病机与证候并重的阴阳分治法治疗肝郁化火型失眠的临床研究

【作者】 丰茂玲；

【导师】 张根明；

【作者基本信息】 北京中医药大学 ， 中医内科学， 2011， 硕士

【摘要】 目的本研究采用临床随机对照试验方案,探讨病机与证候并重的阴阳分治法治疗肝郁化火型失眠的临床疗效。方法对符合诊断标准的肝郁化火型失眠患者49例,随机分为阴阳分治法治疗的试验组26例和辨证论治的对照组23例,试验组予龙胆泻肝汤原方口服,每日一剂,水煎两次,共取汁400ml,晨起、睡前两次分服；同时晨起给予益气维血颗粒20g冲服,睡前予枣仁安神液20ml口服。对照组予龙胆泻肝汤原方口服,每日一剂,水煎两次,共取汁400ml,晨起、睡前两次分服。两组病人均在治疗前和治疗1周后进行匹兹堡睡眠质量指数(PSQI)和改良Epworth思睡量表(mESS)以及自制中医证候评分标准的评定,治疗后按照《中药新药临床研究指导原则》和匹兹堡睡眠质量指数(PSQI)评定其临床疗效。试验结束后,用SPSS 18.0统计软件建立数据库,进行统计学分析,明确试验组和对照组的最终结果。结果本研究的入选病例来源于2009年5月至2010年10月北京中医药大学东直门医院神经内科门诊符合诊断标准的肝郁化火型失眠患者,共49例。以上完成的观察病例中,脱落病例5例,试验组男性11例,女性13例,年龄最小20岁,最大64岁,平均44.58±9.179岁,病程最短者1周,最长者为30年,平均3.75±6.102年；对照组男性9例,女性11例,年龄最小19岁,最大62岁,平均43.40±12.206岁,病程最短者4天,最长者为30年,平均3.95±6.798年。经统计学分析,试验组与对照组在治疗前的一般资料,包括性别、年龄、受教育程度、病程、睡眠时间、入睡时间、是否服用助眠药物、PSQI各因子积分及总分、mESS评分总分及中医证候各因子积分及总分的评分均具有可比性(P>0.05)。治疗后两组PSQI、mESS及中医证候评分总分都得到明显改善,试验组与对照组的临床总有效率分别为91.67%和90%,睡眠质量的临床总有效率分别95.83%和90%,中医证候改善的临床总有效率分别为87.5%和85%,两组疗效的差别均无统计学意义(P>0.05),但试验组mESS评分总分、PSQI评分总分的改善程度优于对照组。试验组平均延长实际睡眠时间2.00小时,平均缩短入睡时间30.42分钟,平均提高睡眠效率19.49%。结论(1)阴阳分治法的试验组与辨证论治的对照组治疗肝郁化火型失眠的临床总疗效类似,但试验组的日间觉醒状态及睡眠质量的改善程度优于对照组。(2)病机与证候并重的阴阳分治法治疗肝郁化火型失眠的方案具有明确的临床和理论基础,临床疗效肯定,方法可行,是治疗失眠症的有效方法。更多还原

【Abstract】 To evaluate the clinical efficacy of the treatment based on difference between the treatment of yin and yang on Liver-fire type insomnia with random clinical research method. MethodRandomly divide 49 patients with liver-fire type of insomnia into two groups which the treatment based on difference between the treatment of yin and yang group included 26 patients and the treatment based on syndrome differentiation group included 23 patients. And the first group is the treatment and the second group is the control group. The treatment group patients take the Longdan xiegan decoction one dose per day. At the same time, the treatment group takes the Qi-dimensional blood particles 20mg in the morning and Zaoren liquid sedative 20ml before going to bed. The control group patients take Longdan xiegan decoction one dose per day. The study carries out an investigation and con tradistinction to the two groups using PSQI, Epworth drowsiness scale, and syndrome scale of TCM. Evaluate the clinical efficacy with Pittsburgh Sleep Quality Index(PSQI) and Doctrine Clinical Study of Traditional Chinese New Drug Curing to Insomnia after the 1 week taking the medicine. After collecting the data, record the data, analyze with SPSS 18.0 statistic softy-ware.These 49 cases patients of Liver-fire type insomnia come from the outpatients of Neurology in the Dongzhimen Hospital of Beijing University of Traditional Chinese Medicine from May 2009 to October 2010. The loss account for 5 cases in all cases. The treatment group includes 11 cases of male patients and 13 patients of female patients, the youngest is 20 years old, the largest is 64 years, the mean age is 44.58±9.179 years, the shortest duration is 1 week, the longest is 30 years, the mean disease duration is3.75±6.102 years. The control group there are 9 male patients andll female patients, the youngest is 19 years old and the largest is 62 years old, the mean age is 43.40±12.206 years, the shortest duration is 4 days and the longest is 30 years, the mean disease duration was 3.95±6.798 years.There is comparability of two group of the age, sex, duration level of education, the sleep time, the time required to fall asleep, each item and total score of PSQI and syndrome scale of TCM of the patients, total score of mESS before therapy (P> 0.05). After treatment the two groups, each item and total score of PSQI and syndrome scale of TCM of the patients, total score of mESS all improved. The total effective rate of the both groups is 91.67% and 90%. The total effective rate of sleep quality is 95.83% and 90% in the both groups. The total effective rate of TCM syndrome rates 87.5% in treatment group and 85% in control group (P>0.05). And there were no significance difference comparing with the total clinical effective. The effect of the decrease of the value of the total of PSQI and mESS in the treatment group is better than the one of the control group (P <0.05).(1) The effect on Liver-fire type insomnia by the treatment based on difference between the treatment of yin and yang is same as the one of the treatment based on syndrome differentiation. But the wakefulness and the quality of sleep in the treatment group is better than the one of the control group.(2) The treatment based on difference between the treatment of yin and yang has a clear clinical and theoretical basis and a positive clinical effect. SO it is an effective method for the treatment of insomnia.更多还原