Zhang Bin-Fei, Wang Jiao, Liu Zun-Wei, Zhao Yong-Lin, Li Dan-Dong, Huang Ting-Qin, Gu Hua, Song Jin-Ning
Department of Neurosurgery, the First Affiliated Hospital, Medical School of Xi'an Jiaotong University, Xi'an, Shaanxi Province, China.
Department of Pediatrics, the First Affiliated Hospital, Medical School of Xi'an Jiaotong University, Xi'an, Shaanxi Province, China.
World Neurosurg. 2015 Apr;83(4):567-73. doi: 10.1016/j.wneu.2014.12.010. Epub 2014 Dec 13.
To evaluate the efficacy and safety of therapeutic hypothermia in children with acute traumatic brain injury (TBI).
A systematic literature review using PubMed, Embase, Cochrane Library, Chinese National Knowledge Infrastructure, Wanfang, VIP, and Chinese Biomedical Database was performed to retrieve studies of randomized controlled trials (RCTs) on therapeutic hypothermia for children with TBI published before March 2014. Data extraction and quality evaluation of RCTs were performed by 2 investigators independently. A meta-analysis was performed by RevMan 5.2.7.
There were 7 RCTs comprising 442 children (218 in hypothermia group and 224 in normothermia group). Meta-analysis showed therapeutic hypothermia could increase mortality compared with the normothermia group (relative risk [RR] = 1.84, 95% confidence interval [CI] = 1.15-2.93, P = 0.01). On the Glasgow Outcome Scale (GOS), the following scores did not differ between the hypothermia group and normothermia group: 3-month GOS 4-5 (RR = 0.89, 95% CI = 0.68-1.16, P = 0.39), 3-month GOS 1-3 (RR = 1.19, 95% CI = 0.80-1.76, P = 0.39), 6-month GOS 4-5 (RR = 0.91, 95% CI = 0.78-1.07, P = 0.26), and 6-month GOS 1-3 (RR = 1.18, 95% CI = 0.88-1.59, P = 0.27). Hypothermia did not increase the rate of pneumonia (RR = 0.84, 95% CI = 0.63-1.12, P = 0.23) or bleeding (RR = 0.94, 95% CI = 0.39-2.26, P = 0.89), but the incidence of arrhythmias was higher in the hypothermia group (RR = 2.60, 95% CI = 1.06-6.41, P = 0.04).
No benefit of therapeutic hypothermia in children with TBI is shown in this study; therapeutic hypothermia may increase the risk of mortality and arrhythmia. There is no evidence that therapeutic hypothermia improves prognosis of children with TBI; there is also no evidence that therapeutic hypothermia increases the risk of pneumonia and coagulation dysfunction. These results are limited by the quality of the included studies and need to be considered with caution. Further large-scale, well-designed RCTs on this topic are needed.
评估治疗性低温对急性创伤性脑损伤(TBI)患儿的疗效及安全性。
采用PubMed、Embase、Cochrane图书馆、中国知网、万方、维普和中国生物医学数据库进行系统文献回顾,以检索2014年3月之前发表的关于治疗性低温用于TBI患儿的随机对照试验(RCT)研究。由2名研究者独立进行RCT的数据提取和质量评估。使用RevMan 5.2.7进行荟萃分析。
有7项RCT,共纳入442例患儿(低温治疗组218例,正常体温组224例)。荟萃分析显示,与正常体温组相比,治疗性低温可增加死亡率(相对危险度[RR]=1.84,95%置信区间[CI]=1.15 - 2.93,P=0.01)。在格拉斯哥预后量表(GOS)方面,低温治疗组与正常体温组的以下评分无差异:3个月时GOS 4 - 5分(RR = 0.89,95% CI = 0.68 - 1.16,P = 0.39)、3个月时GOS 1 - 3分(RR = 1.19,95% CI = 0.80 - 1.76,P = 0.39)、6个月时GOS 4 - 5分(RR = 0.91,95% CI = 0.78 - 1.07,P = 0.26)以及6个月时GOS 1 - 3分(RR = 1.18,95% CI = 0.88 - 1.59,P = 0.27)。低温治疗未增加肺炎发生率(RR = 0.84,95% CI = 0.63 - 1.12,P = 0.23)或出血发生率(RR = 0.94,95% CI = 0.39 - 2.26,P = 0.89),但低温治疗组心律失常的发生率更高(RR = 2.60,95% CI = 1.06 - 6.41,P = 0.04)。
本研究未显示治疗性低温对TBI患儿有益;治疗性低温可能增加死亡风险和心律失常风险。没有证据表明治疗性低温可改善TBI患儿的预后;也没有证据表明治疗性低温会增加肺炎和凝血功能障碍的风险。这些结果受纳入研究质量的限制,需谨慎看待。需要进一步开展关于该主题的大规模、设计良好的RCT。