背景:创伤性脑损伤(TBI)管理的主要重点是预防继发性损伤。治疗性低温(TH),有针对性的低核心体温的诱导,已被用作TBI中潜在的神经保护剂。本文的目的是综合现有的临床数据,比较TBI中使用TH和使用正常体温。
方法:通过MEDLINE进行了系统搜索,EMBASE,和Cochrane中央对照试验注册,用于随机临床试验,包括与TBI中使用TH相关的一个或多个感兴趣的结果。独立评审员评估了研究质量,并提取了接受TH治疗的TBI患者与接受正常体温治疗的TBI患者的数据。汇总估计,置信区间(CI),并计算所有结局的风险比(RR)或比值比.
结果:来自32项研究的3,909名患者符合分析条件。汇总分析显示,TH对死亡率和功能结局具有显着益处(RR0.81,95%CI0.68-0.96,I2=41%;RR0.77;95%CI0.67-0.88,I2=68%,分别)。然而,基于偏倚风险的亚组分析显示,只有偏倚风险高的研究保持了这种获益.按冷却方法划分时,全身表面冷却和颅骨冷却组的不良功能结局降低(RR0.68,95%CI0.59-0.79,I2=35%;RR0.44,95%CI0.29-0.67,I2=0%),全身静脉或胃降温组无差异。仅在全身表面降温组中观察到死亡率降低(RR0.63,95%CI0.53-0.75,I2=0%,);然而,该组的偏倚研究大多存在高风险.TH的肺炎发生率增加(RR1.24,95%CI1.10-1.40,I2=32%),凝血异常(RR1.63,95%CI1.09-2.44,I2=55%),和心律失常(RR1.78,95%CI1.05-3.01,I2=21%)。一旦被低和高风险的偏见分开,在偏倚风险低的组中,我们发现这些并发症没有差异.死亡率的总体证据质量适中,功能结果,和肺炎,低凝血异常和心律失常。
结论:加上最近的几项随机临床试验和全面的质量评估,我们提供了最新的系统综述和荟萃分析,结论是,就死亡率和功能结局而言,TH并未显示出任何优于常温的获益.
BACKGROUND: The main focus of traumatic brain injury (
TBI) management is prevention of secondary injury. Therapeutic hypothermia (TH), the induction of a targeted low core body temperature, has been explored as a potential neuroprotectant in
TBI. The aim of this article is to synthesize the available clinical data comparing the use of TH with the use of normothermia in
TBI.
METHODS: A systematic search was conducted through MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials for randomized clinical trials including one or more outcome of interest associated with TH use in
TBI. Independent reviewers evaluated quality of the studies and extracted data on patients with TBI undergoing TH treatment compared with those undergoing normothermia treatment. Pooled estimates, confidence intervals (CIs), and risk ratios (RRs) or odds ratios were calculated for all outcomes.
RESULTS: A total of 3,909 patients from 32 studies were eligible for analysis. Pooled analysis revealed a significant benefit of TH on mortality and functional outcome (RR 0.81, 95% CI 0.68-0.96, I2 = 41%; and RR 0.77; 95% CI 0.67-0.88, I2 = 68%, respectively). However, subgroup analysis based on risk of bias showed that only studies with a high risk of bias maintained this benefit. When divided by cooling method, reduced poor functional outcome was seen in the systemic surface cooling and cranial cooling groups (RR 0.68, 95% CI 0.59-0.79, I2 = 35%; and RR 0.44, 95% CI 0.29-0.67, I2 = 0%), and no difference was seen for the systemic intravenous or gastric cooling group. Reduced mortality was only seen in the systemic surface cooling group (RR 0.63, 95% CI 0.53-0.75, I2 = 0%,); however, this group had mostly high risk of bias studies. TH had an increased rate of pneumonia (RR 1.24, 95% CI 1.10-1.40, I2 = 32%), coagulation abnormalities (RR 1.63, 95% CI 1.09-2.44, I2 = 55%), and cardiac arrhythmias (RR 1.78, 95% CI 1.05-3.01, I2 = 21%). Once separated by low and high risk of bias, we saw no difference in these complications in the groups with low risk of bias. Overall quality of the evidence was moderate for mortality, functional outcome, and pneumonia and was low for coagulation abnormalities and cardiac arrhythmias.
CONCLUSIONS: With the addition of several recent randomized clinical trials and a thorough quality assessment, we have provided an updated systematic
review and meta-analysis that concludes that TH does not show any benefit over normothermia in terms of mortality and functional outcome.