| HBV-related cirrhosis is a chronic, progressive liver disease caused by hepatitis B virus long-term damage to the liver.According to the severity of the disease, can be divided into compensatory period and decompensatory period.According to the theory of TCM, the disease exist at the same time Qi and blood disorders and liver yin and Yang, storing blood and distributing in the physiological and pathological exist in close contact, which compensated most common disease syndrome elements of damp-heat, Qi deficiency, qi stagnation and blood stasis.Therefore, in the treatment in addition to the clearing heat and removing dampness, boosting qi and rectifying qi, dissolving stasis and softening mass, should also early in the disease notice of the Yin and blood of liver, by enriching yin, nourishing blood and softening the liver to help qi flow of liver.Based on the TCM’s understanding of compensated HBV-related cirrhosis basic pathogenesis, the research used the randomized, controlled and blind clinical trial, proposed in based on the treatment of antiviral (usually antiviral dugs in clinical department of liver disease as function of clearing away heat and dampness), through randomized controlled trials observed the two formulas’effects of liver stiffness and four results of liver fiber, to explore the Chinese medicine theory "the liver stores the blood and governs the free flow of qi" and guide clinical provide certain basis.ObjectiveTo observe the different effects in liver stiffness and four results of liver fiber of two formulas which take "boost qi to fortify the spleen, soothe the liver and rectify qi, soften hard masses and unblock the collaterals" and "boost qi to fortify the spleen, soothe the liver and rectify qi, soften hard masses and unblock the collaterals, enrich yin and nourish the blood" as the principle in the treatment of compensated HBV-related cirrhosis.Methods1.Source of subjectsCompensated HBV-related cirrhosis patients which are included in the analysis are from the Chinese people’s Liberation Army of three hundred and second hospital, Capital Medical University Ditan Hospital, Xiyuan Hospital of China Academy of traditional Chinese medicine from December 2013 to January 2015. A total of 116 cases were included in the analysis of liver stiffness. There are 83 males (71.55%), their mean age is (47.39±8.18) years; there are 33 cases (28.45%), their mean age is (51.30±8.39) years.There are 43 cases(37.07%) in active stage,73 cases (62.93%) in resting stage; there are 38 cases(32.76%) in group A,41 cases(35.34%) in group B,37 cases(31.90%) in group C. Group A, Group B and Group C,these three groups of patients with age, sex composition and baseline of the liver stiffness are no significant difference; there are no significant differences in age and gender between the groups in male and female, and in the active and resting stage.Compensated HBV-related cirrhosis patients which are included in the analysis are from the Chinese people’s Liberation Army of three hundred and second hospital, Capital Medical University Ditan Hospital, Xiyuan Hospital of China Academy of traditional Chinese medicine from December 2013 to January 2015. A total of 117 cases were included in the analysis of four results of liver fiber. There are 84 males (71.79%), their mean age is (47.49±7.80) years; there are 33 cases (28.21%), their mean age is (52.03±8.73) years.There are 41 cases(35.04%) in active stage,76 cases (64.96%) in resting stage; there are 40 cases(34.19%) in group A,38 cases(32.48%) in group B,39 cases(33.33%) in group C. Group A, Group B and Group C,these three groups of patients with age, sex composition and baseline of the liver stiffness are no significant difference; there are no significant differences in age and gender between the groups in male and female, and in the active and resting stage.2.Grouping and intervention methodsThe subjects who is in accordance with the inclusive and exclusive criterions were divided into three groups:Group A, Group B and Group C. Patients were intervened by formula A, formula B and stimulant (formula C) for 6 months. In the baseline (To), the third months (T3) and the 6 months (T6) three point, using FibroScan to detect patients’ liver stiffness and the level of the four results of liver fiberLiver stiffness value:the use of Fibroscan (referred to as FS, by the French Echosens company) for the detection of liver stiffness. The greater the hardness of liver tissue, the higher the value of stiffness, the unit is KPa.Four results of liver fiber include:Ⅲ procollagen amino-terminal peptide (P Ⅲ-NP) Ⅳ collagen(Ⅳ- C),hyaluronic (acid,HA),laminin(LN). The normal value is:Ⅲ procollagen amino-terminal peptide< 12ng/ml; Ⅳ collagen(Ⅳ-C)< 140ng/ml; hyaluronic (acid,HA)< 120ng/ml; laminin (LN)< 130ng/ml.3.Statistical methodsAll data were recorded by two independent persons and checked for two times. Using SPSS20.0 software for statistical analysis. The measurement data:Obey normal distribution between the two groups compared using t test, three groups and above using single factor analysis of variance; Don’t obey the normal distribution, the differences between each group of three point compared with the Friedman test, each time point among the three groups compared with the Kruskal Wallis h test. Counting data:Using chi square test. Statistical inference to 0.05 as a test level.Results1.Chinese medicine intervention on the compensated HBV-related cirrhosispatients’ liver stiffness level.Chinese medicine intervention on group A, group B and group C of liver stiffness values generally decreased, compared within each group. The comparison among the groups was carried out in gender, group A of male p=0.014< 0.05, group B of male P=0.016< 0.05, group B of female P=0.045< 0.05, group C of male p=0.013< 0.05, group C of women p=0.04< 0.05.In addition to women in the A group, the rest were statistically different.The comparison among the groups was carried out in the resting stage and the active stage, group A of active stage p=0.007<0.05, group B of resting group p=0.002<0.05, group C of resting stage p=0.037<0.05, group C of active stage p=0.011<0.05. In addition to group A, the rest of the two groups have a statistically significant difference, in addition to the active stage of group B, the rest of the two groups are statistically significant differences. Whether there were no statistical differences between any two or three groups.2.Chinese medicine intervention on the compensated HBV-related cirrhosis patients’ four results of liver fiber.Ⅲ procollagen amino-terminal peptide:Before and after the intervention, the results which has significant differences is,group A of active stage between three time point, p=0.037 < 0.05, there is a significant difference; group B of women between three time point, p=0.013 < 0.05, there is a significant difference; group C of men between three time point, p=0.048< 0.05, there is a significant difference. A group values in the normal range of the number of cases in the three time point comparison, p=0.044<0.05, there is a significant difference, and increased significantly. There is no significant difference in group B and C.Ⅳ collagen and laminin:There is no significant difference in the comparison of the changes of Ⅳ collagen and laminin between the three groups before and after the intervention. There is no significant difference between the three groups in the range of normal values at three time points.Hyaluronic:There is a significant difference between the three time points of hyaluronic in group A at resting stage(p=0.025<0.05), and it is gradually increased. There are no significant differences in the changes of the three groups of hyaluronic acid before and after the intervention. There is no significant difference between the three groups in the normal value range of the three groups.ConclusionBased on the liver stiffness value and the four results of liver fiber, compared formula A, formula B and formula C, the curative effect is not remarkable difference. May be due to the intervention, the observation period is short, the sample size is few, not enough to observe the effectiveness of the medicine, it may also be the subject after nucleoside (acid) analogues of antiviral therapy after HBV-DNA negative difficult to get further efficacy.If combined with the stratification factors, compared with the trend of formula A and formula B’s difference, liver stiffness and the four results of liver fiber obtain the same results: Formula A’s intervention effect on the active stage was more obvious, formula B’s intervention effect on women was more obvious. According to the differences of trend of formula A and formula B’s effect on compensated HBV-related cirrhosis patients, from the western medicine view, the liver stores the blood and governs the free flow of qi are closely related. Moreover, this correlation may be different because of the different stages of the disease and the individual differences of patients. In the clinical using of traditional Chinese medicine treat the HBV-related cirrhosis with complicated pathogenesis, still need to pay attention to the comprehensive consideration of disease’s different stages (such as individual differences resting stage and active stage, etc.) and individual differences in patients (male and female) caused by the integrated reaction’s difference. Long-term using of the same prescription may not be conducive to play the advantages of Chinese medicine. |
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