镇惊泻火颗粒治疗痰热内扰型轻中度焦虑症的随机、双盲、安慰剂对照研究  

Efficacy of Zhenjing Xiehuo Granule on mild-to-moderate anxiety with internal disturbance of phlegm-heat:a randomized,double-blind,placebo controlled trial

作　　者：叶青[1] 袁晓蕾[1] 周洁[1] 袁灿兴[1] 

机构地区：[1]上海中医药大学附属龙华医院脑病科,上海200032

出　　处：《上海中医药杂志》2016年第12期37-40,共4页Shanghai Journal of Traditional Chinese Medicine

基　　金：上海市科委科研计划项目(13401901701);国家自然科学基金面上项目(81673726);上海市卫计委杏林新星人才计划项目(ZY3-RCPY-2-2005)

摘　　要：目的观察镇惊泻火颗粒治疗痰热内扰型轻中度焦虑症的临床疗效。方法将100例痰热内扰型轻中度焦虑症患者随机分为治疗组与对照组,每组50例。治疗组予镇惊泻火颗粒,对照组予安慰剂颗粒。两组疗程均为2个月,观察Hamilton焦虑量表(HAMA)评分、焦虑自评量表(SAS)评分、匹茨堡睡眠质量指数量表(PSQI)评分、中医证候积分的情况及用药安全性。结果 1试验中共脱落7例,最终有93例患者完成试验,其中治疗组为48例,对照组为45例。2组间治疗后比较,HAMA及SAS评分差异有统计学意义,治疗组比对照组进一步降低(P<0.05)。3治疗前后组内比较,两组PSQI评分差异均有统计学意义,均显著降低(P<0.05);组间治疗前后PSQI评分差值比较,差异有统计学意义,治疗组比对照组进一步降低(P<0.05)。4治疗前后组内比较,两组中医证候积分差异均有统计学意义,均显著降低(P<0.05);组间治疗前后中医证候积分差值比较,差异有统计学意义,治疗组比对照组进一步降低(P<0.05)。5组间不良反应发生率比较,差异无统计学意义(P>0.05)。结论镇惊泻火颗粒治疗痰热内扰型轻中度焦虑症的疗效满意,可有效降低患者焦虑程度,改善睡眠质量。Objective To observe the clinical efficacy of Zhenjing Xiehuo Granule on mild-to-moderate anxiety with internal disturbance of phlegm-heat. Methods100 cases of mild-to-moderate anxiety with internal disturbance of phlegm-heat were randomly divided into the treatment group and control group,50 cases in each group. The treatment group was given Zhenjing Xiehuo Granule,and the control group was treated with the placebo granule,with a course of 2 months. The Hamilton anxiety（ HAMA） scale,self-rating anxiety scale（ SAS） score,Pittsburgh sleep quality index（ PSQI） score,TCM syndrome score and medication safety were observed. Results ①93 patients completed the trials in the end,among which 48 in the treatment group and 45 in the control group,7 cases fell off.②Comparison between the two groups after treatment,there were statistically significant differences on the HAMA and SAS scores,and the scores of the treatment group were decreased more significantly than those of the control group（ P〈0. 05）. ③Comparison between the treatment before and after within group,there were statistically significant differences on the PSQI scores in both groups,and the scores were both significantly decreased in the two groups（ P〈0. 05）. Comparison of the difference before and after treatment,there were statistically significant differences on the PSQI scores between the two group,and the scores of the treatment group were decreased more significantly than those of the control group（ P〈0. 05）. ④Comparison between the treatment before and after within group,there were statistically significant differences on the TCM syndrome scores in both groups,and the scores were both significantly decreased in the two groups（ P〈0. 05）.Comparison of the difference before and after treatment,there were statistically significant differences on the TCM syndrome scores between the two group,and the scores of the treatment group were decreased more significantly than those of the control group（ P〈0. 05）. ⑤ Th

关 键 词：广泛性焦虑症 痰热内扰 镇惊泻火 随机双盲平行对照 安慰剂 

分 类 号：R277.7[医药卫生—中医学]