越鞠丸治疗抑郁症随机双盲对照试验的病证结合研究

Yueju Pill in the Treatment of Depression Combining TCM Syndrome and Disease:A Randomized Double-Blind Controlled Trial

目的检验越鞠丸的抗抑郁作用以及起效时间的快速性,研究越鞠丸对抑郁症患者中医证候改善的特点。方法本试验收集精神科门诊就诊的抑郁症患者,将其分为2组,越鞠丸组患者使用中药越鞠丸及艾司西酞普兰安慰剂治疗,艾司西酞普兰组患者使用艾司西酞普兰及越鞠丸安慰剂进行治疗,两组患者治疗28天。使用《汉密尔顿抑郁量表(HAMD-24)》在治疗前及服药后第7、14、28天进行抗抑郁疗效评定。使用《郁证中医辨证分型量表》将患者的证候要素进行分类统计,得出5种证候因子分。结果HAMD-24评分显示,越鞠丸组与艾司西酞普兰组服药后第7天起,与服药前相比显著下降(P<0.05),且持续至第28天。服药28天后,越鞠丸组,肝气郁结因子分、气结痰阻因子分、气郁化火因子分显著下降(P<0.05);艾司西酞普兰组,肝气郁结因子分、脾肾阳虚因子分、气郁化火因子分显著下降(P<0.05)。结论越鞠丸具有与艾司西酞普兰相当的抗抑郁的疗效。一方面,越鞠丸显著改善患者肝气郁结证、气结痰阻证、气郁化火证作用,符合中医理论预期。另一方面,越鞠丸对虚证特征明显患者的抑郁症治疗也有效,提示其具有广泛的治疗抑郁症疾病的作用。

Objective To evaluate the effect of Yueju Pill on depression and the rapidity of its effectiveness,and to study the characteristics of Yueju Pill on the improvement of TCM syndromes in depressed patients.Methods Patients with depression were collected from psychiatric outpatient clinics and divided into two groups.The patients in the Yueju Pill group were treated with Yueju Pill and escitalopram placebo.The patients in the escitalopram group were treated with escitalopram and Yueju Pill placebo.The two groups were treated for 28 days.The efficacy was assessed by using the Hamilton Depression Rating Scale(HAMD-24)at baseline and day 7,14,28.The patient’s syndrome elements were categorized and counted using the Depression of TCM Syndrome Differentiation Scale.Results The HAMD-24 score showed that the Yueju group and the escitalopram group showed a significant decrease(P<0.05)from the 7th day to the 28th day.At day 28,the Yueju Pill group,stagnation of liver qi factor,phlegm-qi stagnation factor,and qi stagnation transforming into fire factor decreased significantly(P<0.05).The escitalopram group,stagnation of liver qi factor,stagnation of spleen deficiency factor significantly decreased(P<0.05).Conclusion Yueju Pill has similar antidepressant effects as escitalopram.Yueju Pill significantly improved stagnation of liver qi,phlegm-qi stagnation,and qi stagnation transforming into fire,in line with the theoretical expectations of Chinese medicine.Yueju Pill is effective in the treatment of depression in patients with deficiency syndrome,suggesting it has a wide range of treatments.