曲克芦丁脑蛋白水解物注射液治疗急性脑梗死的随机、单盲和安慰剂对照研究Curative effect and security of troxerutin and cerebroprotein hydrolysate injection in acute cerebral infarction,a multicenter,randomized,single blind and placebo control study
陈海波;梁克山;周绍新;胡风云;特木其乐;陆晖;于明;钟善全;袁栋才;陈文明;文国强;李光来;李维国;
摘要(Abstract):
目的探讨曲克芦丁脑蛋白水解物注射液治疗急性脑梗死的疗效及安全性。方法选取符合入组条件的急性脑梗死患者456例,按1∶3比例随机分为对照组和治疗组,其中治疗组共342例给予曲克芦丁脑蛋白水解物注射液治疗14d,对照组共114例给予灭菌注射用水,两组基础治疗一致。主要疗效观察指标为两组患者发病90d时的改良Rankin量表评价分析无明显残障(0~2级)患者的比例,次要疗效指标为治疗7d、14d后美国国立卫生院神经功能缺损评分(NIHSS)评分较基线降低≥7分者所占百分比和治疗14d、发病后90d Barthel指数评价≥75分者所占百分比。结果治疗组发病90d后无明显残障病例(改良Rankin量表评分0~2级)百分比明显高于对照组(83.92%νs.69.3%,P<0.01);用药14d时治疗组NIHSS评分降低≥7分者所占百分比明显高于对照组(31.37%νs.4.08%,P<0.01);治疗组发病90d后Barthel指数≥75者所占百分比高于对照组(85.38%νs.76.32%,P<0.05)。治疗组和对照组分别发生26例(7.28%)、11例(9.17%)不良反应(一般不良事件),组间比较差异无统计学意义(P>0.05)。结论曲克芦丁脑蛋白水解物注射液可改善急性脑梗死患者的神经功能缺损程度,促进功能恢复,且不良反应少,安全性较好,值得临床推广。
关键词(KeyWords): 曲克芦丁脑蛋白水解物;急性脑梗死;疗效;安全性
基金项目(Foundation):
作者(Author): 陈海波;梁克山;周绍新;胡风云;特木其乐;陆晖;于明;钟善全;袁栋才;陈文明;文国强;李光来;李维国;
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参考文献(References):
- [1]Roger VL,Go AS,Lloyd-Jones DM,et al.Heart disease and stroke statistics—2012update:a report from the American Heart Association[J].Circulation,2012,125(1):188-197.
- [2]Glacet-Bernard A,Coscas G,Chabanel A,et al.A randomized,double-masked study on the treatment of retinal vein occlusion with troxerutin[J].Am J Ophthalmol,1994,15:118(4):421-429.
- [3]Panat NA,Maurya DK,Ghaskadbi SS,et al.Troxerutin,a plant flavonoid,protects cells against oxidative stress-induced cell death through radical scavenging mechanism[J].Food Chem,2016,194:32-45.
- [4]丁胜超,金永成,林贵军,等.大鼠脑挫裂伤半暗带水肿与血-脑屏障破坏的关系[J].中国微侵袭神经外科杂志,2007,12(12):548-551.
- [5]饶明俐.中国脑血管病防治指南[M].第1版.北京:人民卫生出版社,2007.
- [6]Spilker J,Kongable G,Barch C,et al.Using the NIH Stroke Scale to assess stroke patients.The NINDS t-PA Stroke Study Group[J].J Neurosci Nurs,1997,29(6):384-392.
- [7]Gao X,Zhang J,Peng Y,et al.Admission clinical characteristics and early clinical outcomes among acute ischemic stroke patients[J].J Biomed Res,2012,26(3):152-158.
- [8]Lo EH.Experimental models,neurovascular mechanisms and translational issues in stroke research[J].Br J Pharmacol,2008,153(Suppl 1):396-405.
- [9]Green AR.Pharmacological approaches to acute ischaemic stroke:reperfusion certainly,neuroprotection possibly[J].Br J Pharmacol,2008,153(Suppl 1):325-338.
- [10]张微微,郭斌,王艺东,等.普洛迪(曲克芦丁脑蛋白水解物注射液)治疗缺血性卒中的随机、多中心临床研究[J].中国医刊,2006,41(8):39-42.
- [11]邓跃飞,张锦祥,钟伟健,等.曲克芦丁脑蛋白水解物治疗高血压脑出血术后的疗效观察[J].中国医刊,2006,41(5):42-43.
- [12]尤志军.曲克芦丁脑蛋白水解物治疗急性脑梗死的临床研究[J].黑龙江医药,2013,26(6):1043-1044.
- [13]熊百炼,李慧.曲克芦丁脑蛋白水解物联合疏血通治疗急性脑梗死临床疗效观察[J].中国药物经济学,2014,10(03):230-231.
- [14]李娟,马广胜,魏亚洲,等.普洛迪治疗缺血性脑卒中的临床有效性和安全性观察[J].现代中西医结合杂志,2005,14(22):2922-2923.