【作者】 黎氏白贤(LE THI BACH HIEN)；

【导师】 薛博瑜；

【作者基本信息】 南京中医药大学 ， 中医内科学， 2013， 博士

【摘要】 丙型病毒性肝炎是由丙肝病毒感染引起的一种感染病。丙型病毒性肝炎流行范围之广、发病率之高、危害性之大,居各种传染病之首、症状表现多种多样,现代医学应用抗病毒药治疗取得了一定疗效,但长期疗效差、复发率高,因为病毒的变异性比较高,而且抗病毒药的副作用也不少。近年来中医药对丙型性肝炎的机理研究及辨证治疗显示了一定的优越性。A.研究背景慢性丙型肝发病率高,知晓率低,是引起肝硬化、肝癌主要原因之一,感染25-30年后肝硬化发生率为5%-25%,是影响重大传染病。临床治疗慢性丙型肝炎的西药主要是聚乙二醇干扰素联合利巴韦林为标准方案,其适应征要求严格、且禁忌症和副作用较多等局限性。中医药用于防治慢性丙型肝炎具有较大优势。在此背景下,本课题用中西医结合治疗慢性丙型肝炎的临床研究,探讨安全、有效的临床治疗方案。B.研究目的：根据中医理论与临床观察,明确中药益气清化法联合干扰素治疗慢性丙型肝炎正虚邪恋证能改善症状,恢复肝功能、抑制病毒复制、改善肝组织损伤、防治肝纤维化及癌变,从而提高临床益气清化法治疗慢性丙型肝炎的疗效。C.研究方法：本研究以确诊为慢性丙型肝炎正虚邪恋证进行临床研究,通过随机对照,观察60例患者,随机分2组,其中治疗组30例,对照组30例,疗程为48周。观察两组患者在治疗前、治疗12周及治疗结束时的综合疗效、抗病毒疗效、症候疗效、中医症候积分、肝功能、肝脾B超的变化及安全性指标,进行比较两组的治疗效果。治疗组(中西医结合治疗组)：聚乙二醇干扰素180ug,皮下注射,每周一次。利巴韦林,每天900mg分三次口服,早中晚各300mg。中药基本方,每天1剂,每天两次(中药基本方组成：黄芪15g、白术15g、栀子15g、苦参15g、胡黄连6g)对照组(西医治疗组)：聚乙二醇干扰素180ug,皮下注射,每周一次。利巴韦林,每天900mg分三次口服,早中晚各300mg。D.研究结果：1.治疗组有效率为90%,对照组总有效率为73.3%,治疗组整体疗效与对照组相比,治疗组明显优于对照组(P<0.05),表明本研究中药结合干扰素治疗慢性丙型肝炎正虚邪恋证的疗效比对照组单纯用干扰素疗效较佳。两组总体疗效比较明显著差：。治疗组30例,有效27例(90%),无效3例(10%),总有效率90%对照组30例,有效24例(73.3%),无效8例(26.7%),总有效率为73.3%。2.益气清化法结合干扰素治疗慢性丙型性肝炎正虚邪恋证能改善临床症状体征：两组治疗前症状体征分布无明显差异,差异无统计学意义,具有可比性(P>0.05)。两组患者治疗后乏力、腹胀、黄疸、口干口苦、肝脾肿大、怯冷或热症状均有显著性差异,差异有统计学意义(P<0.05)；纳差、便溏、胁痛、腰膝酸软症状有非常显著改善,差异有统计学意义(P<0.01)。由治疗组的症状积分均数0.6908>对照组的症状积分均数0.6817,可以认为治疗组的症状积分转化率数高于对照组的症状积分。3.益气清化法结合干扰素治疗慢性丙型性肝炎正虚邪恋证能改善肝脏炎症,恢复肝功能治疗前两组肝功能数值经t检验,P>0.05,提示：两组肝功能无明显差异。治疗后两组肝功能数值经t检验：ALT、AST、GGT P<0.05,提示：两组肝功能ALT、AST、GGT明显改善。治疗后两组肝功能数值经t检验ALB、GLB、TBlil、DBlil均无明显改善,差异无统计学意义(P>0.05),提示：两组肝功能ALB、GLB、TBlil、DBlil无明显改善。由治疗组的肝功能均数28.416<对照组的肝功能均数52.9814,可以认为治疗组的肝功能转化率数低于对照组的肝功能。4.益气清化法结合干扰素治疗慢性丙型性肝炎正虚邪恋证能改善血常规指标：治疗前两组血常规指标无明显差异,差异无统计学意义,具有可比性(P>0.05)两组治疗后白细胞、红细胞、血小板均有显著改善,有显著差异,差异有统计意义(P<0.05)。提示：两组治疗后血常规指标有明显改善(P<0.05)5.益气清化法结合干扰素治疗慢性丙型性肝炎正虚邪恋证能改善病毒定量HCV-RNA,抑制病毒复制：治疗前两组病毒定量数值经t检验,P>0.05,提示：两组的病毒定量无明显差异。治疗后两组病毒定量数值经t检验,P<0.05,提示：两组的病毒定量明显差异。由治疗组的病毒定量均数1000<对照组的病毒定量均数2018,可以认为治疗组的病毒定量转化率数低于对照组的病毒定量。两组在治疗过程中未发生任何过敏反应或严重不良事件者,治疗后血常规、尿常规检测均无明显异常变化,过程中亦无研究对象失访,表明益气清化法结合干扰素治疗正虚邪恋证的临床研究安全有效,无明显毒副作用,且依从性好。治疗中、治疗后未见任何不良反应。E.研究结论：论文通过中药益气清化法联合干扰素治疗慢性丙型肝炎患者,以干扰素作为对照组。结果表明能够明显改善患者的乏力、腹胀、纳差、黄疸、口干口苦、便溏、胁痛腰膝酸软、怯冷或热症状,肝功能、病毒定量均有显著性差异P<0.05。因此,益气清化法联合干扰素治疗慢性丙型肝炎正虚邪恋证的临床研究能够改善患者的症状、恢复肝功能、抑制病毒复制、改善肝组织损伤、防止肝纤维化及肝癌,从而提高临床益气清化法治疗慢性丙型肝炎的疗效。益气清化法联合干扰素治疗慢性丙型肝炎正虚邪恋证的临床研究获得较好的疗效,主要体现在改善临床症状体征方面,是一种方便、无毒、无副作用的方法。更多还原

【Abstract】 Hepatitis C virus is an infectious disease caused by hepatitis C virus infection.The incidence of hepatitis C range, high, harmfulness of it, in a variety of infectious diseases, the first symptoms varied, modern medical application of antiviral therapy and achieved a certain effect, but the long-term effect is poor, the recurrence rate is high, because of the variability of the virus is relatively high, and the side effects of antiviral drugs also many.In recent years, research on the mechanism of Chinese medicine for hepatitis C hepatitis and dialectical treatment shows certain superiority.A. OBJECTIVE:To observe the clinical effects of the Chinese herb (The Clinical Research of the Therapy Zhengxuxielian combined with interferon for Treating Chronic Hepatitis C) in treating chronic hepatitis C.It is expected to improve the patients’signs and symptoms,the liver function test,inhibit viral replication, recover the liver tissue damage,prevent progression to liver fibrosis and liver cancer.B. METHOD:60cases with chronic hepatitis are randomly divided into2groups,there are30cases in each groups.The treatment group were given "Yiqiqinghua" for oral administration combine with oral INF once daily; the control group were merely given ora IFN once daily. Both groups took for12months.C. RESULTS:1. A total of60patients completed48weeks of treatment, the treatment group of30cases, control group30cases.2. Two groups of clinical comprehensive therapeutic effect by P<0.05, two groups of overall efficacy comparison, significant difference.The overall efficacy analysis:the treatment group of30cases,0cases were cured (0%), partially effective in27cases (90%), invalid in3cases (10%), the total effective rate was90%; the control group of30cases,0cases were cured (0%), partially effective in24cases (73.3%), invalid in8cases (26.7%), the total efficiency of73.3%.In the treatment, after treatment and no any adverse reaction.3. The two groups before treatment, bloating, anorexia, fatigue, dry mouth, along with jaundice, hypochondriac pain, tongue, hepatosplenomegaly, Yaoxisuanruan, afraid of cold or heat symptoms showed no significant difference between P>0.05. Two groups of patients before and after treatment of fatigue, bloating, anorexia, jaundice, dry mouth pain, loose stools, hypochondriac pain, hepatosplenomegaly, Yaoxisuanruan, afraid of cold or heat symptoms were significantly different P<0.05.The treatment group symptoms integral average0.6908>controls symptoms integral average0.6817, can be considered the treatment of symptom clusters integral conversion rate number higher than the control group the symptom score.4. In two groups before treatment liver function numerical inspection by T, P>0.05, tips: two groups had no significant difference in liver function.The two groups after treatment of liver function numerical inspection by t ALT alanine aminotransferase (U/L), AST aspartate aminotransferase (U/L), GGT glutamyl transpeptidase (U/L) P>0.05, tips:two groups of liver function ALT, AST, GGT difference.The two groups after treatment of liver function numerical inspection by t ALB albumin (g/L), GLB globulin (g/L), TBlil (umol/L), total bilirubin bilirubin direct bilirubin (DBlil umol/L) P>0.05, tips:two groups of liver function ALB, GLB, TBlil, DBlil showed no significant difference.The treatment group of liver function were number28.416<control group of liver function were number52.9814, can be considered the treatment group liver function conversion rate number lower than the control group on liver function.5. In two groups before treatment virus quantitative inspection by T, t=-1.182, P=0.242, P>0.05, tips:two groups had no significant difference in the virus quantitative.In two groups after the treatment virus quantitative inspection by T, t=-2.590, P=0.012, P<0.05, tips:two groups of virus quantitative difference.The treatment group virus quantitative average1000<controls virus quantitative average2018, can be considered the treatment group virus quantitative conversion rate number lower than the control group virus quantitative.6. Two group during treatment did not produce any allergic reactions or serious adverse events after treatment, blood, urine routine test showed no abnormal changes in the process of study, nor as lost to follow-up, clearing heat and detoxicating method that is effective and safe in treatment of chronic hepatitis B, no obvious toxic side effect, and good compliance.D.CONCLUSION:The results of this study show that Qinghua method combined with interferon for chronic hepatitis C positive imaginary evil love card can significantly improve patients with fatigue, bloating, anorexia, jaundice, dry mouth pain, loose stools, hypochondriac pain, hepatosplenomegaly, Yaoxisuanruan, afraid of cold or heat symptoms were significantly different P<0.05.But the treatment group on liver function, viral quantitation of HCV-RNA were smaller than those in the control group of liver function, viral quantitation of HCV-RNA mean that treatment group, liver function, viral quantitative conversion rate number lower than the control group on liver function, viral quantitation.Therefore, Qinghua method combined with interferon for chronic hepatitis C positive imaginary evil love card is mainly reflected in the can improve the clinical symptoms and signs.The clinical trial process, a treatment group and a control group of patients were not any allergic reactions or serious adverse events after treatment, blood, urine routine test showed no abnormal changes, safety evaluation for Grade1, at the same time the whole process and no research on as lost, without shedding case, indicated in combination with lamivudine Chinese herbal medicine is safe and effective, and has no obvious toxic side effect, good compliance.Because of the limited time, this study has many deficiencies, in follow-up clinical studies need to be improved.Such as:in the choice of sample size, no sample size, may affect the experimental rigor and feasibility; the small number of cases, in a relatively short time, the drugs on liver function, viral markers, hepatosplenomegaly clinical study is not fully, can enlarge the number of cases, prolong time of observation, further validate its clinical efficacy.Qinghua method combined with interferon for chronic hepatitis C positive imaginary evil love card in clinical studies to obtain better curative effect, mainly reflected in the improvement of clinical symptoms and signs, is a kind of convenient use, no toxic side effect method.更多还原