期刊文献+

依达拉奉注射液治疗急性脑梗死疗效及安全性随机双盲多中心研究 被引量:76

Efficacy and safety evaluation of edaravone injection in treatment of acute cerebral infarction:a multicenter,double-blind,and randomized controlled clinical trial
下载PDF
导出
摘要 目的:观察依达拉奉注射液治疗急性脑梗死的疗效和安全性。方法:采用多中心、随机双盲、安慰剂平行对照试验。急性脑梗死病人202例。治疗组100例,给予依达拉奉30 mg加入氯化钠注射液100 mL, iv,gtt,bid×14 d;对照组102例,给予等量氯化钠注射液10 mL加入氯化钠注射液100 mL,iv,gtt, bid×14 d;2组病人基础治疗相同。治疗前,治疗后d 7,d 14,d 28对2组病人进行神经功能缺损评分和日常生活能力评分,并进行疗效比较。结果:治疗后d 28治疗组和对照组日常生活能力有效率分别为77.0%和27.4%(P<0.000 1),神经功能缺损有效率分别为78.0%和26.5%(P<0.000 1)。治疗组不良事件发生率为4.0%,对照组为6.9%(P>0.05)。结论:依达拉奉注射液能有效改善急性脑梗死病人的神经功能缺损和日常生活能力,未见明显不良反应。 AIM: To evaluate the clinical effects and safety of edaravone injection on acute cerebral infarction (ACI). METHODS: A multicenter, randomized, placebo-controlled, parallel, double-blind trial was carried out on patients with ACI. Two hundred and two patients were randomly allocated to treatment group (n = 100) and control group (n = 102). Besides the basic treatment, the individual in treatment group received edaravone 30 mg dissolved in sodium chloride injection 100 mL, twice a day, for lg d, while that of the control group received similar quantity of sodium chloride injection to those of edaravone group but without edaravone. Before treatment and at 7 th, lg th and 28 th day after treatment, the neurological deficits and activities of daily living (ADL) were evaluated using European Stroke Scale (ESS) and Bathel index respectively. RESULTS: After 28 d of treatment, the effective rates of ADL in treatment group and control group were 77.0 % and 27.4 % respectively (P 〈 0.000 1 ), while those of the neurological deficits (ESS) were 78.0 % and 26.5 % respectively (P 〈 0.000 1). The adverse reactions occurred as 4.0 % and 6.9 % (P 〉 0.05) in the former and later group, showing no significant difference. CONCLUSION: Edaravone injection provides effective improvements for both neurological deficits and ADL in ACI without conspicuous adverse reactions.
出处 《中国新药与临床杂志》 CAS CSCD 北大核心 2007年第2期105-108,共4页 Chinese Journal of New Drugs and Clinical Remedies
关键词 依达拉奉 自由基清除剂 脑梗死 药物评价 双盲法 随机对照试验 odaravone free radical scavengers cerebral infarction drug evaluation double-blindmethod randomized controlled trials
  • 相关文献

参考文献8

  • 1ABE K,YUKI S,KOGURE K.Strong attenuation of ischemic and postischemic brain edema in rats by a novel free radical scavenger[J].Stroke,1988,19(4):480-485.
  • 2WATANABE T,YUKI S,EGAWA M,et al.Protective effects of MCI-186 on cerebral ischemia:possible involvement of free radical scavenging and antioxidant actions[J].J Pharmacol Exp Ther,1994,268 (3):1597-1604.
  • 3各类脑血管疾病诊断要点[J].中华神经科杂志,1996,29(6):379-380. 被引量:33029
  • 4SCHMIDLEY JW.Free radicals in central nervous system ischemia[J].Stroke,1990,21 (7):1086-1090.
  • 5HALLIWELL B.Reactive oxygen species and the central nervous system[J].J Neurochem,1992,59(5):1609-1623.
  • 6顾学兰,高艳坤,孙涛,朱东亚.依达拉奉对脑出血大鼠神经行为学、脑缺血面积及出血量的影响[J].中国新药与临床杂志,2006,25(5):358-361. 被引量:14
  • 7Edaravone Acute Infarction Study Group.Effect of a novel free radical scavenger,edaravone (MCI2186),on acute brain infarction:randomized,placebo-controlled,double blind study at multicenters[J].Cerebrovasc Dis,2003,15 (3):222-229.
  • 8TAKABATAKE Y,UNO E,WAKAMATSU K,et al.The clini cal effect of combination therapy with edaravone and sodium ozagrel for acute cerebral infarction[J].No To Shinkei,2003,55(7):589-593.

二级参考文献9

  • 1顾学兰,丁新生,狄晴,赵忠新,陈家慧,李健华.依达拉奉注射液治疗急性脑梗死的临床疗效评价[J].中国新药与临床杂志,2005,24(2):113-116. 被引量:172
  • 2周庆博,毕建忠,李鲁扬,邵念方,贾青.β-七叶皂甙钠对大鼠脑出血后血SOD、NO、TNF-α的影响[J].山东大学学报(医学版),2005,43(1):44-47. 被引量:11
  • 3WANG J, ROGOVE AD, TSIRKA AE, et al. Protective role of tuftsin fragment 1-3 in an animal model of intracerebral hemorrhage[J]. Ann Neurol, 2003,54 (5) : 655-664.
  • 4CLARK W, GUNION-RINKER L, LESSOV N, et al. Citicoloine treatment for experimental intracerebral hemorrhage in mice [J].Stroke, 1998,29(10) :2136-2140.
  • 5MARTZ D,BEER M,BETZ AL, et al. Dimethylthiourea reduces ischemic brain edema without affecting cerebral blood flow[J]. J Cereb Blood Flow Metab, 1990,10(3):352-357.
  • 6MAYER SA, KESSLER DB, van HEERUM RL, et al. Perilesional and global cerebral blood flow in acute intracerebral hemorrhage : a SPECT study[J]. Nucl Med, 1995,36 Suppl : 52.
  • 7YAMAMOTO M,SHIMA T,UOZUMIT T,et al. A possible role of lipid peroxidation in cellular damages caused by cerebral ischemia and the protective effect of alpha-tocopherol administration[J]. Stroke, 1983,14 (6) : 977-982.
  • 8BANNO M, MIZUNO T, KATO H, et al. The radical scavenger edaravone prevents oxidative neurotoxicity induced by peroxynitrite and activated microglia [J]. Neuropharmacology,2005,48(2):283-290.
  • 9SHICHINOHE H,KURODA S,YASUDA H,et al. Neuroprotecrive effects of the free radical scavenger Edaravone(MCI-186) in mice permanent focal brain ischemia [J]. Brain Res,2004,1029(2):200-206.

共引文献33038

同被引文献768

引证文献76

二级引证文献25249

相关作者

内容加载中请稍等...

相关机构

内容加载中请稍等...

相关主题

内容加载中请稍等...

浏览历史

内容加载中请稍等...
;
使用帮助 返回顶部