温阳通脉颗粒治疗缺血性脑血管病（脾肾阳虚型中风）的临床研究

发布时间：2018-07-13 13:20

【摘要】：目的:温阳通脉颗粒、常规西药联合治疗脑缺血性疾病(脾肾阳虚型脑梗死)的临床数据收集、观察,分析和研究该方法的临床疗效,为温阳通脉颗粒在辩证论治、病证结合以及中药的多环节、多途径、多靶点的治疗优势上提供进一步的依据。方法:选取干部神经内科收治的、符合临床观察要求的患者60例(病例来源于安徽中医药大学第一附属医院)为研究对象,采用随机分组法,治疗组(30例)和对照组(30例)。分别设立治疗组(温阳通脉颗粒+常规西药组)、对照组(常规西药组)进行随机对照观察,两组均以4周为一疗程。两组患者临床治疗过程中分别于治疗前、2周、4周后检测相应的观察指标(血流变、凝血),同时观察治疗前后的脑彩超(TCD)变化、神经功能缺损程度(CSS评分)、中医临床证候的变化,并应用统计学对结果进行分析。结果:(1)疗效评估:温阳通脉颗粒在治疗组中医证候积分改善的愈显率为86.7%、总有效率96.7%,其两者的结果均高于对照组的60.0%和73.3%(p0.01或p0.05);温阳通脉组在体征、症状、中医证候各积分均较单纯西药组有显著的改善(p0.01或p0.05),尤其是在减少神经功能缺损的评分与对照组比较差异显著(p0.05);温阳通脉颗粒治疗组临床的愈显率和总有效率(66.7%、90.3%)均高于对照组(36.7%、80.0%),其中临床愈显率与对照组比较差异显著(p0.05)。(2)指标评估:(1)血流变指标方面,温阳通脉治疗组能明显降低各项指标值,其中全血粘度、血浆粘度、红细胞电泳、纤维蛋白原与对照组比较呈显著下降(p0.01或p0.05)。(2)凝血指标方面,治疗组能明显延长PT、APTT、TT,其中PT、APTT与对照组比较差异显著(p0.01)(3)经颅超声血流图检查(TCD)方面,治疗组血流速度参数(Vm)与对照组比较差异显著(p0.05);脉动参数(PI)除了BA与对照组比较差异显著(p0.05),其余组内、组间PI变化差异不显著(p0.05)。(3)安全评估:治疗期间观察两组患者服用药物的毒副反应,并做好详细的记录,其结果均未出现明显的不良反应。而且两组患者在三大常规、肝肾功能、电解质及心电图等各项安全性指标与治疗前相比均没有统计学差异(p0.05),说明温阳通脉颗粒配合西药对患者各项安全指标无不良影响,临床应用是安全的。结论:温阳通脉颗粒联合常规西药在缺血性脑梗死患者的治疗上临床疗效较为显著,对血液流变学、凝血指标较单纯的西药产生较积极的影响,尤其改善症状显著。其作用机制可能是通过中药多途径、多环节、多靶点作用于脑缺血性中风的复杂的病理环节,从而改善微循环、降低机体的高凝状态,从而产生肯定的疗效和独特的优势。
[Abstract]:Objective: to collect clinical data, observe, analyze and study the clinical effect of Wenyang Tongmai granule and routine western medicine in treating cerebral ischemic disease (spleen and kidney yang deficiency cerebral infarction), and to provide dialectical treatment for Wenyang Tongmai granule. The combination of disease and syndromes and the advantages of multi-link, multi-channel and multi-target of traditional Chinese medicine provide further basis. Methods: sixty patients (from the first affiliated Hospital of Anhui University of traditional Chinese Medicine) who were admitted to the Department of Neurology were randomly divided into treatment group (n = 30) and control group (n = 30). The treatment group (Wenyang Tongmai granule routine western medicine group) and the control group (conventional western medicine group) were set up for randomized controlled observation. The two groups were treated with 4 weeks as a course of treatment. In the course of clinical treatment, the corresponding observation indexes (hemorheology, coagulation), changes of brain color Doppler (TCD), degree of nerve function defect (CSS) and clinical syndrome of TCM were detected before and after 2 weeks and 4 weeks of treatment respectively, and the changes of TCM clinical syndromes were also observed before and after treatment, and the changes of brain color Doppler ultrasound (TCD) before and after treatment were also observed. The results were analyzed by statistics. Results: (1) Therapeutic evaluation: the effective rate of Wenyang Tongmai granule in the treatment group was 86.7%, the total effective rate was 96.70.The results of both of them were higher than that of the control group (60.0% or 73.3%, p0.01 or p0.05), and the symptoms and signs of Wenyang Tongmai group were higher than that of the control group (p0.01 or p0.05). The scores of TCM syndromes were significantly improved compared with the control group (p0.01 or p0.05), especially the scores of reducing nerve function defect were significantly different from those of the control group (p0.05), the effective rate and the total effective rate of Wenyang Tongmai granule group (66.7%) were significantly higher than that of the control group (66.7%, 90.3%). All of them were higher than the control group (36.7%), and the clinical recovery rate was significantly higher than that of the control group (p0. 05). (2): (1) the hemorheology index; The blood viscosity, plasma viscosity, erythrocyte electrophoresis and fibrinogen were significantly decreased in the treatment group compared with the control group (p0.01 or p0.05). (2). In the treatment group, there was a significant difference between the PTT APTT and the control group (p0.01). (3) Transcranial ultrasound flow imaging (TCD). The blood flow velocity parameters (VM) of the treatment group were significantly different from those of the control group (p0.05), the pulse parameters (Pi) of the treatment group were significantly different from those of the control group (p0.05) except BA (p0.05). There was no significant difference in Pi between the two groups (p0. 05). (3). During the course of treatment, the toxicity and side effects of the two groups were observed, and detailed records were made. In addition, there was no statistical difference between the two groups in three major routine, liver and kidney function, electrolyte and electrocardiogram (p0.05), which indicated that Wenyang Tongmai granule combined with western medicine had no adverse effect on the safety indexes of the patients. Clinical application is safe. Conclusion: Wenyang Tongmai granule combined with routine western medicine is more effective in the treatment of patients with ischemic cerebral infarction, and has a more positive effect on hemorheology and coagulation index than simple western medicine, especially the improvement of symptoms. The mechanism may be that traditional Chinese medicine acts on the complex pathological links of cerebral ischemic stroke through multiple ways, links and targets, thus improving microcirculation and reducing the hypercoagulability of the body, thus producing positive curative effect and unique advantages.
【学位授予单位】：安徽中医药大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R743

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