银丹心脑通软胶囊治疗脑梗死恢复期的疗效观察和评价

发布时间：2018-09-18 18:53

【摘要】：目的:观察银丹心脑通软胶囊治疗大动脉粥样硬化性脑梗死恢复期瘀血阻络证的临床疗效。方法:采用随机、双盲、阳性药和安慰剂平行对照方法,将360例大动脉粥样硬化性脑梗死恢复期的患者且辨证为瘀血阻络证者随机分成3组,分别服用银丹心脑通软胶囊、脑心通胶囊或安慰剂,用药3个月并随访3个月。观察用药后患者生活能力、神经功能缺损程度、残障程度的变化,同时观察药物对动脉狭窄程度的影响,中医证候改善的情况。结果:12周后,试验组中Barthel指数≥75的病例显著多于阳性药组和安慰剂组(77.94%vs.63.57%vs.42.03%,P0.017);NIHSS量表评分较入组前降低≥5分患者比例也显著多于阳性药组和安慰剂组(63.97%vs.52.86%vs.24.64%,P0.017);有64.71%的病例达到无明显残障水平(改良Rankin量表0~2级),显著高于安慰剂组(37.31%,P0.017),与阳性药组比较无统计学意义(59.85%,P0.017);中医证候总有效率为83.09%,显著高于安慰剂组(57.97%,P0.017),与阳性药组相当(77.86%,P0.017);银丹心脑通软胶囊有改善颈动脉狭窄程度的趋势,尚需进一步验证。结论:银丹心脑通软胶囊治疗脑梗死后恢复期-瘀血阻络证,能有效减轻患者中风后的残障程度、神经功能缺损程度,改善中医证候,提高患者生活质量。
[Abstract]:Objective: to observe the clinical effect of Yindan Xinnaotong soft capsule (Yindan Xinnaotong soft capsule) on blood stasis and collaterals obstruction in convalescent stage of atherosclerotic cerebral infarction. Methods: 360 patients with atherosclerotic cerebral infarction in convalescence stage were randomly divided into 3 groups by randomized, double-blind, positive drug and placebo parallel control, and were treated with Yindan Xinnaotong soft capsule, respectively. Naoxintong capsule or placebo was used for 3 months and followed up for 3 months. The changes of the patients' living ability, the degree of nerve function defect and the degree of disability were observed. The influence of drugs on the degree of arterial stenosis and the improvement of TCM syndromes were observed at the same time. It turns out that 12 weeks later, The number of patients with Barthel index 鈮，

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