天龙通络胶囊治中风病（脑梗死）恢复期风痰瘀阻证的临床研究

发布时间：2019-03-26 21:09

【摘要】：目的:通过对比患者神经功能缺损程度、日常生活活动能力量表评分、中医证候评分以及血脂、血流流变学等方面,经过药物治疗前后的变化,观察以“熄风祛痰,活血化瘀”为用药指导原则的相关药物治疗中风病(脑梗死)恢复期风痰瘀阻证的临床疗效。方法:一般资料:搜集大量来自湖北省中医院、湖北省人民医院的病例,选取了符合脑梗塞恢复期西医的诊断标准,中医符合中经络风痰瘀阻证诊断及辨证标准的60例,在签署知情同意书的情况下,志愿参加此次临床试验观察。选取病例的一般资料经过统计学检验,存在可比性。治疗方法:采取随机、双盲、安慰剂对照设计方法,随机分配为观察组及对照组各30例,并且同时分别服用基础药品拜阿司匹林肠溶片(0.1g每天一片),予以相关常规及对症治疗。另外观察组:口服天龙通络胶囊,每日3次,一次5颗;对照组:口服天龙通络胶囊安慰剂,每日3次,一次5颗;疗程均为14天,分别进行临床总疗效、NIHSS评分、中医症候评分、日常生活能力(ADL)评分、血脂及血流流变学评分,作为临床疗效性指标评价疗效。将血常规、尿常规、肝肾功能、凝血全套作为安全性指标,在试验前后均做检测,观察不良反应并详细及时记录。统计方法:统计分析采用SPSS17.0统计软件处理,等级资料采用Ridit分析,计数资料采用x2检验或方差分析,计量资料采用t检验或秩和检验进行数据统计。结果:1.治疗前的基线比较,一般资料经过统计学检验,具有可比性。2.就观察组及对照组的疗效观察主要从以下几个方面来进行比较,临床总疗效、NIHSS评分、中医症候评分、日常生活能力(ADL)评分、血脂及血流流变学评分,结果显示差异有统计学意义,(P0.05)。3.安全性评价统计观察组用药前后的血常规、肝肾功能、凝血功能均未见明显差异,且患者未出现不良反应及不适症状,无明显恶化及不良后果,结果表明安全性可。结论天龙通络胶囊联合西医常规治疗中风病(脑梗死)恢复期(风痰瘀阻证)的方法较单纯应用西药的疗效更佳。天龙通络胶囊治疗脑梗死恢复期在改善临床疗效、NIHSS评分、中医症候评分、日常生活能力、血脂、血流流变学等明显优于对照组,在改善中风患者生活质量,减少后遗症,降低整体致残率,减少家庭及社会的巨大经济及心理负担上有一定的优势,同时治疗过程中对患者的肝肾功能、凝血功能等进行统计分析,差异无统计学意义,未出现明显的不良反应及毒副作用,结果显示观察组在改善中风病(脑梗死)恢复期安全性和临床疗效明显优于对照组,具有临床优势,可指导临床。
[Abstract]:Objective: to compare the degree of neurological function defect, the score of activity of daily living scale, the score of TCM syndrome, blood lipid, hemorrheology and so on, after the changes before and after drug treatment, to observe "extinguish wind and remove phlegm," Huoxue Huayu "is the guiding principle of drug use in the treatment of stroke (cerebral infarction) recovery wind phlegm stasis syndrome clinical efficacy." Methods: general data: a large number of cases from Hubei Provincial traditional Chinese Medicine Hospital and Hubei Provincial people's Hospital were collected, and 60 cases which met the diagnostic criteria of western medicine in the recovery period of cerebral infarction were selected, and 60 cases of TCM accorded with the diagnosis and syndrome differentiation standard of wind-phlegm-stasis syndrome of the middle meridian and collateral wind and blood stasis. In the case of signing informed consent, volunteer to participate in the clinical trial observation. The general data of selected cases were statistically tested, and there was comparability. Treatment: a randomized, double-blind, placebo-controlled design was conducted in which 30 patients in the observation group and 30 in the control group were randomly assigned to receive the basic drug aspirin enteric-coated tablets (0.1g / d) at the same time. All patients were treated with routine and symptomatic therapy. In addition, observation group: oral Tianlong Tongluo capsule, 3 times a day, once 5; control group: oral Tianlong Tongluo capsule placebo, 3 times a day, 5 pieces at a time; The course of treatment was 14 days. The total clinical efficacy, NIHSS score, TCM symptom score, ADL (ADL) score, blood lipid and hemorheology score were used to evaluate the curative effect as clinical therapeutic efficacy index. Blood routine, urine routine, liver and kidney function and coagulation were used as safety indexes. The adverse reactions were observed and recorded in time before and after the test. Statistical methods: SPSS17.0 software was used for statistical analysis, Ridit analysis was used for grade data, x2 test or ANOVA was used for counting data, t test or rank sum test was used for data statistics. Results: 1. Baseline comparison before treatment, general data were statistically tested and comparable. 2. The therapeutic effects of the observation group and the control group were compared from the following aspects: total clinical efficacy, NIHSS score, TCM symptom score, (ADL) score, blood lipid and hemorheology score. The results showed that the difference was statistically significant (P0.05). Safety evaluation: there was no significant difference in blood routine, liver and kidney function and coagulation function before and after treatment in the observation group. There were no adverse reactions and discomfort symptoms, no obvious deterioration and adverse consequences in the observation group. The results showed that the safety was good. Conclusion Tianlong Tongluo capsule combined with western medicine is more effective in treating apoplexy (cerebral infarction) recovery stage (wind phlegm stasis syndrome) than using western medicine alone. Tianlong Tongluo capsule is superior to the control group in improving the clinical efficacy, NIHSS score, TCM symptom score, daily living ability, blood lipid and hemorheology in the recovery period of cerebral infarction, and in improving the quality of life of stroke patients and reducing the sequelae. Reducing the overall disability rate, reducing the huge economic and psychological burden of the family and society have certain advantages. At the same time, the patients' liver and kidney function, coagulation function and so on are statistically analyzed in the course of treatment, and there is no statistical significance. There were no obvious adverse reactions and toxic side effects. The results showed that the observation group was superior to the control group in improving the safety and clinical efficacy of stroke (cerebral infarction) in convalescence. It had clinical advantages and could guide clinical practice.
【学位授予单位】：湖北中医药大学
【学位级别】：硕士
【学位授予年份】：2016
【分类号】：R277.7

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