益气活血颗粒治疗慢性乙型肝炎气虚血瘀证的临床研究
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摘要
目的:本课题以中医理论为指导,在国内外医学研究及导师临床经验的指导下,探讨慢性乙型病毒性肝炎(CHB)患者眼底血管扩张度与CHB病情程度、门静脉及脾静脉内径、脾厚度的联系,初步为“肝开窍于目”提供现代医学依据,为早期肝硬化的早期诊断提供新方法;并通过对患者治疗过程中临床症状、体征、肝功能、HBV-DNA的对比观察,探讨益气活血颗粒治疗CHB的临床疗效,发挥中医药诊治该病的优势。
临床研究一
方法:选取符合诊断及纳入标准的慢性乙型病毒性肝炎患者30例,观察患者的眼底情况、病情程度、腹部B超(测肝门静脉及脾静脉内径、脾脏厚度)等指标。
结果:
1. 30例患者的眼底血管扩张度与病情程度经统计学处理,Spearman相关系数为0.595,P<0.01,提示CHB患者眼底血管扩张度与CHB病情程度呈显著正相关关系。
2.眼底血管扩张度与门静脉及脾静脉内径、脾厚度呈正相关关系(P<0.05)。
临床研究二
方法:选取慢性乙型病毒性肝炎患者70例,均符合该病诊断标准及纳入标准,按随机数字表法分为治疗组(35例,阿德福韦酯、复方益肝灵片、益气活血颗粒),对照组(35例,阿德福韦酯、复方益肝灵片)。两组疗程均为2个月,按规定的用药方法用药,用药期间停用其它拮抗或协同药物,详细观察治疗组和对照组在治疗过程中临床症状、体征的变化,治疗前后肝功能、HBV-DNA等指标的改变。
结果:
1.治疗组35例中,临床痊愈9例、显效16例、有效7例、无效3例,总有效率为91.43%;对照组35例,临床痊愈5例、显效11例、有效9例、无效10例,总有效率为71.43%。两组比较有显著性差异(P<0.05)。
2.两组治疗后主症、次症及总计分较治疗前均显著降低(P<0.01),并且治疗组较对照组降低有极显著性意义(P<0.01)。
3.治疗后两组在倦怠乏力、胁肋刺痛、胁下痞块、食欲减退、神疲懒言、便秘或腹泻症状记分及面部或手掌赤红、蜘蛛痣体征记分均较治疗前明显降低(P<0.01),治疗组能明显降低患者的倦怠乏力、胁肋刺痛、胁下痞块等主症计分及食欲减退、神疲懒言、面部或手掌赤红、蜘蛛痣等次症计分(P<0.05,P<0.01),尤其对倦怠乏力、面部或手掌赤红、蜘蛛痣的改善有极显著差异(P<0.01)。
4.两组患者治疗后TBIL、ALT、AST均明显降低(P<0.05,P<0.01),且治疗组较对照组降低有显著性意义(P<0.05,P<0.01)。
5.两组治疗后HBV-DNA均降低,与治疗前相比有极显著差异(P<0.01),治疗组较对照组下降明显,但两者相比无显著性差异(P>0.05)。
结论
1.慢性乙型病毒性肝炎患者的眼底血管扩张度与慢性乙型病毒性肝炎病情程度呈显著正相关关系,与门静脉及脾静脉内径、脾厚度呈正相关关系,为“肝开窍于目”提供了现代医学依据,眼底血管变化可作为预测早期肝硬化的新指标。
2.益气活血颗粒组总体疗效明显优于对照组,可明显减轻慢性乙型病毒性肝炎患者倦怠乏力、胁肋刺痛、胁下痞块、食欲减退、神疲懒言、面部或手掌赤红、蜘蛛痣等临床症状。
3.益气活血颗粒可降低慢性乙型病毒性肝炎患者血清TBIL、ALT、AST水平,促进肝功能恢复,减轻肝脏炎症活动。
Objective:With the guidance of the theory of TCM,on the basis of in tutor formerly clinical and experimental study, First of all discuss the relationship between optical fundus blood vessels and chronic hepatitis B (CHB) disease, the diameter of portal vein and splenic vein, spleen thickness, to provide modern medical basis for the''liver opens into the eye", and for the early diagnosis of the early liver cirrhosis provide new targets; Through the changes before and after treatment of symptoms and signs, liver function and HBV-DNA, observe Yiqihuoxue particles on the clinical efficacy of chronic hepatitis B, to play the advantage of the Traditional Chinese Medicine.
Clinical studies 1
Methods: According with diagnostic criteria, selecte the patients with chronic hepatitis B in 30 cases, observed the optical fundus blood vessels, the serious extent, abdominal ultrasonography(the diameter of portal vein and splenic vein, spleen thickness) and so on.
Results:
1.After statistical treatment, the Spearman rank correlation coefficient between the chronic hepatitis B patients' optical fundus blood vessels and the serious extent was 0.595, P<0.01, results both were significant positive correlation.
2.There was a positive correlation between the optical fundus blood vessels and the diameter of portal vein and splenic vein, between the optical fundus blood vessels and spleen thickness(P<0.05).
Clinical Study 2
Methods: Meet the diagnostic criteria for selection into the standard and the 70 cases of patients with chronic hepatitis B, a random number table will be divided into the treatment group(35 cases, adefovir dipivoxil, yigan compound tablets, Yiqihuoxue particles) and control group(35 cases, adefovir dipivoxil, yigan compound tablets). All patients were treated for 2 months and were forbidden to use antagonistic or concordant remedies during the period. The treatment group and the control group were observed clinical symptoms and signs, measured before and after treatment with liver function and HBV-DNA and so on.
Results:
1.In the treatment group of 35 patients, 9 cases were clinical well-healed, 16 cases were markedly effective, 7 cases were effective and 3 cases were ineffective, the total effective rate was 91.43%; that were 5 cases, 11 cases, 9 cases, 10 cases and 71.43% respectively in the control group. After statistical treatment, there was a significant difference between groups (P<0.05).
2.After treatment, the scores of symptoms and signs were decreased significantly in both groups (P<0.01), the treatment group were decreased more significantly than the control group (P<0.01).
3.After treatment, the scores of symptoms and signs(burnout fatigue, hypochondriac pain, lump in the abdomen, anorexia, lazy statement, constipation or diarrhea, facial or hand red, spider angioma) were decreased significantly in both groups (P<0.01).The scores of burnout fatigue, hypochondriac pain, lump in the abdomen, anorexia, lazy statement, facial or hand red, spider angioma were reduced more significantly in the treatment group than that in the control group(P<0.05, P<0.01), especially for burnout fatigue, facial or hand red, spider angioma change is very significant difference (P<0.01).
4.After treatment, the levels of TBIL, ALT, AST were decreased significantly in both groups(P<0.05, P<0.01), and the treatment group were decreased more significantly than the control group(P<0.05, P<0.01).
5.After treatment, HBV-DNA was decreased significantly in both groups(P<0.01), but it showed no statistical significance between the groups (P>0.05).
Conclusions:
1.There was a positive correlation between the chronic hepatitis B patients' optical fundus blood vessels and the serious extent(P<0.01), between the optical fundus blood vessels and the diameter of portal vein and splenic vein, between the optical fundus blood vessels and spleen thickness(P<0.05). It provide modern medical basis for the "liver opens into the eye", and for the early diagnosis of the early liver cirrhosis provide new targets.
2.Yiqihuoxue particles can reduce more significantly the scores of burnout fatigue, hypochondriac pain, lump in the abdomen, anorexia, lazy statement, facial or hand red, spider angioma. The clinical effect is better than that of the control group.
3.Yiqihuoxue particles can reduce serum TBIL, ALT, AST levels, inhibit the hepatic inflammatory activity and liver fibrosis, promote the recovery of liver function, delay the progress of the disease.
临床研究一
方法:选取符合诊断及纳入标准的慢性乙型病毒性肝炎患者30例,观察患者的眼底情况、病情程度、腹部B超(测肝门静脉及脾静脉内径、脾脏厚度)等指标。
结果:
1. 30例患者的眼底血管扩张度与病情程度经统计学处理,Spearman相关系数为0.595,P<0.01,提示CHB患者眼底血管扩张度与CHB病情程度呈显著正相关关系。
2.眼底血管扩张度与门静脉及脾静脉内径、脾厚度呈正相关关系(P<0.05)。
临床研究二
方法:选取慢性乙型病毒性肝炎患者70例,均符合该病诊断标准及纳入标准,按随机数字表法分为治疗组(35例,阿德福韦酯、复方益肝灵片、益气活血颗粒),对照组(35例,阿德福韦酯、复方益肝灵片)。两组疗程均为2个月,按规定的用药方法用药,用药期间停用其它拮抗或协同药物,详细观察治疗组和对照组在治疗过程中临床症状、体征的变化,治疗前后肝功能、HBV-DNA等指标的改变。
结果:
1.治疗组35例中,临床痊愈9例、显效16例、有效7例、无效3例,总有效率为91.43%;对照组35例,临床痊愈5例、显效11例、有效9例、无效10例,总有效率为71.43%。两组比较有显著性差异(P<0.05)。
2.两组治疗后主症、次症及总计分较治疗前均显著降低(P<0.01),并且治疗组较对照组降低有极显著性意义(P<0.01)。
3.治疗后两组在倦怠乏力、胁肋刺痛、胁下痞块、食欲减退、神疲懒言、便秘或腹泻症状记分及面部或手掌赤红、蜘蛛痣体征记分均较治疗前明显降低(P<0.01),治疗组能明显降低患者的倦怠乏力、胁肋刺痛、胁下痞块等主症计分及食欲减退、神疲懒言、面部或手掌赤红、蜘蛛痣等次症计分(P<0.05,P<0.01),尤其对倦怠乏力、面部或手掌赤红、蜘蛛痣的改善有极显著差异(P<0.01)。
4.两组患者治疗后TBIL、ALT、AST均明显降低(P<0.05,P<0.01),且治疗组较对照组降低有显著性意义(P<0.05,P<0.01)。
5.两组治疗后HBV-DNA均降低,与治疗前相比有极显著差异(P<0.01),治疗组较对照组下降明显,但两者相比无显著性差异(P>0.05)。
结论
1.慢性乙型病毒性肝炎患者的眼底血管扩张度与慢性乙型病毒性肝炎病情程度呈显著正相关关系,与门静脉及脾静脉内径、脾厚度呈正相关关系,为“肝开窍于目”提供了现代医学依据,眼底血管变化可作为预测早期肝硬化的新指标。
2.益气活血颗粒组总体疗效明显优于对照组,可明显减轻慢性乙型病毒性肝炎患者倦怠乏力、胁肋刺痛、胁下痞块、食欲减退、神疲懒言、面部或手掌赤红、蜘蛛痣等临床症状。
3.益气活血颗粒可降低慢性乙型病毒性肝炎患者血清TBIL、ALT、AST水平,促进肝功能恢复,减轻肝脏炎症活动。
Objective:With the guidance of the theory of TCM,on the basis of in tutor formerly clinical and experimental study, First of all discuss the relationship between optical fundus blood vessels and chronic hepatitis B (CHB) disease, the diameter of portal vein and splenic vein, spleen thickness, to provide modern medical basis for the''liver opens into the eye", and for the early diagnosis of the early liver cirrhosis provide new targets; Through the changes before and after treatment of symptoms and signs, liver function and HBV-DNA, observe Yiqihuoxue particles on the clinical efficacy of chronic hepatitis B, to play the advantage of the Traditional Chinese Medicine.
Clinical studies 1
Methods: According with diagnostic criteria, selecte the patients with chronic hepatitis B in 30 cases, observed the optical fundus blood vessels, the serious extent, abdominal ultrasonography(the diameter of portal vein and splenic vein, spleen thickness) and so on.
Results:
1.After statistical treatment, the Spearman rank correlation coefficient between the chronic hepatitis B patients' optical fundus blood vessels and the serious extent was 0.595, P<0.01, results both were significant positive correlation.
2.There was a positive correlation between the optical fundus blood vessels and the diameter of portal vein and splenic vein, between the optical fundus blood vessels and spleen thickness(P<0.05).
Clinical Study 2
Methods: Meet the diagnostic criteria for selection into the standard and the 70 cases of patients with chronic hepatitis B, a random number table will be divided into the treatment group(35 cases, adefovir dipivoxil, yigan compound tablets, Yiqihuoxue particles) and control group(35 cases, adefovir dipivoxil, yigan compound tablets). All patients were treated for 2 months and were forbidden to use antagonistic or concordant remedies during the period. The treatment group and the control group were observed clinical symptoms and signs, measured before and after treatment with liver function and HBV-DNA and so on.
Results:
1.In the treatment group of 35 patients, 9 cases were clinical well-healed, 16 cases were markedly effective, 7 cases were effective and 3 cases were ineffective, the total effective rate was 91.43%; that were 5 cases, 11 cases, 9 cases, 10 cases and 71.43% respectively in the control group. After statistical treatment, there was a significant difference between groups (P<0.05).
2.After treatment, the scores of symptoms and signs were decreased significantly in both groups (P<0.01), the treatment group were decreased more significantly than the control group (P<0.01).
3.After treatment, the scores of symptoms and signs(burnout fatigue, hypochondriac pain, lump in the abdomen, anorexia, lazy statement, constipation or diarrhea, facial or hand red, spider angioma) were decreased significantly in both groups (P<0.01).The scores of burnout fatigue, hypochondriac pain, lump in the abdomen, anorexia, lazy statement, facial or hand red, spider angioma were reduced more significantly in the treatment group than that in the control group(P<0.05, P<0.01), especially for burnout fatigue, facial or hand red, spider angioma change is very significant difference (P<0.01).
4.After treatment, the levels of TBIL, ALT, AST were decreased significantly in both groups(P<0.05, P<0.01), and the treatment group were decreased more significantly than the control group(P<0.05, P<0.01).
5.After treatment, HBV-DNA was decreased significantly in both groups(P<0.01), but it showed no statistical significance between the groups (P>0.05).
Conclusions:
1.There was a positive correlation between the chronic hepatitis B patients' optical fundus blood vessels and the serious extent(P<0.01), between the optical fundus blood vessels and the diameter of portal vein and splenic vein, between the optical fundus blood vessels and spleen thickness(P<0.05). It provide modern medical basis for the "liver opens into the eye", and for the early diagnosis of the early liver cirrhosis provide new targets.
2.Yiqihuoxue particles can reduce more significantly the scores of burnout fatigue, hypochondriac pain, lump in the abdomen, anorexia, lazy statement, facial or hand red, spider angioma. The clinical effect is better than that of the control group.
3.Yiqihuoxue particles can reduce serum TBIL, ALT, AST levels, inhibit the hepatic inflammatory activity and liver fibrosis, promote the recovery of liver function, delay the progress of the disease.
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[1]于冰华.慢乙肝的抗病毒治疗[J].中国社区医生,2004,22(6):8-9.
[2]张秋云,刘绍能.慢性乙型肝炎“毒邪论”[J].中国中医药信息杂志,2006,13(8):82-83.
[3]王春芳,刘光伟,陈建杰.从湿邪论治慢性乙型肝炎探讨[J].世界中医药,2007,2(2):99-100.
[4]蔡行平.肝病缠绵治脾为先[J].中医药学刊,2006,24(4):708-709.
[5]李伟林.论治肝病须重视滋养受损之肝体[J].浙江中医杂志,2007,42(9):500-501.
[6]谢蓉.从瘀论治慢性乙型肝炎探讨[J].陕西中医,2004,25(4):383-384.
[7]柴霞.张俊富教授治疗肝病的经验[J].上海中医药杂志,2003,37(1):16-18.
[8]李川.中医辨治慢性病毒型肝炎概况[J].中医药信息,2005,22(4):20-21.
[9]张秋云,李秀惠.钱英体用同调治疗慢性病毒性肝病经验[J].山东中医杂志, 2005,24(6):375-376.
[10]郝建梅,凌曼芝,杨彩虹.杨震主任医师应用相火论辨治乙肝的学术思想[J].陕西中医,2005,26(9):941-942.
[11]翟长云.慢性乙型肝炎证治体会[J].黑龙江中医药,2005,5:27-28.
[12]叶丽红.浅谈慢性乙型肝炎的中医辨证治疗[J].辽宁中医杂志,2002,29(11):661
[13]阎平,刘书珍.四蒿四花汤治疗病毒性黄疸型肝炎130例[J].中国自然医学杂志,2005,7(2):162-163.
[14]陈兰玲.逍遥散加减治疗慢性乙型肝炎42例疗效观察[J].湖南中医杂志,2002,18(1):5-6.
[15]邝卫红.鳖甲煎汤治疗慢性乙型肝炎27例疗效观察[J].山东中医杂志, 2005 ,24(11):655-657.
[16]王萍,孔令强,陈彦文.温阳补肾益气法治疗慢性乙型肝炎60例临床观察[J].中国中医药科技,2005,12(1):49-50.
[17]兰少波,李瀚文,罗建君,等.滋水涵木法治疗慢性乙型病毒性肝炎的临床研究[J].湖北中医杂志,2006,28(8):3-6.
[18]赵胜利.冬虫夏草治疗慢性肝病的研究进展[J].山西中医,2000,16(1):59-60.
[19]陈咏梅,程新华.黄芪治疗慢性乙型肝炎资料分析[J].实用中医药杂志,2004.20(11):656
[20]程延安,贾晓黎.大黄治疗肝胆疾病[J].世界最新医学信息文摘,2003,2(4):770-772
[21]罗德辉,王群江.叶下珠治疗慢性乙肝研究进展[J].新疆中医药,2004,22(2):58-60.
[22]赵文莉,白宇鹏,刘华平.氧化苦参碱治疗慢性乙型肝炎后肝纤维化的疗效观察[J].长江大学学报(自科版),2006,3(1):232-235.
[23]张菊娥.丹参治疗慢性乙型肝炎疗效对比观察[J].华夏医学,2005,18(1):21-22.