纳洛酮治疗急性重症颅脑损伤的Meta分析

Naloxone for the treatment of severe traumatic brain injury: a meta-analysis

目的系统评价纳洛酮治疗急性重症颅脑损伤(sTBI)的临床疗效及安全性。方法通过计算机检索中国生物医学文献数据库(CBM)、维普(VIP)、中国期刊网全文数据库(CNKI)、万方数据库等。纳入纳洛酮对比安慰剂治疗急性重症颅脑损伤的随机对照试验(RCT)进行Meta分析。结果共纳入19个RCT,共2 332例患者。Meta分析结果显示:①早期疗效方面,纳洛酮组对比安慰剂组具有统计学意义:心率异常发生率优势比(OR)为0.30,0.21,0.43,95%可信区间(95%CL);P<0.00001,血压异常发生率[OR=0.25,0.17,0.36,95%CI;P<0.00001],高颅压控制率[OR=0.35,0.23,0.54,95%CI;P<0.00001];②中期疗效:两组患者GCS评分、GOS评分具有显著统计学意义:治疗后10 d GCS评分[OR=1.76,1.55,1.97,95%CI;P<0.00001],语言、运动障碍发生率[OR=0.65,0.43,0.98,95%CI;P=0.04],重残率[OR=0.47,0.30,0.73,95%CI;P=0.0001];③随访死亡率:纳洛酮组明显低于安慰剂组,两组间差异具有显著统计学意义[OR=0.51,0.38,0.67,95%CI;P<0.00001]。结论国内现有的临床随机对照试验研究结果显示,纳洛酮在早期能有效降低呼吸异常、血压异常的发生率,还能有效控制颅内高压症状,在远期可显著改善患者GOS评分、降低死亡率。纳洛酮具有较高的临床实用性和安全性。

Objective The efficacy and safety of naloxone in patients with severe traumatic brain injury are evaluated.Methods The electronic databases,including Chinese Biomedical Literature Database （CBM）,Weipu Database （VIP）,China National Knowledge Infrastructure （CNKI）,were included to collect all randomized controlled trials （RCT） of naloxone on patients with severe traumatic brain injury.The quality of the included trials was assessed and meta-analysis was conducted by RevMan 5.1 software.Results Nineteen RCT were included （2332 cases）.The early efficacy of naloxone for traumatic brain injury showed significantly difference compared with control group （P 〈0.00001）.The GCS and GOS showed there were significant differences between naloxone group and control group.Mortality rates between these two groups showed statistically significant differences （P 〈 0.00001）.Conclusion The results of current clinical randomized controlled trial show that the application of naloxone in the early stage of traumatic brain injury can effectively control the intracranial pressure,significantly improve the long-term prognosis,and reduce the disability and mortality.