| ObjectivesThrough the prospectively study on the inpatient and outpatientof the liver fibrosis in Hepatitis B in Guangdong Provincial Hospital of TCM, to investigate and analyze the efficacy in patient with liver fibrosis in Hepatitis B treating by the method of shuganjianpihuoxue, in order to evaluate the influence in patient with liver fibrosis in Hepatitis B treating by TCM and confer reference for establishing the effective program to intervent the patient with liver fibrosis in Hepatitis B by TCM.MethodsBy using the method of clinical epidemiology and DME,53 cases according with the diagnostic criteria, inclusion criteria, exclusion criteria from Guangdong Provincial Hospital of TCM were reviewed in a prospectively study from October 2009 to March 2011. There are 6 cases off the study due to lost. All included patients treated with the method of shuganjianpihuoxue and the medicine of Chai Shao Liu Jun Tang combined Anluohuaxian pill for six months. The data were established a database and analysed by descriptive analysis, frequency analysis, variance analysis and other methods with SPSS15.0 software package.Result1. The general conditions The 53 cases came from the inpatient and outpatientof the liver fibrosis in Hepatitis B in Guangdong Provincial Hospital of TCM. By analysising the clinical data,we find that the proportion of male and female was 1.65:1(male 33, female 20). The age ranged from 19 to 57 years old and the average age was 38.49 years old. All the 53cases' liver function Child-pugh are A and 1 case is diagonosing early cirrhosis. There are 36 patients with normal ALT and ALT abnormal in 17 cases. The course of the disease from 2 months to 31 years ranged, the average course of disease was 13.67 years.2. syndromes(1) The Symptoms and signsSee form the symptoms, by statistics, drowsiness, fatigue, threatening pain, abdominal fullness has highest frequency, respectively 42times,36times, 34times. The other common symptoms are poor appetite, dry mouth, pale complexion, weight loss, epigastric swelling nausea, emotional depression, insomnia, loose stool, body weight difficulties, shortness of breath, less gas lazy words, god wilt, mouth bitter, spider angioma, whose frequencice are above 10%;and the less symptoms are abdominal pain, dizziness, belching, fever, dry stool, irregular menstruation, whose frequencice are under 10%.In the aspect of tongue and pulse condition, on the tongue body part,31 patients of 53 cases are of 58.5%,it means that Spleen deficiency is one of the common syndrome types. On the part of tongue coulor, the percentage of dark-red tongue was 52.8%(28 cases) and dark-pale accounts 32. 1%(17cases)and 45.3%(24 cases),24.5%(13 cases),17.0%(9 cases) in the white greasy, yellow and white greasy on the tongue and yellow and greasy fur. The pulse string slippery and pulse string are the main pulse,accounting for 52.8%(28cases) and 13.2% (7cases) respectively. (2) The syndrome typesIn the aspect of TCM syndrome types, there are 1 pure types as the Liver depression and Spleen deficiency (33cases) and 4 combined types (20cases). The common types except the Liver depression and Spleen deficiency type besides still with:the liver and gallbladder damp-heat Type, liver and blood stasis type, the kidney-yang deficiency Type liver-stomach disharmony Type, accounting for 15.1%,9.4%,7.5%,5.7%. (3) The pathologyTerms of age groups, age= 51 years higher in patients with fibrosis,≧ 51-year-old group and 19 to 30 age group,41 to 50 age group were compared, the difference was statistically significant (p<0.05). Aged 19 to 30 age group in the pathological inflammation high, but compared with the other groups no significant difference (p>0.05). In the pathological degree of respect, no significant differences among the groups (p>0.05). Groups from a gender perspective, fibrosis, inflammation, high levels of male, but the two groups was not significant (p>0.05). Groups from the syndrome types, the basic mean fibrosis was liver depression and spleen and blood stasis>liver depression and spleen and heat in the resistance-type>simple liver depression and spleen) liver depression and spleen and kidney yang>liver spleen and liver stomach type, the difference between the groups was statistically significant (p <0.05). Basic degree of inflammation was liver depression and spleen and blood stasis>simple liver depression and spleen>liver depression and spleen and heat in the resistance-type>liver and incoordination between liver and spleen) liver depression and spleen and kidney yang, each group statistically significant difference (p<0.05). View from the ALT group, the mean fibrosis score of each group of up to ALT>80 U/L group, followed by 0~40 U/L group, a minimum of 41~80 U/L group, but between the groups by the test no significant difference (P>0.05). Mean inflammation score of each group of up to ALT>80U/L group, followed by 41~80 U/L group, a minimum of 0~40 U/ L group, but after test no significant difference among the groups (P>0.05). (4) The constitution53 cases of liver fibrosis in patients with hepatitis B group were filled into the physical survey, carried out physical survey and found that body as Qi deficiency, qi quality the most, were 20 cases (37.74%),15 cases (28.30%), followed by quality for the heat, blood stasis quality, gentleness, phlegm, kidney quality, were 6 cases (11.32%),5 cases (9.43%),5 cases (9.43%),1 (1.89%),1 cases (1.89%), while yang and quality, yin deficiency, special intrinsic quality are 0 cases. 3. Efficacy evaluation (1) Security47 cases of liver fibrosis in hepatitis B patients completed at least six months of the Chinese medicine treatment, not one case of adverse reactions. (2) Syndrome47 cases of liver fibrosis in hepatitis B patients with the end of treatment, all patients have varying degrees of symptoms, to flank pain, abdominal distention, malaise, fatigue, loss of appetite, always heave a deep sigh, Shenpi lazy words to improve the most obvious difference was significance (p <0.01). Tongue changed significantly before and after treatment, with scalloped edges sharp decrease compared with the previous cases, the difference was statistically significant (p<0.05). Change significantly before and after treatment tongue, greasy fur, yellow tongue coating than before the reduction, the difference was statistically significant (p<0.05). (3) BiochemistryThe end of treatment, the patient HA, LN, CⅣsignificantly lower than before, the test was statistically significant (P<0.05), and HBV-DNA, TBIL, ALT, AST, ALB, GLB, PCIII no significant change, the difference No statistical significance (P>0.05). (4) The overall effect47 cases of liver fibrosis in hepatitis B patients with the end of treatment, according to hepatitis B hepatic fibrosis effect of assessment criteria, effective in 11 cases (23.4%), effective in 35 (74.5%),1 patient (2.1%). 4. Quality of Life.Chronic liver disease scale of six dimensions including abdominal symptoms (AS), fatigue (FA), system symptoms (SS), activity (AC), emotional function (EF), worry (WO) before and after therapy will be improved obviously, the difference was statistically significant (P<0.05). SF36 scale of 8 dimensions including physical Functioning (PF), role-physical (RP), and bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role-emotional (RE), mental health (MH) before and after therapy will be improved obviously, the difference was statistically significant(P<0.05).ConclusionIn this study, by using the method of shugan jianpi huoxue to treat 53 cases of hepatitis B with liver fibrosis (liver and spleen deficiency) in the initial study, we get the following conclusions:1. ALT and liver pathological damage (mild, moderate and severe) had no significant correlation between onset of occult hepatitis B liver fibrosis, ALT normal liver fibrosis also tend to be obvious.2. Different syndromes in different pathological damage the liver, TCM syndrome and liver pathology correlated significantly damage.3. Age and liver fibrosis staging of pathologic correlation, age, the more severe the higher the degree of hepatic fibrosis.4. Hepatitis B for liver and spleen deficiency of liver fibrosis using Shuganjianpi activating blood to guide treatment, can improve symptoms and signs of liver fiber and improve their quality of life indicators. |