解郁安神汤治疗肝火扰心型失眠的临床研究

发布时间：2018-12-30 17:21

【摘要】：目的：通过使用“解郁安神汤”治疗肝火扰心型失眠的随机对照研究,观察“解郁安神汤”的相关疗效。方法：本研究按照非劣性检验公式计算,共需要60例有效病例,考虑到随访过程中可能出现病例脱落,故将样本量扩大10%,按照纳入标准筛选66例患者作为受试对象。试验采用完全随机分组,应用DPS2.0软件指定试验样本数66,分组数2,得到治疗组和对照组相关的对应编号。按照就诊顺序依次将符合纳入标准的66例肝火扰心型失眠患者编号,并依照软件预先设计的分组结果纳入到治疗组和对照组中,每组33人。其中治疗组服用“解郁安神汤”；对照组服用右佐匹克隆片,4周为一个疗程,统计并观察治疗前后两组PSQI评分和中医症候评分变化。结果：经治疗后两组组内在PSQI各成分及总分上较前对比均有显著性差异(P0.01)。PSQI减分率方面,治疗组有效率为83.3%,对照组有效率为93.3%,治疗后两组对比无统计学差异(P0.05)。治疗组和对照组治疗后PSQI各成分、总分组间对比无显著性差异(P0.05)。在治疗后的中医证候总分评定中,两组比较有显著统计学差异(P0.01),治疗组优于对照组。在中医证候的单症状评定中,治疗组在多梦、急躁易怒、胸胁疼痛、口干、小便黄赤的症状改善方面优于对照组,结果具有统计学意义(P0.05),其中,在多梦、急躁易怒、胸胁疼痛、小便黄赤的改善方面具有显著统计学意义(P0.01),而在失眠的单项比较中两组无统计学差异(P0.05)结论：解郁安神汤可以提高肝火扰心型失眠患者的睡眠质量,缩短入睡时间,增加肝火扰心型失眠患者的睡眠时间,改善其睡眠效率、睡眠障碍及日间功能障碍,与右佐匹克隆有相近的疗效。解郁安神汤在多梦、急躁易怒、胸胁疼痛、口干、小便黄赤的中医症状改善方面优于右佐匹克隆。
[Abstract]:Objective: to observe the effect of Jieyu Anshen decoction on insomnia caused by liver fire. Methods: according to the formula of non-inferiority test, 60 effective cases were needed. Taking into account the possibility of cases falling off during the follow-up, the sample size was expanded by 10% and 66 patients were selected as subjects according to the inclusive criteria. The experiment was divided into complete random groups, 66 samples and 2 groups were assigned by DPS2.0 software. The corresponding numbers of the treatment group and the control group were obtained. According to the order of seeing a doctor, 66 cases of insomniacs with liver fire and heart disturbance were enrolled into the treatment group and the control group according to the pre-designed results of the software, with 33 patients in each group. The treatment group took "Jiayu Anshen decoction" and the control group took right zopicone tablet for a course of 4 weeks. The changes of PSQI score and TCM symptom score before and after treatment were statistically observed. Results: after treatment, there were significant differences in the components and total scores of PSQI between the two groups (P0.01). PSQI score reduction rate, the effective rate was 83.3% in the treatment group and 93.3% in the control group). There was no statistical difference between the two groups after treatment (P0.05). There was no significant difference in the components and total scores of PSQI between the treatment group and the control group (P0.05). In the total score of TCM syndromes after treatment, there was significant difference between the two groups (P0.01), the treatment group was better than the control group. In the single symptom evaluation of TCM syndromes, the treatment group was superior to the control group in the improvement of the symptoms of multiple dreams, irritability and irritability, chest and flank pain, dry mouth, and yellow red urine. The results were statistically significant (P0.05), among which, in many dreams, irritability and irritability, The improvement of chest and flank pain and urine yellow red were statistically significant (P0.01). There was no statistical difference between the two groups in the single comparison of insomnia (P0.05) conclusion: Jieyu Anshen decoction can improve the sleep quality of patients with insomnia caused by liver fire, shorten the time to sleep, increase the sleep time of patients with insomnia caused by liver fire. The improvement of sleep efficiency, sleep disorder and daytime dysfunction is similar to that of right zopicron. Jieyu Anshen decoction is superior to right Zopicron in improving TCM symptoms of dreamy, irritable, chest and flank pain, dry mouth and yellow red urine.
【学位授予单位】：成都中医药大学
【学位级别】：硕士
【学位授予年份】：2016
【分类号】：R256.23

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