| Vascular depression (VD) is a new concept proposed by past decade, mainly refers to depressive symptoms associated with vascular risk factors or cerebrovascular disease, often manifest as ADL impairment, mental retardation, reduced narrow depression thinking, observation low, mainly physical condition deteriorated, there are individual differences and fluctuate regularly, and subsequently prone to dementia, with late onset, vascular-related characteristics.Current treatment on vascular depression including monoamine oxidase inhibitors,5-serotonin reuptake inhibitors, tricyclic, etc, as on depression. But clinical studies in recent years have found the western medicine’s poor resistance, dependence, and side effects while more expensive, so physicians began to explore the use of Chinese medicine treatment on vascular depression. There are numerous prescription and treatment of Chinese medicine treatment of VD now, most studies show that traditional Chinese medicine treatment of vascular depression have good effect, and no significant side effects, bringing hope to patients with VD.Traditional Chinese medicine identifies vascular disease with depression, Consumption, Dementia, et. There are many researches on VD by classical prescription treatment such as " Xiaoyaosan ","ChaiHuShugansan", etc, and also doctors self herbs, mostly with good results in clinical trials and found no adverse reactions to the treatment, which widened the road to cure senile depression. Based on years of clinical experiences, Academician Wang summarizes the pathogenesis of vascular depression as "Stasis Caused by Deficient Qi",that pathogenesis of vascular depression is deficiency of vital qi and stasis of qi, blood and phlegm. It is believed that the basic method of treatment vascular depression is benefiting vital qi and disspating depression. Or benefiting vital qi as the first, or disspating depression, or a combination of both was proposed, and so Wang summed up the experience prescription-"KaiXinJieYu" decoction, with good efficacy in clinical practice. To further clarify its effect on vascular depression, explain scientific connotation of benefiting vital qi and disspating depression, reveal its mechanism of action, we hereby carry out clinical observation, in order to inherit academic thought old Chinese heritage, promote their clinical experience, play characteristics and advantages of Chinese medicine, contribute to new treatment of vascular depressionObjective:To evaluate the clinical efficacy of KaiXinJieYu decoction and explore its mechanism of action.Methods:Use prospective, controlled experimental design, screening objects met diagnostic criteria for vascular depression, and belong to the pattern of deficiency of vital qi and stasis of qi, blood and phlegm in elderly patients, from eldly and psychological sections in GAM hospital. After signing the informed consent, they began to be observed by recording the patient’s name, age, gender, disease duration, and other diseases. According to the rate of not more than20%loss ratio,72cases were included,60cases completed at last.Among the patients,35were in treatment group while25in the control group. The treatment group took KaiXinJieYu decoction (Granules) twice a day, at morning and evening meals; control group were given citalopram hydrobromide tablets (Cipramil),20mg one day.Two groups of patients have to take there medicines for eight weeks. During the experimental observation, we completed observation records at different times such as HAMD scale, TCM symptom score sheet and MMSE scores. Each patient have to complete security check before and after the test (electro cardio gram, blood, urine, liver and renal function), and were drawn blood5ml before and after the observation, to test detect serum5-hydroxytryptamine (5-HT), brain-derived neurotrophic factor (BDNF) concentration changes by using ELASA method. During the test, patient’s adverse reactions and adverse events should be recorded. After the observation, all above information should put into the computer, using SPASS17.0statistical analysis, including measurement data written by (x±s), using t test in line with the normal distribution and homogeneity of variance, while count data using the x2test, P<0.05 will be considered examined the difference was statistically, P<0.01were considered to have examined the difference statistically significant.Results:(1) General Data Analysis:During March2012to December2013period,72patients met diagnostic criteria for vascular depression, and belong to the pattern of deficiency of vital qi and stasis of qi, blood and phlegm in elderly patients were screened, from eldly and psychological sections in GAM hospital.,12cases shedded and60cases completed. Treatment group35cases,5males and30females, aged55years to83years, mean (69.00±8.50) years, state of illness duration0.5months to4years, an average of7.6months, HAMD scores (23.06±4.48) points, MMSE scores (23.83±4.29) points, TCM symptom score (59.44±14.58) points.25cases in the control group,4males and21females, aged56years to79years, mean (67.20±5.07) years old; state of illness duration of0.5to5years, with an average12.8months, HAMD scores (22.12±5.19) points, MMSE scale score (23.92±3.43) points, TCM symptom score (65.43±14.09) points. Two groups of patients are generally no significant difference in the data (P>0.05), so they are comparable.(2) HAMD scores:HAMD scale score of the treatment group before treatment was (23.06±4.48) points, after two weeks of treatment (18.51±5.04) points, after4weeks of treatment (15.37±5.96) points,8weeks of treatment (11.86±5.28) points; before and after treatment P<0.01, with statistically significant. Four cases were ineffective,12cases of progress, significant progress in15cases, four cases were cured, the total effective rate was88.57%,11.43%was invalid. HAMD scale score of control group before treatment was (22.12±5.19) points, after two weeks of treatment (18.32±5.98) points, after4weeks of treatment (13.84±5.84) points, after8weeks of treatment (11.64±6.42) points, before and after treatment P<0.01, with statistically significant.3cases ineffective,9cases of progress, significant progress in10cases,3were cured, the total efficiency of88%,12%invalid. Rating changes for each period between the two groups, P>0.05, there is not statistically significant; either no significant difference in clinical efficacy or statistically significant.(3) TCM symptom score:clinical symptoms score of treatment group before treatment was (65.43±14.09) points, after two weeks of treatment (53.29±14.99) points, after4weeks (40.09±17.01) points,8weeks was (29.46±16.27) points; after2weeks of treatment P>0.05, not statistically significant, after4weeks,8weeks, P<0.05, statistically significant,In which markedly7cases (20%), effective23cases (65.71%), ineffective in5cases (14.29%), The total efficiency is85.71%Control group before treatment TCM symptom score was (59.44±14.58)points, after two weeks of treatment (49.92±16.44) points, after4weeks (40.48±16.53) points,8weeks (38.4±16.97) points; after4weeks,8weeks,P<0.05, statistically significant, after2weeks of treatment P>0.05, no statistical significance, In which markedly one case (4%), effective in15cases (60%), ineffective9cases (36%), the total efficiency is64%.Between the two groups of TCM symptom score,2and4weeks after treatment, P>0.05,there is not statistically significant, but8weeks after, P <0.05, statistically significant. There was no significant difference in efficiency between the two groups (P=0.067>0.05).(4) MMSE scores:MMSE scale of treatment group before treatment was(23.06±4.48) points, the average score in the control group before treatment was (23.92±3.43) points, both are lower than normal, suggesting that patients with vascular depression are more associated with mild cognitive impairment.(5) TCM symptoms:Every term of the control group were statistically significant compared to pre-treatment,except" not eating "; Every term of the treatment groups statistically significant except "chest threat of inflation", especially "not eating","bitter taste ", P<0.01. Between the two groups, each symptoms score was not statistically significant P>0.05;after8weeks of treatment,some item’s scores of treatment group, like "fatigue","not eating","sighing""Insomnia" reduced significantly compared with the control group (P<0.05),while "dizziness","mouth pain","chest" and other symptoms P>0.05, no statistical difference.(6)5-HT:Before treatment, the serum levels of5-HT concentrations are considerably equal between2groups, in which the pre-treated level of treatment group is (16.35±4.18) nmol/L, after treatment (22.34±6.40) nmol/L,), P<0.01, a highly statistically significant. Pre-treatment level of control group is (16.21±4.42) nmol/L, after treatment (22.10±3.57) nmol/L, P<0.01, highly statistically significant. Between the two groups before treatment P=0.94>0.05, not statistically significant; after treatment P=0.92>0.05, not statistically significant either.(7) BDNF:pre-treatment levels of serum BDNF levels are considerably equal between2groups, w in which the pre-treated level of treatment group is (8.65±1.68) nmol/L, the treatment group was (12.53±2.66) nmol/L, after treatment than before concentration increased significantly, P<0.01, a highly statistically significant. Pre-treatment level of control group is (8.62±2.05) nmol/L, after treatment (11.65±2.80) nmol/L, after treatment than before concentrations increased significantly, P<0.01, highly statistically significant. Between the2groups before treatment P=0.97>0.05, not statistically significant, comparable after treatment control group P=0.37>0.05, not statistically significant either.(8) Safety Evaluation:treatment group had spontaneous one case, the control group had not eating two cases, one case of dizziness. Other subjects no adverse reaction occurs.There are no significant difference in Urinalysis, electrocardiogram, liver and kidney function in patients in the2groups after treatment. No adverse events occurred. |
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