| Research background:Depression usually refers to affective disorder is a common mood disorder can be caused by a variety of reasons, significantly low long-lasting state of mind as the main clinical features, and the depressed state of mind and its not commensurate with the situation, clinical manifestations can be depressed to griefstricken, and even stupor; in some cases there is significant anxiety and agitation; severe cases, hallucinations, delusions and other psychotic symptoms. Most cases have a tendency to recurrent episodes of most of each attack can be alleviated, some may have residual symptoms or become chronic.World Health Organization of one to15cities as the center of global collaborative research to investigate the psychological barrier in the hospital who found suffering from depression and dysthymia of12.5%. Community survey of38,000individuals in10countries and regions (including the United States, Canada, Lebanon, Korea, China Taiwan) and found that the lifetime prevalence rate of the national depression disparities, China Taiwan only.5%up to19.0%in Lebanon; annual incidence in China Taiwan is0.8%, New Jersey, compared with5.8percent. WHO (1993), multi-center study of global cooperation, the Shanghai survey showed that the prevalence rate of4.0%in the general hospital medical outpatient depression, dysthymia0.6%. Chinese in Taiwan, Hong Kong, the prevalence of depression is low, the population of Taiwan depression lifetime prevalence rate of1.5%, much lower than other regions in Asia (South Korea2times in Taiwan). Shown in the comprehensive analysis of epidemiological data on the23cross-section of the Chinese elderly patients with depression in Taiwan, the prevalence of depression was3.86%incidence of depression in rural areas dangerous rate of5.07%, higher than the city’s2.61%, much lower than the prevalence of Western countries.WHO(1993)Global Burden of Disease (GBD) studies have shown that the global burden of neuropsychiatric disease, depression, suicide, respectively,17.3%,15.9%, topped the list; depression accounted for disability-adjusted life years(DALY)4.2%; reduce depression and suicide accounted for5.9%. Prompt depression, suicide/self-injury in mental disorders lead to the loss of the burden of disease the biggest problem, attention should be paid. The study also predicted that by2020depression will become the following coronary heart disease after the second largest disease burden of the source. Forecast from1990to2020, China’s burden of neuropsychiatric disease increased from14.2%to15.5%, coupled with suicide and self-injury, and from18.1%to20.2%, accounting for1/5of the total burden of disease. Mental disorders and suicide share of the burden of disease will be ranked1,2(20.2%), depression, suicide and self-injury, and Alzheimer’s disease burden increased significantly, while depression is the main burden of mental illness problems (44%in1990to predict2020will be47%).Depressive disorder with high incidence, high recurrence, high disability characteristics, the consequences of a heavy economic burden, causing huge economic losses to society. United States (1994) in total health costs4%for the treatment of major depressive disorder, up to$43billion; of which only$9,000,000,000(28%) is the direct medical costs, and the remaining$34billion of patients with disease or disability caused by the loss. Diagnosis and treatment of the situation is not optimistic, lower overall recognition rate of depressive disorder, especially in the General Hospital. WHO multi-center collaborative research shows that15different countries or regions physician average recognition rate of depression was55.6%, Shanghai, China, the identification rate of21percent, far below the level of foreign Therefore, to enhance the prevention and treatment of depression, to find a positive and effective treatment, has a very important social and economic significance.The treatment of depression medication, psychotherapy, and ECT treatment of a variety of ways, the most common treatment remain antidepressant drug treatment. The relevant data show that10%-30%of patients for poor treatment response to antidepressants. In addition, for the therapy of antidepressant agents showed a lot of negative effects, such as decreased libido, nausea, vomiting, tremor, urinary block, physiological disorders, obesity, etc. Of SSRI and SNRI antidepressants side effects than traditional antidepressants weaken, but the mechanism of action and tricyclic drug is essentially the same, only for a single pathogenesis, only relieve some symptoms, not enough to take into account a variety of risk factors, depression can not solve a variety of problem incidence etiology and pathogenesis. And the efficacy and scope of application is not superior to conventional drugs, only50%of patients are completely relieved of symptoms. Its efficacy, onset latency, the pharmacological effects play a role can not be quickly resolved the patient complained of symptoms in2-4weeks.Venlafaxine is a5-serotonin and norepinephrine reuptake inhibitors, the mechanism of action of its dual activity in the treatment of depression than selective5 -HT reuptake inhibitors have an advantage, in the conversion strategycompared with SSRI has potential advantages. Safety and tolerability of the test statistics into the venlafaxine and SSRI side effects are nausea, vomiting, dry mouth and other digestive symptoms; dizziness, headaches and other neurological symptoms, no significant difference between the two. Prompt venlafaxine is a good safety and tolerability of antidepressants.Depression is a traditional Chinese medicine "depressive" category by qi stagnation, dysfunctional organs to the depressed, restless mood, chest stuffiness, flank pain, or irritability Yuku, or foreign body sensation in the pharynxdisease as the main clinical features. Understanding of the motherland medicine depressive for a long time, traditional Chinese medicine practitioners believe that the cause of depression has both internal and external, external because the emotional hurt, because dirty air, Yi Yu. Its pathogenesis is for qi stagnation, dysfunctional organs. The beginning of the depressive disease mainly to stagnation of qi, qi long time can cause blood stasis of the fire, phlegm knot, food stagnation, wet stop, and more true the card falling is easy to turn by the real imaginary, with its affect the organs and loss of blood, yin and yang are different, while the formation of a virtual lesion of heart, liver, spleen, kidney malfunction. The qi Gloomy builds easy is the basic principle of the treatment.The Modified Chaihuguizhi the soup national old TCM Professor Chen Baotian refer to the ancient and modern literature, on the basis of many years of clinical experience treating depression, after years of painstaking research, the important pathogenesis of depression, liver depression and exhausting, the by side Chaihuguizhi soupprepared on the basis of the Liver qi, stagnation and soothe the nerves of the level of yin and yang, five gods of the tune, and business health is characterized by the experience side. Chaihuguizhi soup Shugan Qi, phlegm achievements, raw Longmu and spiritual magnet town liver, Liver and Caulis, Fu Shen stagnation and soothe the nerves of various drugs to reach the liver and gas town liver Pinggan spleen and nourishing the heart, stagnation and sedative effect.In recent years, we have in clinical practice, using the Modified Chaihuguizhi soup merger venlafaxine treatment of depression carried out to obtain a certain effect. Clinical observation, combined with our previous treatment of moderate to severe depression in a retrospective analysis of flavored Chaihuguizhi soup combined with venlafaxine in the treatment efficacy. This topic will be more concerned about the mitigation of adverse reactions in patients with medication and to improve the situation, the efficacy and safety of traditional Chinese medicine to reduce the side effects of antidepressants to alleviate the core symptoms of depression and peripheral symptoms.Objective:Integrative efficacy and safety of the treatment of depression through a retrospective analysis of105patients with depression, further evaluation, especially of Chinese medicine in the antidepressant efficacy and alleviate Western medicine side effects. Objects and methods:1.ObjectsNanfang Hospital of Traditional Chinese Medicine clinic, ward and Chinese and Western medicine combined with the out-patient clinic of the Hospital encephalopathy in January2010to December2011, the ward diagnosis of depression in105patients.2.Inclusion and exclusion criteriaDiagnostic criteria of depression:are in line with the Chinese mental illness classification and diagnostic criteria3(CCMD-3) diagnostic criteria of depression. Inclusion criteria:(1) meet the diagnostic criteria of the CCMD-3depression cases;(2) Hamilton Depression Rating Scale (of HAMD-17) score≥17points;(3) gender and race is not restricted, inpatient and outpatient is not restricted;(4) age>18years;(5) Duration of≥30days or more;(6) Improve the routine examination, no significant serious organic disease;(7) the patients with completed12weeks of treatment.Exclusion criteria:(1) rule out other mental illnesses that do not meet the diagnostic criteria of the CCMD-3depression;(2) patients with the serious risk of suicide;(3) age<18years of age;(4) Improve the routine examination, associated with significant serious organic disease;(5) Pregnant women, lactating women;(6) The drug allergy;(7) Long-term use of psychotropic drugs and the dose of instability, monoamine oxidase inhibitors, lithium agents and valproic acid, carbamazepine and other antiepileptic agents;(8) Who do not meet the criteria for inclusion, not to take medication as prescribed, to determine the efficacy or infonnation is not congruent effects on efficacy and safety of judge.3.MethodsTest Method:A retrospective study.Patient selection criteria:diagnostic criteria, inclusion criteria and exclusion criteria. Diagnostic criteria with reference to the Chinese mental illness classification and diagnostic criteria3(CCMD-3) diagnostic criteria of depression, combined with traditional Chinese medicine dialectical standards.Therapy:the treatment group received venlafaxine sustained release tablets based on the joint the Modified Chaihuguizhi Tang (Bupleurum, Pinellia, Codonopsis, Licorice, Scutellaria, Cinnamon Twig, white peony root, ginger, jujube, Health keel, raw oystersspiritual magnet Caulis, Fu Shen, etc.); the control group was treated with venlafaxine sustained release tablets. Medication methods:two groups were treated with venlafaxine tablets, the treatment group combined with traditional Chinese flavored Chaihuguizhi soup. The treatment period of12weeks.Combination therapy provides that:during the treatment may not be combined for the use of any antipsychotic, antidepressant, mood stabilizer drugs. During the treatment of severe insomnia, can be an appropriate combination of zolpidem or alprazolam, zopiclone and short-acting benzodiazepines Zhuozhen Jing drugs, such as estazolam.Outcome measures:including demographic data, the impact of therapeutic factors, general physical examination and laboratory tests.Clinical criteria:Clinical criteria including depression, changes in scale scores before and after treatment.Observation of adverse events:the term covers of adverse events during clinical studies, the subjects and will affect the health of any clinical symptoms, the emergence or worsening of symptoms, syndrome, or certain diseases. Adverse events: new disease; treatment status of symptoms or signs of deterioration, or accompanied by the deterioration of the disease; the role of drug control; to participate in the trial; combination of one or more factors. Therefore, the term "adverse events" does not mean that a causal relationship to study drug.4.Statistical analysisAll data SPSS13.0statistical package for statistical analysis. The measurement data for the normality tests, such as the samples comply with the normal distribution with mean±standard deviation (±SD) said. Medication before and after each time point scale score change data using a repeated measures analysis of variance. After treatment, the HAMD reduction the sub efficacy analysis using generalized estimating equations (generalized estimating equations, GEE).Count data with the number of cases (%) said that the groups were analyzed using the X2test; such as data the theoretical value of<1, using Fisher’s exact test. Grade information Wilcoxon test was used. p<0.05was considered statistically significant.Results:1.HAMD scale score change:the difference between the two groups at different time points before and after administration were statistically significant (F=1204.507, P=0.000), treatment group, F=295.401, P=0.000, control group, F=167.256, P=0.000. HAMD scale score difference between the two groups was statistically significant (F=7.776, P=0.006) from each time point, with the exception of baseline HAMD scale score was no significant difference (t=-0.618, P=0.538), the medication for one week, two groups HAMD scale score differences were statistically significant (t=2weeks,4weeks,6weeks,8weeks-and12weeks-after-for2.654,3.397,3.203,2.840,3.322,3.821respectively, P=0.009,0.001,0.002,0.005,0.001,0.000), indicating that the medication from the patients at each time point, patients with depression HAMD scale scores decreased treatment group than the control group after one week. Between the two groups and taking time interaction effect (F=7.667, P=0.000), with the front at different time points between the two groups, multiple comparisons analysis coincide, indicating that changes in the two groups of patients with depression HAMD scale scores with to the medicine time to extend a downward trend.2.SDS scale score change:the difference between the two groups at different time points before and after administration were statistically significant (F=2012.564, P=0.000), treatment group, F=610.854, P=0.000, control group, F=68.278, P=0.000. SDS scale score differences between the two groups was statistically significant (F=116.876, P=0.000) from each time point of view, in addition to the baseline of SDS scale score difference was not statistically significant (t=-1.529, P=0.129), the medication for1week,2weeks,4weeks,6weeks,8weeks and12weeks after the two groups of SDS scale score differences were statistically significant (t=for3.037,7.126,11.466,16.711,21.326,23.747P value for0.003,0.000,0.000,0.000,0.000,0.000), show that the medication from patients at each time point, patients with depression SDS scale scores decreased treatment group than the control group after one week. Between the two groups and taking time interaction effect (F=258.781, P=0.000), with the front at different time points between the two groups, multiple comparisons analysis consistent, indicating that the two groups of patients with depression SDS scale score changes with to the medicine time to extend a downward trend.3.SAS scale score change:the difference between the two groups at different time points before and after administration were statistically significant (F=1123.184, P=0.000), treatment group, F=402.742, P=0.000, control group, F=60.464, P=0.000. SAS scale score difference between the two groups was statistically significant (F=92.576, P=0.000) from each time point of view, in addition to the baseline of SAS scale score difference was not statistically significant (t=-1.712, P=0.090), the medication for1week,2weeks,4weeks,6weeks,8weeks and12weeks after the two groups of SAS scale score differences were statistically significant (t=respectively2.209,6.873,12.002,17.548,17.172,18.394respectively,P=0.029,0.000,0.000,0.000,0.000,0.000), indicating that the medication from the patients at each time point, the depression scale scores of patients with SAS to reduce the magnitude of the treatment group than the control group after one week. Between the two groups and taking time interaction effect (F=150.707, P=0.000), with the front at different time points between the two groups, multiple comparisons analysis results coincide, indicating that changes in the two groups of depression scale scores of patients with SAS with to the medicine time to extend a downward trend. 4.HAMD sleep disturbance analysis:before and after administration there were significant differences between the two different time points (F=531.498, P=0.000) between the two groups and taking time interaction effect (F=7.657, P=0.000). Treatment group, F=137.232, P=0.000, control group, F=72.397, p=.000. Sleep disturbance score difference between the two groups was statistically significant (F=27.041, P=0.000) from each time point, with the exception of baseline sleep disturbance score was no significant difference (t=0.518, P=0.605). In addition, medication1week,2weeks,4weeks,6weeks,8weeks and12weeks after the two sets of sleep disturbance score differences were statistically significant (t=3.946,5.417,4.636,5.787,5.739,5.3575,Pvalueswere0.000,0.000,0.000,0.000,0.000,0.000), indicating that the two groups before treatment in patients with sleep disturbance score at the same level are comparable. At each time point from one week after the patients with medication, depression in patients with HAMD sleep disturbance score decreased treatment group than the control group.5.HAMD depressive and anxiety reaction analysis:before and after administration there were significant differences between the two different time points (F=546.509, P=0.000) between the two groups and taking time interaction effect (F=2.911,P<0.008). Treatment group, F=133.542, P=0.000, control group, F=79.791, p=.000. Depressive and anxiety reaction differences in scores between the two groups was statistically significant (F=2.032, P=0.157) from each time point, the baseline period and medication for one week, two weeks, four weeks, six weeks of depressive and anxiety reaction score was no significant difference(t=-0.658,1.368,1.904,1.573,1.444,Pvalueswere0.512,0.174,0.060,0.119,0.152), the two groups after8weeks and12weeks of depressive and anxiety reaction score difference was statistically significant (t=2.578,2.125,P values were0.011,0.037), indicating that the two groups of patients with depressive and anxiety reaction score at the same level before treatment, comparable, and since the patients taking a week,2weeks,4weeks,6weeks, two groups of depression in patients with HAMD depressive and anxiety reaction score lower of considerable magnitude. However, since patients with medication for eight weeks and12weeks of HAMD response of depressive and anxiety reaction decreased after the treatment group than the control group.6.HAMD apathy analysis:There were significant differences between the two groups at different time points before and after administration (F=125.812, P=0.000) between the two groups and taking the time does not exist an interaction effect (F=0.660, P=0.682). Treatment group, F=27.778, P=0.000, control group, F=19.172, p=.000. Between the two groups apathy score was no significant difference (F=0.003. P=0.954) from each time point, the baseline period and medication for1week,2weeks,4weeks,6weeks,8weeks,12weeks after two sets of apathy score differences were not statistically significant (t values were-0.801,0.036,0.343,0.521,-0.037,-0.174,-0.243, P value for0.425,0.971,0.732,0.604,0.9700.862,0.808), indicating that the two groups of patients with emotional indifference in the pre-treatment score at the same level are comparable, and medication from patients at different time points after one week, two groups of patients with depression HAMD apathy reduction of the score of considerable magnitude.7.HAMD somatic symptoms analysis:before and after administration there were significant differences between the two different time points (F=421.576, P=0.000) between the two groups and taking the time does not exist an interaction effect (F=1.675, P=0.125). Treatment group, F=114.595, P=0.000, control group, F=96.139, p=0.000. Somatic symptoms score differences between the two groups was statistically significant (F=0.886, P=.349) from each time point, the baseline period and medication for1week,2weeks,4weeks,6weeks,8weeks,12weeks the two groups after the somatic symptoms score differences were not statistically significant (t value were-0.418,1.447,1.186,1.583.0.904,0.472,0.399, P values were0.677,0.151,0.238,0.116,0.368,0.638,0.691) that before treatment in patients with somatic symptoms score at the same level are comparable, and medication from patients at different time points after one week, a considerable decrease of somatic symptoms in patients with HAMD scores of two groups of depression.8.HAMD points reduction efficacy analysis:Treatment group and control group (Z=3.82, P<0.001), treatment group than the control group; significant difference (Z=13.64, P<0.001) between the different time points, with time, the efficacy ofthe better; no interaction effect between group and time point (Z=-0.43, P=0.668).one week, two weeks after treatment,4weeks,6weeks,8weeks,12weeks each time point, treatment group and the level of efficacy in the control group Rank:55.63,49.50;61.85,41.20;60.50,43.00;63.21,39.39;58.83,45.22;60.43,43.09. The two groups after treatment at each time point differences were statistically significant (Z=-2.360, P=0.018; Z=-3.985, P<0.000; Z=-3.714, P<0.000; Z=-4.403, P <0.000; Z=-2.723, P=0.006; Z=-3.809, P<0.000).9.The onset time of analysis:one week of treatment, the treatment group and control group differences in the onset time was statistically significant (X2=16.293, P <0.000), treatment group,30%of patients the onset, while the control group did notapparent onset. In the first two weeks of treatment, treatment and control groups, more significant difference (X2=19.604, P<0.000), treatment group88.3%of patients on the onset time of onset, and control group, only48.9%in patients with onset.10.Treatment of the12th week cure rate:the treatment and control groups in clinical cure rates on the difference was statistically significant (X2=14.463, P0.000).12th week of treatment, the treatment group clinical cure rate was88.3%, while the control group, the clinical cure rate was only55.6%. 11.Analysis of adverse reactions:a variety of adverse effects of the treatment group were lower than the control group (X2=10.423, P<0.001), constipation (X2=6.099, P=0.014<0.05) and sexual dysfunction in both groups in the dry mouth (X2=4.257, P=0.039<0.05) differences compared to the incidence of statistically significant treatment group were significantly lower incidence of dry mouth, constipation and sexual dysfunction.Conclusions:1.Venlafaxine the Modified Chaihuguizhi soup merge text on the improvement of depression and with anxiety disorders is superior to single venlafaxine, but with the extension of the duration of treatment, the improvement of depression and anxiety disorders may be more stable.2.Modified Chaihuguizhi soup combined venlafaxine on sleep disorders to improve better than the venlafaxine group. Improvement in response to depression and anxiety, until after8weeks of treatment, venlafaxine group is superior to single, may be prompted with the treatment time, improve the efficacy of depression and anxiety reaction became clear. Of apathy and the improvement of physical symptoms, the efficacy of performance is not obvious.3.Modified Chaihuguizhi soup with venlafaxine clinical cure rate was88.3%, while only55.6%clinical cure rate in the venlafaxine group alone. Prompted the Modified Chaihuguizhi soup joint venlafaxine clinical cure rates may be higher than venlafaxine alone.4.Modified Chaihuguizhi soup combined venlafaxine30%in patients with onset during the first week, after two weeks of treatment, the onset of88.3percent. At the same time, a single venlafaxine only in the second week,48.9%in patients with onset. Tip the time of onset was significantly faster than venlafaxine alone.5.Modified Chaihuguizhi soup with venlafaxine may alleviate the side effects of venlafaxine in varying degrees, especially in reducing performance on adverse reactions such as dry mouth, constipation and sexual dysfunction may be more significant. |
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