朱建贵教授辨治更年期潮热经验验证研究
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摘要
本篇论文的各部分,是根据现象学社会学及诠释学的思路设计的,第一部分文献综述是对中医的社会共享知识做一般陈述,代表现存的科学范式；第二部分是对朱建贵教授个人知识库的类型化规则进行观察,是一种对现象的诠释；第三部分是对朱建贵教授的临床思维做简要说明和举例,是诠释个人知识库和社会知识库的协调方法,以及个人知识库对类型化技巧的修正轨迹；第四部分是对第二部分和第三部分进行科学的验证,以便将个人知识库的结果外推至社会知识库,成为科学范式所能承认的共享知识,参与社会科学的构建。
论文主要是研究专家经验,但朱建贵教授治老年病经验仍不断依临床反馈优化：2001年曾总结老年病内热多为阴虚内热型或肝郁化热型；在逐年积累临床经验后,病例中逐渐凸显对痰湿的重视,在对2005-2006年病例进行的数据挖掘结果显示出阴虚化热、痰湿蕴热、肝郁化热为三种最常见的老年病火热证型；而近几年在总结治疗更年期潮热的临床经验后,由博返约,自拟“滋肾清心方”,逐渐以该方随证加减,来简化分型方法。本论文的各部分就是研究朱建贵教授后两种治疗更年期潮热方案的疗效。
1研究目的
分析朱建贵教授治疗老年病火热证候的辨证方法,并建立信息化的辨证模型。
验证以上述模型用来治疗更年期潮热的疗效,并藉此探索该病的证候规律。
验证以朱建贵教授自拟方--滋肾清心方随证加减,治疗更年期潮热的疗效。
分析上述两种治疗方案的优劣,以提供辨证方法的优化方向。
2研究方法
利用2007年对朱建贵教授病例的数据挖掘工作,对其中45岁以上(共870例次),且具有火热证候的205例次数据进行二级证候的分析研究,找出与证候要素关联性较高的临床症状和体征,设计成可以信息化操作的火热病辨证模型,并设计成电脑软件。属于临床流行病学的描述性研究之现况研究范畴。应用的技术手段为数据挖掘。(论文第二部分)
设计两组各30例作为临床观察对象：一组为分型组,以上述模型诊疗,在广安门医院第二门诊部开设更年期专题门诊；另一组为协定方组,以滋肾清心方加减通治所有患者,在广安门医院老年病科采集病例。针对两组病例数据,整理后利用统计方法,评价两组各自的疗效,并比较两组对潮热和失眠症状的疗效。本研究为临床观察,应用组群随机的方法,设立两个独立的系列样本,属于组群随机对照的临床研究,是前瞻性的随机研究设计方案。(论文第四部分)
3研究结果
朱建贵教授治老年病火热证的辨证经验分析
870例次45岁以上老年病中,火热证候出现频率有205个,而其二维的复合证候集中在三个证型上,分别是兼有阴虚证的占59.5%,兼有痰湿证的占40%,兼有气机失调的占19.5%,其余的兼证频率皆不足3%。可见,朱建贵教授在火热证的辨证上习惯以阴虚内热、痰湿化热、肝郁化热的概念来分型,其余证型可以暂且忽略。
症状类选取具有特异性者,舌脉类根据专家本人意见,拟出下列分型指标：
(1)症状类分型指标：
①阴虚内热型：腰痛、气短。
②痰湿蕴热型：有痰、大便不畅。
③气郁化热型：胁胀、嗳气。
(2)舌脉类分型指标：
①阴虚内热型：舌红绛、舌质嫩、舌龟裂、舌苔少或无、脉细、脉弱。
②痰湿蕴热型：舌苔腻或水滑、脉滑。
③气郁化热型：舌两侧暗、脉弦、脉濇。分型组的组内分析
分型组初诊30例的证型分布为：阴虚内热型14例(47%),气郁化热型9例(30%),痰湿蕴热型7例(23%)；全疗程65例次的证型分布为：阴虚内热型34例(52%),痰湿蕴热型17例(26%),气郁化热型14例(22%)。
三种证型的符合率间仅有阴虚内热型和痰湿蕴热型间有负相关(r=-0.454,p=0.012),其余证型间的相关性不显著。追踪全疗程中的证型转换规律发现,阴虚内热型和痰湿郁热型用药干预后,彼此间存在相互转化,但都未向气郁化热型转化。
综合疗效方面,治疗结束后,依Kupperman评分法,总分值减少的有28例,持平的有2例,总有效率94%。临床将KI值分成轻度(15～20分),中度(21～35分),重度(>35分),按照这个标准：重度者治疗前有4例,一周后重度者为0例；中度者治疗前有19例,一周后6例,治疗结束后是3例；轻度者治疗前有6例,一周后9例,治疗结束后2例；不典型者治疗前1例,一周后15例,治疗结束后25例。治疗结束后86%的不同程度更年期综合征患者都改善为症状不典型(15分以下)。
协定方组的组内分析
潮热症状的疗效,治疗一周后,潮热症状分值减少的有24例,持平的有6例；治疗结束后,最终潮热症状分值减少的有28例,持平的有2例,总有效率达94%。回顾病例发现,无效的2例舌象皆呈腻苔。
治疗一周后,失眠症状分值减少的有19例,持平的有11例(含4例无症状者)；治疗结束后,最终潮热症状分值减少的有22例,持平的有8例(含4例无症状者),总有效率达84%。
两组间的疗效比较
两组间的最终疗效比较,无论是潮热(p=0.696),还是失眠(p=0.215),都没有统计学上的显著优劣之分。
4结论
研究显示,在小样本观察中,分三型或协定方加减都能有效治疗本病,同时,两种治疗方案的有效率是不分伯仲的。但回顾治疗潮热无效的病历,协定方组无效的2例舌苔都是腻苔,提示滋肾清心方对更年期潮热的治疗虽然具有稳定的疗效,但此方忌用于具有明显湿热证候的患者。
阴虚证候和痰湿证候呈显著的负相关,提示这两个证型有互斥性,治疗上是不可替代的。依此,治疗更年期潮热的证型分型,至少应包括阴虚和痰湿证型。可以考虑将模型简化为二种证型,即阴虚内热型和痰湿蕴热型,并将处方改为可治疗阴虚证候的滋肾清心方,和一组可清化痰湿的处方,例如黄连温胆汤、蒿芩清胆汤、龙胆泻肝汤、小柴胡汤等都可以考虑。简化后更有利于临床操作,同时提高疗效。
综上所述,本研究设计方案是比较单一基础方和三种基础方的治疗方案,但结果推论分成两种证型(阴虚内热和痰湿蕴热),采用两组基础方(滋肾清心方和清化痰湿的处方)是优化的方向,其实证工作,有赖于未来的临床观察。本研究得出的证型结果,具有规律性,且与基础理论相符,显示所用的辨证模型具有一定的准确度。
1. Purposes
(?) To analyze Zhu Jiangui's syndrome differentiation methods in treating geriatrics Fiery-Hot syndrome and establish dialectical models by information technology.
(?) To validate the curative effect of the menopausal hot flashes treatment by using the above described models and to explore the syndrome regularity of the disease.
(?) To validate the curative effect of Zhu Jiangui's self-drafted formula, Zi Shen Qing Xin Formula in all menopausal hot flashes treatment.
(?) To analyze the advantages and disadvantages of the Zi Shen Qing Xin Formula in substituting the syndrome typing dialectical treatment.
2. Methods
Using data mining work for Zhu Jiangui's cases in2007to design information operated Fiery-Hot syndrome differentiation models and thus developing computer software. This belongs to the category of the current status of research in descriptive studies of the clinical epidemiology. The technical application adopted is data mining.(Refer to part2of the thesis)
Two groups each of30patients were devised as clinical observation objects:one group referred as the syndrome typing group, diagnosed and treated as the above described models in the outpatient clinic set up for the menopause topic in the second outpatient department of the Guanganmen Hospital; the other group was the prescription-agreed group that utilized the Zi Shen Qing Xin Formula to treat all patients collected from the Geriatrics Department of the Guanganmen Hospital. In the light of the data collected from the two groups, statistical methods were employed to evaluate the curative effect of the individual group and also to compare the curative effect between the two groups on hot flashes and insomnia treatments. In this clinical observation research, using the cluster randomized method to establish two independent serial samples, belongs to cluster randomized controlled clinical study.(Refer to part4of the thesis)
3. Results
Analysis of Zhu Jiangui's experiences in syndrome differentiation of the geriatrics Fiery-Hot treatment.
In the Fiery-Hot syndrome differentiation, Zhu Jiangui practices the concept of internal heat due to yin deficiency, heat derived from phlegm-dampness, heat derived from liver-Qi stagnation for syndrome typing, while the remaining syndrome typing can be ignored.
(1) Symptom classification index (Based on the results of data mining):
(a) Internal heat due to yin deficiency type:lumbago, shortness of breath.
(b) Heat derived from phlegm-dampness type:sputum, unsmooth defecation.
(c) Heat derived from liver-Qi stagnation type:hypochondrium flatulence, eructation.
(2) Tongue and pulse classification index (According to expert opinion)
(a) Internal heat due to yin deficiency type:deep red, tender, cracked tongue with little or no coating, thready pulse, weak pulse.
(b) Heat derived from phlegm-dampness type:greasy or watery tongue coating, slippery pulse.
(c) Heat derived from liver-Qi stagnation type:dark color at the lingual sides, stringy pulse, unsmooth pulse.
Analysis within the syndrome typing group
The coincidence rate between the3syndrome types showed only the internal heat due to yin deficiency type and heat derived from phlegm-dampness type was negatively correlated (r=-0.454, p=0.012), while there was no significant correlation between the rest of the syndrome types. Tracking the full treatment course of the syndrome conversion pattern had revealed that after drug intervention, internal heat due to yin deficiency type and heat derived from phlegm-dampness type exhibited reciprocal conversion, but neither was converted to heat derived from Qi stagnation type.
In terms of comprehensive efficacy, at the end of treatment, based on Kupperman scale,28cases displayed KI reduction,2cases displayed no changes, indicating94%total efficiency. After the treatment,86%of the patients with varying degrees of menopausal syndrome had improved to atypical symptoms (KI<15)
Analysis within the prescription-agreed group
The curative effect of hot flashes symptom, after1week of treatment,24cases showed hot flashes score reduction,6cases showed no changes; after the treatment,28cases indicated reduction in the final hot flashes score,2cases indicated no changes, the total efficacy was94%. After reviewing the cases, it was discovered that in the2ineffective cases, both displayed greasy tongue coating.
After a week of treatment, insomnia score decreased in19cases, while11cases showed no changes (including4asymptomatic cases); after the treatment, the final insomnia score decreased in22cases,8cases indicated no changes (including4asymptomatic cases), the total efficacy was84%.
Comparison of the efficacy between the two groups
The baselines of the two groups were basically the same, the ultimate curative effect comparison between the2groups demonstrated that there is no significant statistical difference be it for hot flashes (p=0.696), or insomnia (p=0.215) treatment.
4. Conclusions
Be it categorizing into3syndrome types or non-typing, both were equally effective in treating the disease. The study also revealed that the efficiency of the2treatment regimens was on par with each other. But in actual operation, non-typing is better at reducing the wrong treatment probability caused by the clinical disagreement. Review of the ineffective cases in the hot flashes treatment, the2ineffective cases from the prescription-agreed group both presented greasy tongue coating and this suggested that although Zi Shen Qing Xin Formula showed stable curative effect for the menopausal hot flashes treatment, it is prohibited for patients with obvious damp-heat syndrome.
Yin deficiency syndrome and phlegm-dampness syndrome showed a significant negative correlation; suggesting that these two syndromes are mutually exclusive and thus treatment is irreplaceable. Therefore the syndrome typing for menopausal hot flashes treatment should at least include the yin deficiency and phlegm-dampness syndromes. Thus could consider simplifying the models into2syndrome types, the internal heat due to yin deficiency type and heat derived from phlegm-dampness type. And change the prescription to Zi Shen Qing Xin Formula that treats the yin deficiency syndrome and the other group that uses prescriptions capable of eliminating phlegm-dampness such as the Huang Lian Wen Dan Decoction, Hao Qin Qing Dan Decoction, Long Dan Xie Gan Decoction and Xiao Chai Hu Decoction can be taken into consideration. It is more suitable for clinical operation after simplification and improving the curative effect concurrently.
In summary, the design scheme of this study is to compare the treatment regimens between a single syndrome type and3syndrome types. But the results suggest that2syndrome types (internal heat due to yin deficiency and heat derived from phlegm-dampness), with2sets of prescriptions (Zi Shen Qing Xin Formula and prescriptions that eliminate phlegm-dampness) is the optimized direction. The validation work relies on the future clinical observation to verify. The syndrome typing outcomes derived from the research showed regularity, and is consistent with the basic theory, indicating that the dialectical models used have a certain degree of accuracy.
论文主要是研究专家经验,但朱建贵教授治老年病经验仍不断依临床反馈优化：2001年曾总结老年病内热多为阴虚内热型或肝郁化热型；在逐年积累临床经验后,病例中逐渐凸显对痰湿的重视,在对2005-2006年病例进行的数据挖掘结果显示出阴虚化热、痰湿蕴热、肝郁化热为三种最常见的老年病火热证型；而近几年在总结治疗更年期潮热的临床经验后,由博返约,自拟“滋肾清心方”,逐渐以该方随证加减,来简化分型方法。本论文的各部分就是研究朱建贵教授后两种治疗更年期潮热方案的疗效。
1研究目的
分析朱建贵教授治疗老年病火热证候的辨证方法,并建立信息化的辨证模型。
验证以上述模型用来治疗更年期潮热的疗效,并藉此探索该病的证候规律。
验证以朱建贵教授自拟方--滋肾清心方随证加减,治疗更年期潮热的疗效。
分析上述两种治疗方案的优劣,以提供辨证方法的优化方向。
2研究方法
利用2007年对朱建贵教授病例的数据挖掘工作,对其中45岁以上(共870例次),且具有火热证候的205例次数据进行二级证候的分析研究,找出与证候要素关联性较高的临床症状和体征,设计成可以信息化操作的火热病辨证模型,并设计成电脑软件。属于临床流行病学的描述性研究之现况研究范畴。应用的技术手段为数据挖掘。(论文第二部分)
设计两组各30例作为临床观察对象：一组为分型组,以上述模型诊疗,在广安门医院第二门诊部开设更年期专题门诊；另一组为协定方组,以滋肾清心方加减通治所有患者,在广安门医院老年病科采集病例。针对两组病例数据,整理后利用统计方法,评价两组各自的疗效,并比较两组对潮热和失眠症状的疗效。本研究为临床观察,应用组群随机的方法,设立两个独立的系列样本,属于组群随机对照的临床研究,是前瞻性的随机研究设计方案。(论文第四部分)
3研究结果
朱建贵教授治老年病火热证的辨证经验分析
870例次45岁以上老年病中,火热证候出现频率有205个,而其二维的复合证候集中在三个证型上,分别是兼有阴虚证的占59.5%,兼有痰湿证的占40%,兼有气机失调的占19.5%,其余的兼证频率皆不足3%。可见,朱建贵教授在火热证的辨证上习惯以阴虚内热、痰湿化热、肝郁化热的概念来分型,其余证型可以暂且忽略。
症状类选取具有特异性者,舌脉类根据专家本人意见,拟出下列分型指标：
(1)症状类分型指标：
①阴虚内热型：腰痛、气短。
②痰湿蕴热型：有痰、大便不畅。
③气郁化热型：胁胀、嗳气。
(2)舌脉类分型指标：
①阴虚内热型：舌红绛、舌质嫩、舌龟裂、舌苔少或无、脉细、脉弱。
②痰湿蕴热型：舌苔腻或水滑、脉滑。
③气郁化热型：舌两侧暗、脉弦、脉濇。分型组的组内分析
分型组初诊30例的证型分布为：阴虚内热型14例(47%),气郁化热型9例(30%),痰湿蕴热型7例(23%)；全疗程65例次的证型分布为：阴虚内热型34例(52%),痰湿蕴热型17例(26%),气郁化热型14例(22%)。
三种证型的符合率间仅有阴虚内热型和痰湿蕴热型间有负相关(r=-0.454,p=0.012),其余证型间的相关性不显著。追踪全疗程中的证型转换规律发现,阴虚内热型和痰湿郁热型用药干预后,彼此间存在相互转化,但都未向气郁化热型转化。
综合疗效方面,治疗结束后,依Kupperman评分法,总分值减少的有28例,持平的有2例,总有效率94%。临床将KI值分成轻度(15～20分),中度(21～35分),重度(>35分),按照这个标准：重度者治疗前有4例,一周后重度者为0例；中度者治疗前有19例,一周后6例,治疗结束后是3例；轻度者治疗前有6例,一周后9例,治疗结束后2例；不典型者治疗前1例,一周后15例,治疗结束后25例。治疗结束后86%的不同程度更年期综合征患者都改善为症状不典型(15分以下)。
协定方组的组内分析
潮热症状的疗效,治疗一周后,潮热症状分值减少的有24例,持平的有6例；治疗结束后,最终潮热症状分值减少的有28例,持平的有2例,总有效率达94%。回顾病例发现,无效的2例舌象皆呈腻苔。
治疗一周后,失眠症状分值减少的有19例,持平的有11例(含4例无症状者)；治疗结束后,最终潮热症状分值减少的有22例,持平的有8例(含4例无症状者),总有效率达84%。
两组间的疗效比较
两组间的最终疗效比较,无论是潮热(p=0.696),还是失眠(p=0.215),都没有统计学上的显著优劣之分。
4结论
研究显示,在小样本观察中,分三型或协定方加减都能有效治疗本病,同时,两种治疗方案的有效率是不分伯仲的。但回顾治疗潮热无效的病历,协定方组无效的2例舌苔都是腻苔,提示滋肾清心方对更年期潮热的治疗虽然具有稳定的疗效,但此方忌用于具有明显湿热证候的患者。
阴虚证候和痰湿证候呈显著的负相关,提示这两个证型有互斥性,治疗上是不可替代的。依此,治疗更年期潮热的证型分型,至少应包括阴虚和痰湿证型。可以考虑将模型简化为二种证型,即阴虚内热型和痰湿蕴热型,并将处方改为可治疗阴虚证候的滋肾清心方,和一组可清化痰湿的处方,例如黄连温胆汤、蒿芩清胆汤、龙胆泻肝汤、小柴胡汤等都可以考虑。简化后更有利于临床操作,同时提高疗效。
综上所述,本研究设计方案是比较单一基础方和三种基础方的治疗方案,但结果推论分成两种证型(阴虚内热和痰湿蕴热),采用两组基础方(滋肾清心方和清化痰湿的处方)是优化的方向,其实证工作,有赖于未来的临床观察。本研究得出的证型结果,具有规律性,且与基础理论相符,显示所用的辨证模型具有一定的准确度。
1. Purposes
(?) To analyze Zhu Jiangui's syndrome differentiation methods in treating geriatrics Fiery-Hot syndrome and establish dialectical models by information technology.
(?) To validate the curative effect of the menopausal hot flashes treatment by using the above described models and to explore the syndrome regularity of the disease.
(?) To validate the curative effect of Zhu Jiangui's self-drafted formula, Zi Shen Qing Xin Formula in all menopausal hot flashes treatment.
(?) To analyze the advantages and disadvantages of the Zi Shen Qing Xin Formula in substituting the syndrome typing dialectical treatment.
2. Methods
Using data mining work for Zhu Jiangui's cases in2007to design information operated Fiery-Hot syndrome differentiation models and thus developing computer software. This belongs to the category of the current status of research in descriptive studies of the clinical epidemiology. The technical application adopted is data mining.(Refer to part2of the thesis)
Two groups each of30patients were devised as clinical observation objects:one group referred as the syndrome typing group, diagnosed and treated as the above described models in the outpatient clinic set up for the menopause topic in the second outpatient department of the Guanganmen Hospital; the other group was the prescription-agreed group that utilized the Zi Shen Qing Xin Formula to treat all patients collected from the Geriatrics Department of the Guanganmen Hospital. In the light of the data collected from the two groups, statistical methods were employed to evaluate the curative effect of the individual group and also to compare the curative effect between the two groups on hot flashes and insomnia treatments. In this clinical observation research, using the cluster randomized method to establish two independent serial samples, belongs to cluster randomized controlled clinical study.(Refer to part4of the thesis)
3. Results
Analysis of Zhu Jiangui's experiences in syndrome differentiation of the geriatrics Fiery-Hot treatment.
In the Fiery-Hot syndrome differentiation, Zhu Jiangui practices the concept of internal heat due to yin deficiency, heat derived from phlegm-dampness, heat derived from liver-Qi stagnation for syndrome typing, while the remaining syndrome typing can be ignored.
(1) Symptom classification index (Based on the results of data mining):
(a) Internal heat due to yin deficiency type:lumbago, shortness of breath.
(b) Heat derived from phlegm-dampness type:sputum, unsmooth defecation.
(c) Heat derived from liver-Qi stagnation type:hypochondrium flatulence, eructation.
(2) Tongue and pulse classification index (According to expert opinion)
(a) Internal heat due to yin deficiency type:deep red, tender, cracked tongue with little or no coating, thready pulse, weak pulse.
(b) Heat derived from phlegm-dampness type:greasy or watery tongue coating, slippery pulse.
(c) Heat derived from liver-Qi stagnation type:dark color at the lingual sides, stringy pulse, unsmooth pulse.
Analysis within the syndrome typing group
The coincidence rate between the3syndrome types showed only the internal heat due to yin deficiency type and heat derived from phlegm-dampness type was negatively correlated (r=-0.454, p=0.012), while there was no significant correlation between the rest of the syndrome types. Tracking the full treatment course of the syndrome conversion pattern had revealed that after drug intervention, internal heat due to yin deficiency type and heat derived from phlegm-dampness type exhibited reciprocal conversion, but neither was converted to heat derived from Qi stagnation type.
In terms of comprehensive efficacy, at the end of treatment, based on Kupperman scale,28cases displayed KI reduction,2cases displayed no changes, indicating94%total efficiency. After the treatment,86%of the patients with varying degrees of menopausal syndrome had improved to atypical symptoms (KI<15)
Analysis within the prescription-agreed group
The curative effect of hot flashes symptom, after1week of treatment,24cases showed hot flashes score reduction,6cases showed no changes; after the treatment,28cases indicated reduction in the final hot flashes score,2cases indicated no changes, the total efficacy was94%. After reviewing the cases, it was discovered that in the2ineffective cases, both displayed greasy tongue coating.
After a week of treatment, insomnia score decreased in19cases, while11cases showed no changes (including4asymptomatic cases); after the treatment, the final insomnia score decreased in22cases,8cases indicated no changes (including4asymptomatic cases), the total efficacy was84%.
Comparison of the efficacy between the two groups
The baselines of the two groups were basically the same, the ultimate curative effect comparison between the2groups demonstrated that there is no significant statistical difference be it for hot flashes (p=0.696), or insomnia (p=0.215) treatment.
4. Conclusions
Be it categorizing into3syndrome types or non-typing, both were equally effective in treating the disease. The study also revealed that the efficiency of the2treatment regimens was on par with each other. But in actual operation, non-typing is better at reducing the wrong treatment probability caused by the clinical disagreement. Review of the ineffective cases in the hot flashes treatment, the2ineffective cases from the prescription-agreed group both presented greasy tongue coating and this suggested that although Zi Shen Qing Xin Formula showed stable curative effect for the menopausal hot flashes treatment, it is prohibited for patients with obvious damp-heat syndrome.
Yin deficiency syndrome and phlegm-dampness syndrome showed a significant negative correlation; suggesting that these two syndromes are mutually exclusive and thus treatment is irreplaceable. Therefore the syndrome typing for menopausal hot flashes treatment should at least include the yin deficiency and phlegm-dampness syndromes. Thus could consider simplifying the models into2syndrome types, the internal heat due to yin deficiency type and heat derived from phlegm-dampness type. And change the prescription to Zi Shen Qing Xin Formula that treats the yin deficiency syndrome and the other group that uses prescriptions capable of eliminating phlegm-dampness such as the Huang Lian Wen Dan Decoction, Hao Qin Qing Dan Decoction, Long Dan Xie Gan Decoction and Xiao Chai Hu Decoction can be taken into consideration. It is more suitable for clinical operation after simplification and improving the curative effect concurrently.
In summary, the design scheme of this study is to compare the treatment regimens between a single syndrome type and3syndrome types. But the results suggest that2syndrome types (internal heat due to yin deficiency and heat derived from phlegm-dampness), with2sets of prescriptions (Zi Shen Qing Xin Formula and prescriptions that eliminate phlegm-dampness) is the optimized direction. The validation work relies on the future clinical observation to verify. The syndrome typing outcomes derived from the research showed regularity, and is consistent with the basic theory, indicating that the dialectical models used have a certain degree of accuracy.
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