| Background:HCV is one of Flaviviridae, with the single-stranded positive-strand RNA, can be divided into six genotypes and more than 100 subtypes, of which gene 1 distributes globally, accounting for HCV infection more than 70%, genotype lb-type account for major infections (80%) in China. Clinical study found that infection of 1 or 4 type HCV response unsatisfiedly to interferon. Hepatitis C is easy to become chronic, rate of 75%-85%. Occult onset of chronic hepatitis C, a complex pathogenesis, symptoms varied, and the syptom is not special, these features are not conducive to the early diagnosis, early treatment, but the longer course of persistent, with more chance to progress to the liver cirrhosis and liver cancer.after 10 to 20 years, at least 20% of patients developed the liver cirrhosis, about 15% of which may develop decompensated liver cirrhosis. It has been reported case of liver cirrhosis, 10-year survival rate is about 80%, where there is decompensated cirrhosis, a 10-year survival rate of only 25%. HCV-related hepatocellular carcinoma (HCC) incidence after 30 years is 1%-3%, mainly seen in the progress of cirrhosis and liver fibrosis, once developed into liver cirrhosis, HCC incidence rate of annual 1%-7%. Cirrhosis and HCC in patients with chronic hepatitis C leading cause of death.Objective:The part of epidemiological survey is by means of the epidemiological investigation, identifiing distribution of common symptoms and signs, characteristic symptoms or signs should be found in chronic hepatitis C, the clinical features of chronic hepatitis C could make an early warning so as to enhance the chance of early diagnosis, early therapeutic, reversing the course of the disease, reduce complications of the disease and associated mortality. The part of clinical trials is to assess the effect of Bingganning compound treatment with CHC, and can embody characteristics and advantages of Chinese medicine, faciliating to grasp and promote the standardization of Chinese medicine treatment of chronic hepatitis C treatment programs, effectively raising the treatment efficacy of chronic hepatitis C, reducing mortality and the incidence of cirrhosis of the liver.Methods:The part of epidemiological survey investigates the CHC in Chinese medicine hospital in Jiangsu Province, Jiangsu Province Wuxi Hospital for Infectious Diseases, Affiliated Hospital of Xuzhou Medical College, Jiangsu Province, Xuzhou Second People's Hospital's outpatients and inpatients, designing syndromes scale, SF-36 scale, chronic liver disease questionnarie (CLDQ), investigating the symptoms, signs, establishing an epidemiological database. Topics include general information, including patient name, sex, age, tobacco habits, infection route, course, treatment, family history and so on. Syndrome indicators, including headache, heavy head, dizziness, vertigo, red eye, dry eye, yellow eye, fatigue when seeing, heavy eyelids, tinnitus, epistaxis, nasal dry, pale, dull face, red face, lip bruising, tough skin, skin purpura, spider angioma, liver palms, dry mouth, mouth pain, mouth pale, greasy mouth, thirst, bad breath, teeth bleed at the nose, mouth ulcers, gum swelling, pain, sore throat, limbs, joint pain, edema, Tai Xi, yawn, spontaneous perspiration, palpitation, chest tightness, Tunsuan, belching, hiccups, nausea, vomiting, nausea, loss of appetite, malaise and fatigue, Xie Tong, lumbar acid, knees soft, back pain, irritability, upset hot, hot flashes, night sweats, bowel, constipation, loose stools, diarrhea, tenesmus, urine, nocturia Kiyonaga, insomnia, drowsiness, more dreams, women'sign, tongue, pulse, etc.; SF-36 scale, chronic liver disease questionnaire (CLDQ) and so on. Data entry used Epidata 3.1, upon verification of the data, identify outliers value, evaluate the meaning or misuse of their professional input, the data after the verdict, locked, no modifying. Statistical analysis used SPSS11.5 for windows, count data with the frequency that the measurement data with the (X±s) that the use of t test and analysis of variance (One-Way ANOVA). Symptom score after screening, using factor analysis (Factor Analysis) to identify commonalities between the symptoms and their respective weights.Clinical trials will be incorporated into 192 cases of patients with chronic hepatitis C, all cases have come from Chinese medicine hospital in Jiangsu Province, Changzhou hird People's Hospital, Huaiyin hospital for infectious diseases, Jiangsu Hospital of Jiangbei, People's Liberation Army 81 hospitals in-patient and part outpatients. Were randomly divided into treatment group and control group.140 cases in which the treatment group and control group 52 cases. Interferon and hepatitis C were randomly divided, observed indicators include the treatment effects (liver function, viral load, liver fibrosis, cellular immunity, pathological observations, etc.), the treatment group with the traditional Chinese medicine Bingganning granules,1 package for 1 day, treatment for 6 months; the control group with interferon 3 million u intramuscular injection every other day. In case of interferon treatment of adverse reactions, give symptomatic treatment, such as leukopenia, white blood cells may be given drugs to increase WBC, paracetamol for fever and other persons. All information entered into the computer by hand, after checking outliers, assessing the possible causes of data after verified, locked.the statistical method in accordance with the design, can be used t test, variance analysis and other methods, counting the frequency distribution of data using descriptive statistics, inferential statistical methods included Chi-square test, rank sum test and so on. Statistical software SPSS11.5 for windows.Results:epidemiological part find the common symptoms of chronic hepatitis C is fatigue, mouth bitter, often the main complaint of patients with a direct impact on the material life and mental state, other symptoms of the frequency of appearance followed by loss of appetite (frequency 148), yellow urine (frequency 145), dry mouth (frequency 137), dream much(frequency 135), insomnia (frequency 127), dry eye (frequency 87), nausea and vomiting (frequency 79), loose stool (frequency 78) and so on. The severity of the symptoms, malaise fatigue (397) the most points, followed by loss of appetite (322), and common symptoms of chronic hepatitis C in line. Other symptom score followed by yellow urine (202), mouth bitter(189), dry mouth(186), dream much(119), dry eye(115), nausea and vomiting (114), vertigo (100), Xie Lei discomfort (93), etc., in which more than dry mouth symptoms associated with mouth pain, insomnia and the symptoms associated with multi-multi-dream. For the investigation of patients with chronic hepatitis C signs and symptoms, through the statistical factor analysis varimax orthogonal rotation rotation rotation transformation, the total extract the characteristic roots of a common factor greater than 13, the cumulative contribution rate of 75.9%. According to common factor analysis of 13 weight, combined with the expertise of chronic hepatitis C can be common factors of 13 symptoms classified according to:(1) the head and face symptoms, including Factor 1, Factor 2, Factor 5, Factor 8 and Factor 13; (2) sleep, including the factor 3; (3) gastrointestinal symptoms, including the factor 6, factor 7, factor 9, and factor 10; (4) liver symptoms, including the factor 11; (5) Other symptoms, including the factor 4 and factor 12. Common factor will be 13 categories according to pathogenesis:(1) liver and kidney, including the factor 1, factor 2, factor 4 and factor 8; (2) hot and humid Ecchymosis, including the factor 5, factor 10, factor 12 and factor 13; (3) spleen lose health movement, including the factor 6, factor 7, and Factor 9; (4) Other, including the factor 3. As can be seen in patients with chronic hepatitis C symptoms of addition to documentation specifically mentioned in the digestive system performance (factor 6, factor 7, factor 9, and factor 10), liver-bit performance characteristics of sexually transmitted diseases (factor 11), also includes the literature more recorded in the head and face less symptoms (Factor 1, Factor 2, Factor 5, Factor 8 and Factor 13), sleep situation (Factor 3), other symptoms (factor 4 and factor 12). This study investigated 219 cases of chronic hepatitis C patients quality of life scale reliability standards within the overall Cronbach'sαcoefficient was 0.919, suggesting that SF-36 scale, the internal consistency. Eight dimensions, the physiological function PF, physiological functions of the RP, the overall health of GH, vitality VT, emotional functions of the RE, the six dimensions of mental health MH no significant difference between the two sexes, in the dimensions of bodily pain and social function SF aspects BP two statistically significant difference between sex (P <0.05). Unlike other studies, this study, body pain women scored are significantly higher than that among men, suggesting that it may be due to small sample size; mostly cases included were hospitalized patients; women are mild symptoms good prognosis. SF social function dimension, the men scored higher. Investigate cases of all ages divided into three sections, in addition to the functions of RE emotion, the other seven dimensions, the points decrease with increasing age, indicating the increase with age, chronic hepatitis C patients quality of life (physical and psychological) decreased. In addition to physiological functions of the RP, the other groups the difference was statistically significant. In the current study in patients with chronic hepatitis C SF-36 scale and chronic liver disease questionnaire (CLDQ) points were found by the weighted average of all dimensions, we can see that SF-36 scale score reduction is more general health (GH), vitality (VT), mental health (MH), bodily pain (BP) several dimensions; CLDQ integral reduction mainly in the activity (AC), abdominal symptoms (AS), sleepy (FA), Anxiety (WO) number of dimensions. Some clinical trials observed the compound Bingganning the efficacy of the treatment of chronic hepatitis C, compound treatment group,140 cases of hepatitis C Ning, interferon-control group,52 cases, general information that routes of infection are mostly blood transfusion, surgery, blood, drugs, etc.. Duration of the treatment group 1 to 8 years, an average of 2.90 years; the control group was 1 to 7 years, an average of 2.95 years. The main symptoms were fatigue, anorexia, Xie Tong, abdominal distension, epistaxis, gingival bleeding, constipation, Niaohuang and so on, there are signs of hepatomegaly, splenomegaly, jaundice, tongue, pulse and changes. The two groups after six months of treatment in patients with treatment, the treatment group 140 patients, the basic cured 51 cases, accounting for 36.43%;effective 10 cases, accounting for 71.43%;effective in 37 cases, accounting for 26.43%,with a total effective rate was 70%. The basic control group,52 cases cured 16 cases, accounting for 30.77%; markedly effective in 6 cases, accounting for 6.52%; effective in 15 cases, accounting for 28.85%, with a total effective rate was 71.15%. Tip compound in the treatment of Bingganning with chronic hepatitis C in the overall efficacy similar to the general effect of interferon. In the observation of two symptoms, signs, fur changes in pulse, signs and symptoms after treatment than those in the two groups before treatment significantly improved level of two groups of patients with signs and symptoms reduce or disappear, symptom score decreased significantly, including fatigue, Xie Tong, bleeding, constipation, urine, jaundice and other symptoms to improve the situation of the treatment group than the control group, statistically significant differences between the two groups. Chronic hepatitis C laboratory tests, including liver function, virological indicators, indicators of liver fibrosis, immunological parameters, including liver function such as Alanine aminotransferase(ALT), aspartate aminotransferase (AST) and other major response to HCV infection on liver injury, y-glutamyltransferase (GGT) in the liver mainly distributed in the cytoplasm of liver and intrahepatic bile duct epithelium. In this study, pre-treatment Serum ALT, AST, GGT were significantly higher, and protein metabolism in normal albumin, globulin are mildly to moderately elevated after treatment, serum ALT, GGT were significantly reduced, globulin have dropped. Study on 149 patients were measured in serum CD3, CD4, CD8, CD4/CD8, which treated 101 patients, control group 48 cases. Increase in CD4 cells after treatment, CD8 cells decreased, and the difference was statistically significant, indicating that Bingganning Granules have a certain role in immune regulation. However, the sample was detected in peripheral blood cell-activated cell viability is still controversial, because the reaction of peripheral blood cells produced too low. At the same time it should be noted is that in clinical studies, peripheral blood CD4+ T cell proliferation and liver tissue CD4+ T cell proliferation relevance. Animal experiments show that chimpanzees cleared the virus occurs chronically infected chimpanzees with the peripheral blood CD4+ T cell proliferation was no significant difference, while the liver tissue within the CD4+ T cell proliferation and viral clear correlation. Bingganning regulate cell-mediated immunity against HCV mechanism, it is worth further study.118 patients were studied by the serum HA, LN, PC-Ⅲand typeⅣcollagen determination, of which 70 cases in the treatment group and 48 cases in the control group. The results showed that the two groups after treatment than those before treatment improved each indicator, the difference was statistically significant, the two groups after treatment compared to the mean distribution from the observation, the treatment group are on downward trend than in the control group, but the difference was not statistically significant, may be related to the sample size, it is worth further studying. With regard to anti-viral effect of compound Bingganning, we have studied the effect of 192 patients before and after 6 months follow-up, in which 140 patients of treatment group and 52 cases of control group became negative. After 6-month follow-up, there are still negative in 67 cases (47.86%). Interferon-control group were 33 cases (63.47%) and 23 cases (44.23%) respectively. The results show that Bingganning Granules were significantly effect of anti-HCV. Further observation of quantitative changes in HCV RNA,113 cases in treatment group and 52 cases in control group underwent quantitative measurement of HCV RNA before and after treatment, there were 24 cases of Bingganning group became negative,38 cases titer decline,38 cases increased. The control group, negative in 9 cases,25 cases decreased, 16 cases increased, quantitative changes in the two groups compared by Kruskal-Wallis, X2=0.00807, P=0.9284, There was no significant difference (P <0.05). Pathological changes, hepatitis C Infusion treatment has improved to some extent. Mainly to expand the narrow portal area, to reduce infiltration of inflammatory cells, liver cells spotty necrosis and piecemeal necrosis and a liver regeneration to reduce liver cell sector board-varying., Liver fibrosis was reduced. Portal area to reduce proliferation of collagen, part of the fiber spacing disappeared.Conclusion:Symptoms in patients with chronic hepatitis C can be divided into physical and psychological performance, physical performance, including the head and face symptoms, gastrointestinal symptoms, liver symptoms, other symptoms, in the early period, these physical symptoms are mild or without specificity, such as dry mouth, dry eyes, spontaneous perspiration, night sweats, etc., are often easy to overlook in clinical; mental performance are often not given due attention, easy to be overlooked by patients, even by non-mental health professionals, such as anxiety, depression and other problems, which showed a significant decline in the quality of sleep, as observed in this study, insomnia, dreaminess. This two health-related quality of life (Health-Related Quality of Life HRQoL) scale reflects overall health (GH), vitality (VT), mental health (MH), activity (AC), sleepy (FA), anxiety (WO) and other damage consistent with the integral dimension. Compound Bingganning can improve significantly liver function, improve liver fibrosis, improve symptoms and signs in patients with chronic hepatitis C; The antiviral therapy between two group was no significant difference; mechanisms of Compound Bingganning granule treating chronic hepatitis C may be lie in the anti HCV, regulate cellular immune.
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