新马地区酒精性脂肪肝的证候特点及利湿化瘀解毒通降法干预的研究
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摘要
本研究报告将以新加坡、马来西亚的地理环境,居民的生活形态及日常饮食特色,来阐述以利湿化瘀解毒通降法方药治疗因过量饮酒而患酒精性脂肪肝的理论及临床价值研究之探讨。新加坡是一个多元种族文化的国家,其人口组成如下:华人约占77.3%、马来人约占14.1%、印度人约占7.3%、欧亚混血及其他种族约占1.3%。新加坡当前已发展成为现代化国家,故吸引了马来西亚人、华人、印度人等来新加坡工作,面对环境竞争力所带来的挑战,新加坡本地人和来新加坡工作(马来西亚人、华人、印度人等)的居民皆处於工作高度竞争紧张的繁忙生活中,因此,过量饮酒病证之临床病例应蕴而生,尤其以患酒精性脂肪肝最为突出明显易见,这种疾病已引起东南亚医学界广泛重视。
本研究拟以符合临床流行病学要求的医院及诊所适宜样本的临床资料为依据,寻求新马地区酒精性脂肪肝患者中医证型的规律及临床诊断试验的评价。本研究目的分述如下:
1分析新马地区酒精性脂肪肝患者中医临床证型的特点;
2通过四诊资料对新马地区酒精性脂肪肝患者中医临床证型进行计量鉴别诊断;
3探讨以利湿化瘀解毒通降法方药当归白术汤加减治疗新马地区酒精性脂肪肝的可行性;
4剖析以利湿化瘀解毒通降法方药当归白术汤加减在酒精性脂肪肝中的应用机理;
5观察以利湿化瘀解毒通降法方药当归白术汤加减对酒精性脂肪肝的临床疗效;
6寻找符合新加坡、马来西亚地区治疗酒精性脂肪肝病证的有效中医方药。
本课题由理论研究、流行病学研究及临床研究三部分组成:
第一部分理论研究:一部分内容总结了中医对利湿化瘀解毒通降法的文献综述,另一部分系统论述了酒精性脂肪肝的文献综述,包含古代中医学对酒精性脂肪肝的述要、中医药对酒精性脂肪肝的研究进展及现代医学对酒精性脂肪肝的研究进展等。
第二部分流行病学研究:为多中心前瞻性研究。以符合临床流行病学要求的新马地区多家医院病例资料为基础,对酒精性脂肪肝患者的临床资料进行调查,探讨酒精性脂肪肝患者中医证候分布的特点,应用因子分析的方法,研究了500例酒精性脂肪肝患者中医证候特点的分布,发病的特点。分析酒精性脂肪肝的中医临床证候规律,为制定相应的辨证规范提供依据。
第三部分临床研究:
本临床研究设计病例数146例,均为新加坡和马来西亚医院及中医诊所门诊病人,随机分成两组,分为当归白术汤加减治疗组(简称治疗组)和养肝丸(台湾卫署成制字第007128号,台湾肝王制药股份有限公司生产,上市成方,已应用于临床15年,每丸300mg)对照组(简称对照组),每组各73例,均符合中西医诊断标准,并经纳入排除标准所选合格者。
本临床研究的方法:(1)治疗组用当归白术汤加减饮片每日1剂,水煎服2次,分早晚2次,每次服用200ml,对照组用养肝丸,每日2次,每次15粒,饭前或饭后服用,3个月为1疗程,3个月后检查各项指标,并评定疗效。(2)统计方法: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,以P≤0.05作为具有显著性差异,以P≤0.01作为具有极显著性差异。
本临床研究的疗效:
本研究观察病例数146例,剔除病例数3例,脱落病例数3例,入组病例数140例,治疗组70例,对照组70例。入组病例均按照要求服药并进行了证候学观察。
本研究中,两组在临床证候疗效方面:治疗组70例患者中临床痊愈25例(35.8%),显效35例(50%),有效5例(7.1%),无效5例(7.1%),总有效率92.9%。对照组70例患者中临床痊愈22例(31.4%),显效24例(34.3%),有效14例(20%),无效10例(14.3%),总有效率85.7%,两组总有效率差异有显著性(P=0.011＜0.05),说明两组在改善中医证候上疗效不一致,提示治疗组在临床证候疗效总有效率方面优于对照组。
结论:
酒精性脂肪患者多发于男性,年龄在41-50岁左右,干部或商人居多。病机为酒毒、湿热、痰浊、瘀血蕴结于肝,并累及脾胃,湿、瘀、痰、毒是本病的主要病理因素。患者中医证候特点为虚实夹杂,中医病位主要在肝胆脾肾。故以利湿化瘀,解毒通降,解酒化痰,,疏肝健脾为治疗大法。结果表明:当归白术汤加减治疗酒精性脂肪肝效果明显,临床证候积分总有效率为92.9%,可使天冬酸氨基转移酶(AST)、丙氨酸氨基转移酶(ALT)、血清总胆固醇(TC)、甘油三酯(TG)明显下降,使肝脏的影像学改变减轻或消失,其中临床症状和脂肪肝的影像学疗效指标均优于养肝丸组。所以,当归白术汤加减对酒精性脂肪肝具有较好的临床疗效。
This research paper will elaborate and discuss the theories and clinical values of "Li Shi Hua Yu Jie Du Tong Jiang" method in the treatment of alcohol fatty liver caused by drinking excessive alcohol.The research resource is based specifically on the Xin-Ma geographical environment and daily life styles and eating habits of the people.
Singapore is a nation with diverse races and cultures.Its population constitutes of the following:77.3%are Chinese,14.1%are Malays and 7.3%are Indians.Europeans, Asian half-blooded and other races stands around 1.3%.Singapore is a developed country, thus it attracts many foreigners to work there.Faced with the challenges brought by environmental competition,people in Singapore,both local and foreign,have a very stressful lifestyle.Therefore,the emergence of the clinical cases caused by excessive alcohol,with the alcohol fatty liver case being the most frequent and commonly occurring.The Southeast Asia medical field has already given much attention to this disease.
This research intends to discover the rule of the Chinese medicine symptoms and the evaluation of clinical diagnoses from the patients of alcohol fatty liver in the Xin-Ma area.The research is based according to the clinical material of adequate samples from hospitals and clinics which meet the needs of clinical epidemiology.The aims of this research are as follows:
1.The research analyzes the characteristics of the Chinese medicine clinical symptoms of the patients suffering from alcohol fatty liver in the Xin-Ma area.
2.Through the four diagnoses material,the quantity distinction diagnoses are given to the Chinese medicine clinical symptom of the patients suffering from alcohol fatty liver in Xin-Ma area.
3.The research also pays attention to feasibility of the treatment of alcohol fatty liver in Xin-Ma area with the Chinese medicine method "Li Shi Hua Yu Jie Du Tong Jiang" and "Dang Gui Bai Zhu Tang".
4.The applying mechanism of the treatment of alcohol fatty liver with the Chinese medicine method "Li Shi Hua Yu Jie Du Tong Jiang" and "Dang Gui Bai Zhu Tang" is also studied.
5.The research also observes the clinical effect of the treatment of alcohol fatty liver with the Chinese medicine methods "Li Shi Hua Yu Jie Du Tong Jiang" and "Dang Gui Bai Zhu Tang".
6.The research also finds the effective Chinese medicine which meets the requirement of the treatment of alcohol fatty liver in Xin-Ma area.
This research is made up of theory part,epidemiology part and clinical-part.
The first part is the theory part,it summarizes the reviews of papers about how the Chinese medicine explains the method "Li Shi Hua Yu Jie Du Tong Jiang".The other part discusses the reviews of papers about alcohol fatty liver,including the narration of the ancient Chinese medicine to the treatment of alcohol fatty liver,the research process of the Chinese medicine and herbal medicine on the treatment of alcohol fatty liver,and also the research process of the modern medicine on the treatment of alcohol fatty liver.
The second part:the research of epidemiology is one that focuses on a few latest research centers.It is based on the case materials from several hospitals in Xin-Ma Area which satisfy the demand of epidemiology.And the survey is carried out on the case materials of alcohol fatty liver.Thus,the characteristics of the Chinese Medicine symptom distribution of patients suffering from alcohol fatty liver can be probed into.The research uses the method of factor analysis.500 patients suffering from alcohol fatty liver are studied on the characteristics of the Chinese Medicine symptom distribution and the cause of the disease.It also analyzes the rule of the Chinese Medicine clinical symptom,which provides the evidence for the distinction criterion.
The third part of clinical research:
This clinical research selects 146 observational cases which are all from the out-patient department of both Chinese and western medicine in Singapore and Malaysia. These people are divided into two groups randomly.One is the treatment of "Dang Gui Bai Zhu Tang Jia Jian'.The other is the control group of "Pro-Liver Pills"(it is a pill in the market,weighing 300 mg).Each group has 73 persons who all meets the standard of the treatment of Chinese and western medicine.And they are admitted to the eligible ones except the standard.
The method of this clinical research:(1)the treatment group has one dose of "Dang Gui Bai Zhu Tang Jia Jian" liquid every day.This dose is fried and drunk twice a day.One in the morning and the other in the evening,both with 200 ml.The control group uses "Pro-Liver Pills" twice a day,with 15 pills once.They are taken before or after the meal with 3 months as a period of treatment.After 3 months,every part is inspected and the effect will be judged.(2)method for statistics:assume that all the tests uniformly use two-way test.After the test,the quantity of test statistics and the p value of it are given.When the p value is less than 0.05,it is thought to have significant difference.If the p value is less than 0.01,it is thought to have extremely significant difference.
The effect of the clinical treatment:the research observation case counts 146 and pick and get rid of a case count 3,shed off a case count 3,go into set case count 140,the treatment group is 70 and the control group is 70.in this research,the two groups have different effects of the clinical symptom.In the treatment group, 25 cases recover in 70 cases,and the percentage is 35.8%.And 35 cases have obvious effect with the percentage 50%,5 cases have some effect with the percentage 7.1%.The rest has no effect with the percentage 7.1%.The total effective percentage is 92.9%. In the control group,22 cases recover in 70 cases,and the percentage is 31.4%.And 24 cases have obvious effect with the percentage 34.3%,14 cases have some effect with the percentage 20%.The rest has no effect with the percentage 14.3%.The total effective percentage is 85.7%.The total effective percentages of the two groups have significant difference(P=0.011＜0.05).This result shows that the two groups have different effects on the improvement of the Chinese medicine symptom,which hints that the treatment group has better result in the total effective percentage of the clinical symptom treatment than the control group.
Conclusion:
Alcohol fatty liver is often observed on men aged between 41-50,officials and businessmen are the majority in this group.The cause of the disease is that the alcohol toxin,in damp and hot environment,phlegm and coagulated blood cumulate in the liver, which also does damage to the spleen and the stomach.Dampness,coagulation,phlegm, and toxin are the main factors of the disease.The characteristic of the Chinese Medicine symptom is the mixture of false and true symptoms.The Chinese medicine disease mainly occurs at the liver,the gall,the spleen,and the kidney.Thus,the method mainly adopts "Li Shi Hua Yu,Jie Du Tong Jiang,Jie Jiu Hua Tan,Shu Gan Jian Pi".The result turns out:the effect of the treatment that uses "Dang Gui Bai Zhu Tang Jia Jian" method is very obvious.The rate of efficiency of the clinical test of the method is up to 92.9%.The method can decrease the AST,ALT,TC,TG in a large amount,which alleviates the liver graph or makes it disappear.What' s more,the clinical symptom and the graph of the fatty liver have better effects of treatment than the group of "Yang Gan".Thus,the method "Dang Gui Bai Zhu Tang Jia Jian" does have better clinical effect on the treatment of AFL.
本研究拟以符合临床流行病学要求的医院及诊所适宜样本的临床资料为依据,寻求新马地区酒精性脂肪肝患者中医证型的规律及临床诊断试验的评价。本研究目的分述如下:
1分析新马地区酒精性脂肪肝患者中医临床证型的特点;
2通过四诊资料对新马地区酒精性脂肪肝患者中医临床证型进行计量鉴别诊断;
3探讨以利湿化瘀解毒通降法方药当归白术汤加减治疗新马地区酒精性脂肪肝的可行性;
4剖析以利湿化瘀解毒通降法方药当归白术汤加减在酒精性脂肪肝中的应用机理;
5观察以利湿化瘀解毒通降法方药当归白术汤加减对酒精性脂肪肝的临床疗效;
6寻找符合新加坡、马来西亚地区治疗酒精性脂肪肝病证的有效中医方药。
本课题由理论研究、流行病学研究及临床研究三部分组成:
第一部分理论研究:一部分内容总结了中医对利湿化瘀解毒通降法的文献综述,另一部分系统论述了酒精性脂肪肝的文献综述,包含古代中医学对酒精性脂肪肝的述要、中医药对酒精性脂肪肝的研究进展及现代医学对酒精性脂肪肝的研究进展等。
第二部分流行病学研究:为多中心前瞻性研究。以符合临床流行病学要求的新马地区多家医院病例资料为基础,对酒精性脂肪肝患者的临床资料进行调查,探讨酒精性脂肪肝患者中医证候分布的特点,应用因子分析的方法,研究了500例酒精性脂肪肝患者中医证候特点的分布,发病的特点。分析酒精性脂肪肝的中医临床证候规律,为制定相应的辨证规范提供依据。
第三部分临床研究:
本临床研究设计病例数146例,均为新加坡和马来西亚医院及中医诊所门诊病人,随机分成两组,分为当归白术汤加减治疗组(简称治疗组)和养肝丸(台湾卫署成制字第007128号,台湾肝王制药股份有限公司生产,上市成方,已应用于临床15年,每丸300mg)对照组(简称对照组),每组各73例,均符合中西医诊断标准,并经纳入排除标准所选合格者。
本临床研究的方法:(1)治疗组用当归白术汤加减饮片每日1剂,水煎服2次,分早晚2次,每次服用200ml,对照组用养肝丸,每日2次,每次15粒,饭前或饭后服用,3个月为1疗程,3个月后检查各项指标,并评定疗效。(2)统计方法: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,以P≤0.05作为具有显著性差异,以P≤0.01作为具有极显著性差异。
本临床研究的疗效:
本研究观察病例数146例,剔除病例数3例,脱落病例数3例,入组病例数140例,治疗组70例,对照组70例。入组病例均按照要求服药并进行了证候学观察。
本研究中,两组在临床证候疗效方面:治疗组70例患者中临床痊愈25例(35.8%),显效35例(50%),有效5例(7.1%),无效5例(7.1%),总有效率92.9%。对照组70例患者中临床痊愈22例(31.4%),显效24例(34.3%),有效14例(20%),无效10例(14.3%),总有效率85.7%,两组总有效率差异有显著性(P=0.011＜0.05),说明两组在改善中医证候上疗效不一致,提示治疗组在临床证候疗效总有效率方面优于对照组。
结论:
酒精性脂肪患者多发于男性,年龄在41-50岁左右,干部或商人居多。病机为酒毒、湿热、痰浊、瘀血蕴结于肝,并累及脾胃,湿、瘀、痰、毒是本病的主要病理因素。患者中医证候特点为虚实夹杂,中医病位主要在肝胆脾肾。故以利湿化瘀,解毒通降,解酒化痰,,疏肝健脾为治疗大法。结果表明:当归白术汤加减治疗酒精性脂肪肝效果明显,临床证候积分总有效率为92.9%,可使天冬酸氨基转移酶(AST)、丙氨酸氨基转移酶(ALT)、血清总胆固醇(TC)、甘油三酯(TG)明显下降,使肝脏的影像学改变减轻或消失,其中临床症状和脂肪肝的影像学疗效指标均优于养肝丸组。所以,当归白术汤加减对酒精性脂肪肝具有较好的临床疗效。
This research paper will elaborate and discuss the theories and clinical values of "Li Shi Hua Yu Jie Du Tong Jiang" method in the treatment of alcohol fatty liver caused by drinking excessive alcohol.The research resource is based specifically on the Xin-Ma geographical environment and daily life styles and eating habits of the people.
Singapore is a nation with diverse races and cultures.Its population constitutes of the following:77.3%are Chinese,14.1%are Malays and 7.3%are Indians.Europeans, Asian half-blooded and other races stands around 1.3%.Singapore is a developed country, thus it attracts many foreigners to work there.Faced with the challenges brought by environmental competition,people in Singapore,both local and foreign,have a very stressful lifestyle.Therefore,the emergence of the clinical cases caused by excessive alcohol,with the alcohol fatty liver case being the most frequent and commonly occurring.The Southeast Asia medical field has already given much attention to this disease.
This research intends to discover the rule of the Chinese medicine symptoms and the evaluation of clinical diagnoses from the patients of alcohol fatty liver in the Xin-Ma area.The research is based according to the clinical material of adequate samples from hospitals and clinics which meet the needs of clinical epidemiology.The aims of this research are as follows:
1.The research analyzes the characteristics of the Chinese medicine clinical symptoms of the patients suffering from alcohol fatty liver in the Xin-Ma area.
2.Through the four diagnoses material,the quantity distinction diagnoses are given to the Chinese medicine clinical symptom of the patients suffering from alcohol fatty liver in Xin-Ma area.
3.The research also pays attention to feasibility of the treatment of alcohol fatty liver in Xin-Ma area with the Chinese medicine method "Li Shi Hua Yu Jie Du Tong Jiang" and "Dang Gui Bai Zhu Tang".
4.The applying mechanism of the treatment of alcohol fatty liver with the Chinese medicine method "Li Shi Hua Yu Jie Du Tong Jiang" and "Dang Gui Bai Zhu Tang" is also studied.
5.The research also observes the clinical effect of the treatment of alcohol fatty liver with the Chinese medicine methods "Li Shi Hua Yu Jie Du Tong Jiang" and "Dang Gui Bai Zhu Tang".
6.The research also finds the effective Chinese medicine which meets the requirement of the treatment of alcohol fatty liver in Xin-Ma area.
This research is made up of theory part,epidemiology part and clinical-part.
The first part is the theory part,it summarizes the reviews of papers about how the Chinese medicine explains the method "Li Shi Hua Yu Jie Du Tong Jiang".The other part discusses the reviews of papers about alcohol fatty liver,including the narration of the ancient Chinese medicine to the treatment of alcohol fatty liver,the research process of the Chinese medicine and herbal medicine on the treatment of alcohol fatty liver,and also the research process of the modern medicine on the treatment of alcohol fatty liver.
The second part:the research of epidemiology is one that focuses on a few latest research centers.It is based on the case materials from several hospitals in Xin-Ma Area which satisfy the demand of epidemiology.And the survey is carried out on the case materials of alcohol fatty liver.Thus,the characteristics of the Chinese Medicine symptom distribution of patients suffering from alcohol fatty liver can be probed into.The research uses the method of factor analysis.500 patients suffering from alcohol fatty liver are studied on the characteristics of the Chinese Medicine symptom distribution and the cause of the disease.It also analyzes the rule of the Chinese Medicine clinical symptom,which provides the evidence for the distinction criterion.
The third part of clinical research:
This clinical research selects 146 observational cases which are all from the out-patient department of both Chinese and western medicine in Singapore and Malaysia. These people are divided into two groups randomly.One is the treatment of "Dang Gui Bai Zhu Tang Jia Jian'.The other is the control group of "Pro-Liver Pills"(it is a pill in the market,weighing 300 mg).Each group has 73 persons who all meets the standard of the treatment of Chinese and western medicine.And they are admitted to the eligible ones except the standard.
The method of this clinical research:(1)the treatment group has one dose of "Dang Gui Bai Zhu Tang Jia Jian" liquid every day.This dose is fried and drunk twice a day.One in the morning and the other in the evening,both with 200 ml.The control group uses "Pro-Liver Pills" twice a day,with 15 pills once.They are taken before or after the meal with 3 months as a period of treatment.After 3 months,every part is inspected and the effect will be judged.(2)method for statistics:assume that all the tests uniformly use two-way test.After the test,the quantity of test statistics and the p value of it are given.When the p value is less than 0.05,it is thought to have significant difference.If the p value is less than 0.01,it is thought to have extremely significant difference.
The effect of the clinical treatment:the research observation case counts 146 and pick and get rid of a case count 3,shed off a case count 3,go into set case count 140,the treatment group is 70 and the control group is 70.in this research,the two groups have different effects of the clinical symptom.In the treatment group, 25 cases recover in 70 cases,and the percentage is 35.8%.And 35 cases have obvious effect with the percentage 50%,5 cases have some effect with the percentage 7.1%.The rest has no effect with the percentage 7.1%.The total effective percentage is 92.9%. In the control group,22 cases recover in 70 cases,and the percentage is 31.4%.And 24 cases have obvious effect with the percentage 34.3%,14 cases have some effect with the percentage 20%.The rest has no effect with the percentage 14.3%.The total effective percentage is 85.7%.The total effective percentages of the two groups have significant difference(P=0.011＜0.05).This result shows that the two groups have different effects on the improvement of the Chinese medicine symptom,which hints that the treatment group has better result in the total effective percentage of the clinical symptom treatment than the control group.
Conclusion:
Alcohol fatty liver is often observed on men aged between 41-50,officials and businessmen are the majority in this group.The cause of the disease is that the alcohol toxin,in damp and hot environment,phlegm and coagulated blood cumulate in the liver, which also does damage to the spleen and the stomach.Dampness,coagulation,phlegm, and toxin are the main factors of the disease.The characteristic of the Chinese Medicine symptom is the mixture of false and true symptoms.The Chinese medicine disease mainly occurs at the liver,the gall,the spleen,and the kidney.Thus,the method mainly adopts "Li Shi Hua Yu,Jie Du Tong Jiang,Jie Jiu Hua Tan,Shu Gan Jian Pi".The result turns out:the effect of the treatment that uses "Dang Gui Bai Zhu Tang Jia Jian" method is very obvious.The rate of efficiency of the clinical test of the method is up to 92.9%.The method can decrease the AST,ALT,TC,TG in a large amount,which alleviates the liver graph or makes it disappear.What' s more,the clinical symptom and the graph of the fatty liver have better effects of treatment than the group of "Yang Gan".Thus,the method "Dang Gui Bai Zhu Tang Jia Jian" does have better clinical effect on the treatment of AFL.
引文
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