| Objective:To observe the clinical efficacy and safety of Supplemented danzhi xi aoyao Decoction on depression qi stagnation disease(mild and moderate-grade depression).Method:Random number table was used to divide 54 cases of 108 patients into treatment group 54 cases, the other 54 cases in the control group.The treatme nt group took Supplemented danzhi xiaoyao Decoction, 60 ml,tid. Ingredients of Supplemented danzhi xiaoyao Decoction:mudanpi xxg,zhizixxg,chaihu xxg,chuanxiong xxg,baishao xxg,danggui xxg,baizhu xxg,ganjiang xxg,bohe xxg,xiangfu x xg,fushou xxg,hehuanpi xxg,yejiaoteng xxg,fushen xxg,zhigancao xxg.The control group was treated with Shugan granule(steamed dangguiã€baishao with wineã€vinegar chaihuã€vinegar xiangfuã€bran fried baizhuã€fulingã€fried zhiziã€mudan piã€boheã€gancao),3g,tid.During treatment,both groups should be given basic tr-eatment on hypertension,hyperlipidemia, diabetes and other underlying diseases,but the drug with antidepressant efficacy should be forbidden. Two groups of patients were treated for six weeks±7days.After the treatment,respectivelycollec values of two groups of patients before, during and after the TCM Syndrom Scale,the Hamilton Depression Scale(HAMD)(17 version of the item),Hamilton Anxiety Scale(HAMA)for statistical analysis,summarize the total efficiency and blood routineã€liver functionã€kidney functionã€electrocardiogram and other saf-ety items.Results:1ã€Total efficiency comparison:TCM Syndrome Scale: The treatment group was 88.9%,the control group 74.1%, P<0.05; Hamilton Depression Rating Scale(HAMD): 87.1% in the treatment group and 83.4%in the control group,P>0.05; Hamilton Anxiety scale(HAMA): The treatment group was 90.7%,the control group was 74.1%, P<0.05.2ã€Comparison of TCM Syndrome Scale Integration:TCM Syndrome Scale Integration of two groups before treatment have no statistical difference(P>0.05);during treatmentã€after treatment compared with before treatment, two groups have statistically significant difference(P<0.01); after treatment compared with therapy,both groups have statistically significant difference(P<0.01);treatment and after treatment,there are statistically difference between the treatment group andthe control group(P<0.05).3ã€HAMD scale score comparison:Before treatment,HAMD scale score of t wo groups were relatively comparable(P>0.05);during treatmentã€after treatment compared with before treatment,two groups have statistically significant difference(P<0.01);after treatment compared with therapy,both groups have statisticallys ignificant difference(P<0.01);during treatment,there are statistically difference between the treatment group and the control group(P<0.05);after treatment, there are no statistically difference between the treatment group and the controlgroup(P>0.05).4ã€HAMA scale score comparison:HAMA scale scores of two groups before treatment were comparable(P>0.05);during treatmentã€after treatment compareed with before treatment,two groups have statistically significant difference(P< 0.01);after treatment compared with therapy,both groups have statistically significant difference(P<0.01);treatment and after treatment, there are statistically difference between the treatment group and the control group(P<0.05).5ã€Safety judgment: During the treatment,both groups have 1 patient with minor adverse reactions,but did not affect the continued medication.ECG, blood routine(WBC, RBC, HGB, PLT),liver function(ALT, AST),renal function(CR, UREA) of two groups before and after treatment had no statistical difference(P>0.05).Discussion:In improving TCM symptoms:the total efficiency of treatment group was 88.9%,the control group was 74.1%, P<0.05, two groups during treatment〠after treatment compared with before treatment,P<0.01,comparison between the two groups during treatment, P<0.01,comparison between the two groups after treatment, P<0.05. It showed that Supplemented Danzhi Xiaoyao Decoction and Shugan granule can significantly improve the TCM symptoms,and Supplemented Danzhi Xiaoyao Decoction had rapider onset and better effect than Shugan granule.In improving depressive symptoms,the overall response rate(the treatment group:87.1%,the control group:83.4%, P>0.05),two groups during treatmentã€after treatment compared with before treatment, P<0.01,comparison between the two groups during treatment, P<0.05, comparison between the two groups after treatment,P>0.05, It showed that Supplemented Danzhi Xiaoyao Decoctionand and Shugan granule can significantly improve the depressive symptoms, and Supplemented Danzhi Xiaoyao Decoction had rapider onset than Shugan granule.But with prolonged treatment, the two groups tend to be quite.In improving anxiety symptoms,the overall response rate(the treatment group:90.7%,the control group:74.1%, P<0.01),two groups during treatmentã€after treatment compared with before treatment, P<0.01, comparison between the two groups during and after treatment,P<0.01. It showed that Supplemented Danzhi Xiaoyao Decoction and Shugan granule can significantly improve symptoms of anxiety,and Supplemented Danzhi Xiaoyao Decoction had rapider onset and more significant effect than Shugan granule.Conclusion: Supplemented Danzhi Xiaoyao Decoctionand and Shugan granule are both safe and effective on depression qi stagnation disease(mild-to-moderatedepressive episode).Through clinical observation we can find that:Supplemented Danzhi Xiaoyao Decoction can significantly improve symptoms of anxiety,effectively improve the TCM depressive symptoms,and depressive symptomsof patients, worthy of further clinical and experimental research. |