| ObjectiveDepression is a kind of mental disorder of emotional type, which severely harms people’s body and mind.This program observed the curative effect of Danzhi Xiaoyaosan Capsule on depression from experimental and clinical study and investigated the mechanism of Danzhi Xiaoyaosan Capsule in treating depression. The program validated the scientific characteristics of TCM theory "treatment for depression according to the condition of liver and brain".MethodsClinical study: 60 patients (30 in the treatment group and 30 in the fluoxetine capsule group) were observed. A course of treatment for both groups is 8 weeks. Index: 1. safety observation: general physical examination, including blood, urine excrement, Hepatic function, renal function and electrocardiography. 2. adverse effect observation; 3. observation of chief complaints and correlated symptoms, observation of Hamilton’s depression scale, observation of self-rating depressive scale and observation of TCM curative effect standard.Experimental study: 50 SD healthy male rats with the body weight from 240g to 260g were randomly divided into 5 groups, each having 10 rats. They were normal group, model group, low-dose group, high-dose group, and fluoxetine group. Then each group was administrated through intragastric perfusion daily with the rate of 1.0ml/100g according to their weight before stimulation: fluoxetine group with 0.75 mg/kg, low-dose group with 1.8g/kg, high-dose group with 3.6g/kg; normal group and model group with 1.0ml/100g of isotonic Na chloride. The whole course is 21 days from the first day of model making to the day of death, model rats with depression being adopted as chronic light stimulated model. The pathologic character of hippocampus was observed by light microscopic examination and the change of cell ultramicrostructure by transmission electron microscope. The content change of dihydroxy-phenyl acetic acid, 5-hydroxytryptamine and 5-hydroxyindole acetic acid was detected by high performance liquid chromatogram electrochemical detection and CORT of blood serum, ACTH and IL-1βwere detected by immunohistochemistry. We evaluated the ethology index of model rats and the change of body weight by immovability time of forced swimming, rate of julep consumption, and so on. The influence of Danzhi Xiaoyaosan on expression of CRH gene in hypothalamus of model rats was detected by molecular biology technique.ResultsClinical study:①The total effective rate of Danzhi Xiaoyaosan Capsule for depression was 90.0%, and the improvement rate for TCM syndrome was 96.67%. It suggested that Danzhi Xiaoyaosan Capsule was effective in the improvement of the patients’ symptoms.②The total score of HRSD was significantly lower than that before the treatment in the treated group and control group after 2 weeks’ treatment, there was no significant difference between two groups (p＞0.05). But at the end of the treatment course, there was significant difference between the treated group and the control group (p＜0.05). It suggested that Danzhi Xiaoyaosan Capsule was much more effective than the control group in the improvement of the patients’ symptoms, which embodied the advantage of holistic regulation of TCMExperimental study:①The model rats had fewer times of activity, slower gain of body weight and less julep consumption compared with the normal group. The electronic needling therapy could significantly increase the number of times of activity, improve the sugar-addictive degree and rats’ depressive state.②There was an increase in 5-hydroxytryptamine and decrease in 5-hydroxyindoleacetic acid and DA in hypothalamus in the high-dose-group (p＜0.05). There was no marked change in DOPAC compared with the model group, which meant this prescription could improve the content of 5-HT in the brain. There was significant improvement in 5-HT in hypothalamus of fluoxetine group (p＜0.05). There was no marked change between fluoxetine group and high-dose group (p＞0.05).③The blood CORT level and ACTH level of model group was significantly higher than that of the normal group. There was an abnormal excitement of HPA axle, and high corticosteroid in the blood of model rats. The blood CORT level and ACTH of rats was remarkably decreased after the treatment of high-dose group. Danzhi Xiaoyaosan Capsule had pharmacologic action of curative effect on depression. The blood IL-1βlevel of model group was significantly higher than that of the normal group (P＜0.05). The blood IL-1β level of Danzhi Xiaoyaosan Capsule group was significantly lower than that of the model group (P＜0.05). Danzhi Xiaoyaosan Capsule could decrease IL-1β, and adjust the function of HPA axle to cure depression.④The expression of CRH mRNA of hypothalamus of model group was much higher than that of the blank group (P＜0.05). The expression of CRH mRNA of each treated group was significantly lower than that of fluoxetine group, there was statistical significance (p＜0.05). It may resist depression through reducing the expression of CRH mRNA.⑤There were cell pyknosis, cytochondriome swelling and vascular degeneration etc. in model group. Hippocampus cell morphosis was damaged by chronic stimulation. Hippocampus cell morphosis was integral, and the damage is lesser in high-dose group. Danzhi Xiaoyaosan Capsule could lighten the damage of neuron, and protect brain injury from chronic stringent state.ConclusionsThe experiment illuminates the mechanism of Danzhi Xiaoyaosan Capsule for depression and the scientific connotation of "treatment for depression according to the condition of liver and brain". It confirms that this drug has precise effect to prevent and cure depression. |
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