依达拉奉治疗急性重型颅脑损伤的疗效及安全性的Meta分析

Meta-analysis of the therapeutic efficacy and safety of edaravone for the patients with acute severe traumatic brain injury

目的:系统评价依达拉奉治疗急性重型颅脑损伤的疗效及安全性。方法:计算机检索PubMed、EMbase、Cochrane图书馆临床对照试验资料库、CBMdisc、CNKI和万方数据库,检索时间均从建库至2011年12月。收集依达拉奉治疗急性重型颅脑损伤的随机对照试验(RCT)。对符合纳入标准的临床研究进行质量评价和资料提取后,采用RevMan 5.0软件进行Me-ta分析。结果:共纳入24个RCT,包括1 909例患者。Meta分析结果显示:(1)对Glasgow昏迷评分(GCS)的影响:共纳入12个研究(884例患者),与常规治疗组相比,依达拉奉组能显著升高患者GCS,差异有统计学意义[MD=1.60,95%CI(1.04,2.17)]。(2)对GCS分段在不同范围内的患者数量的影响:共纳入7个研究(486例患者),与常规治疗组相比,依达拉奉组GCS<8分的患者数量少,2组差异有统计学意义[OR=0.46,95%CI(0.31,0.68)];依达拉奉组GCS为9～12分的患者与常规治疗组差异无统计学意义[OR=0.97,95%CI(0.67,1.39)];依达拉奉组GCS为13～15分的患者数量多,差异有统计学意义[OR=2.34,95%CI(1.54,3.56)]。(3)对Glasgow预后评分(GOS)的影响:纳入8个研究(608例患者),与常规治疗组比较,依达拉奉组升高患者GOS,差异有统计学意义[MD=0.80,95%CI(0.49,1.10)]。(4)GOS评分中恢复良好率:纳入9个研究(696例患者),依达拉奉组恢复良好率高于常规治疗组,差异有统计学意义[OR=3.13,95%CI(2.27,4.31)]。(5)不良反应发生率:纳入10个研究(635例患者),依达拉奉组不良反应发生率与常规治疗组差异无统计学意义[OR=1.41,95%CI(0.79,2.50)]。结论:现有的临床研究证据显示,与常规治疗组比较,依达拉奉能显著升高急性重型颅脑损伤患者的GCS、GOS、恢复良好率,不良反应发生率两组无差异,但对远期预后的影响尚需进一步的临床研究。

OBJECTIVE To assess the therapeutic efficacy and safety of edaravone for patients with acute severe traumatic brain injury. METHODS We searched PubMed, EMbase, Central Register of Controlled Trials, CBMdisc, CNKI and Wang-fang database from the date of establishment to December 2011. And collected the randomized controlled trials （RCTs） of edaravone for patients with acute severe traumatic brain injury. Data were extracted and evaluated by two reviewers independently with a designed extraction form. The RevMan 5.0 software was used to carry out statistical analysis. RESULTS Twenty-four randomized trials involving 1909 patients were included. The results of Meta-analyses showed the following facts： edaravone increased significantly Glasgow coma score （GCS） compared to the control group with statistical significance [MD = 1.60, 95 CI （1.04,2. 17）] there was less patients of GCS〈8 in edaravone group than the control group with statistical significance[OR = 0. 46, 95GCI（0.31,0. 68）];there was no difference in patients of CK2S = 9-12 between edaravone group and control group [OR = 0. 97, 95%CI（0. 67,1.39）] ;there was more patients of GCS= ]3-15 in edaravone group than the control group with statistical significance[OR = 2. 34, 95%CI（1. 54,3. 56）]; edaravone increased GOS compared to the control group with statistical significance[MD= 0. 80, 95%CI （0. 49, 1.10）]; edaravone increased good recovery rate compared to the control group with statistical significance[OR = 3. 13, 95 G CI （2. 27,4. 31）]; there was no significant difference in incidence of adverse reactions between edaravone group and control group[OR = 1.41, 95 %CI （0. 79,2. 50）. CONCLUSION The evidence currently available shows that edaravone can increase OCS,GOS and good recovery rate of patients with acute severe traumatic brain injury compared to the control group. There was no difference on incidence of adverse reactions in two groups. However, further high quality and large sample randomized controlled trials should be carried out to evaluate its long-term effectiveness.