亚低温治疗急性缺血性脑卒中Meta分析

摘要

目的：系统评价国外亚低温治疗急性缺血性脑卒中(Acute ischemic stroke, AIS)安全性和疗效。方法计算机检索Cochrane Library、Pubmed、Embase、Ovid和Medline数据库(均截至2015年1月)，查找所有关于亚低温辅助治疗急性缺血性脑卒中的随机对照试验(Randomized controlled trial, RCT)的文献，同时手检纳入文献的参考文献。按Cohranne协作网系统评价方法进行评价，并与国内系统评价结果进行比较。结果纳入6个随机对照试验(252例患者)，6个试验进行死亡率随访，Meta分析结果显示亚低温治疗不增加远期病死率[RR=1.12，95%CI：0.62~2.05，P=0.70]。6个试验均报道并发症，主要的并发症是肺炎[RR=3.30，95%CI：1.48~7.34， P=0.003]，无严重并发症。国内研究显示亚低温治疗不增加病死率，但肺炎和心率失常风险增加，结果与本研究基本一致。2个试验采用NIHSS评分评估神经功能缺损(120例患者)的Meta分析结果显示，亚低温治疗未改善患者神经功能[WMD=0.78，95%CI：-0.22~1.77，P=0.13]；5个试验采用mRS量表评估神经功能预后结局(227例患者)的Meta分析结果显示亚低温未提高患者预后功能[RR=0.85，95%CI：0.56~1.29，P=0.46]。国内研究显示亚低温治疗可以改善患者神经功能预后。结论国内外Meta分析结果均提示亚低温治疗不增加远期的死亡率，同时不良反应较少，但亚低温治疗的有效性存在一定差异，需要进一步研究。%Objective To assess the safty and efficacy of therapeutic hypothermia for acute ischemic stroke. Methods We collected randomized controlled trials (RCTs), which compared therapeutic hypothermia with normo-thermia in patients with acute ischemic stroke, by searching Cochrane Library, PubMed, Ovid and Medline database (from inception to January 2015). The references of the included RCTs were also searched by hand. Meta-analysis was conducted based on the method recommended by the Cochrane Collaboration, and the results were compared to those of domestic systematic evaluation. Results A total of six RCTs involving 252 patients were eligible for meta-analy-sis, in which all patients accepted long term follow-up of mortality. Meta-analysis showed that therapeutic hypother-mia did not result in increased long-term mortality rate [RR=1.12, 95%CI:0.62~2.05, P=0.70]. Adverse complications were reported in all the 6 RCTs, with pneumonia as the most common complication [RR=3.30, 95%CI:1.48~7.34, P=0.003]. However, no severe adverse events were reported. Domestic studies showed no increase of mortality in hypo-thermia, but the risk of pneumonia and arrhythmias would be enhanced, which were consistent with our study. Me-ta-analysis of 2 RCTs (n=120), in which neurological deficits were assessed by NIHSS, demonstrated that hypother-mia resulted in no improvement in neurological function [WMD=0.78, 95%CI:-0.22~1.77, P=0.13]. Meta-analysis of 5 RCTs (n=227), in which prognosis of neurological function were assessed by mRS, showed that hypothermia result-ed in no significant improvement in the prognosis [RR=0.85, 95%CI:0.56~1.29, P=0.46]. Domestic studies indicated that hypothermia could improve neurological outcome in acute ischemic stroke. Conclusion Overseas and domestic studies all indicates that therapeutic hypothermia does not increase long-term mortality, with less adverse complica-tions. However, further study is needed to confirm the efficacy of therapeutic hypothermia for neurological protection.