急性缺血性中风综合治疗方案多中心临床试验研究

Clinical trial of comprehensive therapeutic protocal in multicenter on acute ischemic stroke treated with traditional Chinese medicine

关键词:  急性缺血性中风  多中心临床试验  综合治疗方案

Key words:  acute ischemic stroke  multi-center clinical trial  NIHSS

摘要:

[目的] 观察中西医结合综合方案治疗急性缺血性中风的疗效。[方法] 采用前瞻性、多中心、中央随机、平行对照试验的设计方法,606例患者分别用中西医结合综合(试验组274例)和西医加中药安慰剂(对照组263例)治疗,并观察神经功能缺损、生存质量、中医症状体征积分等。[结果] 与对照组比较,试验组患者治疗治疗21d后两组比较,差异有显著性(P<0.05);中医综合治疗方案可以改善患者21、60、90d的症状和体征(P<0.05)。[结论] 中西医结合综合治疗方案对急性缺血性中风有确切疗效,作用靶点在降低神经功能缺损和改善患者症状及体征。

Abstract:

[Objective] To observe the effect of a comprehensive protocol of integrated Chinese and western medicine(ICWM) in treating acute ischemic stroke.[Methods] A multi-center, prospective, random assigned and controlled clinical trial was adopted in 606 patients of acute ischemic stroke. They were divided into the treatment group(274 cases) treated with ICWM protocol, and the control group(263 cases) treated with western medicine plus placebo, and BI, mRS were assessed after treatment.[Results] Compared with the control group, 21 days later the assessment showed that the neurological impairment (national institute of health stroke scale, NIHSS) rate was lower(P<0.05), and the symptoms and signs levels (Stroke Scale of Traditional Chinese Medicine, SSTCM) were improved (P<0.05)in the treatment group and those were not observed in the control group.[Conclusions] The ICWM treatment protocol used in this study may improve neural function and symptoms and signs of acute ischemic stroke patients.