银丹心脑通软胶囊治疗脑梗死恢复期瘀血阻络证的随机对照研究  

Efficacy of Yindan Xinnaotong Soft Capsule on Cerebral Infarction Reconvalescents of Static Blood Blocking Collaterals Syndrome:a Randomized Controlled Study

作　　者：吴智兵[1] 赵性泉[2] 陈银环[1] 黄坚红[3] 刘振华[4] 江小萍 柯玲玲[6] 宋颍民 王领娣 

机构地区：[1]广州中医药大学第一附属医院脑病科,广州510405 [2]首都医科大学附属北京天坛医院神经内科,北京100050 [3]广东省广州市中医医院神经内科,广州510130 [4]南方医科大学珠江医院神经内科,广州510282 [5]广东省清远市中医院内科,广东511500 [6]广西省柳州市中医院脑病科,广西545001 [7]河南省漯河市中医院脑病科,河南462000 [8]广州博济医药生物技术股份有限公司,广州510635

出　　处：《中国中西医结合杂志》2014年第11期1310-1314,共5页Chinese Journal of Integrated Traditional and Western Medicine

摘　　要：目的评价银丹心脑通软胶囊治疗脑梗死恢复期瘀血阻络证的有效性与安全性。方法采用按中心分层的随机化方法,将118例脑梗死恢复期患者分为银丹心脑通软胶囊组(试验组)和脑心通胶囊组(对照组),每组59例,疗程均为12周。观察两组日常生活能力量表巴氏指数(Bathel-Index,BI)、美国国立卫生研究院卒中量表(National Institutes of Health Stroke Scale,NIHSS)评分、改良Rankin量表(modified Rankin Scale,mRS)分级、中医证候疗效及血脂的变化。结果治疗第12周后与对照组比较,试验组日常生活能力BI指数≥75分的患者比例升高(分别为80.7%、62.5%,P<0.05);与本组治疗前比较,两组治疗后第4、8及12周NIHSS评分均降低(P<0.05),治疗第12周后,试验组神经功能缺损程度NIHSS评分降低≥5分的患者比例高于对照组(分别为80.7%57.14%,P<0.05);中医证候总有效率试验组优于对照组(分别为89.47%、71.43%,P<0.05);两组治疗第12周残障程度mRS≤1、mRS≤2的患者比例及两组治疗前后血脂比较,差异均无统计学意义(P>0.05)。结论银丹心脑通软胶囊用于脑梗死恢复期,在提高日常生活活动能力、减轻患者神经功能缺损和改善中医证候总有效率方面有一定的疗效。Objective To evaluate the efficacy and safety of Yindan Xinnaotong Soft Capsule（ YXSC） on cerebral infarction（ CI） reconvalescents of static blood blocking collaterals syndrome（ SBBCS）. Methods Totally 118 CI reconvalescents of SBBCS were randomly assigned to the test group（ treated by YXSC） and the control group [treated by Naoxintong Capsule（ NC） ],59 in each group. The therapeutic course for all was 12 weeks. Changes of National Institute of Health Stroke Scale（ NIHSS）,Barthel Index（ BI）,modified Rankin Scale（ mRS）,Chinese medical syn-drome scores,and serum lipid indices were observed in the two groups. Results Compared with the control group,the patient proportion of improving activities of daily life by more than or equal to 75 score was elevated（ 80. 7 % vs62. 5 %; P 〈0. 05）. Compared with before treatment in the same group,the NIHSS score decreased at post-treatment4,8,and 12 weeks in the two groups（ P 〈0. 05）. The patient proportion of dropped NIHSS score by more than or equal to 5 score was lowered（ 80. 7 % vs 57. 14 %）,and the total effective rate of improving Chinese medical syndromes was superior in the test group after 12-week treatment（ 89. 47 % vs 71. 43 %,all P 〈0. 05）. After 12-week treatment there was no statistical difference in the patient proportion of lowering mRS lower than or equal to 2 or blood lipids between the two groups（ P 〉0. 05）. Conclusion YXSC showed certain effect in improving activities of daily life,attenuating the neurological impairment,and elevating the total effective rate of improving Chinese medical syndromes in CI patients in the recovery stage.

关 键 词：银丹心脑通软胶囊 脑梗死 恢复期 瘀血阻络证 随机对照研究 

分 类 号：R277.7[医药卫生—中医学]