【作者】 郭贞君；

【导师】 薛博瑜；

【作者基本信息】 南京中医药大学 ， 中医内科学， 2012， 博士

【摘要】 目的：观察芪珠方治疗慢性乙型病毒性肝炎的疗效,包括改善症状、阳性体征及肝功能和肝纤维化为指针,寻找中医有效治疗慢性乙型病毒性肝炎的方药。方法：自2009年1月至2011年12月,确诊为慢性乙型肝炎的住院及部分门诊病例列为观察对象,来源于江苏省中医院肝炎门诊、常州市第三人民医院、南京江北人民医院、南通市第三人民医院等。随机分成治疗组和对照组,各120例。治疗组：芪珠方,处方组成：黄芪15g、叶下珠30g、土茯苓30g、虎杖15g、蛇舌草30g、赤芍10g、丹参10g,水煎100ml剂,口服,1日2次。对照组：拉米夫定,口服,每次1粒,1日1次。1个疗程为连续30天服药,每30天复诊1次。观察时间为6个疗程,其中部分病例,可延长疗程至1年。治疗结束后随访6个月。临床试验结束后,按临床常规方法治疗。观察指标包括(1)临床症状,观察胁痛、食欲、无力采用积分法记录。每4周观察记录1次。(2)实验室检查,肝功能指针：ALT、AST、ALP、r-GT、TB、Al、G,每四周检查1次；病原学指标(HBsAg、抗HBs、HBeAg、抗HBe、抗HBc、HBV-DNA)、每12周各检查1次。血液与尿液常规、粪便常规、心电图、肾功能(BUN、Scr),治疗前后各检查1次。采描述性统计分析,定性指标以频数表,构成比或百分率描述；定量指标以均数±标准差表示。两组对比分析,定性数据采用卡方检验。定量数据符合正态分布用t检验(组间进行方差齐性检验,以0.05作为检验水平,方差不齐时选用Satterthwaite方法进行校正的t检验),假设检验统一使用双侧检验,给出检验统计量及其对应的P值。结果：治疗组男性70例,女性50例,平均年龄为38.44±9.06岁；对照组男性76例,女性44例,平均年龄为39.28±8.70岁两组患者在性别和年龄方面无显著性差异(P>0.05)。治疗组120例病人中,65人属轻度慢性乙型肝炎者,中度55人；对照组120例病人中,62人属轻度慢性乙型肝炎者,中度58人。两组患者在病情轻重方面无显著差异(P>0.05)。两组患者治疗前后积分经t检验,治疗组各组症状均有不同程度的改善(无力、胁痛、纳差、腹胀、黄疽的P值分别为0.000,0.003,0.002,0.002,0.004)；对照组乏力、黄疸也有一定改善(P值分别为0.014,0.027)；与对照组相比,芪珠方能明显改善患者的胁痛、纳差症状(P值分别为0.025,0.014)。两组治疗前后肝功能ALT、AST、GGT、ALP均有明显改善。两组患者治疗前后,肝纤维化指标(透明质酸(HA)、层粘蛋白(LN)、Ⅳ型胶原(IVC))均有不同程度的改善。本研究两组患者HBeAg、HBV-DNA变化相似,经卡方检验,差异无统计学意义。治疗组120例中,完全应答22例(18.3%),部分应答44例(36.7%),无应答54例(45.0%),总有效率为55.0%；对照组120例,完全应答26例(21.7%),部分应答42例(35.0%),无应答52例(43.3%),总有效率56.7%,两组总体疗效比较,差异无统计学意义。两组总体疗效比较,经检验,χ2=0.015,P=0.352。治疗前后观察血常规、肾功能、心电图等安全性指标均无明显异常。结论：芪珠方能改善慢性乙型病毒性肝炎病患之症状、体征及肝功能,且有一定的抗病毒作用,其机制可能是通过扶助身体正气,清化湿热瘀毒来发挥作用,值得进一步深入研究。更多还原

【Abstract】 Objective:To observe the effect of QIZHUFANG in treating chronic hepatitis b curative effect, including symptoms, positive syndrome improved and liver function and hepatic fibrosis of chronic hepatitis B, to try looking for treating method of traditional Chinese medicine.Methods:from2009January to2011December, from Jiangsu Province Traditional Chinese Medicine Hospital, Changzhou Third People’s Hospital, Nanjing Jiangbei hepatitis outpatient service people’s Hospital, Nantong Third People’s hospital. Patients diagnosed with chronic hepatitis B were classified as observation objects, randomly divided into treatment group and control group,120cases in each. The test group,lto2times daily. Control group:Lamivudine, oral,1capsules each time,1timesldays. Continuous medication for30days. After the end of treatment were followed up for6months. Clinical trials after the end of treatment, according to clinical routine method. Outcome measures included (1) the clinical symptoms, chest pain, loss of appetite, fatigue was observed using integral method of recording. Every4weeks a record1time.(2) laboratory examination, liver function indices:ALT, AST, ALP, r-GT, TB, Al, G, around1times each check; etiological indexes (HBsAg, anti HBs, HBeAg, anti HBe, anti HBc, HBV-DNA), the examination1times every12weeks. Blood, urine, stool, electrocardiogram, renal function (BUN, Scr), before and after each treatment were examined1times. Descriptive statistical analysis, qualitative index using frequency table, percentage or proportion description; quantitative indicators to mean±SD. Two groups of comparative analysis, qualitative data by using the chi-square test. t test.Results:the treatment group70cases male,50female, mean age of38.44±9.06years; the control group76cases male,44female, mean age of39.28±8.70years two groups in gender and age have no significant difference (P>0.05). The treatment group of120cases of chronic hepatitis B patients with mild in65, moderate in55; the control group of120cases patients of mild chronic hepatitis of62, moderate in58. The severity of two groups of patients is of no significant difference (P>0.05). Two groups of patients before and after treatment with integral inspection by T, the treatment group had different degrees of improvement in symptoms (fatigue, chest pain, anorexia, abdominal distension, jaundice of the P values were0,0.003,0.002,0.002,0.004); the control group fatigue, jaundice also have improved (P=0.014,0.027); compared with the control group, Qi beads can significantly improve patients with chest pain, anorexia symptoms (P=0.025,0.014). Two groups of liver function in the treatment of ALT, AST, GGT, ALP were significantly improved. Two groups of patients before and after treatment, liver fibrosis indexes (hyaluronic acid (HA). laminin (LN), type IV collagen (IVC)) were improved to different degree. The study of two groups of patients with HBeAg, HBVDNA changes are similar, the chi-square test, no significant difference. The treatment group120cases. complete response in22cases (18.3%), partial response in44cases (36.7%), no response in54cases (45%), the total effective rate was55%; the control group of120cases,26cases of complete response (21.7%), partial response in42cases (35%),52cases (43.3%)., the total efficiency of56.7%, two groups of overall efficacy comparison, the difference was not statistically significant. Comparison of curative effect of two groups, upon examination, x2=0.015, P=0.352. Before and after treatment, renal function, blood routine electrocardiogram safety indicators have no obvious abnormality.Conclusion:QIZHUFANG can improve chronic hepatitis B patients with symptoms, signs and liver function, there are certain antiviral effect, the mechanism may be the support body, clearing dampness heat Stasis Toxin, it is worth studying further.更多还原