自拟柔肝熄风汤对肝阳上亢型偏头痛预防性治疗疗效的临床研究

发布时间：2018-06-23 22:26

本文选题：自拟柔肝熄风汤 + 肝阳上亢型偏头痛　；参考：《河南中医药大学》2016年硕士论文

【摘要】：目的：本课题通过采用标准对照的研究方法与随机、平行对照的临床试验设计,系统观察自拟柔肝熄风汤在肝阳上亢型偏头痛患者预防性治疗中的有效性和安全性,并通过自拟柔肝熄风汤与已知有效的偏头痛预防性治疗药物盐酸氟桂利嗪胶囊的疗效对比,进一步验证自拟柔肝熄风汤对肝阳上亢型偏头痛预防性治疗的临床疗效,并对其安全性作出客观的评价。为自拟柔肝熄风汤在偏头痛预防性治疗中的推广作初步的临床研究,为中医药在偏头痛预防性治疗中的运用提供一种,安全有效的方法。方法：本课题共观察120例于开封市中医院脑病科门诊就诊的肝阳上亢型偏头痛患者。采用SPSS软件产生随机数字及编码,按1：1的比例设对照组和试验组,其中试验组60例,对照组60例,试验组与对照组疗程均为8崩,疗程结束后随访4周。试验组的偏头痛患者内服自拟柔肝熄风汤以用于偏头痛的预防性治疗(中药配方颗粒,广东一方制药有限公司,产品批号：1308816,有效期至2016年7月),每日1剂,200-300m1开水冲服,每日2次；对照组的偏头痛患者口服盐酸氟桂利嗪胶囊以用于预防性治疗,由西安杨森制药有限公司生产(国药准字H10930003),主要成分：盐酸氟桂利嗪,1次10mg,每日1次。治疗结束后依据偏头痛患者记录的头痛日记,观察并详细记录治疗开始前4周与治疗结束后4周内头痛发作次数,头痛发作时间,头痛疼痛程度评分、伴随症状及头痛影响测定—6(HIT-6)得分,并根据头痛发作次数；治疗结束后4周内头痛发作总时间；数字疼痛量表测定法头痛程度的平均评分；头痛症状积分及头痛影响测定—6(HIT-6)得分来判定药物的临床治疗效果。结果：经过对试验组与对照组偏头痛患者治疗结束后4周内头痛发作次数、头痛发作总时间、数字疼痛量表测定法头痛程度的平均评分、头痈症状积分及头痛影响测定—6(HIT-6)得分的统计学分析,结果表明自拟柔肝熄风汤能明显降低偏头痛肝阳上亢型患者的头痛次数、减少头痛持续时间、减轻头痛程度,改善患者头痛发作时的症状及头痛对患者生活的负面影响。在偏头痛治疗效果方面,试验组总有效率为90.00%,对照组总有效率为65.00%,两组治疗效果之间的差异具有统计学意义(P=0.010.05),说明自拟柔肝熄风汤在肝阳上亢型偏头痛患者预防性治疗中的疗效强于对照组药物。在治疗后4周内头痛持续时间、头痛程度、症状积分及头痛影Ⅱ响测定—6(HIT-6)得分方面,试验组与对照组之间的差异具有统计学意义(P时间=0.010.05；P程度=0.000.05；P评分=0.000.05;PHIT-6=0.000.05),说明试验组药物在减少头痛持续时间、减轻偏头痛患者头痛发作时头痛程度,降低偏头痛患者头痛发作时症状积分,改善患者头痛发作时的症状及头痛对患者生活的负面影响方面的治疗效果优于对照组药物。在治疗后4周内头痛发作次数方面,试验组与对照组之间的差异无统计学意义(P=0.100.05),说明在改善偏头痛患者头痛发作次数方面,试验组的药物与对照组药物的治疗效果相同。在治疗过程中试验组与对照组的偏头痛患者均无不良反应及不良事件的发生,说明试验组与对照组的药物在治疗过程中安全性相当。结论：自拟柔肝熄风汤能显著改善肝阳上亢型偏头痛患者的症状、体征及头痛对生活的负面影响,是一种安全有效的可用于肝阳上亢型偏头痛预防性治疗的方药。
[Abstract]:Objective: to systematically observe the efficacy and safety of the self-designed Soft Liver Xifeng Decoction in the preventive treatment of migraine patients with hyperactivity of liver Yang type by using a standard controlled study method and a randomized, parallel controlled clinical trial design, and through the self-designed suppressing Soft Liver extinguishing Decoction and the known effective migraine prophylactic treatment of fluorine hydrochloride. To compare the curative effect of Cinnarizine Capsules, further verify the clinical curative effect of self-made Soft Liver Xifeng Decoction on the prophylactic treatment of migraine with hyperactivity of liver Yang, and make an objective evaluation on its safety. Methods: to provide a safe and effective method. Methods: a total of 120 cases of hyperhyperhyperactivity migraine in the clinic of encephalopathy of Kaifeng City Chinese medicine hospital were observed. Random numbers and codes were produced by SPSS software. The control group and test group were set up according to the proportion of 1:1, including 60 cases in the experimental group, 60 cases in the control group, and the course of treatment in the experimental group and the control group. 8 avalanche, followed up for 4 weeks after the end of the course. The migraine patients in the experimental group were given a self-designed Soft Liver quenching Soup for the preventive treatment of migraine (traditional Chinese medicine formula, Guangdong Fang Pharmaceutical Co., Ltd., product batch number: 1308816, valid to July 2016), 1 doses per day, 200-300m1 boiling water, 2 times a day, and a control group of migraine patients. Oral Flunarizine Hydrochloride Capsules for prophylactic treatment, produced by the Xi'an Janssen Pharmaceutical Ltd (Chinese medicine quasi word H10930003), the main ingredient: flunarizine hydrochloride, 1 times 10mg, 1 times a day. After the treatment, the headache diary recorded by the migraine patients was observed and recorded in detail in the first 4 weeks before the treatment and the first 4 weeks after the end of the treatment. The number of pain attacks, the time of the headache, the score of the headache and pain, the score of 6 (HIT-6), the number of headache attacks, the total time of the headache within 4 weeks after the end of the treatment, the average score of the headache degree in the digital pain scale, the score of headache symptoms and the determination of the influence of headache - 6 (HIT-6) Results: the results showed that the number of headache episodes, the total time of headache attack, the average score of headache in the digital pain scale, the score of head carbuncle and the influence of headache, and the impact of headache on the score of 6 (HIT-6) were analyzed in the test group and the control group, and the results showed that the score of the headache was determined in 4 weeks. The self-designed Decoction of suppressing the liver and extinguishing the wind can obviously reduce the number of headache in the patients with migraine liver hyperactivity, reduce the duration of the headache, reduce the degree of headache, and improve the negative effects of the symptoms and headache on the patient's life. In the treatment effect of migraine, the total effective rate of the experimental group is 90%, the total effective rate of the control group is 65%, two. The difference between the therapeutic effects of the group was statistically significant (P=0.010.05), indicating that the therapeutic effect of the self-made Soft Liver Xifeng Decoction in the prophylactic treatment of migraine patients with hyperactivity of liver yang hyperactivity was better than that of the control group. The duration of the headache, the degree of headache, the score of the symptoms and the score of the headache shadow - 6 (HIT-6) in the 4 weeks after the treatment were compared with the experimental group. The differences between the groups were statistically significant (P time =0.010.05; P degree =0.000.05; P score =0.000.05; PHIT-6=0.000.05), indicating that the drug in the test group reduced the duration of the headache, alleviated the degree of headache in the migraine headache, reduced the symptom score of migraine headache, and improved the symptoms of the patient's headache attack. There was no significant difference in the number of headache attacks between the experimental group and the control group within 4 weeks after 4 weeks of treatment (P=0.100.05), indicating the therapeutic effect of the drug and the control group in the improvement of the number of migraine attacks in patients with migraine. In the course of treatment, both the experimental group and the control group had no adverse reactions and adverse events, indicating that the drugs in the test group and the control group were safe in the course of treatment. Conclusion: the self-designed Soft Liver quenching decoction can significantly improve the symptoms, signs and headache of the patients with migraine in the liver yang hyperactivity type migraine. Ringing is a safe and effective prescription for the prevention of migraine with hyperactivity of liver yang.
【学位授予单位】：河南中医药大学
【学位级别】：硕士
【学位授予年份】：2016
【分类号】：R277.7

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