针对肝郁化热证的证候类中药新药临床评价研究  

Clinical Evaluation Study on Syndrome-Based New Chinese Medicine with Liver Depression of the Heat Syndrome

作　　者：韩芳[1] 范吉平[2] 郭盛楠[3] 曹克刚[1] 姜思竹 高颖[1] Han Fang;Fan Jiping;Guo Shengnan;Cao Kegang;Jiang Sizhu;Gao Ying(Dongzhimen Hospital,Beijing University of Chinese Medicine,Beijing 100700,China;China Academy of Chinese Medical Sciences,Beijing 100700,China;Institute of Acupuncture and Moxibustion,China Academy of Chinese Medical Sciences,Beijing 100700,China;Beijing Hepingli Hospital,Beijing 100013,China)

机构地区：[1]北京中医药大学东直门医院,北京100700 [2]中国中医科学院,北京100700 [3]中国中医科学院针灸研究所,北京100700 [4]北京市和平里医院,北京100013

出　　处：《世界中医药》2018年第7期1633-1636,1640,共5页World Chinese Medicine

基　　金：2012国家公益性行业科研专项(201207009)--证候类中药新药疗效评价方法研究

摘　　要：目的:为探讨证候类中药新药的临床评价方法,采用证病结合的临床研究模式,针对肝郁化热证,选择具有该证候的偏头痛、非器质性失眠和广泛性焦虑障碍患者,评价清肝解郁方对患者证候及生命质量的改善情况。方法:选取2013年07月至2014年12月北京中医药大学东直门医院收治的符合入组标准的患者180例,采用分层随机、阳性药对照的临床试验设计,将患者随机分为观察组和对照组,观察组采用清肝解郁方免煎颗粒进行治疗,偏头痛对照组患者使用天舒胶囊,失眠或焦虑对照组患者使用乌灵胶囊进行治疗。应用《肝郁化热证证候评价量表》对2组患者的证候改善情况进行评价,并采用SF-36生命质量量表评价2组患者生命质量。结果:1)经治疗后,2组患者肝郁化热证证候评分均呈下降趋势,治疗前后证候评分差值的组间比较,差异有统计学意义(P<0.05),观察组下降较对照组更明显;2)治疗前后,2组患者生命质量各维度得分均较治疗前提高,其中社会功能(SF)维度组间比较,差异有统计学意义(P<0.05),观察组改善更明显;3)肝郁化热证证候评分变化与生命质量各维度得分变化的相关性分析提示:生理功能(PF)、生理职能(RP)、精力(VT)、社会功能(SF)、情感职能(RE)与肝郁化热证证候评分变化呈显著正相关。结论:清肝解郁方可改善偏头痛、非器质性失眠及广泛性焦虑障碍患者的肝郁化热证证候,并可提高患者的生命质量。Objective： To explore the clinical evaluation methods of syndrome-based new formulas by adopting the clinical research model which combines with diseases to evaluate the efficacy of Qinggan Jieyu Formula in improving liver depression of the heat and life quality of patients with migraine,non-organic insomnia and generalized anxiety disorder（ GAD）.Methods： In this stratified randomized positive-controlled clinical trial,180 eligible patients were recruited and randomized into experimental group and control group.Patients in the experimental groups received Qinggan Jieyu Herbal Formula Granule for 4 weeks.For the control groups,migraineurs received Tianshu Capsule for 4 weeks and patients with non-organic insomnia or GAD received Wuling Capsule for 4 weeks.The liver depression of the heat syndrome diagnostic scale was used to evaluate the improvement of syndrome,while the SF-36 questionnaire was used to evaluate the quality of life.Results： 1） After each treatment,the scores of the liver depression of the heat syndrome decreased at each visit.When compared the change of syndrome scores before with after treatment,there was a statistical significant difference between groups（ P 〈0.05）.2） After treatment,the scores of each dimension of life quality were raised in both groups and the change of scores between the two groups was statistically significant for the dimension of social function（ SF）.3） The analysis of correlation between change of syndrome and change of each dimension of SF-36 showed that,the physical functioning（ PF）,role physical（ RP）,vitality（ VT）,social functioning（ SF） and role emotional（ RE） were significantly and positively related to the change of syndrome.Conclusion： Qinggan Jieyu Formula can improve the liver depression of the heat syndrome and life quality of patients with migraine,non-organic insomnia and GAD.

关 键 词：证候类中药新药 证病结合 肝郁化热证 清肝解郁方 偏头痛 非器质性失眠 广泛性焦虑障碍 生命质量 

分 类 号：R256.4[医药卫生—中医内科学]