复方丹栀逍遥颗粒联合米氮平片治疗肝郁化火型焦虑性失眠临床观察

Clinical observation of compound Danzhi Xiaoyao Granules combined with mirtazapine tablets for anxiety insomnia of liver-fire type

目的观察复方丹栀逍遥颗粒联合米氮平片治疗肝郁化火型焦虑性失眠的临床疗效。方法将70例肝郁化火型焦虑性失眠患者按照随机数字表法分为2组。对照组35例予米氮平片治疗,治疗组35例在对照组治疗基础上联合复方丹栀逍遥颗粒治疗。2组均治疗4周。比较2组治疗前后失眠症临床观察(SPIEGEL)量表评分、匹兹堡睡眠质量指数(PSQI)评分、汉密尔顿焦虑量表(HAMA)评分及中医证候评分,并统计2组疗效及治疗期间不良反应发生情况。结果治疗组总有效率97.14%(34/35),对照组总有效率77.14%(27/35),治疗组疗效优于对照组(P<0.05)。治疗后2组SPIEGEL量表、PSQI、HAMA评分均较本组治疗前降低(P<0.05),且治疗后治疗组均低于对照组(P<0.05)。治疗后2组中医证候各项评分及总分均较本组治疗前降低(P<0.05),且治疗后治疗组均低于对照组(P<0.05)。2组不良反应发生率比较差异无统计学意义(P>0.05)。结论复方丹栀逍遥颗粒联合米氮平片治疗肝郁化火型焦虑性失眠能明显改善患者焦虑症状、睡眠程度、睡眠质量,中医证候明显好转,未增加不良反应,值得临床推广。

Objective To observe the clinical effect of compound Danzhi Xiaoyao Granules combined with mirtazapine tablets for anxiety insomnia of liver-fire type.Methods Totally 70 patients with anxiety insomnia(liver-fire type)were randomly divided into two groups,35 cases in control group were given mirtazapine tablets,and 35 cases in treatment group were additionally given compound Danzhi Xiaoyao Granules on the basis of control group.Treated for 4 weeks,the aim was to compare SPIEGEL sleep scale score,pittsburgh sleep quality index(PSQI)score,Hamilton Anxiety Rating Scale(HAMA),and traditional Chinese medicine(TCM)syndrome score;the curative effect and adverse reactions were counted.Results The total effective rates were better in treatment group than in control group[97.14%(34/35)vs 77.14%(27/35),(P<0.05),respectively].After treatment,SPIEGEL,PSQI,HAMA in groups were decreased(P<0.05),which was decreased in treatment group than in control group(P<0.05);TCM syndrome score in groups was decreased(P<0.05),treatment group was decreased than control group(P<0.05).The difference was not statistically significant in adverse reactions between groups(P>0.05).Conclusion For patients with anxiety insomnia(liver-fire type),compound Danzhi Xiaoyao Granules combined with mirtazapine tablets can significantly improve anxiety symptoms,sleep degree,sleep quality,TCM syndromes,has no increased adverse reactions,and with worthy of clinical promotion.