息风止痛颗粒治疗偏头痛血虚风动证的临床研究

发布时间：2018-06-08 03:01

本文选题：息风止痛颗粒 + 血虚风动证　；参考：《湖北中医药大学》2016年硕士论文

【摘要】：目的:观察并客观分析评价息风止痛颗粒治疗偏头痛血虚风动证的临床有效性及安全性。方法:本临床试验采用随机、安慰剂平行对照法,将56例中医证型属于血虚风动证的偏头痛患者随机分组,其中试验组42例,对照组14例。试验组给以息风止痛颗粒(由广西强寿药业集团有限公司提供),每次1袋(每袋10克),温开水冲服,每天3次。对照组给以息风止痛颗粒模拟剂(由广西强寿药业集团有限公司提供),每次1袋(每袋10克),温开水冲服,每天3次。可酌情口服应急备用药品布洛芬缓释胶囊,以缓解偏头痛患者剧烈难以忍受的头痛。两组患者治疗的疗程均为28天,观察时间点为入组的第1天(基线)、治疗第14天(访视1)、治疗第28天(访视2)和停药后的第28天(随访),每次观察时间点进行一次临床观察。观察患者的头痛评分、头痛VAS评分、中医证候积分、临床疗效、中医证候疗效、止痛药使用情况等有效性指标;检测生命体征,观察肝肾功能、血尿常规、心电图、不良事件等安全性指标。观察期间所有患者禁止应用偏头痛的其他治疗药物。依据观察指标进行统计学数据处理,然后加以分析和评价。结果:1.头痛症状评分:治疗4周后两组的头痛症状评分各均值和标准差均较基线时降低,两组分别与基线比较差异有统计学意义(P0.05)。治疗4周后两组的头痛症状评分组间比较,差异有统计学意义(P0.05)。停药4周后,两组患者的头痛症状评分的均值、标准差均有增加,但仍低于基线,对两组的头痛症状评分进行组间、组内对比,差异均无统计学意义(P0.05)。2.头痛VAS评分:治疗4周后两组治疗前后头痛VAS评分较基线均有减少,P0.01,差异有统计学意义。组间比较,治疗后治疗组与对照组之间头痛VAS评分评分,差异具有显著性(P0.05)。3.单项中医证候积分:在治疗4周后两组患者的单项中医症状积分的均值和标准差均比基线时低,差异有统计学意义(P0.05)。组间比较,试验组降低比对照组降低明显(P0.05)。停药4周后,对两组的各种单项中医症候积分进行组间、组内对比,差异均无统计学意义(P0.05)。4.使用止痛药情况:两组在治疗4周时止痛药使用的次数、剂量均较基线时减少(P0.05)。对两组患者治疗4周后进行组间比较,发现两组患者止痛药使用情况差异不明显(P0.05)。5.临床疗效:试验组的临床有效率为83.33%,对照组为42.86%,试验组高于对照组,经秩和检验差异有统计学意义(P0.05)。6.中医临床疗效:试验组的中医证候有效率为85.71%,对照组为57.14%,试验组高于对照组,经秩和检验差异有统计学意义(P0.05)。7.安全指标:试验研究期间,两组患者的肝肾功能、血常规、尿常规等安全性观察指标均良好;两组患者的生命体征在访视和随访期均无明显波动,平稳良好;且两组所有患者均未见明显不良反应。结论:息风止痛颗粒可以安全、有效的治疗偏头痛血虚风动证,能明显降低偏头痛血虚风动证患者的头痛症状评分、头痛VAS评分、中医证候积分;可有效减少患者止痛药的使用次数和剂量;具有良好的临床疗效和中医证候疗效。本临床研究期间所有患者均未见明显不良反应,也未见肝肾功能损害现象。
[Abstract]:Objective: To observe and objectively evaluate the clinical effectiveness and safety of xanfeng Zhitong granule in the treatment of migraine blood deficiency syndrome. Methods: This clinical trial was randomized into a randomized, placebo parallel control method. 56 cases of migraine were randomly divided into 42 cases in the experimental group and 14 cases in the control group. Feng Zhitong granule (provided by Guangxi Qiang Shou Pharmaceutical Group Co., Ltd.), 1 bags (10 grams per bag) each time, warm boiled water, 3 times a day. The control group is provided with interest wind analgesic granule simulant (provided by Guangxi Qiang Shou Pharmaceutical Group Co., Ltd.), 1 bags (10 grams per bag) each time, warm boiled water, 3 times a day. The sustained release capsule was used to relieve the severe headache of migraine patients. The treatment course of the two groups was 28 days, the observation time was first days (baseline), the treatment fourteenth days (visit 1), the twenty-eighth days (visit 2) and the twenty-eighth days after the withdrawal (follow up), each observation time point was observed. The headache score of the patients was observed. Headache VAS score, TCM syndrome score, clinical efficacy, TCM syndrome effect, analgesic use and other effective indicators, detection of vital signs, observation of liver and kidney function, hematuria routine, electrocardiogram, adverse events and other safety indicators. During the observation period, all patients are prohibited from using migraine other treatment drugs. According to the observation index to carry out statistics. Data processing, and then analyzed and evaluated. Results: 1. headache symptom score: after 4 weeks of treatment, the mean and standard deviation of the two groups of headache symptoms were lower than the baseline, and the difference between the two groups and the baseline was statistically significant (P0.05). The difference between the two groups of headache symptom scores after 4 weeks was statistically significant (P0.05). After 4 weeks of drug withdrawal, the mean value of the headache symptom score of the two groups increased, but still lower than the baseline. The headache symptom score of the two groups was between groups, and the difference was not statistically significant (P0.05).2. headache VAS score: 4 weeks after treatment, the two groups had less VAS score than the baseline, P0.01, the difference was statistically significant. The difference of VAS score between the treatment group and the control group was significant (P0.05).3. score of TCM syndrome: the mean and standard deviation of the symptom score of the single Chinese medicine symptom in the two groups were lower than that of the baseline after 4 weeks of treatment, and the difference had the significance (P0.05). The comparison between the groups was lower than the control group. The group decreased significantly (P0.05). After 4 weeks of withdrawal, the scores of the various TCM syndrome scores in the two groups were between groups, and the differences were not statistically significant (P0.05).4. used painkillers: the number of painkillers used in the two group at 4 weeks was less than that in the baseline (P0.05). The comparison between the two groups after 4 weeks of treatment was found. The two groups of patients with pain medication were not significantly different (P0.05).5. clinical efficacy: the clinical efficacy of the experimental group was 83.33%, the control group was 42.86%, the test group was higher than the control group, and the difference between the test group and the control group was statistically significant (P0.05) the clinical efficacy of the TCM syndrome in the experimental group was 85.71%, the control group was 57.14%, and the test group was higher than the control group. There were statistically significant (P0.05).7. safety indicators in the control group (P0.05): during the trial study, the liver and kidney function, blood routine, and urine routine were all well observed in the two groups of patients; the two groups of patients had no obvious fluctuations in the visit and follow-up period, and the two groups had no obvious adverse reactions. Conclusion: xanfeng Zhitong granule can be safe and effective in the treatment of migraine blood deficiency syndrome. It can obviously reduce the score of headache symptoms, VAS score of headache and TCM syndrome, which can effectively reduce the use and dose of painkillers, and have good clinical curative effect and TCM syndrome curative effect. This clinical effect. No obvious adverse reactions were observed in all patients during the study period, nor did the liver and kidney function damage occur.
【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

【相似文献】