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作 者 ：苏莉雅,李应昆,吕斌,吉海旺,丁红,胡铃香,方素钦,梁晖,曹小菊,王忠

期 刊 ：中国中药杂志 2011年 36卷 11期 页码：1530.

关键词：脑心通；中风；脑梗塞；气虚血瘀证；疗效；非劣效性；

Keywords:Naoxintong capsule, stroke, cerebral, infarction, Qi-deficiency and blood-stasis syndrome, effect non-inferiority, efficacy,

摘 要 ：目的: 研究脑心通胶囊治疗中风病恢复期气虚血瘀证(脑梗塞)的有效性和安全性,并与阳性药通心络胶囊作非劣分析。 方法 :以通心络胶囊为对照,进行随机、双盲、对照、多中心临床试验。评价指标有中风病积分值的减少,中医证候的变化,患者生活能力状态(病残程度)的改善,中国脑卒中量表(CSS),日常生活活动(DAL)量表及Barthel指数(BI)记分。 结果 :两组总疗效、中医症候等比较均无显著的统计学意义。 结论 :脑心通胶囊对中风恢复期,气虚血瘀证(脑梗塞)具有治疗作用,且较为安全。

Abstract:Objective : To study the efficacy and safety of Naoxintong capsule treatment of stroke recovery with Qi-deficiency and blood-stasis syndrome (cerebral infarction), and to compared the non-inferiority analysis with the positive drug Tongxinluo capsule. Method : Taking Tongxinluo capsules as control, randomized, double-blind, controlled, multi-center clinical experiments were studied. The evaluating indexes included the decrease of integral value of stroke patients, changes in traditional Chinese medicine, the improvement of the patient viability status (disability level), Chinese stroke scale (CSS), activities of daily living (DAL) scale and barthel index (BI ) points. Result : The total effect of the two groups, Chinese and other symptoms, showed no significant statistical significance. Conclusion : Naoxintong capsule stroke recovery, with Qi-deficiency and blood-stasis syndrome (cerebral infarction) has a therapeutic effect, and more secure.

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