益肾调气法治疗肾虚肝郁型抑郁症的多中心、随机、对照临床研究  

Multicenter,Randomized and Controlled Clinical Study on the Treatment of Depression of Kidney Deficiency and Liver Depression with the Method of Benefiting Kidney and Regulating Qi

作　　者：曲淼 孙文军 徐向青[3] 贾竑晓[4] 马云枝[5] 赵建军[6] 唐启盛 Qu Miao;Sun Wenjun;Xu Xiangqing;Jia Hongxiao;Ma Yunzhi;Zhao Jianjun;Tang Qisheng(Xuanwu Hospital of Capital Medical University,Beijing 100053,China;Beijing University of Chinese Medicine Third Affiliated Hospital,Beijing 100029,China;Hospital Affiliated to Shandong University of Chinese Medicine,Jinan 250011,China;Anding Hospital of Capital Medical University,Beijing 100088,China;The First Affiliated Hospital of Henan University of Chinese Medicine,Beijing 450000,China;Affiliated Hospital of Changchun University of Chinese Medicine,Changchun 130021,China)

机构地区：[1]首都医科大学宣武医院,北京100053 [2]北京中医药大学第三附属医院,北京100029 [3]山东中医药大学附属医院,济南250011 [4]首都医科大学附属北京安定医院,北京100088 [5]河南中医药大学第一附属医院,北京450000 [6]长春中医药大学附属医院,长春130021

出　　处：《世界中医药》2019年第7期1710-1713,1718,共5页World Chinese Medicine

基　　金：国家“十一˙五”科技支撑计划项目(2007BAI20B05)

摘　　要：目的:观察益肾调气法中药复方治疗肾虚肝郁型抑郁症的临床疗效。方法:选取2008年1月至2010年12月在全国5家三甲医院和1家精神专科医院收治的抑郁症肾虚肝郁证的患者216例作为研究对象,进行多中心、随机、对照研究,观察组采用益肾调气法中药“颐脑解郁方”,对照组采用盐酸氟西汀,治疗6周,并进行HAMD抑郁量表、中医证候量表疗效评价研究,验证益肾调气法中药的疗效。结果:本研究共纳入患者216例,脱落11例,剔除4例,最终201例完成临床试验。统计结果显示:1)观察组6周有效率为90%,西药组为77%;2)中药起效时间明显快于西药氟西汀组,7天即开始起效,至第2周时有效率达到63.6%,而西药氟西汀组则在2周时有效率仅为18.9%;3)观察组未发现头晕、失眠、胃肠道反应和激发自杀行为及肝肾损害等明显不良反应。结论:益肾调气法中药颐脑解郁方对于肾虚肝郁型抑郁症具有肯定的疗效,具有起效快、疗效好、不良反应小的优势。Objective:To observe the clinical effect of benefiting kidney and regulating qi Chinese medicine compound on depression of kidney deficiency and liver stagnation type. Methods:A total of 216 patients with depression with kidney deficiency and liver stagnation syndrome were enrolled in 5 top-three hospitals and 1 psychiatric hospital from January 2008 to December 2010.A multicenter,randomized,controlled study was conducted.The observation group was treated with benefiting kidney and regulating qi method “Yinao Jieyu Decoction”,and the control group was treated with fluoxetine hydrochloride for 6 weeks.The HAMD Depression Scale and TCM Syndrome Scale Efficacy Evaluation Study was carried out to verify the efficacy of Chinese medicine of benefiting kidney and regulating qi. Results:A total of 216 patients were enrolled in the study,11 were lost,4 were excluded,and 201 patients completed the clinical trial.The statistical results showed that:1)the effective rate of the observation group was 90% at 6 weeks,and that of the western medicine group was 77%. 2)the onset time of Chinese medicine was significantly faster than that of the western medicine fluoxetine group,and it began to take effect in 7 days,reaching to 63.6% until the 2nd week,while the western medicine fluoxetine group had an effective rate of only 18.9% at 2 weeks. 3)The observation group did not show side effects of dizziness,insomnia,gastrointestinal reactions,suicidal behavior and liver and kidney damage. Conclusion:Benefiting kidney and regulating qi Chinese medicine Yinao Jieyu Decoction has a positive effect on kidney deficiency and liver stagnation syndrome depression,and has the advantages of quick onset,good curative effect and small side effects.

关 键 词：益肾调气法 抑郁症 颐脑解郁方 多中心 随机对照 盐酸氟西汀 抑郁量表 中医证候 

分 类 号：R277.7[医药卫生—中医学] R749.41