| Subthreshold depression (SD) is a state between health and clinical depression, it will cause similar damage with clinical depression, and have prediction and a high risk to clinical depression in the future. The diagnosis and treatment of depression had develop from pure treatment into combination of prevention and treatment, so understanding and intervention on SD have become an important topic of prevention and treatment of depression. Because SD isn’ t reach clinical diagnosis standard, there’ s some debate among intervention and selection by drug, and trade-off between efficacy and side effects. According to reports, the beginning of depression is the best period that treating by Chinese medicine, intervention by Chinese medicine can effectively prevent the development of disease, so it’ s necessary to carry out the reserch of prevention and treatment of Chinese medicine on SD to extend the intervention. Results of many clinical epidemiological investigations and questionnairies from experts show that "stagnation of liver qi and spleen deficiency"、"asthenia of both the heart and the spleen" is the most common in depression, So there’ s some superiority of simplicity、convenience、efficient、cheapness that adopting the corresponding medicine "Xiaoyao Pill" and "Guipi pills", and two of them are suitable for long-term treatment.The pattern identification of formulae with syndrome is the main foundation of properly using Chinese patent drug. The difference of subjective cognizance and ability of pattern identification brings difficulty to regular application of Chinese patent drug. Based on tho literature, this project carry out the research the structure of simple diagnosis chart to those two patent drugs by combination of disease and symptom, that provide reasonable, scientific and simple mode for application of popularizing these two patent drugsThis project is divided into theoretical research and clinical research:A.Theorotieal studyBased on modern literature research on SD to discussthe TCM’ s interpretation to SD from the holistic concept of traditional Chinese medicine and the theory of visceral manifestations, including cognizance throughout the ages, the development of depression, and SD related disease of TCM, and discussing consolidated relationship between five zangs and emotions from the view of TCM on the mental and psychological activity-the theory of the five zang (viscera) storing vitality to sum up the theory of prevention and treatment to SD. It was consider that related to "liver-and-spleen""heart-and-spleen". The main mechanism includes the lack of liver’dredging, the low function of spleen and the nutritional insufficiency of heart, and has closely relative to imbalance from viscera、Qi-Blood, Yin-Yang. Dominated by stagnates at the beginning of disease, and it becomes weakly or deficiency and excess with time. Therefore, the treatment to heart、liver、spleen was firstly gave consideration, the major remendy are "harmonizing liver and spleen" and "invigorate spleen and heart", that provides remedial train of thought for clinical prevention and treatment of SD. By "dredging liverand and adjust Qi"、"nourishing spleen and blood" from Xiaoyao Pill, and "nourish spleen and Qi"、"nourish the heart to calm the mind" from Guipi pills, it correspond tocommon syndrome and basic mechanism with SD, so that the Xiaoyao Pill and the Guipi pills are corresponding to SD base on disease differentiation.B. Clinical study:Prospectively collected, exploration research method from the point of SD, confirming prevalence of "stagnation of liver qi and spleen deficiency"、"asthenia of both the heart and the spleen", combined with the literature and export opinion to preliminary draft the initial differentiation standard of Xiaoyao Pill/Guipi; Using CES-D depression scale, HAMD-17depression scale, and self-made scale according to "major depressive episode" in DSM-IV as a screening tool for SD people. This project included61patients of SD Xiaoyao Pill group and71patients of Guipi pills group,with Xiaoyao Pill, Guipi pills for twelve weeks intervention,at the first times and in the end of1st,4th,8th,12th week to melancholia symptom questionnaire and HAMD-17scale were used to evaluate the intervention effect to observation. Analysis by SAS9.2statistical software for the two groups for the first time stagnation syndrome of traditional Chinese medicine48symptom questionnaire for the principal component and factor,through the linear combination method to obtain small and retains most of symptom information new syndrome to replace the original symptoms, and analyse new symptoms to simplified the relation and the number of symptoms; Evaluate all patients through the symptoms in order to get the weighted diagnosis model formula, to establish "the diagnostic threshold" and "the classification standard" for the standardization of diagnosis to obtain the diagnostic criteria for a combination of qualitative and quantitative. In order to improve the operational.draft ing simplify entry from combining literature and expert opinion, and analysis principal component factor analysis to obtain a simple diagnostic model symptom of diagnoses、 standard threshold and classification diagnosis. The dialectical procedure is simplified, make the application more simple, provides a scientific and simple method for the reasonable application of the two patent drugs. The results are as follows:1. Xiaoyao Pill group:There were16factors to explain76.59%of the total variable. According to the contribution and the theory of TCM from6factors: the1st factor with significant depression, difficulty sleeping, wake up early, sleep, dreams, which explain by "stagnation and blood lack of liver, lost domination in the spirit "; the2nd factor with chest tightness, pain in rib, sigh deeply, which explain by "nonfluency of the liver-Qi that blocks Qi "; the3"’ factors including abdominal pain、bulge or distention, acid regurgitation, which explain by "stagnation of liver-qi wich encroach spleen and stomach "; the4th factor with flushes, dry eye discomfort, feverish sensation over five centers,fatigue,which explain by" blood deficiency of liver, disturbance by deficiency-heat"; The5th factors including dizzines headache, dizziness,, which explain by " head disarrange by heat from stagnation of liver—qi": the6th factor containing temperaments, tinnitus, bad breath, which explain by " heat from stagnation of Qi".Follow above-mentioned, we amended and added original "SD Xiaoyao Pill preseription and syndrome differentiation standard" to set the qualitative diagnostic table (table3-1-17). From the empowerment of symptoms to ohtine SD Xiaoyao Pill48syndrome diagnosis model for the integration formula, evaluation of patients to obtain hierarchical syndrome diagnostic threshold and degree: when the integral X18≥57.2bo diagnostic of Xiaoyao Pill; grade: mild (57.2≤X18<88.5), moderate (88.5≤X18<108), overweight (108≤X18<125.9), severe (X18=125.9). For patients with a first (unexposed), after taking the first, four, eight, twelve weeks to HAMD-17score evaluation, and analysis of variance were compared at each time point HAMD-17score, the results show: in addition to the first (unexposed) to reduce HAMD-17scores were the first weekend the medication rate is not statistically significant, and the remaining time minus score difference ratio has significant statistical significance, from the first weekend after treatment, HAMD-17score decreased with time of taking medicine. The formula of Xiaoyao Pill syndrome diagnosis model based on61patients for the first time (unexposed), after taking the first, four, eight, twelve at the end of the integral evaluation, and analysis of variance at each time point of the integral difference comparison, the results showed: each time the integral difference and the decrease rates of statistical significance, the Xiaoyao Pill syndrome integral and decreased with the time of taking medicine. Through statistical processing of the simplified entry and empowerment, the simplified SD Xiaoyao Pill syndrome diagnosis model formula, this formula for the integral evaluation of61patients to obtain the diagnosis and severity grading the threshold: when the score≥33can be diagnosed with Xiaoyao Pill prescription. Mild (33≤X<91), moderate (91≤X<123), overweight (123≤X<158), severe (158≤X.). As the SD Xiaoyao Pill prescription and quantitative diagnosis table (table3-1-18).2.Guipi pills group:There were13factors to explain86.82%of the total variable. According to the contribution and the theory of TCM from five factors: the1st factor-containing meaningful fatigue, abdominal bulge, soft and not forming faeces abdominal distension, which explain by "spleen qi deficiency, transport and dereliction of duty"; The2nd factor containing sweating from slightly movement, hot flushes, heat, feverish sensation over five centers, fear, which explain by "deficiency nourish to mind from lack of qi and blood"; the3" factors including dizziness, dizziness, tinnitus, forget fulness, which explain by Qing Yang lost glory from lack of qi and blood"; the4th factors including depression, grief, difficulty falling asleep, drowsiness, which explain by sleep disorder from the spleen injury "; the5th factor wake up early, shock, dreaminess, palpitation, by "loss of convergence in mind from blood deficiency,". Follow above-mentioned, we amended and added original ""SD Guipi pills the initial differentiation standard"to set the qualitative diagnostic table (table3-2-22). The symptoms of weighted SD Guipi pills48 syndrome diagnosis model for the integration formula, evaluation of patients to obtain hierarchical syndrome diagnostic threshold and degree: when the integral G48≥57.2be diagnostic of Guipi pills prescription; grade: mild (26≤G48<44.6), moderate (44.6≤G48<60.2), overweight (60.2≤G48<101.1), severe (G48=101.1.For patients with a first (unexposed), after taking the first, four, eight, twelve weeks to HAMD-17score evaluation, and analysis of variance the difference between each time point, HAMD-17score results show: in addition to the first (unexposed) to reduce HAMD-17scores were the first weekend the medication rate is not statistically significant, and the remaining time minus score difference ratio has significant statistical significance, from the first weekend after treatment, HAMD-17score decreased with the time of taking medicine. The formula of Guipi pills syndrome diagnosis model based on71patients for the first time (unexposed), after taking the first, four, eight, twelve at the end of the integral evaluation, and analysis of variance at each time point of the integral difference comparison, results showed: each time the integral difference and less statistically significant fraction, the Guipi pills syndrome integral and decreased with the time of taking medicine. Through statistical processing of the simplified entry and empowerment, the simplified SD Guipi pills syndrome diagnosis model formula, thisFormula for the integral evaluation of71patients to obtain the diagnosis and simplify the classification threshold level:: when G≥31be diagnostic of Guipi pi11s syndrome. Mild (31≤G<46), moderate (46≤G<83), overweight (83≤G<125), severe (123≤G.). As the SD Guipi pills the quantitative diagnosis table (table3-2-23).C. Conclusion:1. Based on the theory of "five zangs generating five spirits" and "body and spirit are unified", from tho mian treatment to "liver and spleen" and "heart and spleen", using patent drugs Xiaoyao Pill and Guipi pills to cure stagnation of liver qi and spleen deficiency"、"asthenia of both the heart and the spleen" would reduce the degree of symptoms, and the HAMD-17has certain improvement rate, verify the feasibility of treating the subliminal depression from liver-spleen, heart-spleen.2. The popularity of reasonable application and promotion of TCM patent drugs will be perform through the combination of qualitative and quantitative diagnosis of syndromes scale, and the establishment of diagnostic criteria of syndrome classification, and to master the severity, with objective indicators according to the symptoms improved after medication. |
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