注射用血塞通治疗脑梗死恢复期瘀血阻滞证的随机对照研究
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摘要
目的:评价注射用血塞通(冻干)治疗脑梗死恢复期瘀血阻滞证的有效性和安全性。方法:采用区组随机、盲法、阳性药/安慰剂平行对照、多中心临床研究的方法,选取2012年10月至2014年1月北京中医药大学东方医院收治的脑梗死恢复期患者282例,随机分为观察组(高剂量) 105例、阳性药对照组35例、低剂量组71例及安慰剂组71例。疗程均为15d。观察各组患者治疗前后美国国立卫生研究所卒中量表(NIHSS)评分、改良Rankin量表(mRS)评分、Barthel指数、中医证候积分、各项生命体征及相关实验室检查的变化,并观察不良反应。结果:观察组在改善NIHSS评分、mRS评分、Barthel指数及中医证候方面疗效皆优于阳性药物组、低剂量组、安慰剂组,差异有统计学意义(P <0. 05);观察组与其他各组比较,能明显改善中医单项症状中下肢不遂、口舌歪斜、舌强言謇或不语、偏身麻木、头痛、头晕、唇色紫暗(P <0. 05)。各组不良反应发生率差异无统计学意义(P> 0. 05)。结论:注射用血塞通(冻干)用于脑梗死恢复期疗效好,安全性较高。
Objective: To evaluate the efficacy and safety of freeze-dried Xuesaitong injection in the treatment of cerebral infarction with blood stasis syndrome at the recovery stage. Methods: A total of 282 subjects who were selected from October 2012 to January2014 in Dongfang Hospital affiliated to Beijing University of Chinese Medicine were randomly divided into experimental( highdose) group,positive drug group,low-dose group and placebo group with a course of treatment of 15 days. Changes in National Institutes of Health Stroke Scale( NIHSS) score,modified Rankin Scale( mRS) score,Barthel index,the efficacy score of traditional Chinese medicine( TCM) syndromes,vital signs,and related laboratory examination of each group were observed. Moreover,adverse reactions were observed. Results: Compared with the positive drug group,low-dose group and placebo group,the efficacy score of NIHSS,mRS,Barthel,and the TCM syndromes in the experimental group improved( P < 0. 05). The experimental group had an advantage of TCM syndromes include paralysis of lower limb,skew of tongue and mouth,stiff tongue,dysphasia and aphasia,hemianesthesia,headache,dizziness,oral dark purple( P < 0. 05). The incidence of adverse reactions showed no statistical differences among each group. Conclusion: Application of freeze-dried Xuesaitong injection in the treatment of cerebral infarction with blood stasis syndrome at the recovery stage presents certain efficacy and high safety.
Objective: To evaluate the efficacy and safety of freeze-dried Xuesaitong injection in the treatment of cerebral infarction with blood stasis syndrome at the recovery stage. Methods: A total of 282 subjects who were selected from October 2012 to January2014 in Dongfang Hospital affiliated to Beijing University of Chinese Medicine were randomly divided into experimental( highdose) group,positive drug group,low-dose group and placebo group with a course of treatment of 15 days. Changes in National Institutes of Health Stroke Scale( NIHSS) score,modified Rankin Scale( mRS) score,Barthel index,the efficacy score of traditional Chinese medicine( TCM) syndromes,vital signs,and related laboratory examination of each group were observed. Moreover,adverse reactions were observed. Results: Compared with the positive drug group,low-dose group and placebo group,the efficacy score of NIHSS,mRS,Barthel,and the TCM syndromes in the experimental group improved( P < 0. 05). The experimental group had an advantage of TCM syndromes include paralysis of lower limb,skew of tongue and mouth,stiff tongue,dysphasia and aphasia,hemianesthesia,headache,dizziness,oral dark purple( P < 0. 05). The incidence of adverse reactions showed no statistical differences among each group. Conclusion: Application of freeze-dried Xuesaitong injection in the treatment of cerebral infarction with blood stasis syndrome at the recovery stage presents certain efficacy and high safety.
引文
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[18]王东华,马斌,孙春燕,等.注射用血塞通(冻干)治疗脑梗死恢复期(瘀血阻滞证)的多中心临床研究[J].现代药物与临床,2017,21(10):1864-1871.
[19]程丽波.血塞通软胶囊治疗脑梗塞临床疗效观察[J].药学与临床,2014,8(6):147.
[2]金瑛,田勇,叶丹,等.护理干预对颅脑外伤保守治疗期间合并大面积脑梗死患者并发症及预后的影响[J].中华现代护理杂志,2014,20(17):2068-2070.
[3]顾志娥.应用临床护理路径对急性脑梗死静脉溶栓治疗的探讨[J].实用临床医药杂志,2014,18(20):25-27.
[4]国家中医药管理局脑病急症协作组.中风病诊断与疗效评定标准(试行)[J].北京中医药大学学报,1996,19(1):55-56.
[5]国家食品药品监督管理局.中药新药临床研究指导原则(试行)[S].北京:中国医药科技出版社,2002.
[6]李勇君,杨媛.脑梗塞超早期静脉溶栓治疗的护理体会[J].医药前沿,2014,21(7):255-256.
[7]易伟,罗娟.脑梗塞超早期静脉溶栓治疗的临床护理观察[J].中国保健营养(上旬刊),2014,24(5):2745-2746.
[8]肖桂荣,王赵伟,朱仁洋,等.丁苯酞注射液联合依达拉奉治疗急性脑梗死的疗效观察[J].中国神经免疫学和神经病学杂志,2016,23(1):51-54.
[9]黄华栋,施伟红,李冬辉,等.丁苯酞胶囊联合刺五加治疗急性脑梗死的临床研究[J].中国临床药理学杂志,2016,32(24):2218-2221.
[10]孙秀芳,马丽,赫文清,等.脑梗死后遗症患者临床综合护理观察[J].中西医结合心血管病(连续型电子期刊),2014,9(13)167-168.
[11]曹祝华,邝艳云,黄伟珠,等.临床护理途径在初次脑梗死患者中的疗效对比分析[J].医学理论与实践,2015,8(13):1100-1102.
[12]方鹏飞,常丽霞,宋渊,等.三七总皂苷临床应用研究进展[J].中医药学报,2016,44(3):120-123.
[13]LIU J J,WANG Y T,QIU L,et al.Saponins of Panax notoginsengchemistry,cellular targets and therapeutic opportunities incardiovascular diseases[J].Expert Opin Investig Drugs,2014,23(4):523-523.
[14]臧妍妍,李卫红,郭晓谨,等.三七总皂苷对拟缺血损伤脑微血管内皮细胞转化生长因子-β、血管内皮生长因子表达的影响[J].云南中医学院学报,2016,39(2):1-4.
[15]程丽波.血塞通软胶囊治疗脑梗塞临床疗效观察[J].药学与临床,2014,8(6):147.
[17]段寅慧,吴敏.三七总皂苷药理研究及临床应用进展[J].中医药信息,2014,31(2):108-110.
[18]王东华,马斌,孙春燕,等.注射用血塞通(冻干)治疗脑梗死恢复期(瘀血阻滞证)的多中心临床研究[J].现代药物与临床,2017,21(10):1864-1871.
[19]程丽波.血塞通软胶囊治疗脑梗塞临床疗效观察[J].药学与临床,2014,8(6):147.