脾胃湿热证诊断标准研究及以药测证方法初探
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摘要
目的：证候在中医学学术体系中起连接理论与临床实践的桥梁作用，其重要性是不言而喻的。研究中医证候，首要的工作就是明确界定中医证候的涵义。否则研究无法开展，即便开展，结论也难以重复验证，也无法推广应用。证候并不仅仅是表面的、症状群的描述，它也是患者对特定药物反应的总结。由于中医学的病机、病势等概念较之现代医学病理生理概念要抽象得多，临床手段的应用对中医学证候概念的影响比起现代医学更加重要。中医不存在一个独立于治疗过程的诊断证候的“黄金标准”，也就无法用与“黄金标准”相对照的形式在孤立的诊断过程中建立恰当的临床诊断标准，我们要明确界定中医证候，要充分理解前人论述，应当在实践上掌握证候对特定药物的反应。证候诊断标准首先要符合中医过去的文献。其次，以之用于临床实践要有效验。第三，标准本身要明白简练。本文的主要目的，是寻找脾胃湿热证的恰当的诊断标准。同时探讨以药测证的证候标准研究。提出这一方法，目的是为了解决中医诊断学研究中难以解决的“黄金标准”问题。
方法；本次研究首先探讨中医学对脾胃湿热证的诊断、治疗方面的学术渊源，进行了国内专家对脾胃湿热证的诊断意见的问卷调查。对医学刊物中涉及脾胃湿热证和其他湿热证证候诊断的论述作一定范围的统计。临床调研分两个部分。首先按照以往证候诊断标准研究方式进行诊断标准的临床调查，以我校第一附属医院内科门诊及二内科住院病人为调查总体。参考我所拟定的脾胃湿热证诊断标准和/或《中药新药临床研究指导原则》脾胃湿热证诊断标准作为观察对象的诊断标准。参考《中药新药临床研究指导原则》中其它证候诊断标准作为非脾胃湿热证的诊断标准，观察项目按文献研究所得脾胃湿热证证候调查表所列项目进行。重点记录症状及中西医诊断。为准确记录患者症状，对于不容易准确判断的舌象、脉象均由有经验的医师复核。对于一些不完全符合诊断标准但医师认为确属中医某一证候的，以有经验的医师诊断为准，以免遗漏有价值的症状。完成一定数量病例后，按脾胃湿热证组和非脾胃湿热证组对症状进行卡方检验，选出具有显著性意义的症状。然后进行logistic回归分析，得出判别函数。继续增加病例，再以判别函数对患者进行分类，与原判别式进行比较，观察其较能。然后探讨“以药探证”方法，对按纳入标准诊断为脾胃湿热证患者进行治疗研究。患者所用方药主要以三仁汤加减。一般加藿香止呕，黄芩清热，菖蒲、郁金芳香化浊，砂仁、陈皮开胃醒脾。主要以主观症状如食欲、精神状态、口味、身体不适感的消失作为疗效标准，少量客观症状如口臭、
大便性状的变化也作为衡量指标。而由医生判断的舌象和脉象则作为观察患者证候向阴
虚等其它证候转化的指针，但不列入疗效衡量指标中。作为疗效衡量指标的症状消失，
记为有效。如用药两周后相应症状未消失则记为无效。用药期间，疗效衡量指标未消失，
而证候出现转化，需要转以其它非清化湿热方药治疗者，予以剔除。以有效者为脾胃湿
热证，无效者为非脾胃湿热证纳入统计。按脾胃湿热征组和非脾胃湿热证组对症状进行
lOgistiC回归，得出判别函数。继续增加病例，再以判别函数对患者进行分类，分别以清
热化湿汤药进行治疗，观察其有效率。与原诊断标准比较，判断治疗有效率的差别。
结论：总结占代文献，关于湿热证的舌象，主要有9种。关于湿热证的见症，主要有52
种。总共55位专家参与脾胃湿热证的诊断意见的问卷调查，涉及全国绝大多数中医脾胃
病学的主要专家。调查中提到相关症状95种。查阅1995－2000年的中国医学文献数据
库。以主题词“湿热”进行检索，排除“无副主题词”项目，共得文献269篇。检阅文
献，共有 185篇提到有关湿热证的症状。粗略统计，在文献所涉及的湿热证的各种表现
症状当中，身困乏力、身重肢倦、胃院胀痛、大便不爽、口舌溃疡、水样便、呕恶、脐
腹痞满及类似症状8种是脾胃湿热证的特征；舌质红、水肿、面目发黄、尿灼热涩痛、
尿频、尿急6种是其它湿热证的特征。诊断标准临床调查，学习阶段总计观察患者151
例。其中脾胃湿热证63例，肝胆湿热证20例，肝郁脾虚证58例，气血两虚证10例。
回代研究收集85例病例。结果得到模型公式1。这一标准与人工辨证效能无明显差别。
其敏感度是80％，特异度是98％。以药探理探讨，学习阶段共治疗61例思者，其中男
性33例，女性30例。3例患者在治疗结束还有指标症状存在；另有3例患者在治疗期
间出现证型转化。其余患者的指标症状多在一周内消失。将3例治疗无效惠者计入非脾
胃湿热证患者中。回代研究治疗35例病例。通过以药探理的探讨，得到公式2。这一标
准与人工辨证效能有明显差别。其敏感度是刀％，特异度是90％。但是通过这一标准辨
证后，用三仁汤加味治疗，其疗效与用原有标准辨证治疗没有明显差别。
Object: The theory of syndrome is the connection part from theory to clinical practice in traditional Chinese medicine system, the significance is self-evident To study T.C.M. theory of syndrome, the primary task is to define the meaning of syndrome dearly. Otherwise the study cannot be carry out, even if carry out. the conclusion is hard of reauthenticafon. and cannot be deployed. The "syndrome" of T.C.M. is more than just description of external sign and symptom group, it is also the summarization of reaction to specific T.C.M. drugs. As a result that the concept of pathogenesis, degree of seriousness of illness in T.C.M. is much more abstract than modem medical theory, the influence of clinical practice is much more important to T.C.M. syndrome than modem medicine. In T.C.M.. there is no "gold standard" of diagnosing syndrome or symptom complex that was independent to medical treatment procedural, so there has no means of establishing clinical diagnosis standard by compare with "gold standard" To define T.C.M. syndrome clearly, we should comprehend the discuss of predecessor, we should also master it's reaction to specific T.C.M. medicine. First of all. diagnostic criteria of T.C.M. syndrome should meet the literature in the past. Secondly, it should effective when applied in practice. Thirdly, the standard itself should plain and terse. The main object of this article is in search of a proper diagnostic stander of damp-heat in the spleen-stomach syndrome. At the same time, we would like to discuss the method of "measure syndrome with drug" in syndrome standard study. The purpose of introducing this method is to try solving the insoluble "gold standard" issue in T.C.M. diagnostics study.
Method: In this study, first we will discuss the academic source of diagnosing and treating damp-heat in the spleen-stomach syndrome. Then we went on a questionnaire survey of diagnosing damp-heat in the spleen-stomach syndrome in specialist around the state. And then there is a statistic on discusses of medical publication that involved diagnose of damp-heat in the spleen-stomach syndrome and other dampheat syndromes. Clinical research is in two parts. Part one is a clinical investigation of diagnostic standard according to formerly described study mode. The population of survey is the inpatient of the No.2 department of internal medicine and outpatient of outpatient service department of internal medicine of the 1st affiliated hospital of our university. Diagnostic standard of observation object is the damp-heat in the spleen-stomach syndrome diagnostic standard described in Chinese traditional medicine new drug clinical research guiding principle and / or the diagnostic standard made by our department. Diagnostic standard of other syndrome is those described in Chinese traditional medicine new drug clinical research guiding principle. The observation item is obtained in literature study. Sign and diagnose of Western medicine and T.C.M. is recorded. The signs that is hard to judge such as type of the tongue, type of pulse, is verified by experienced physician. To some cases that failed to meet diagnostic standard, but diagnosed a certain syndrome by physician, the physician's diagnose is supported, in case of missing valuable sign. Chi-square test is performed to pick up sign and symptom with significance after certain quantity of case is entered. Logistic regression analysis is performed to get discriminant function. Grouping is performed
with discriminant function when new cases added, and the effectiveness of grouping is compared with the original diagnostic standard. Treatment study is performed with the patients diagnosed damp-heat in the spleen-stomach syndrome, to discuss the method of "measure syndrome with drug". The therapy is the SanRen recipe. Radix scutellariae, calamus, turmeric hairy china cardamoms, dried old orange peel is added to the recipes. Disappearances of subjective symptom like appetite, mental state and taste is taken as criterion of therapeutical effect. Some objective symptom like halitosis,
方法；本次研究首先探讨中医学对脾胃湿热证的诊断、治疗方面的学术渊源，进行了国内专家对脾胃湿热证的诊断意见的问卷调查。对医学刊物中涉及脾胃湿热证和其他湿热证证候诊断的论述作一定范围的统计。临床调研分两个部分。首先按照以往证候诊断标准研究方式进行诊断标准的临床调查，以我校第一附属医院内科门诊及二内科住院病人为调查总体。参考我所拟定的脾胃湿热证诊断标准和/或《中药新药临床研究指导原则》脾胃湿热证诊断标准作为观察对象的诊断标准。参考《中药新药临床研究指导原则》中其它证候诊断标准作为非脾胃湿热证的诊断标准，观察项目按文献研究所得脾胃湿热证证候调查表所列项目进行。重点记录症状及中西医诊断。为准确记录患者症状，对于不容易准确判断的舌象、脉象均由有经验的医师复核。对于一些不完全符合诊断标准但医师认为确属中医某一证候的，以有经验的医师诊断为准，以免遗漏有价值的症状。完成一定数量病例后，按脾胃湿热证组和非脾胃湿热证组对症状进行卡方检验，选出具有显著性意义的症状。然后进行logistic回归分析，得出判别函数。继续增加病例，再以判别函数对患者进行分类，与原判别式进行比较，观察其较能。然后探讨“以药探证”方法，对按纳入标准诊断为脾胃湿热证患者进行治疗研究。患者所用方药主要以三仁汤加减。一般加藿香止呕，黄芩清热，菖蒲、郁金芳香化浊，砂仁、陈皮开胃醒脾。主要以主观症状如食欲、精神状态、口味、身体不适感的消失作为疗效标准，少量客观症状如口臭、
大便性状的变化也作为衡量指标。而由医生判断的舌象和脉象则作为观察患者证候向阴
虚等其它证候转化的指针，但不列入疗效衡量指标中。作为疗效衡量指标的症状消失，
记为有效。如用药两周后相应症状未消失则记为无效。用药期间，疗效衡量指标未消失，
而证候出现转化，需要转以其它非清化湿热方药治疗者，予以剔除。以有效者为脾胃湿
热证，无效者为非脾胃湿热证纳入统计。按脾胃湿热征组和非脾胃湿热证组对症状进行
lOgistiC回归，得出判别函数。继续增加病例，再以判别函数对患者进行分类，分别以清
热化湿汤药进行治疗，观察其有效率。与原诊断标准比较，判断治疗有效率的差别。
结论：总结占代文献，关于湿热证的舌象，主要有9种。关于湿热证的见症，主要有52
种。总共55位专家参与脾胃湿热证的诊断意见的问卷调查，涉及全国绝大多数中医脾胃
病学的主要专家。调查中提到相关症状95种。查阅1995－2000年的中国医学文献数据
库。以主题词“湿热”进行检索，排除“无副主题词”项目，共得文献269篇。检阅文
献，共有 185篇提到有关湿热证的症状。粗略统计，在文献所涉及的湿热证的各种表现
症状当中，身困乏力、身重肢倦、胃院胀痛、大便不爽、口舌溃疡、水样便、呕恶、脐
腹痞满及类似症状8种是脾胃湿热证的特征；舌质红、水肿、面目发黄、尿灼热涩痛、
尿频、尿急6种是其它湿热证的特征。诊断标准临床调查，学习阶段总计观察患者151
例。其中脾胃湿热证63例，肝胆湿热证20例，肝郁脾虚证58例，气血两虚证10例。
回代研究收集85例病例。结果得到模型公式1。这一标准与人工辨证效能无明显差别。
其敏感度是80％，特异度是98％。以药探理探讨，学习阶段共治疗61例思者，其中男
性33例，女性30例。3例患者在治疗结束还有指标症状存在；另有3例患者在治疗期
间出现证型转化。其余患者的指标症状多在一周内消失。将3例治疗无效惠者计入非脾
胃湿热证患者中。回代研究治疗35例病例。通过以药探理的探讨，得到公式2。这一标
准与人工辨证效能有明显差别。其敏感度是刀％，特异度是90％。但是通过这一标准辨
证后，用三仁汤加味治疗，其疗效与用原有标准辨证治疗没有明显差别。
Object: The theory of syndrome is the connection part from theory to clinical practice in traditional Chinese medicine system, the significance is self-evident To study T.C.M. theory of syndrome, the primary task is to define the meaning of syndrome dearly. Otherwise the study cannot be carry out, even if carry out. the conclusion is hard of reauthenticafon. and cannot be deployed. The "syndrome" of T.C.M. is more than just description of external sign and symptom group, it is also the summarization of reaction to specific T.C.M. drugs. As a result that the concept of pathogenesis, degree of seriousness of illness in T.C.M. is much more abstract than modem medical theory, the influence of clinical practice is much more important to T.C.M. syndrome than modem medicine. In T.C.M.. there is no "gold standard" of diagnosing syndrome or symptom complex that was independent to medical treatment procedural, so there has no means of establishing clinical diagnosis standard by compare with "gold standard" To define T.C.M. syndrome clearly, we should comprehend the discuss of predecessor, we should also master it's reaction to specific T.C.M. medicine. First of all. diagnostic criteria of T.C.M. syndrome should meet the literature in the past. Secondly, it should effective when applied in practice. Thirdly, the standard itself should plain and terse. The main object of this article is in search of a proper diagnostic stander of damp-heat in the spleen-stomach syndrome. At the same time, we would like to discuss the method of "measure syndrome with drug" in syndrome standard study. The purpose of introducing this method is to try solving the insoluble "gold standard" issue in T.C.M. diagnostics study.
Method: In this study, first we will discuss the academic source of diagnosing and treating damp-heat in the spleen-stomach syndrome. Then we went on a questionnaire survey of diagnosing damp-heat in the spleen-stomach syndrome in specialist around the state. And then there is a statistic on discusses of medical publication that involved diagnose of damp-heat in the spleen-stomach syndrome and other dampheat syndromes. Clinical research is in two parts. Part one is a clinical investigation of diagnostic standard according to formerly described study mode. The population of survey is the inpatient of the No.2 department of internal medicine and outpatient of outpatient service department of internal medicine of the 1st affiliated hospital of our university. Diagnostic standard of observation object is the damp-heat in the spleen-stomach syndrome diagnostic standard described in Chinese traditional medicine new drug clinical research guiding principle and / or the diagnostic standard made by our department. Diagnostic standard of other syndrome is those described in Chinese traditional medicine new drug clinical research guiding principle. The observation item is obtained in literature study. Sign and diagnose of Western medicine and T.C.M. is recorded. The signs that is hard to judge such as type of the tongue, type of pulse, is verified by experienced physician. To some cases that failed to meet diagnostic standard, but diagnosed a certain syndrome by physician, the physician's diagnose is supported, in case of missing valuable sign. Chi-square test is performed to pick up sign and symptom with significance after certain quantity of case is entered. Logistic regression analysis is performed to get discriminant function. Grouping is performed
with discriminant function when new cases added, and the effectiveness of grouping is compared with the original diagnostic standard. Treatment study is performed with the patients diagnosed damp-heat in the spleen-stomach syndrome, to discuss the method of "measure syndrome with drug". The therapy is the SanRen recipe. Radix scutellariae, calamus, turmeric hairy china cardamoms, dried old orange peel is added to the recipes. Disappearances of subjective symptom like appetite, mental state and taste is taken as criterion of therapeutical effect. Some objective symptom like halitosis,
引文
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Guides to Evidence- based Medicine and reproduced with permission from JAMA. (1999;281(21):2029-2034). Copyright 1999, American Medical Association.
[19] 刘凤斌，脾胃病辨证量表的研究，中山医科大学博士后研究工作报告，1999．9；P40
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