慢性丙型病毒性肝炎症状判识及复方丙肝宁治疗研究
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摘要
研究背景：HCV属黄病毒科(flaviviridae),为单股正链RNA,目前从HCV毒株可分为6个基因型及100多个亚型,其中基因1型呈全球性分布,占所有HCV感染的70%以上,1b型是我国主要感染的基因型,约占80%,临床研究发现感染1型和4型HCV患者对干扰素的反应性较低。
丙型肝炎自然转阴率低,慢性化率极高,为75%-85%。慢性丙型病毒性肝炎起病隐匿,病机复杂,症状多样,且特异性不高,这些特点均不利于本病的早期诊断,早期治疗,而病程迁延时间越长,本病进展为肝硬化肝癌的几率就越高。感染后10-20年,至少20%患者发展为肝硬化,其中约15%肝硬化患者可发展为失代偿期肝硬化。有报道一旦发生肝硬化,10年生存率约为80%,如出现失代偿期肝硬化,10年的生存率仅为25%。HCV相关的原发性肝细胞癌(Hepatic cell carcinoma HCC)发生率在感染30年后为1%-3%,主要见于肝硬化和进展性肝纤维化患者,一旦发展成为肝硬化,HCC的年发生率为1%-7%。肝硬化和HCC是慢性丙型肝炎患者的主要死因。
研究目的：流行病学调查部分通过对慢性丙型病毒性肝炎的流行病学调查,归纳患者的症状体征分布规律,找出常见症状,特征性较强的症状或体征,初步明确慢性丙型病毒性肝炎疾病的证候分布特点,为临床慢性丙型病毒性肝炎的发现做出预警,达到提高本病的早期诊断,及早治疗目的。进而早期扭转病程进展,降低本病及相关并发症的死亡率。临床试验部分通过对临床慢性丙型病毒性肝炎患者干扰素和复方丙肝宁治疗,观察中药复方丙肝宁治疗的慢性丙肝的疗效,形成一套有效的、能体现中医特色和优势的、易于掌握和推广的规范化中医治疗慢性丙型病毒性肝炎诊疗方案,从而有效提高中医药治疗慢性丙型肝炎的临床疗效,降低病死率和肝硬化等的发生率。
研究方法：流行病学调查部分通过对江苏省中医院、江苏省无锡市传染病医院、江苏省徐州医学院附属医院、江苏省徐州市第二人民医院等多家医院的丙肝门诊和住院患者的流行病学调查,运用设计的证候积分表、SF-36量表、慢性肝病量表(Chronic Liver Disease Questionnaire CLDQ),调查患者的症状、体征,建立流行病学数据库。调查内容包括一般资料,包括患者姓名、性别、年龄、烟酒嗜好、感染途径、病程、治疗经过、家族史等。证候学指标,包括头痛、头重、头晕、眼花、目赤、目干、目黄、视物疲劳、眼皮重、耳鸣、鼻衄、鼻干、面色无华、面色晦暗、面赤、唇甲青紫、肌肤甲错、皮肤紫癜、蜘蛛痣、肝掌、口干、口苦、口淡、口腻、口渴、口臭、齿衄、口腔溃疡、牙龈肿痛、咽痛、四肢关节痛、浮肿、太息、呵欠、自汗、心悸、胸闷、吞酸、嗳气、呃逆、恶心、呕吐、脘闷、食欲不振、倦怠乏力、胁痛、腰酸、膝软、腰痛、烦躁易怒、五心烦热、潮热、盗汗、肠鸣、便秘、便溏、泄泻、里急后重、尿黄、夜尿清长、失眠、嗜睡、多梦、妇女经带变化、舌苔、脉象等；SF-36量表、CLDQ等。数据录入软件采用Epidata 3.1,经数据核查,找出异常值、离群值,评价其专业意义或误输入,数据经核实后即予锁定,不得修改。统计学分析软件采用SPSS11.5 for windows,计数资料用频次表示,计量资料用(X±s)表示,采用t检验和方差分析(One-Way ANOVA).症状积分经初筛,运用因子分析(Factor Analysis)找出症状间的共性和权重。
临床试验部分纳入192例慢性丙型病毒性肝炎患者,所有病例来自江苏省中医院、常州市第三人民医院、淮阴市传染病院、江苏江北人民医院、解放军八一医院等单位的住院及部分门诊病人。随机分为治疗组与对照组,其中复方丙肝宁治疗组140例,干扰素对照组52例。观察的指标包括疗效性指标(肝功能、病毒载量、肝纤维化、病理学观察等)等,治疗组用中药复方丙肝宁,每次1包,1日1次冲服,治疗6个月；对照组用干扰素(赛诺金)300万u肌注,隔日1次,疗程同上。治疗过程中如出现干扰素不良反应,可给予对症治疗,如白细胞下降,可给予提升白细胞药物地榆升白片,发热者予扑热息痛等。全部资料输入计算机建立临床数据库,计量资料采用X±S表示,统计方法采用t检验、方差分析等方法,计数资料采用频数分布等描述性统计,推断性统计方法包括卡方检验、秩和检验等。统计软件使用SPSS11.5 for windows。
研究结果：流行病学部分调查了慢性丙型病毒性肝炎的常见症状,以倦怠乏力、口苦为最多见,且多为主诉,直接影响患者的物质生活和精神状态,其它的症状按出现频次依次为食欲不振(频次148)、尿黄(频次145)、口干(频次137)、多梦(频次135)、失眠(频次127)、目干(频次87)、恶心呕吐(频次79)、便溏(频次78)等。在症状的严重程度上,倦怠乏力(397)积分最高,,其次为食欲不振(322),与慢性丙型病毒性肝炎的常见症状相符。其它的症状积分依次为尿黄(202)、口苦(189)、口干(186)、多梦(119)、目干(115)、恶心呕吐(114)、眼花(100)、胁肋不适(93)等,其中口干症状多伴有口苦,失眠症状多伴有多梦。对于调查的慢性丙型病毒性肝炎患者的症状体征,通过统计学因子分析方差最大旋转正交旋转法旋转变换之后,共提取特征根大于1的公因子13个,累积贡献率达75.9%。根据13个公因子解析权重,结合慢性丙型病毒性肝炎的专业知识,可以将13个公因子按症状分类：(1)头面部症状,包括因子1、因子2、因子5、因子8和因子13；(2)睡眠情况,包括因子3;(3)消化道症状,包括因子6、因子7、因子9和因子10；(4)肝区症状,包括因子11；(5)其它系统症状,包括因子4和因子12。将13个公因子按病机分类：(1)肝肾阴虚,包括因子1、因子2、因子4和因子8；(2)湿热瘀毒,包括因子5、因子10、因子12和因子13；(3)脾失健运,包括因子6、因子7和因子9；(4)其它,包括因子3。可以看出,慢性丙型病毒性肝炎患者的症状除文献明确记载的消化系统表现(因子6、因子7、因子9和因子10)、肝区特征性病位表现(因子11),还包括文献较少记载的头面部症状(因子1、因子2、因子5、因子8和因子13)、睡眠情况(因子3)、其它系统症状(因子4和因子12)。
临床试验部分观察了复方丙肝宁治疗慢性丙型病毒性肝炎的疗效,复方丙肝宁治疗组140例,干扰素对照组52例,一般资料显示感染途径多为输血、手术、献血、吸毒等。病程治疗组为1-8年,平均2.90年；对照组为1-7年,平均2.95年。主要症状有乏力、纳差、胁痛、腹胀、鼻衄、牙龈出血、便秘、尿黄等,体征有肝脏肿大,脾肿大,黄疸,舌苔、脉象改变等。两组患者经过半年的疗程治疗,治疗组140例中,基本治愈51例,占36.43%；显效10例,占71.43%；有效37例,占26.43%,总有效率为70%。对照组52例中基本治愈16例,占30.77%；显效6例,占6.52%；有效15例,占28.85%,总有效率为71.15%。提示复方丙肝宁在治疗慢性丙型病毒性肝炎中总体疗效与一般干扰素效果相似。在观察两组症状、体征、舌苔脉象变化方面,治疗后两组症状体征均较治疗前有明显改善,两组患者症状体征程度减轻或消失,症状积分明显下降,其中乏力、胁痛、出血、便秘、尿黄、黄疸等症状改善情况治疗组优于对照组,两组差异有统计学意义。慢性丙型病毒性肝炎实验室检查包括肝功能、病毒学指标、肝纤维化指标、免疫学指标,其中肝功能谷氨酸氨基转氨酶(Alanine aminotransferaseALT)、天门冬氨酸氨基转移酶(Aspartate aminotransferase AST)等主要反应HCV感染对肝脏的损伤程度,谷氨酰转肽酶(y-glutamyltransferase GGT)在肝内主要分布于肝细胞浆和肝内胆管上皮中。本研究中治疗前两组血清ALT、AST、GGT均有明显增高,蛋白代谢方面白蛋白基本正常,球蛋白有轻中度升高,治疗后血清ALT、GGT均有明显下降,球蛋白有一定程度下降,且随治疗时间的延长该四项指标较为稳定。研究对149例患者测定了血清CD3、CD4、CD8、CD4/CD8比值,其中治疗组101例,对照组48例。治疗后CD4细胞上升,CD8细胞下降,且差异有统计学意义,表明复方丙肝宁有一定的免疫调节作用,增强患者细胞免疫功能,有利于机体清除体内的病毒。研究对118例患者作了血清HA、LN、PC-Ⅲ和Ⅳ型胶原测定,其中治疗组70例,对照组48例。结果发现两组治疗后各指标均较治疗前好转,差异有统计学意义,两组治疗后比较,从均值分布上观察,治疗组较对照组有下降趋势,但差异无统计学意义,可能与样本量有一定关系,值得进一步扩大研究样本。关于复方丙肝宁抗病毒疗效观察,我们对192例患者作了治疗前后及随访6个月的定性检查,其中治疗组140例,对照组52例。治疗6个月后,复方丙肝宁组有73例转阴(52.14%)。随访6个月,仍有67例转阴(47.86%)。干扰素对照组分别为33例(63.47%)和23例(44.23%)。结果表明复方丙肝宁和干扰素均有明显抗丙肝病毒作用。进一步观察HCV RNA定量变化,对113例治疗组和52例对照组患者进行了治疗前后HCV RNA定量测定,治疗后复方丙肝宁组共有24例转阴(占24%),38例滴度下降(占38%),38例上升(占38%)。对照组有9例转阴(占18%),25例下降(占50%),16例上升(占32%),两组定量变化比较,经秩和检验,X2=0.00807,P=0.9284,无显著差异(P<0.05)。病理学改变方面,复方丙肝宁治疗后均有一定程度改善。主要表现为汇管区扩大缩小,炎症细胞浸润减轻,肝细胞点状坏死和碎屑样坏死减轻并有肝细胞再生,肝细胞界板变齐,肝纤维化明显减轻。
结论：流行病学调查部分结论认为,慢性丙型病毒性肝炎患者症状可以分为身体表现和心理表现两部分,身体表现包括头面部症状、消化道症状、肝区症状、其它系统症状,在HCV感染早期,这些身体表现症状轻微、或无明确特异性,如口干、口苦、目干、自汗、盗汗等,临床上常常容易忽视；心理表现则时常得不到应有的重视,容易被患者和非心理专业医务人员忽视,如疾病过程中的焦虑、抑郁等问题,其中一个重要表现为睡眠质量下降,如在本研究中观察到的失眠、多梦。这与两个健康相关生存质量(Health-Related Quality of Life HRQoL)量表体现的总体健康(general health GH)、活力(vitality VT)、精神健康(mental healthMH)、活动能力(acitvity AC)、困乏(fatigue FA)、焦虑(worry WO)等维度积分受损相一致。临床试验结论认为,复方丙肝宁有显著的保肝降酶、改善肝纤维化指标、改善慢性丙型病毒性肝炎患者的肝脏病理变化,在改善慢性丙肝患者症状体征、舌苔脉象方面优于干扰素对照组；其抗病毒作用和干扰素疗效无明显差异；复方丙肝宁治疗慢性丙型病毒性肝炎可能是通过抗HCV、调节细胞免疫等机制。
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.
丙型肝炎自然转阴率低,慢性化率极高,为75%-85%。慢性丙型病毒性肝炎起病隐匿,病机复杂,症状多样,且特异性不高,这些特点均不利于本病的早期诊断,早期治疗,而病程迁延时间越长,本病进展为肝硬化肝癌的几率就越高。感染后10-20年,至少20%患者发展为肝硬化,其中约15%肝硬化患者可发展为失代偿期肝硬化。有报道一旦发生肝硬化,10年生存率约为80%,如出现失代偿期肝硬化,10年的生存率仅为25%。HCV相关的原发性肝细胞癌(Hepatic cell carcinoma HCC)发生率在感染30年后为1%-3%,主要见于肝硬化和进展性肝纤维化患者,一旦发展成为肝硬化,HCC的年发生率为1%-7%。肝硬化和HCC是慢性丙型肝炎患者的主要死因。
研究目的：流行病学调查部分通过对慢性丙型病毒性肝炎的流行病学调查,归纳患者的症状体征分布规律,找出常见症状,特征性较强的症状或体征,初步明确慢性丙型病毒性肝炎疾病的证候分布特点,为临床慢性丙型病毒性肝炎的发现做出预警,达到提高本病的早期诊断,及早治疗目的。进而早期扭转病程进展,降低本病及相关并发症的死亡率。临床试验部分通过对临床慢性丙型病毒性肝炎患者干扰素和复方丙肝宁治疗,观察中药复方丙肝宁治疗的慢性丙肝的疗效,形成一套有效的、能体现中医特色和优势的、易于掌握和推广的规范化中医治疗慢性丙型病毒性肝炎诊疗方案,从而有效提高中医药治疗慢性丙型肝炎的临床疗效,降低病死率和肝硬化等的发生率。
研究方法：流行病学调查部分通过对江苏省中医院、江苏省无锡市传染病医院、江苏省徐州医学院附属医院、江苏省徐州市第二人民医院等多家医院的丙肝门诊和住院患者的流行病学调查,运用设计的证候积分表、SF-36量表、慢性肝病量表(Chronic Liver Disease Questionnaire CLDQ),调查患者的症状、体征,建立流行病学数据库。调查内容包括一般资料,包括患者姓名、性别、年龄、烟酒嗜好、感染途径、病程、治疗经过、家族史等。证候学指标,包括头痛、头重、头晕、眼花、目赤、目干、目黄、视物疲劳、眼皮重、耳鸣、鼻衄、鼻干、面色无华、面色晦暗、面赤、唇甲青紫、肌肤甲错、皮肤紫癜、蜘蛛痣、肝掌、口干、口苦、口淡、口腻、口渴、口臭、齿衄、口腔溃疡、牙龈肿痛、咽痛、四肢关节痛、浮肿、太息、呵欠、自汗、心悸、胸闷、吞酸、嗳气、呃逆、恶心、呕吐、脘闷、食欲不振、倦怠乏力、胁痛、腰酸、膝软、腰痛、烦躁易怒、五心烦热、潮热、盗汗、肠鸣、便秘、便溏、泄泻、里急后重、尿黄、夜尿清长、失眠、嗜睡、多梦、妇女经带变化、舌苔、脉象等；SF-36量表、CLDQ等。数据录入软件采用Epidata 3.1,经数据核查,找出异常值、离群值,评价其专业意义或误输入,数据经核实后即予锁定,不得修改。统计学分析软件采用SPSS11.5 for windows,计数资料用频次表示,计量资料用(X±s)表示,采用t检验和方差分析(One-Way ANOVA).症状积分经初筛,运用因子分析(Factor Analysis)找出症状间的共性和权重。
临床试验部分纳入192例慢性丙型病毒性肝炎患者,所有病例来自江苏省中医院、常州市第三人民医院、淮阴市传染病院、江苏江北人民医院、解放军八一医院等单位的住院及部分门诊病人。随机分为治疗组与对照组,其中复方丙肝宁治疗组140例,干扰素对照组52例。观察的指标包括疗效性指标(肝功能、病毒载量、肝纤维化、病理学观察等)等,治疗组用中药复方丙肝宁,每次1包,1日1次冲服,治疗6个月；对照组用干扰素(赛诺金)300万u肌注,隔日1次,疗程同上。治疗过程中如出现干扰素不良反应,可给予对症治疗,如白细胞下降,可给予提升白细胞药物地榆升白片,发热者予扑热息痛等。全部资料输入计算机建立临床数据库,计量资料采用X±S表示,统计方法采用t检验、方差分析等方法,计数资料采用频数分布等描述性统计,推断性统计方法包括卡方检验、秩和检验等。统计软件使用SPSS11.5 for windows。
研究结果：流行病学部分调查了慢性丙型病毒性肝炎的常见症状,以倦怠乏力、口苦为最多见,且多为主诉,直接影响患者的物质生活和精神状态,其它的症状按出现频次依次为食欲不振(频次148)、尿黄(频次145)、口干(频次137)、多梦(频次135)、失眠(频次127)、目干(频次87)、恶心呕吐(频次79)、便溏(频次78)等。在症状的严重程度上,倦怠乏力(397)积分最高,,其次为食欲不振(322),与慢性丙型病毒性肝炎的常见症状相符。其它的症状积分依次为尿黄(202)、口苦(189)、口干(186)、多梦(119)、目干(115)、恶心呕吐(114)、眼花(100)、胁肋不适(93)等,其中口干症状多伴有口苦,失眠症状多伴有多梦。对于调查的慢性丙型病毒性肝炎患者的症状体征,通过统计学因子分析方差最大旋转正交旋转法旋转变换之后,共提取特征根大于1的公因子13个,累积贡献率达75.9%。根据13个公因子解析权重,结合慢性丙型病毒性肝炎的专业知识,可以将13个公因子按症状分类：(1)头面部症状,包括因子1、因子2、因子5、因子8和因子13；(2)睡眠情况,包括因子3;(3)消化道症状,包括因子6、因子7、因子9和因子10；(4)肝区症状,包括因子11；(5)其它系统症状,包括因子4和因子12。将13个公因子按病机分类：(1)肝肾阴虚,包括因子1、因子2、因子4和因子8；(2)湿热瘀毒,包括因子5、因子10、因子12和因子13；(3)脾失健运,包括因子6、因子7和因子9；(4)其它,包括因子3。可以看出,慢性丙型病毒性肝炎患者的症状除文献明确记载的消化系统表现(因子6、因子7、因子9和因子10)、肝区特征性病位表现(因子11),还包括文献较少记载的头面部症状(因子1、因子2、因子5、因子8和因子13)、睡眠情况(因子3)、其它系统症状(因子4和因子12)。
临床试验部分观察了复方丙肝宁治疗慢性丙型病毒性肝炎的疗效,复方丙肝宁治疗组140例,干扰素对照组52例,一般资料显示感染途径多为输血、手术、献血、吸毒等。病程治疗组为1-8年,平均2.90年；对照组为1-7年,平均2.95年。主要症状有乏力、纳差、胁痛、腹胀、鼻衄、牙龈出血、便秘、尿黄等,体征有肝脏肿大,脾肿大,黄疸,舌苔、脉象改变等。两组患者经过半年的疗程治疗,治疗组140例中,基本治愈51例,占36.43%；显效10例,占71.43%；有效37例,占26.43%,总有效率为70%。对照组52例中基本治愈16例,占30.77%；显效6例,占6.52%；有效15例,占28.85%,总有效率为71.15%。提示复方丙肝宁在治疗慢性丙型病毒性肝炎中总体疗效与一般干扰素效果相似。在观察两组症状、体征、舌苔脉象变化方面,治疗后两组症状体征均较治疗前有明显改善,两组患者症状体征程度减轻或消失,症状积分明显下降,其中乏力、胁痛、出血、便秘、尿黄、黄疸等症状改善情况治疗组优于对照组,两组差异有统计学意义。慢性丙型病毒性肝炎实验室检查包括肝功能、病毒学指标、肝纤维化指标、免疫学指标,其中肝功能谷氨酸氨基转氨酶(Alanine aminotransferaseALT)、天门冬氨酸氨基转移酶(Aspartate aminotransferase AST)等主要反应HCV感染对肝脏的损伤程度,谷氨酰转肽酶(y-glutamyltransferase GGT)在肝内主要分布于肝细胞浆和肝内胆管上皮中。本研究中治疗前两组血清ALT、AST、GGT均有明显增高,蛋白代谢方面白蛋白基本正常,球蛋白有轻中度升高,治疗后血清ALT、GGT均有明显下降,球蛋白有一定程度下降,且随治疗时间的延长该四项指标较为稳定。研究对149例患者测定了血清CD3、CD4、CD8、CD4/CD8比值,其中治疗组101例,对照组48例。治疗后CD4细胞上升,CD8细胞下降,且差异有统计学意义,表明复方丙肝宁有一定的免疫调节作用,增强患者细胞免疫功能,有利于机体清除体内的病毒。研究对118例患者作了血清HA、LN、PC-Ⅲ和Ⅳ型胶原测定,其中治疗组70例,对照组48例。结果发现两组治疗后各指标均较治疗前好转,差异有统计学意义,两组治疗后比较,从均值分布上观察,治疗组较对照组有下降趋势,但差异无统计学意义,可能与样本量有一定关系,值得进一步扩大研究样本。关于复方丙肝宁抗病毒疗效观察,我们对192例患者作了治疗前后及随访6个月的定性检查,其中治疗组140例,对照组52例。治疗6个月后,复方丙肝宁组有73例转阴(52.14%)。随访6个月,仍有67例转阴(47.86%)。干扰素对照组分别为33例(63.47%)和23例(44.23%)。结果表明复方丙肝宁和干扰素均有明显抗丙肝病毒作用。进一步观察HCV RNA定量变化,对113例治疗组和52例对照组患者进行了治疗前后HCV RNA定量测定,治疗后复方丙肝宁组共有24例转阴(占24%),38例滴度下降(占38%),38例上升(占38%)。对照组有9例转阴(占18%),25例下降(占50%),16例上升(占32%),两组定量变化比较,经秩和检验,X2=0.00807,P=0.9284,无显著差异(P<0.05)。病理学改变方面,复方丙肝宁治疗后均有一定程度改善。主要表现为汇管区扩大缩小,炎症细胞浸润减轻,肝细胞点状坏死和碎屑样坏死减轻并有肝细胞再生,肝细胞界板变齐,肝纤维化明显减轻。
结论：流行病学调查部分结论认为,慢性丙型病毒性肝炎患者症状可以分为身体表现和心理表现两部分,身体表现包括头面部症状、消化道症状、肝区症状、其它系统症状,在HCV感染早期,这些身体表现症状轻微、或无明确特异性,如口干、口苦、目干、自汗、盗汗等,临床上常常容易忽视；心理表现则时常得不到应有的重视,容易被患者和非心理专业医务人员忽视,如疾病过程中的焦虑、抑郁等问题,其中一个重要表现为睡眠质量下降,如在本研究中观察到的失眠、多梦。这与两个健康相关生存质量(Health-Related Quality of Life HRQoL)量表体现的总体健康(general health GH)、活力(vitality VT)、精神健康(mental healthMH)、活动能力(acitvity AC)、困乏(fatigue FA)、焦虑(worry WO)等维度积分受损相一致。临床试验结论认为,复方丙肝宁有显著的保肝降酶、改善肝纤维化指标、改善慢性丙型病毒性肝炎患者的肝脏病理变化,在改善慢性丙肝患者症状体征、舌苔脉象方面优于干扰素对照组；其抗病毒作用和干扰素疗效无明显差异；复方丙肝宁治疗慢性丙型病毒性肝炎可能是通过抗HCV、调节细胞免疫等机制。
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.
引文
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