| Hepatitis cirrhosis is the end stage of liver disease caused by hepatitis virus infection, have extensive hepatocyte necrosis in histopathology. Homocysteine (Hcy) is a sulfur-containing amino acid, the liver is the main metabolic sites, hepatocyte damage will cause Hcy metabolism disorder. The study found that patients with liver disease often accompanied by elevated serum Hcy. Syndrome elements, referred to as "syndrome elements", is the smallest unit of traditional Chinese medicine. "Syndrome elements" include the location and nature of the disease. Such as heart, kidney, etc., that is, the syndrome types of syndrome elements. Qi deficiency and phlegm damp, namely the nature of syndrome elements. From the start of the syndrome elements of disease syndrome, can simplify the cumbersome role. This study by cross-sectional study correlation analysis of liver cirrhosis patients serum Hcy levels and syndrome factors."concealing blood and dominating diffusion "is the basic physiological functions of the liver. The study found that traditional Chinese medicine has certain advantages in anti liver fibrosis, improvement of symptoms, signs and complications. And play an important role in clinical treatment.According to the fundamental theory of "liver concealing blood and dominating diffusion". Respectively to "replenishing qi and invigorating the spleen, soothing the liver and regulating the circulation of Qi, soft hard and dredging collaterals" and "replenishing qi and invigorating the spleen, soothing the liver and regulating the circulation of Qi, soft hard and dredging collaterals "with" nourishing yin and nourishing the blood" for the composing principle.Take the randomized, controlled, blinded clinical trial research methods,then to observe the effect of traditional Chinese medicine intervention on serum Hcy level in patients with compensated cirrhosis.Objective:1 To explore the relationship between the level of serum Hcy in patients with hepatitis cirrhosis and TCM syndrome elements.2 To observe the effect of Chinese medicine on decompensated hepatitis B cirrhosis patients with serum Hcy level.Methods:1 cross sectional study(1)Through a cross-sectional survey research method, table to September 2011 from the 3 provinces and seven Chinese medicine institutions (the Chinese people’s Liberation Army 302 Hospital of Hubei Province Hospital of traditional Chinese medicine, Capital University of Medical Sciences; Beijing Ditan Hospital, Capital University of Medical Sciences; Beijing Youan Hospital, Beijing Traditional Chinese Medicine University East Hospital, Chinese Academy of Sciences Xiyuan hospital, Capital University of Medical Sciences; Beijing Hospital of traditional Chinese medicine and Guangxi Traditional Chinese Medicine University First Affiliated Hospital) 2012 December included outpatient and ward of hepatitis cirrhosis patients by the study group to develop a unified CRF symptoms were collected. Then combined with the group to develop the hepatitis and cirrhosis is a common syndrome factors identification standard, determining the patients of syndrome elements.(2) the determination of syndrome elements of traditional Chinese Medicine To determine the syndrome elements of the patients, according to the criteria of the hepatitis cirrhosis and the identification of factors identified in this study group.(3) homocysteine detectionBeijing Huada protein research center limited by double antibody sandwichenzyme linked immunosorbent assay.(4) data entry and analysisData entry using a unified management platform, the establishment of database. By two individual input data, and the two check. Data analysis using SPSS 20 statistical software package. The compare measurement data, if the data is subject to normal distribution, T test is used and represented by mean plus and minus standard deviation. if the data Does not obey the normal distribution, Mann-Whitney rank sum test is used and represented by median plus and minus four point spacing. Counting data is compared by chi square test. Statistical inference with P<0.05 as a significant difference.2 chinese medicine intervention research(1)Using multi center, randomized, blind research method.In January 2014 to December 2014 in the Chinese people’s Liberation Army 302 Hospital, Xiyuan Hospital of China Academy of Chinese Medical Sciences, Capital University of Medical Sciences; Beijing Ditan hospital outpatient and ward met the inclusion and exclusion standard of decompensated hepatitis B cirrhosis patients with general information, symptoms, signs and laboratory indicators (including the serum Hcy level) acquisition.(2) homocysteine detection methods and principlesLike cross sectional study.(3) Three groups were in nucleoside antiviral drug treatment based and combined application of traditional Chinese medicine compound or a simulated agent to intervene. The basic treatment is nucleoside analogs treatment. A group with basic treatment combined with" replenishing qi and invigorating the spleen, soothing the liver and regulating the circulation of Qi, soft hard and dredging collaterals" for the principle of composition A granules.Group B by basic treatment plus "replenishing qi and invigorating the spleen, soothing the liver and regulating the circulation of Qi, soft hard and dredging collaterals "with" nourishing yin and nourishing the blood" for the principle of composition B granules. The C group was treated with basic treatment combined with C formula particles which simulating B drug.The patients get Detection of homocysteine levels before intervention and six months later,the patients will get the detection of homocysteine levels agein.And compare the changes of serum homocysteine level before and after the intervention.(4) data entry and analysisLike cross sectional study.Result:1 cross sectional study(1)General data:a total of 801 cases of hepatitis cirrhosis were collected in this cross-sectional survey, including 715 cases of Hcy value, the age between 19~65 years old, mean age (49.61±9.33) years old,510 males and 205 females. In the rest period,149 cases were in the active stage,566 cases were in the active stage,272 cases were in the compensation period,443 cases were in the compensation period.(2) Characteristics of serum Hey level and its correlation with TCM Syndrome Elements1) There was no significant difference in serum Hcy level between patients with compensated cirrhosis and patients with decompensated cirrhosis. The serum level of Hcy in the active stage was significantly higher than that in the rest period.2) Yin deficiency, qi stagnation, Qi deficiency in patients with liver cirrhosis, water stop determination of serum Hcy levels were significantly different from those of non decision group. Which Qi deficiency, water stop to determine the serum Hcy levels in patients was significantly higher than that of non decision group, yin deficiency, qi stagnation to determine the Hcy level of the patients was significantly lower than that of non decision group.3) The age of patients with cirrhosis of the liver cirrhosis was significantly higher than that of the patients with compensatory stage. The frequency of all the syndrome elements in the active phase and the compensatory phase were higher than that in the rest period. To determine the resting qi stagnation. Serum Hcy levels were significantly lower than the non judging group. The active period of yin deficiency group was significantly lower than that in the non decision group, and the deficiency of qi deficiency group was significantly higher than that in the non decision group. There was no significant difference in the serum Hcy levels between the syndrome factors and the non decision groups in the compensatory stage. The level of serum Hcy in the patients with loss of compensation was significantly lower than that in the non determination group, and the serum Hcy level was significantly higher in the patients with Qi deficiency group than in the non decision group;4) The age of the male patients with liver cirrhosis was significantly higher than that of the female, occurrence frequency is higher than that of females in male patients with blood stasis, damp heat, Qi deficiency, water stop syndrome elements, the frequency of yin deficiency, stagnation of Qi, Yang deficiency syndrome factor was lower than that of the female. The blood stasis, yin deficiency, qi stagnation and the distribution of frequency difference between two groups. The serum Hcy level of the male patients with Yin deficiency group was significantly lower than that in the non judgment group, and the serum Hcy level in the patients with Qi deficiency and water retention was significantly higher than that in the non decision group. Determination of serum Hcy levels in female patients with qi stagnation group was significantly lower than that in non judging group.5) Combined with the serum Hcy level and the elements of syndrome of correlation research results and syndrome factors in different stages and different gender distribution, that yin deficiency, Qi Stagnation with serum Hcy levels were relatively low, Qi, water stop with serum Hey level is relatively high.2 chinese medicine intervention research(1) general informationThis study collected 144 patients with decompensated liver cirrhosis patients, the final analysis included 132 patients. There are 12 cases of shedding cases. The serum Hcy values were measured in 132 patients before and after the intervention, the average age was (49.02+ 8.41) years old, the male 87 cases, female 40 cases. Active period in 51 cases,76 cases in static stage. A group of 41 cases, B group of 45 cases, C group of 41 cases.(2) the change of serum Hcy level1) The serum levels of Hcy in three groups of patients with compensatory cirrhosis were significantly lower than those before intervention.2) The serum level of Hcy in female patients of B group was significantly lower than before intervention. There was no significant change in the serum Hcy level of A group and C group before and after the intervention. The level of serum Hcy in male patients with A and C group was significantly lower than that before intervention. There was no significant difference in serum Hcy level before and after the intervention of B group.3)After the intervention,the level of serum Hcy in the patients of A group was significantly lower than before in the patients with active stage. There was no significant change in the serum Hcy level of B group and C group before and after the intervention. The level of serum Hcy in patients of B group was significantly lower than that before intervention. There was no significant difference in serum Hcy level between the two groups of A and C before and after the intervention.Conclusion:1 The level of serum Hcy in the patients with hepatitis cirrhosis can reflect the activity of liver inflammation and the severity of the disease.2 There is a certain correlation between the level of serum Hcy in patients with hepatitis cirrhosis and the common syndrome types, to provide a basis for the study of the pathological basis and standardization of the syndrome elements of the common diseases of liver cirrhosis.3Principles of different prescriptions of traditional Chinese medicine and placebo combined with nucleoside antiviral drugs can significantly reduce the level of serum Hcy in patients with decompensated liver cirrhosis.4The treatment principle of’replenishing qi and invigorating the spleen, soothing the liver and regulating the circulation of Qi, soft hard and dredging collaterals"combined with "nourishing yin and nourishing the blood"drugs and the resting phase of hepatitis B cirrhosis and female patients serum Hcy improvement is better than simple use of’replenishing qi and invigorating the spleen, soothing the liver and regulating the circulation of Qi, soft hard and dredging collaterals"treatment and placebo treatment. In active stage and male patients with "nourishing yin and nourishing the blood"drugs than simple "replenishing qi and invigorating the spleen, soothing the liver and regulating the circulation of Qi, soft hard and dredging collaterals"drug use, which male patients with "nourishing yin and nourishing the blood" drug even less than placebo. |