摘要
目的评价纳洛酮治疗急性中重型颅脑损伤的疗效及安全性。方法通过电子检索和手工检索,运用Cochrane协作网系统评价的方法对纳入使用纳洛酮治疗急性中重型颅脑损伤的随机对照试验(RCT)进行系统评价,共检出32个RCT,其中20个研究符合纳入标准,共2 086例患者。其中常规治疗组1 037例,采用止血、脱水、降颅压、抗炎、营养、预防癫痫、外科手术及其它对症支持治疗;纳洛酮组1 049例,在常规治疗基础上加入纳洛酮治疗。结果纳洛酮组与常规治疗组比较,能显著增加GOS评分的均数,改善患者3个月的预后[WMD=0.74,95%CI(0.57,0.91)];能明显增加GCS评分的均数,改善患者近期的Glasgow昏迷评分[WMD=1.74,95%CI(1.45,2.04)][WMD=1.79,95%CI(1.46,2.13);能明显缩短患者的清醒时间[WMD=-1.03,95%CI(-1.54,-0.52)。6个研究讨论了纳洛酮可能出现的不良反应:包括皮疹、肝肾损害、胃肠道反应及躁动不安等,其不良反应的发生率小于1%。结论本系统评价显示,纳洛酮能明显改善患者近期的疗效及预后,但其远期疗效和安全性还有待更多的多中心、大样本RCT予以证实。
Objective To assess the effectiveness and safety of naloxone for acute moderate and severe brain injury. Methods The method of cochrane systematic review was Used to evaluate the randomized controlled trials （RCTs） of naloxone for acute moderate and severe brain injury. A total of 32 RCTs were identified through date search, and 20 RCTs including 2086 cases were included in the present meta analysis, which consisted of two groups, namely naloxone group and conventional therapy group. The patients （n = 1037） in conventional therapy group were treated with hematischesis, dehydration, anti-infection, surgical operation, anti-epilepsy and stress ulcer therapy. The patients （ n = 1 049 ） in naloxone group were treated with naloxone on the basis of conventional therapy. Results Meta-analysis of glasgow outcome scale after three months of therapy showed Naloxone treatment group and conventional treatment group had statistical significance [ WMD = 0.74,95% CI （0.57,0.91）]. Naloxone treatment group considerably ameliorated prognosis compared with conventional treatment group. Meta-analysis of four trials showed two groups had statistical significance[ RR = 0. 53,95% CI （0.39,0. 71 ） ]. Meta-analysis of Glasgow coma scale showed two groups had statistical significance[ WMD = 1.74,95% CI （1.45,2.04） ] [ WMD = 1.79,95% CI （ 1.46,2.13 ） ] at the Seventh days and tenth days of therapy. Naloxone treatment group considerably improved the recovery of coma than that of conventional treatment group [ WMD = - 1.03,95% CI （ - 1.54, - 0. 52） ]. Only six trials reported the adverse events of Naloxone including skin eruption, renal and hepatic injuries, mania, and so on. While the other trials did not report the adverse events, the incidence rate of adverse events was less than 1.0% ,in addition. Conclusion Meta-regression analysis results suggest that naloxone can significandy improve the recent efficacy and prognosis in patients, but lacking more reliable evidence for long-term follow-up and security, which needed to be verified in further high-quality RCTs.
出处
《中南医学科学杂志》
CAS
2011年第6期669-673,共5页
Medical Science Journal of Central South China
关键词
纳洛酮
急性颅脑损伤
系统评价
naloxone
acute brain injury
systematic review
作者简介
通讯作者：汤石林，电话：0734-8279358，E-mail：strongstone@tona．com
