加味温胆汤治疗病毒性肝炎高胆红素血症（肝胆湿热型）临床研究
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摘要
目的:
观察加味温胆汤治疗病毒性肝炎高胆红素血症(hyperbilirubinemia)的临床疗效,并从临床研究和理论两个方面探讨加味温胆汤的治疗机制。
方法:
1.全部资料均为2006年3月到2007年12月湖北省中医院肝病科门诊及住院患者。所有病例均符合中华医学会传染病与寄生虫病学分会、肝病学分会2000年联合修订的《病毒性肝炎防治方案》及国家药品监督管理局2002年颁布的《中药新药临床研究指导原则》。入组80例,随机分为对照组和治疗组各40例。两组患者在年龄、性别、西医诊断、病原学诊断等各方面无明显差异,具有可比性(P＞0.05)。
2.对照组给予西药常规治疗:甘利欣150mg/d,门冬氨酸钾镁20mL/d,维生素K_120mg/d,及对症支持治疗。治疗组在对照组西药及对症支持治疗的基础上加用中药加味温胆汤(法夏,竹茹,炒枳实,陈皮,生甘草各10g,茯苓15g,丹参20g,赤芍30g,加水煎至250mL)日一剂,分两次口服。两组疗程均为30天。两组患者在治疗期间均不服用除上述药物外其它药物。
3.治疗前后观察一般体格检查项目(如T、P、R、BP)、血常规、尿常规、粪常规及隐血、肾功能、心电图及不良反应,作出安全性评价;治疗前后各记录一次临床症状,血清TBIL、ALT、ALB,根据相应诊疗标准,作出疗效评价。
结果:
1.总疗效分析:治疗组40例,显效21例,有效13例,无效6例,总有效率85.00%;对照组40例,显效11例,有效12例,无效17例,总有效率57.50%。两组经统计学分析,治疗组总有效率优于对照组总有效率(P＜0.05),表明治疗组临床总疗效优于对照组。
2.临床症状总积分:治疗前两组患者临床症状总积分比较无显著性差异(P＞0.05),治疗后两组患者临床症状总积分较治疗前均有显著性差异(P＜0.01),治疗后治疗组临床症状总积分的改善明显优于对照组(P＜0.05),表明治疗组疗效优于对照组。
3.对肝功能的影响:①两组治疗前TBIL、ALT、ALB比较无显著性差异(P＞0.05);②两组治疗后TBIL、ALT、ALB较治疗前比较有明显差异(P＜0.01);③两组治疗后比较,治疗组TBiL较对照组比较有显著性差异(P＜0.05);但在ALT和ALB方面则无显著性差异(P＞0.05)。表明两组均能明显改善患者的肝功能,降低TBiL、ALT,升高ALB;治疗组在降低患者的TBiL方面疗效优于对照组;但在降低ALT、升高ALB方面,两组疗效相似。
4.改善症状疗效分析:①两组治疗前各临床症状积分比较无显著性差异(P＞0.05);②两组治疗后各临床症状积分较治疗前比较有显著性差异(P＜0.01);③两组治疗后比较治疗组能明显改善身目发黄、胁肋疼痛、脘闷腹胀、小便黄赤、食欲不振、恶心呕吐等症状,疗效明显优于对照组(P＜0.05);对口干口苦,困倦乏力症状的改善与对照组无明显差异(P＞0.05)。
5.安全性比较:治疗组与对照组治疗后血常规、尿常规、粪常规、肾功能、心电图检测均无明显异常变化。两组治疗过程中均未见不良反应。表明加味温胆汤联合西药治疗病毒性肝炎高胆红素血症安全、有效,无毒副作用。
结论:
通过本课题临床研究表明,加味温胆汤联合西药治疗病毒性肝炎高胆红素血症(肝胆湿热型)的疗效优于单纯运用西药治疗本病。其机理可能与以下几方面有关:1.保护肝细胞;2.改善肝细胞对胆红素的结合和排泄障碍;3.改善胆汁的排泄障碍。因此,我们要发挥中医药优势,更好的进行中西医结合治疗,提高病毒性肝炎高胆红素血症的治疗效果,以促进中医药学术水平的发展,更有效地解除广大患者的痛苦。
OBJECTIVES:
To observe the clinical therapeutic effect of the modified Wendan Decoction on hyperbilirubinemia induced by viral hepatitis,and explore the mechanism clinically and theoretically.
Methods:
1.All data were collected from the out-patient and in-patient section of Department of Liver Diseases from March 2006 to December 2007 in Hubei Hospital of Traditional Chinese Medicine.All cases were accorded with both the Scheme in the management of viral hepatitis revised by the Chinese Medical Association Branch Association of Infectious Diseases and Parasiyology and the Branch Association of Hepatology in 2000 and the Guiding principles for clinical research on new drugs (traditional Chinese medicine)issued by the State Food and Drug Administration in 2002.80 cases were involved in the study and randomized into Control Group(n=40) and Treatment Group(n=40)with no statistical difference discovered in age,gender, diagnosis with western medicine and pathogenic diagnosis,so as to be comparable (P＞0.05).
2.The Control Group was given routine western medicine treatment as: 150mg/d diammonium glycyrrhizinate,20ml/d potassium magnesium aspartate, 20mg/d vitarnine K1,and symptomatic supportive treatment.The Treatment Group was treated with the above treatment plus the modified Wendan Decoction(Faxia, Zhuru,Chao Zhishi,Chenpi,Sheng Gancao,10g for each,and Fuling15g, Dansheng20g,Chishao30g,decocted with water to 250 ml),one dose a day,twice orally.The two groups were both treated for 30 days,with no other medications were taken during the treatment.
3.Common physical examination(e.g.Temperature,Pulse,Respirations,Blood Pressure),routine examinations of blood,urine,feces,and occult blood,kidney function,electrocardiogram and the adverse reaction were conducted before and after treatment,and the safety was evaluated accordingly.We recorded the clinical symptoms,blood serum TBIL,ALT,ALB before and after treatment and worked out the therapeutic evaluation according to the related diagnostic criteria.
RESULTS:
1.On total efficacy:of the 40 cases in the Treatment Group,21 cases shows remarkably effective,13 effective and 6 ineffective,the total effective rate is 85.00%; of the 40 cases in the Control Group,it is 11 remarkably effective,12 effective and 17 ineffective,with the total effective rate of 57.50%.The statistical analysis of the comparison of the two groups shows a superior effect of Treatment Group to Control Group in total effective rate(P＜0.05),which indicates a better efficacy of clinical overall therapeutic effect in Treatment group than Control group.
2.On total score of clinical symptoms:no significant difference was observed in comparing both groups before treatment(P＞0.05);the total score after treatment was obviously different to that of before in both groups(P＜0.01);and the total score of Treatment Group showed an apparent superior improvement to that of Control Group(P＜0.05),this demonstrated a better therapeutic effect of Treatment Group than of Control Group.
3.On liver function:①Before treatment,TBIL,ALT,ALB in both groups showed no obvious difference(P＞0.05);②After treatment,the differences were statistically significant(P＜0.01);③The comparison between the two groups after treatment showed significant difference in TBIL(P＜0.05),whereas none in ALT and ALB(P＞0.05).These indicated that both groups had obviously improved the patients' liver function,lowered TBIL,ALT and elevated ALB;and the Treatment Group was superior to Control in lowering TBIL in patients,but similar in lowering ALT and elevating ALB.
4.On analysis of symptoms improvement:①Before treatment,the score for clinical symptoms in both groups showed no obvious difference(P＞0.05);②After treatment,the differences were statistically significant(P＜0.01);③When making comparison between the two groups after treatment,the following symptoms were improved significantly in Treatment Group with a superior effect to Control Group: icterus,hypochondriac pain,thoracic stuffiness and abdomen distending,dark urine, anorexia,nausea and vomiting.However,no significant differences were observed on the improvement of thirst,bitter taste and fatigue(P＞0.05).
5.On safety comparison:both groups showed no obvious abnormal changes in routine examinations of blood,urine,feces,and occult blood,kidney function, electrocardiogram.And no adverse reaction was seen during the treatment.These all indicates the safety of the combination therapy of modified Wendan Decoction and western medicine on the hyperbilirubinemia induced by viral hepatitis,as well as its efficiency and no side effects.
CONCLUSIONS:
Our results indicate a better therapeutic effect of the modified Wendan Decoction combined with western medicine than the single use of western medicine on hyperbilirubinemia induced by viral hepatitis.The possible mechanisms for this may include:1.protection of liver cells;2.improvement of the disordered liver function of conjugating and excreting bilirubin;3.improvement of the disordered bile excretion.Therefore,we should give full play to the advantages of the traditional Chinese Medicine and make better application on the combined traditional Chinese and western medicine therapy,enhancing the curative effect on the hyperbilirubinemia induced by viral hepatitis,so as to promote the academic advancement of Chinese medicine and free the pain of the patients with greater efficiency.
观察加味温胆汤治疗病毒性肝炎高胆红素血症(hyperbilirubinemia)的临床疗效,并从临床研究和理论两个方面探讨加味温胆汤的治疗机制。
方法:
1.全部资料均为2006年3月到2007年12月湖北省中医院肝病科门诊及住院患者。所有病例均符合中华医学会传染病与寄生虫病学分会、肝病学分会2000年联合修订的《病毒性肝炎防治方案》及国家药品监督管理局2002年颁布的《中药新药临床研究指导原则》。入组80例,随机分为对照组和治疗组各40例。两组患者在年龄、性别、西医诊断、病原学诊断等各方面无明显差异,具有可比性(P＞0.05)。
2.对照组给予西药常规治疗:甘利欣150mg/d,门冬氨酸钾镁20mL/d,维生素K_120mg/d,及对症支持治疗。治疗组在对照组西药及对症支持治疗的基础上加用中药加味温胆汤(法夏,竹茹,炒枳实,陈皮,生甘草各10g,茯苓15g,丹参20g,赤芍30g,加水煎至250mL)日一剂,分两次口服。两组疗程均为30天。两组患者在治疗期间均不服用除上述药物外其它药物。
3.治疗前后观察一般体格检查项目(如T、P、R、BP)、血常规、尿常规、粪常规及隐血、肾功能、心电图及不良反应,作出安全性评价;治疗前后各记录一次临床症状,血清TBIL、ALT、ALB,根据相应诊疗标准,作出疗效评价。
结果:
1.总疗效分析:治疗组40例,显效21例,有效13例,无效6例,总有效率85.00%;对照组40例,显效11例,有效12例,无效17例,总有效率57.50%。两组经统计学分析,治疗组总有效率优于对照组总有效率(P＜0.05),表明治疗组临床总疗效优于对照组。
2.临床症状总积分:治疗前两组患者临床症状总积分比较无显著性差异(P＞0.05),治疗后两组患者临床症状总积分较治疗前均有显著性差异(P＜0.01),治疗后治疗组临床症状总积分的改善明显优于对照组(P＜0.05),表明治疗组疗效优于对照组。
3.对肝功能的影响:①两组治疗前TBIL、ALT、ALB比较无显著性差异(P＞0.05);②两组治疗后TBIL、ALT、ALB较治疗前比较有明显差异(P＜0.01);③两组治疗后比较,治疗组TBiL较对照组比较有显著性差异(P＜0.05);但在ALT和ALB方面则无显著性差异(P＞0.05)。表明两组均能明显改善患者的肝功能,降低TBiL、ALT,升高ALB;治疗组在降低患者的TBiL方面疗效优于对照组;但在降低ALT、升高ALB方面,两组疗效相似。
4.改善症状疗效分析:①两组治疗前各临床症状积分比较无显著性差异(P＞0.05);②两组治疗后各临床症状积分较治疗前比较有显著性差异(P＜0.01);③两组治疗后比较治疗组能明显改善身目发黄、胁肋疼痛、脘闷腹胀、小便黄赤、食欲不振、恶心呕吐等症状,疗效明显优于对照组(P＜0.05);对口干口苦,困倦乏力症状的改善与对照组无明显差异(P＞0.05)。
5.安全性比较:治疗组与对照组治疗后血常规、尿常规、粪常规、肾功能、心电图检测均无明显异常变化。两组治疗过程中均未见不良反应。表明加味温胆汤联合西药治疗病毒性肝炎高胆红素血症安全、有效,无毒副作用。
结论:
通过本课题临床研究表明,加味温胆汤联合西药治疗病毒性肝炎高胆红素血症(肝胆湿热型)的疗效优于单纯运用西药治疗本病。其机理可能与以下几方面有关:1.保护肝细胞;2.改善肝细胞对胆红素的结合和排泄障碍;3.改善胆汁的排泄障碍。因此,我们要发挥中医药优势,更好的进行中西医结合治疗,提高病毒性肝炎高胆红素血症的治疗效果,以促进中医药学术水平的发展,更有效地解除广大患者的痛苦。
OBJECTIVES:
To observe the clinical therapeutic effect of the modified Wendan Decoction on hyperbilirubinemia induced by viral hepatitis,and explore the mechanism clinically and theoretically.
Methods:
1.All data were collected from the out-patient and in-patient section of Department of Liver Diseases from March 2006 to December 2007 in Hubei Hospital of Traditional Chinese Medicine.All cases were accorded with both the Scheme in the management of viral hepatitis revised by the Chinese Medical Association Branch Association of Infectious Diseases and Parasiyology and the Branch Association of Hepatology in 2000 and the Guiding principles for clinical research on new drugs (traditional Chinese medicine)issued by the State Food and Drug Administration in 2002.80 cases were involved in the study and randomized into Control Group(n=40) and Treatment Group(n=40)with no statistical difference discovered in age,gender, diagnosis with western medicine and pathogenic diagnosis,so as to be comparable (P＞0.05).
2.The Control Group was given routine western medicine treatment as: 150mg/d diammonium glycyrrhizinate,20ml/d potassium magnesium aspartate, 20mg/d vitarnine K1,and symptomatic supportive treatment.The Treatment Group was treated with the above treatment plus the modified Wendan Decoction(Faxia, Zhuru,Chao Zhishi,Chenpi,Sheng Gancao,10g for each,and Fuling15g, Dansheng20g,Chishao30g,decocted with water to 250 ml),one dose a day,twice orally.The two groups were both treated for 30 days,with no other medications were taken during the treatment.
3.Common physical examination(e.g.Temperature,Pulse,Respirations,Blood Pressure),routine examinations of blood,urine,feces,and occult blood,kidney function,electrocardiogram and the adverse reaction were conducted before and after treatment,and the safety was evaluated accordingly.We recorded the clinical symptoms,blood serum TBIL,ALT,ALB before and after treatment and worked out the therapeutic evaluation according to the related diagnostic criteria.
RESULTS:
1.On total efficacy:of the 40 cases in the Treatment Group,21 cases shows remarkably effective,13 effective and 6 ineffective,the total effective rate is 85.00%; of the 40 cases in the Control Group,it is 11 remarkably effective,12 effective and 17 ineffective,with the total effective rate of 57.50%.The statistical analysis of the comparison of the two groups shows a superior effect of Treatment Group to Control Group in total effective rate(P＜0.05),which indicates a better efficacy of clinical overall therapeutic effect in Treatment group than Control group.
2.On total score of clinical symptoms:no significant difference was observed in comparing both groups before treatment(P＞0.05);the total score after treatment was obviously different to that of before in both groups(P＜0.01);and the total score of Treatment Group showed an apparent superior improvement to that of Control Group(P＜0.05),this demonstrated a better therapeutic effect of Treatment Group than of Control Group.
3.On liver function:①Before treatment,TBIL,ALT,ALB in both groups showed no obvious difference(P＞0.05);②After treatment,the differences were statistically significant(P＜0.01);③The comparison between the two groups after treatment showed significant difference in TBIL(P＜0.05),whereas none in ALT and ALB(P＞0.05).These indicated that both groups had obviously improved the patients' liver function,lowered TBIL,ALT and elevated ALB;and the Treatment Group was superior to Control in lowering TBIL in patients,but similar in lowering ALT and elevating ALB.
4.On analysis of symptoms improvement:①Before treatment,the score for clinical symptoms in both groups showed no obvious difference(P＞0.05);②After treatment,the differences were statistically significant(P＜0.01);③When making comparison between the two groups after treatment,the following symptoms were improved significantly in Treatment Group with a superior effect to Control Group: icterus,hypochondriac pain,thoracic stuffiness and abdomen distending,dark urine, anorexia,nausea and vomiting.However,no significant differences were observed on the improvement of thirst,bitter taste and fatigue(P＞0.05).
5.On safety comparison:both groups showed no obvious abnormal changes in routine examinations of blood,urine,feces,and occult blood,kidney function, electrocardiogram.And no adverse reaction was seen during the treatment.These all indicates the safety of the combination therapy of modified Wendan Decoction and western medicine on the hyperbilirubinemia induced by viral hepatitis,as well as its efficiency and no side effects.
CONCLUSIONS:
Our results indicate a better therapeutic effect of the modified Wendan Decoction combined with western medicine than the single use of western medicine on hyperbilirubinemia induced by viral hepatitis.The possible mechanisms for this may include:1.protection of liver cells;2.improvement of the disordered liver function of conjugating and excreting bilirubin;3.improvement of the disordered bile excretion.Therefore,we should give full play to the advantages of the traditional Chinese Medicine and make better application on the combined traditional Chinese and western medicine therapy,enhancing the curative effect on the hyperbilirubinemia induced by viral hepatitis,so as to promote the academic advancement of Chinese medicine and free the pain of the patients with greater efficiency.
引文
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[3]包云.大剂量维生素c加维脑路通治疗急性病毒性肝炎高胆红素血症疗效观察[J].临床荟萃,1996,11(5):226.
[4]于强,杨勇,胡新华等.酚妥拉明、甘利欣联合治疗慢性重度淤胆型肝炎86例的降黄疗效[J].现代诊断与治疗,1999,(S1):14-16.
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[8]李晶,孟庆华.肝素治疗病毒性肝炎高胆红素血症85例临床观察[J].江苏医药,1999,25(6):453-454.
[9]杨忠民,戴鸣,白宇鹏等.蝮蛇抗栓酶治疗黄疸型病毒性肝炎50例[J].临床荟萃,2001,16(22):1034-1034.
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[13]陆建中.思美泰治疗慢性乙型肝炎高胆红素血症97例观察[J].中国血液流变学杂志,2003,13(1):69-70.
[14]曾一涛,刘树嘉.甘露醇治疗急性病毒性肝炎高胆红素血症的临床观察[J].临床荟萃,1998,13(9):431.
[15]王萍,文显国,帅鹏.苯巴比妥治疗淤胆型肝炎疗效观察[J].西藏医药杂志,2002,4:15-16.
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[19]宁晓滨,文竹筠,程迎祥.应用肾上腺皮质激素不同方法治疗淤胆型肝炎的对照观察[J].四川医学,2000,21(11):958-959.
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[1]陈国钟,虞洪斌.前列腺素E1治疗慢性肝炎高胆红素血症40例疗效观察[J].中华临床新医学,2003,3(5):403.
[2]邓欣,王东,聂广.凯时治疗病毒性肝炎高胆红素血症30例[J].中国新药杂志,2002,11(8):647-648.
[3]包云.大剂量维生素c加维脑路通治疗急性病毒性肝炎高胆红素血症疗效观察[J].临床荟萃,1996,11(5):226.
[4]于强,杨勇,胡新华等.酚妥拉明、甘利欣联合治疗慢性重度淤胆型肝炎86例的降黄疗效[J].现代诊断与治疗,1999,(S1):14-16.
[5]李兴国.山莨菪碱治疗淤胆型肝炎9例疗效观察[J].四川医学,2001,22(2):302-303.
[6]侯山平.大剂量654-2联合丹参注射液治疗病毒性肝炎高胆红素血症36例疗效观察[J].浙江临床医学,2003,5(2):136-137.
[7]赵兰英,孙清安.小剂量肝素治疗病毒性肝炎胆汁淤积30例临床观察[J].中原医刊,2002,29(9):52.
[8]李晶,孟庆华.肝素治疗病毒性肝炎高胆红素血症85例临床观察[J].江苏医药,1999,25(6):453-454.
[9]杨忠民,戴鸣,白宇鹏等.蝮蛇抗栓酶治疗黄疸型病毒性肝炎50例[J].临床荟萃,2001,16(22):1034-1034.
[10]Bdtes D,Rodrigues CM,Oliverira N,et aI.Correction of maternal serum bile acid profile during ursodeoxycholic acid therapy in cholestasis ofpregnancy[J].J Hepatol,1998,28(1):91-98.
[11]Paumgartner G,Beuers U.Ursodeoxycholic acid in cholestatic liver disease:mechanisms of acion and therapeutic use revisited[J].Hepatology,2002,36:525-531.
[12]徐小薇,李兰娟,吕芳芳等.熊去氧胆酸治疗大鼠肝内淤胆的实验研究[J].中华肝脏杂志,2003,11(4):244-245.
[13]陆建中.思美泰治疗慢性乙型肝炎高胆红素血症97例观察[J].中国血液流变学杂志,2003,13(1):69-70.
[14]曾一涛,刘树嘉.甘露醇治疗急性病毒性肝炎高胆红素血症的临床观察[J].临床荟萃,1998,13(9):431.
[15]王萍,文显国,帅鹏.苯巴比妥治疗淤胆型肝炎疗效观察[J].西藏医药杂志,2002,4:15-16.
[16]缪新权,鲁慎父,梅光涛等.阿波莫斯治疗重型肝炎高胆红素血症疗效分析[J].中华肝脏杂志,2000,8(3):163.
[17]谢玉桃,谢建萍,鲁猛厚等.甘利欣治疗重度肝内胆汁淤积的疗效[J].湖南医学,1998,15(3):137-138.
[18]马利晔,田桂珍.硫普罗宁治疗黄疸型病毒性肝炎的临川研究[J].药学实践杂志,2002,20(4):199-200.
[19]宁晓滨,文竹筠,程迎祥.应用肾上腺皮质激素不同方法治疗淤胆型肝炎的对照观察[J].四川医学,2000,21(11):958-959.
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