 篇符合条件的文章中，有 44 项关于脓毒症的 RCT 被纳入分析，在 1991 年至 2013 年间，常规治疗组共纳入 13315 例患者。在此期间，死亡率每年下降 0.42%（p=0.04），总下降 9.24%。在调整 APACHE II、SAPS II 和 SOFA 评分的亚组分析中，观察到的时间趋势无统计学意义（p=0.45、0.23 和 0.98 分别）。只有 4 项纳入的试验在死亡率方面显示出任何疗效。
RCT 数据显示，在 1991 年至 2013 年期间，严重脓毒症和脓毒性休克患者 28 天死亡率呈下降趋势。然而，在纳入研究时控制严重程度后，死亡率随时间无显著变化。提出新治疗方案的试验数量较少。
PROSPERO CRD42018091100。注册于 2018 年 8 月 27 日。
