Clinical Research Of Compound Chinese Medicine Treatment Of Depression

Background:In recent years, the incidence of depression is rising year by year, it is predicted that by2020depression will be the second class source of disease burden in both coronary heart disease.So far China’s suicide rate is22.2/10million, and which is related with depressive disorder accounted for40%to70%of suicide[1].The prevention and cure work of depression is given more and more attention by the medical profession and even the community.But there are still many inadequacies in Western medicine treatment,according to the research,Chinese herbal compound has a multi-channel, multi-target, multi-level therapeutic advantage and shows certain curative effect and prospects of research and development in depression gradually.But the curative effect evaluation and attending functions of Chinese herbal compound also exist problems.So we need large sample of clinical studies using the modem research methods to further extract Chinese herbal compound therapeutic target symptoms,and make the effect of compound more persuasive, and be good for better compound used,promote use of the compound.Galanin is a neuropeptide which at first was separated and extracted from pig intestine in1983,in recent years,studies have found that galanin was closely related to anxiety and depression,may be involved in the pathogenesis of depression,some research demonstrated that it can be a new target for treatment of depression,there are broad prospects for development.The study of the relationship of galanin and depression are experimental,clinical research is less, so need for further clinical research to explore the relationship between galanin and depression.Objective:To observe the clinical efficacy,safety and compliance of the Xiaoyao powder,Guipi decoction and Xuefuzhuyu decoction in the treatment of depression,and to compare the efficacy differences of three classic prescriptions in treating depression.To extract therapeutic target symptoms of Xiaoyao powder,Guipi decoction and Xuefuzhuyu decoction in treating depression.To explorer the difference of plasma galanin level in patients with depression,and further to explorer the valve of plasma galanin level in depression diagnosis and efficacy evaluation,to explorer plasma galanin correlation with disease characteristics of depression.Methods:The first part:the clinical research of Chinese herbal compound treating depression.Using ICD-10(F32),《depressive episode diagnostic criteria》 to determine the existence of depression,and using the criteria for TCM syndrome to differentiate syndromes, to collect demographic data,general incidence data,TCM four diagnostic data and give patients with depression professional assessment of the HAMD,HAMA,MADS,GAF scales. Treatment:according to the classification of syndrome differentiation,respectively give inhibition of the liver-qi with spleen deficiency group,deficiency of both heart and spleen group,and qi stagnation and blood stasis group a regular treatment with Chinese herbal compound granules of the Xiaoyao powder,Guipi decoction and Xuefuzhuyu decoction, treatment for12weeks,to evaluate each group situation at baseline,2weeks,4weeks,8weeks,12weeks respectively,including observation of TCM symptoms and HAMD rating scale and so on.At baseline and after treatment for12weeks to observe safety index to assess drug safety.The effects were assessed mainly by reducing score rate of the Hamilton depression rating scale.The second part:the clinical research of influence of Chinese medicine compound on the plasma levels of galanin of patients with depression.Using ELISA method to detect plasma concentration of galanin of135cases of depression patients(57cases of mild depression,78cases of moderate depression) and50cases of healthy control,comparing the difference of plasma levels of galanin in the three groups;and to further explore the difference of galanin plasma levels in the inhibition of liver-qi with spleen deficiency,qi stagnation and blood stasis and deficiency of both heart and spleen those three syndrome types;using HAMD,MADS, HAMA rating scale to evaluate depression and anxiety status of patients with depression to explore the correlations of plasma level of galanin with general situation and disease characteristics,and combined with the first part research of treatment based on syndrome differentiation using traditional Chinese medicine compound in135depression patients, detect plasma level of galanin of depression patients after treatment for12weeks, observe changes of the galanin levels between before and after treatment.Results:Different point of HAMD,HAMA,MADS score of different syndrome types depression patients had significant differences (P<0.01),as the follow-up time showed a trend of gradual decline,and had the relation with time linearly (P<0.01),HAMD score trends in both mild and moderate groups had significant difference(P<0.05).Different point of GAF score had significant difference(P<0.01),as the follow-up time showed a trend of gradual rise, and had the relation with time linearly (P<0.01).Different point of each fator score of HAMD of different syndrome types depression patients had significant differences (P<0.01),as the follow-up time showed a trend of gradual decline,and had the relation with time linearly (P<0.01).There is interaction between anxiety factor score trends over time and syndrome group(P<0.05),there cognition obstacle factor, blocking factor with time changing trend and degree of depression have interaction effect(P<0.05).Through the multiple comparison of each rating scale,HAMD,HAMA,MADS score since2weeks had significant differences compared with baseline,GAF(function overall rating scale) since4weeks had significant difference compared with baseline.In this study the whole process of Chinese medicine treatment,there few adverse reactions,body discomfort in3cases,after processing all adverse reactions disappeared.There were3cases of abnormal blood routine,4cases of abnormal routine urine,8cases of abnormal liver and kidney function test,electrocardiogram abnormality in1case after medication,all in slight degree,and returned to normal after review.Therapeutic target symptoms of Xiaoyao powder in the treatment of depression: psychological symptoms:insecurity,no desire to speak,like to be alone, irritability,timid and overcautious,slow response,depression,easy to panic,apathetic facial expressions,upset; somatic symptoms:pain in the hypochondriac regions,stomach fullness feeling,short of breath,anorexia,addicted to lying,languor,giddy head,frequent sighs,dryness of the eyes, insomnia,blurred vision,dry of mouth and tongue,lusterless complexion.Therapeutic target symptoms of Guipi decoction in the treatment of depression:psychological symptoms:no desire to speak,slow response,irritability,insecurity,upset;somatic symptoms:palpitations, addicted to lying,short of breath, languor,sallow complexion,frequent sighs,blurred vision,dizziness,giddy head,dryness of eyes, insomnia,dry of mouth and tongue.Therapeutic target symptoms of Xuefuzhuyu decoction in the treatment of depression:psychological symptoms:insecurity,irritability,no desire to speak,slow response,apathetic facial expressions, upset,depression;somatic symptoms:pain in the hypochondriae regions,stomach fullness feeling,short of breath,languor,insomnia,palpitations,gloomy complexion,dysmenorrhea,blood clots in menstruation,petechiae and ecchymoses of tongue,limb numbness.Plasma galanin level of patients with mild and moderate depression both higher than normal person significantly(P<0.01),and had a tendency to rise with the increase of depression degree.Plasma galanin level of patients had significantly positive correlations with HAMD score (R=0.126,P=0.126), HAM A score(R=0.160,P=0.160),MADS score(R=0.213,P=0.213), and anxiety factor(R=0.138,P=0.138),retardation factor(R=0.133,P=0.133) of HAMD scale7factors.Plasma galanin level of patients significantly decreased by comparing with baseline after treatment for12weeks with TCM compound,there was significant difference(P<0.01).Conclusion:The Xiaoyao powder,Guipi decoction and Xuefuzhuyu decoction have good efficacy,security and compliance in treatment for depression,and those have the same effect,improvement of depression state and concomitant anxiety state began to work in2weeks,improvement of the overall function state began to work in4weeks,and the curative efficacy increased with treatment time gradually.The core syndrome elements of the inhibition of liver-qi with spleen deficiency syndrome and qi stagnation and blood stasis syndrome are still the main elements of syndrome elements after treatment for12weeks respectively with the Xiaoyao powder and Xuefuzhuyu decoction,not to transform into the other syndromes.The deficiency of both heart and spleen syndrome have the trend to transform into the inhibition of liver-qi with spleen deficiency syndrome after treatment for12weeks with the Guipi decoction.Plasma levels of galanin in mild and moderate depression patients are significantly higher than normal people,and increase with the deterioration of the degree of depression and anxiety,galanin may not only involve in the process of the onset of depression,and also is associated with treatment mechanism,the plasma level of galanin has a certain reference value of efficacy evaluation and diagnosis of depression...