| RATIONALES:Depression is the emotional state of mental disorder(Mood Disorder),with an obviously and lasting depressed state as the basic clinical manifestations,and sustaining impact on patients with physical and mental health and quality of life.The incidence of mild and moderate depression is increasing year by year as the early stages of depression,but the development of drugs for depression is relatively lagging relative to major diseases such as cancer,diabetes,cardiovascular and cerebrovascular diseases.At present,there are three main ways of treatment of depression: drug therapy,psychological treatment and physical therapy,but chemical medicine still is the main treatment.Antidepressant drugs has been listed have poor efficacy,taking a long time,slow onset,withdrawal recurrence,adverse reactions and other issues,playing a therapeutic role as well as threatening the health of patients.The advantage of traditional Chinese medicine is the treatment of chronic disease and "Not sick",although it can not solve the problem of major depression,but the clinical observation of mild to moderate depression has shown a clear advantage.Compound Chaigui prescription originates from classic prescription of "Xiaoyaosan",coming from the "Taiping Huimin Hejiju prescription".The study found that Xiaoyaosan low-level components of antidepressant drug substance and Poria on low-level ingredients almost no contribution,and in the clinical observation of Xiaoyao San clear its good antidepressant effect,but there is a certain "dry " Reaction,may be related to ginger,it is intended exclude Poria and ginger.Clinical observation through our task group ensured the good antidepressant effect using Xiaoyaosan decoction,but the dose applied to clinical were large(370 g/d),and there was a certain degree of adverse reactions.Compound Chaigui prescription obtained by the recipe in the case of reduced dose whether there is antidepressant effect in the clinical,how is the antidepressant effect,the advantages of its treatment of depression comparing with the Xiaoyaosan,adverse reactions and the antidepressant characteristics are not yet clear,needing clinical validation.AIM: 1.To determine the antidepressant effect of high-dose compound Chaigui prescription decoction for mild to moderate depression,to evaluate its antidepressant effect and characteristics,to provide the basis for follow-up clinical work;2.Under clarifying the high dose compound Decoction of antidepressant effect,further reducing its clinical use,continuing to observe the low dose of mild to moderate depression in patients with antidepressant effect,to evaluate its effective rate,treatment advantages,treatment characteristics and adverse reactions.3.The results of the low-dose was compared with the clinical observation results of Xiaoyaosan in order to find out the characteristics of the treatment of depression,so that the continuity and traceability of the work before and after.4.Through the compareing of high and low dose compound prescription decoction clinical observation and low-dose compound prescription and Xiaoyaosan decoction clinical results,it provides the new anti-depression drug clinical trial program and research manual to a certain data support and guidance in the furture.METHODS: 1.The patients with mild to moderate depression in the diagnosis of spleen deficiency syndromes were treated TCM intervention and given high-dose Compound Chaigui(217.5 g/d).Observation and consultation used as well as HAMD-17,TCM Syndrome Scale,CGI,the effective rate of antidepressant,the improvement of depressive symptoms in the subjects,the severity of depression and the adverse reactions were evaluated In the point of 0,2,4,6,8 weeks.2.In the case of ensured antidepressant effect of high-dose Compound Chaigui decoction,the patients with mild to moderate depression were selected in the same way and standard with 145 g/d for 8 weeks.At 0,2,4,6 and 8 weeks HAMD-17,TCM syndrome scale and CGI scale and at 0 and 8 weeks HAMA-14 were applied to evaluate antidepressant efficacy,early onset efficiency,effect of different age groups,improvement of depressive symptoms and TCM syndromes,improvement of depression associated with symptoms,alleviation of anxiety and adverse reactions.3.Comparing the the results of early clinical treatment of mild to moderate depression with Xiaoyaosan with low-dose Compound Chaigui prescription results,comprehensive comparison come from the efficiency,early efficiency,each focused on the treatment of depressive symptoms and adverse reactions and other aspects.RESULTS: Clinical observation High-dose compound Chaigui prescription: a total of 23 patients with mild to moderate depression,shedding and removal of 7 subjects,16 cases completed the observation,accounting for 84% of patients included;after 8 treatment,16 patients with mild to moderate depression,including 10 cases of clinical control,4 cases in significant progress,2 cases in progress,0 cases invalid,the effective rate was 87.5%;treatment after the 2,4,6,8 weeks,scores of HAMD-17 and liver syndrome TCM syndrome significantly reduced compared with the baseline(P <0.001).The CGI-SI score decreased after 2 weeks of treatment,and the CGI severity score decreased to(1.2 ± 0.4)after 8 weeks treatment.After 14 weeks of treatment,the other 14 symptoms were significantly improved(P <0.001)compared with those before treatment,except that the scores of the three symptoms of suicide,sexual symptoms and weight loss were not statistically significant changed before treatment(P <0.001);and the Compound Chaigui prescription had a good effect on the symptoms of depression,such as gastrointestinal symptoms,sleep,anxiety and other depressive symptoms.In addition to no significant improvement in body weight factor,the other four factors: anxiety somatization,cognitive impairment,hysteresis and sleep disorders have a significant improvement.In the study of Low-dose Compound Chaigui,41 patients with mild to moderate depression counter clubs were included,a total of 38 subjects received a clinical observation of 8 weeks,accounting for 93% of the total subjects,the rate of shedding was 7%.The subjects were sexually all women.After 8 weeks of treatment,27 subjects received clinical control,7 subjects received significant progress,3 subjects progressed,and 1 patient was ineffective.In this clinical observation,the markedly effective rate was 89.5%;20 of the 38 subjects had a reduction rate of more than 25% at the end of the 2 week,and the early efficiency was 52.6%.It was seen that subjects were treated after 2 week,the scores of depression,suicide,difficulty falling asleep,agitation,mental anxiety,physical anxiety,gastrointestinal symptoms and systemic symptoms were significantly decreased(P<0.01).After 8 weeks,the scores of 4 factors in HAMD-17 were significantly different from those before treatment(P<0.001).HAMA-14 anxiety scale had significant effect(P <0.001)except for sensory system symptoms(P> 0.05).The anxiety symptoms had no effect on the improvement of depressive symptoms.The results of Low-dose Compound Chaigui compared with those of the early Xiaoyaosan:(1)Prescription: Junchen herbs were preserved in the Compound Chaigui prescription and it was clear that the antidepressant effect was obvious;(2)the prescription was more safe and the dosage was smaller;(3)Compound Chaigui prescription(145 g/d)decoction in the treatment of liver depression and spleen deficiency type mild to moderate depression in patients with clinical efficacy is quite no significant difference with Xiaoyaosan(370 g/d);The early efficiency of Xiaoyaosan is better than the Compound Chaigui prescription,may be related to its large dose of daily dose;stage antidepressant efficacy analysis again indirectly proved that the reduction of the compound had no influence on effect and also prompted 8 weeks of treatment is reasonable;Xiaoyaosan and Compound Chaigui showed that the antidepressant effect of depressive patients after 35 years of age was good,but the subjects were all female and the samples were collected before the age of 35 The amount of too little may also cause the results of false positive,resulting in a certain degree of deviation;through the chi-square test of the rate of reduction,compound Chaigui prescription for the difficulty of sleep disorders gastrointestinal symptoms may be slightly better than Xiaoyaosan effect,in order to exclude the false positive results that may be caused by small samples,a large sample of clinical trials is needed to validate;Compound Chaigui prescription and Xiaoyaosan have the same efficacy of the sleep disorders,body weight and hysteresis factors,as well as the other two factors to target the symptoms Xiaoyaosan are better;(4)Xiaoyaosan and Compound Chaigui prescription adverse reaction records suggest that when we screen the subjects,Yinxu Huowang,liver yang deficiency patients should be carefully included.CONCLUSION:(1)The efficacy of the high-dose decoction in the treatment of mild to moderate depression was 87.5%.(2)On the basis of the clinical observation of high-dose compound prescription.The effective rate of antihypertensive therapy was 89.5%,and the early effective rate of the drug was improved,and the symptoms of depression were improved and the symptoms of depression were also affected.(3)low-dose compound prescription decoction and Xiaoyao Sanqi decoction clinical antidepressant effect is quite early in the efficiency of weaker than Xiaoyaosan. |
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