欣悦颗粒辨证治疗82例抑郁症的临床研究

Clinical Research on the Differential Treatment of Depressive Patients by Xinyue Granule:Observation of 82 Cases

目的:观察欣悦颗粒辨证治疗抑郁症的临床疗效。方法:随机将152例抑郁症患者分为中药组82例、西药组70例,中药组根据辨证分型结果分别给予欣悦颗粒1～5号治疗,西药组给予氟西汀治疗,疗程均为8周。中药组及西药组患者在入组前均进行辨证分型,在治疗第0天(基线期)、第7天(访视1)、28天(访视2)、56天(访视3)行中医症状积分及HAMD抑郁量表评分。运用HAMD抑郁量表评分减分率、中医症状积分减分率进行疗效评定。结果:在8周末,中药组HAMD抑郁量表评分减分疗效、中医症状积分减分疗效均优于西药组(P<0.05);其中肝郁痰阻、心肾不交两证型患者的疗效中药组优于西药组(P值分别<0.05、<0.01)。肝郁痰阻、心脾两虚、心肾不交3个证型的起效时间中药组比西药快,均在访视1(7天)开始起效,从访视1开始,中药组上述3证型的HAMD抑郁量表评分及中医症状积分与各自基线期相比有统计学差异(P<0.05或0.01)。结论:中药欣悦颗粒1～5号序列方辨证治疗抑郁症的疗效优于西药氟西汀,起效时间较氟西汀早,是治疗抑郁症安全有效的中药制剂。

Objective： To research clinical curative effects of Xinyue Granule on depression.Methods： 152 patients suffering from depression were randomly divided into two groups,Xinyue Granule group with 82 cases and Fluoxetine group with 70 cases.152 patients were sperated into five TCM syndrome types： liver qi stagnation,liver depression and spleen deficiency,liver depression and phlegm stagnation,deficiency of both heart and spleen,non-interaction of heart and kidney.Patients in Xinyue Granule group were treated with Xinyue Granule 1-5 according to different TCM syndrome type and in the Fluoxetine group with Fluoxetine for eight weeks.Hamiltion rating scale for depression and the rating scale of TCM syndrome were used to evaluate curative effect.Results： After eight weeks of treatment,Hamilton and TCM syndrome rating scale which reflected the curative effect,were more obvious in Xinyue Granule group with a significant difference（P〈0.05）;the curative effects in TCM syndrome of liver depression and phlegm stagnation and non-interaction of heart and kidney were more obvious in Xinyue Granule group with a significant difference（P〈0.05,P〈0.01）.Drugs acting time in TCM syndrome of liver depression and phlegm stagnation,deficiency of both heart and spleen and non-interaction of heart and kidney.The syndrome in Xinyue Granule group was earlier than the TCM syndrome in Fluoxetine group.They were more obvious in Xinyue Granule group for one week treatment with a significant difference（P〈0.05 or P〈0.01）.Conclusion：Xinyue Granules 1-5 are secure and effective for treating depression,and they are worth further studying.