阿加曲班治疗急性缺血性卒中的系统评价  

A systemic review of argatroban used in acute ischemic stroke

作　　者：孔燕[1] 赵伟佳[1] 廖杨平[1] 苏丽[1] 

机构地区：[1]广西医科大学第一附属医院神经内科,广西南宁530021

出　　处：《中风与神经疾病杂志》2011年第9期800-805,共6页Journal of Apoplexy and Nervous Diseases

摘　　要：目的系统评价阿加曲班治疗急性缺血性卒中的疗效和安全性。方法通过计算机检索、人手检索及向药厂索取资料等方法,全面收集有关阿加曲班治疗急性缺血性卒中的随机对照试验(randomized controlled tri-al,RCT)和半随机对照试验(Quasi-randomized control trial),由两名评价员按纳入标准,进行各自独立检索和筛选文献,并进行资料提取。按Cochrane协作网系统评价的方法进行评价。在严格进行文献质量评价的基础上,使用RevMan5.0软件进行Meta分析。结果最终有10个随机对照试验,1个半随机对照试验复核标准并被录用进行系统分析,它们包括1542例患者,Meta分析显示,阿加曲班治疗组神经功能改善优于安慰剂组[OR2.40,95%CI(1.65,3.49),P<0.00001],神经功能改善优于奥扎格雷组[OR2.01,95%CI(1.02,3.97),P=0.04],神经功能改善优于阿司匹林组[OR2.70,95%CI(1.50,4.85),P=0.0009]。只有2个研究发现有颅内出血病例,进一步对这两个研究进行Meta分析发现,治疗组和对照组比较无统计学显著性差异,表明阿加曲班没有增加患者的颅内出血[OR1.68,95%CI(0.34,8.33),P=0.53]。实验对照试验有2个研究报告了全身性出血的不良反应,分析后发现治疗组和对照组比较差异无统计学意义,表明阿加曲班组没有增加患者的出血并发症[OR4.79,95%CI(0.55,42.07),P=0.16]。阿司匹林对照试验有2个研究报告了全身性出血的不良反应,分析后发现治疗组和对照组比较差异无统计学意义,表明阿加曲班组没有增加患者的出血性并发症[OR1.19,95%CI(0.58,2.45),P=0.64]。结论阿加曲班能有效改善急性缺血性脑卒中患者的神经功能缺损和日常生活能力,降低致残率。阿加曲班用于治疗急性缺血性脑卒中是安全的。然而由于纳入研究证据强度有一定的局限,需要更多高质量、多中心、大样本的随机对照试验进一步验证结论。阿加曲班对远期死亡、复发的疗效尚需进Objectives To assess the efficacy and safety of argatroban used in patients with acute ischemic stroke.Methods All ramdomized controlled trial and quasi-randomized control trial relating the application of argatroban used in acute ischemia stroke were searched and included in systemic review.The search and literature review were done by two persons separately.Meta-analysis was done according to the methods recommended from Cochrane Collaboration and the RevMan5.0 software was applied in data analyses.Results Totally 10 randomized controlled trials and one quasi-randomized controlled trial was selected and 1542 patients were enrolled.Meta-analysis showed that the argatroban treatment group could significantly improve the neurological deficit than placebo group [OR2.40,95%CI(1.65,3.49),P<0.00001].Improvement of neurological deficit showed a better effectiveness of argatroban than Ozagrel Sodium with statistical significance [OR2.01,95%CI(1.02,3.97),P=0.04].Improvement of neurological deficit showed a better effectiveness of argatroban than aspirin with statistical significance [OR2.70,95%CI(1.50,4.85),P=0.0009].Only 2 trials reported that the intracranial hemorrhage(ICH) was found but the significant statistics difference were not proved between the groups[OR1.68,95%CI(0.34,8.33),P=0.53].There were 2 trials in experimental controlled trials that mentioned the onset of systemic hemorrhage in patients.However there was not significantly different between groups respectively.Argatroban did not increase the risk and chance of the systemic hemorrhage after given in patients with acute ischemia stroke [OR4.79,95%CI(0.55,42.07),P=0.16].There were 2 trials in aspirin controlled trials that mentioned the onset of systemic hemorrhage in patients.However there also was not significantly different between groups respectively.Argatroban did not increase the risk and chance of the systemic hemorrhage after given in patients with acute ischemia stroke [OR1.19,95%CI(0.58,2.45),P=0.64].Conclusion Application of argatroban may help

关 键 词：阿加曲班 脑梗死 META分析 系统评价 

分 类 号：R743.3[医药卫生—神经病学与精神病学]