肺胀基础上的风温肺热病证候学规律研究
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摘要
风温肺热病是呼吸科最常见的病种之一,随着中国老龄化社会的到来,患者常常伴有多种基础疾病,就呼吸系统来说,肺胀是较为常见的的基础疾病之一。有肺胀基础疾病的患者由于年高久病,正气亏虚,更加容易殒患风温肺热病,并且其临床表现复杂,有其自身的证候特点。中医的精髓在于辨证论治,对于证候的准确把握则是取得临床疗效的前提,因此本研究通过现代文献研究、临床回顾性研究、临床前瞻性研究三种方式对肺胀基础上的风温肺热病症状、证候分布及用药特点进行了研究,并在导师前期研究成果的基础上,总结有效方药,对肺胀病人殒患风温肺热病后最常见的痰热壅肺证进行临床干预,取得了一些初步的成果。
[目的]
1.通过对现代文献的回顾研究,从文献角度分析肺胀基础上风温肺热病的症状、中医证候、证候要素分布及痰热壅肺证的用药特点。
2.通过对临床病案的回顾性研究,从临床角度对肺胀基础上风温肺热病患者的临床基本资料、中医证候、证素分布及演变规律进行分析研究。
3.通过对肺胀基础上风温肺热病患者的横断面调查,使用多元统计方法,进一步对其中医证候特点进行研究。
4.总结有效方药,对肺胀病人殒患风温肺热病最常见的痰热壅肺证进行临床干预,观察疗效。
[方法]
1.现代文献的回顾研究部分
通过对近10年(2003-2012年)来肺胀基础上的风温肺热病相关文献的检索整理,利用Exce12010分别建立症状数据库、证候数据库、用药数据库,使用SPSS20.0软件进行频数、频率的统计分析。
2.临床病案的回顾性研究部分
通过对近3年(2010-2012年)北京中医药大学东直门医院呼吸科伴有肺胀基础疾病的风温肺热病住院患者的临床资料采集,利用EXCELL2010软件建立数据库,并用SPSS20.0软件进行统计分析。
3.临床病例的前瞻性研究部分
根据临床流行病学横断面调查的方法,在北京中医药大学东直门医院呼吸科住院部对符合纳入标准的肺胀基础上的风温肺热病患者的四诊信息进行采集,应用Epidata3.0软件建立数据库,应用SPSS20.0软件进行统计分析。临床一般资料采用描述性统计分析以频次、百分率形式表示；中医四诊信息应用主成分分析(Principal component analysis,PCA)结合聚类分析(Cluster analysis, CA)进行分析研究。
4.临床干预部分
本部分将60例伴有肺胀基础疾病的风温肺热病患者分为治疗组与对照组两个部分,同时给与规范的基础治疗,治疗组加服中药清热化痰,解毒化瘀中药复方,每日1剂。基本方组成：瓜蒌(皮)15g、黄芩12g、漏芦15g、连翘15g、败酱草30g、生薏米30g、半夏10g、贝母10g、炙麻黄6g、杏仁10g、桔梗10g、炒枳壳10g、桃仁10g、当归10g、太子参30g、炙甘草6g。疗程12天。进行临床干预,采集治疗第六天、第十二天的临床资料,应用Epidata3.0软件建立数据库,应用SPSS20.0软件进行统计分析。
[结果]
1.现代文献的回顾研究部分
1.1.症状分布情况
1.1.1.肺系症状
出现在前十位的肺系症状按出现频次高低依次为：气喘、咳嗽、胸膺满闷、咳痰、痰粘难咯、痰量多、痰黄稠、气短、喘不得卧、喉中痰鸣。
1.1.2.全身症状
出现在前十位的全身症状按出现频次高低依次为：发热、乏力、畏寒、多汗、神疲、恶寒、自汗、恶风、声低气怯、浮肿。
1.1.3.头面部症状
出现在前十位的头面症状按出现频次高低依次为：口唇紫绀、颜面浮肿、头晕、流涕、咽痛、耳鸣、耳聋、头痛、目睛胀突、咽痒、鼻塞。
1.1.4.面色
出现在前五位的异常面色按出现频次高低依次为：面色晦暗、面色青紫、面色咣白、面色红、面色萎黄。
1.1.5.胸胁部症状
胸胁部症状出现七种,按频次高低依次为：心悸、短气、怔忡、胁下痞块、胁痛、胁胀、肋胀。
1.1.6.脘腹部症状
脘腹部症状出现九种,按频次高低依次为：腹胀、胃脘痞满、恶心、呕吐、呕血、腹水、嗳气、腹痛、泛酸。
1.1.7.腰背四肢部症状
出现前五位的腰背部症状按频次高低依次为：爪甲紫绀、肢体浮肿、肢体厥冷、腰膝酸软、抽搐。
1.1.8.皮肤症状
史肤症状有皮肤瘀斑瘀点、肌肤甲错两种,反映出本病有动血、瘀血的可能。
1.1.9.神志症状
排名在前五位的神志症状有：烦躁、神昏嗜睡、神昏谵语、精神萎靡、心烦。
1.1.10.饮食口味症状
出现前五位的饮食口味相关症状有：口干渴、纳差、口苦、口干而不欲饮、口粘腻。
1.1.11.睡眠症状
睡眠相关症状有不寐、多梦。
1.1.12.二便症状
出现在前五位的二便相关症状依次为：大便秘、大便干、小便量少、小便黄、大便溏。
1.1.13.男科及妇科症状
男科及妇科症状有性欲减退、男子遗精、阳痿、女子经少或闭经。
1.2.证候分布情况
从文献中提取证候规范后出现频次前十位的证候有：痰热壅肺证、痰浊阻肺证、痰瘀阻肺证、阳虚水泛证、痰迷心窍证、肺肾气虚证、痰热壅肺,兼血瘀证、表寒里饮证、肺脾气虚证、血瘀证。这10种证候占证候总数的58.29%,可以认为肺胀基础上的风温肺热病常见以上10种证候。
1.3.证素分布情况
将证候进一步分解为证素,排名前五位的证素为：肺、痰、热、血瘀、气虚,占全部证素出现总频次的66.15%
1.3.1.病位类证素分布情况
病位类证素11个按出现频次高低依次为：肺、肾、脾、心神、表、心、肝、经络、大肠、胃、胆。
1.3.2.病性类证素分布情况
病性类证素24个,排名前十位的有痰、热、血瘀、气虚、阳虚、水停、阴虚、寒、饮、风。
1.4.痰热壅肺证用药分布情况
通过对377篇有用药记录的中医药现代文献的分析,共提取出关于痰热壅肺证相关的中药236种,计21类。将用药频次超过10次的药物按用途加以归类,并按使用药物种类多少排名,前五位依次为：
清化热痰药,共有16种：全瓜萎、桔梗、淅贝母、胆南星、冬瓜子、川贝母、生薏苡仁、瓜蒌皮、苇茎、前胡、海蛤粉、瓜蒌仁、竹茹、车前子、天竺黄、海浮石。
清热药,共12种：黄芩、鱼腥草、生石膏、金银花、射干、连翘、芦根、知母、蒲公英、金养麦、焦栀子、黄连。
补气药,共12种：炙甘草、炙黄芪、白术、党参、生甘草、太子参、人参、大枣、生黄芪。
止咳平喘药,共9种：杏仁、桑白皮、葶苈子、苏子、炙麻黄、款冬花、紫苑、百部、白果。
活血化瘀药,共6种：丹参、桃仁、川芎、当归、赤芍、红花。
2.临床病案的回顾性研究部分
通过对524例患者临床资料的回顾性研究,发现肺胀基础上的风温肺热病患者年龄普遍较大,50岁以上人群占总发病人群的99.24%；性别分布上男性多于女性,男性占60.31%,女性占39.69%；通过对366例有肺功能记录的COPD患者的分析,其病情严重程度以Ⅱ级、Ⅲ级、Ⅳ级多见,分别占30.05%、33.33%、31.97%,而Ⅰ级病人少见,仅占4.64%；其发病率以春季最多,占38.36%,秋季最少,占16.60%；春分节气为发病高峰,处暑节气为发病的低谷。在入院前的发病日数方面,3天以内、4-7天、7天以上的各占35.50%、31.87%、32.63%,分布较为平均。在病因诊断方面,本研究显示痰培养阴性率为49.81%,在痰培养阳性患者中,两种以上细菌混合感染的病人最多,占13.74%,其常见致病菌为铜绿假单胞菌、肺炎克雷伯菌、真菌、醋酸钙鲍曼不动杆菌。524例病人经查重后为363人,其中近三年因病情加重住院次数在1次以上的有100例,占总调查人数的27.55%,由此可见,有肺胀基础疾病的病人容易殒患风温肺热病。
其证候总体分布以复合证候最为常见,占证候种类的89.19%,其中两证相兼有75种,占症候种类的67.57%,三证相兼有12种,占10.81%,出现频次前五位的证候分别为痰热壅肺证(75次14.34%)、痰热壅肺,肺肾气虚证(36次6.88%)、痰瘀阻肺,肺肾气虚证(34次6.50%)、痰瘀阻肺,气阴两虚证(32次6.1296)、痰热壅肺,气虚血瘀证(31次5.93%),五种证候中仅有痰热壅肺证为简单证候,其余四种均为复合证候,由此可见肺胀病人殒患风温肺热病后病机较为复杂,容易出现虚实夹杂的证候表现。
将患者按入院前发病时间分为0.5—3天、4—7天、>7天加以分析发现三个时间段均容易表现出痰热壅肺证、痰瘀阻肺证、肺肾气虚证,在0.5-3天时,患者出现气阴两虚的几率较后两个时间段为高；而后两个时间段出现血瘀证的几率则高于第一个时间段。
三个时间段实证的比例各自为66.36%、61.78%、60.44%,虚证的比例各自为33.64%、38·22%、39.56%。可以很明显的看出,随着时间的推移,实证比例逐渐较少,而虚证比例逐渐升高的趋势。
3.临床病例的前瞻性研究部分
通过对196例病人临床资料的前瞻性调查我们发现,本病病人年龄普遍偏大,平均年龄为74.32岁,基础疾病患病时间较长,基础疾病病史在十年以上的病人占总调查人数的67.86%,男性发病率为59.69%,略高于女性40.31%；与回顾性调查结果基本吻合。
196例病人入院时只有1.02%的病人表现为单纯的卫分证,而90.82%的病人表现为气分证,另外,尚有3.57%的病人入院时即表现为营分证,且除新发病病人外,尚有37.24%的病人发病已达1周以上,从一定程度上反映出肺胀病人殒患风温肺热病后,由于基础疾病的存在,导致正气亏虚,无力抗邪于卫分,病邪迅速入里的发病情况,同时患病后病势缠绵难愈的趋势。本次调查的196例病人中,死亡6例,有27例在病程中出现了营分证,占总调查人数的13.78%,并且死亡的6例病人,均包含在这27例病人当中表明肺胀病人殒患风温肺热病后容易出现营分证,一旦出现营分证,病情较重,本次调查显示肺胀基础上的风温肺热病一旦出现营分证候,其死亡率为22.22%。
本部分先用主成分分析法将196例患者的中医四诊信息组合成19个主成分,然后将19个主成分得分作为新变量,应用系统聚类法加以分析,从而得到6个症状群,并应用专业知识加以分析。6个症状群有两个难以判断其证候类型,其余四个可归纳为：类阴虚证、类气虚血瘀,阳虚水停证、类脾肾两虚证、类痰热壅肺证,基本与临床主观辨证结果相吻合。4.临床干预部分
本部分研究显示,虽然在治疗结束时,治疗组与对照组的证候治愈率无明显差异,但是在治疗第六天时,治疗组患者咳嗽、喉中痰鸣、排痰难度、口渴、口苦、唇甲紫绀、腹胀、大便干等主要症状缓解程度明显优于对照组,在治疗第十二天时时,治疗组患者口渴、口苦、唇甲紫绀、腹胀、大便干等症状缓解程度依然优于对照组,显示出中药在迅速而持久的改善患者症状方面的优势。本次研究显示,治疗组与对照组在缓解实验室指标方面无明显差异,症状的缓解与辅助检查指标并不同步,因此,以现代医学微观指标去衡量长于宏观思维的中医疗效这种方式仍然值得商榷,只有从临床实际出发,将宏观与微观有机的结合,才能构建合理的中医疗效评价新体系。
Wind-warm disease with lung heat is one of the most common sicknesses in breath branch, along with the coming of Chinese aging society, the patients often have several basic sicknesses simultaneously, as for breathing system, lung inflation is one of such common basic illnesses. Due to the old age and long-term sickness, the patient suffering from lung inflation is lack of the positive air, and is susceptible to wind-warm disease with lung heat, meanwhile the clinic performance is complex and with its unique syndrome characteristics. The essence of Traditional Chinese Medicine(TCM) lies on treatment based on syndrome differentiation, the accurate control of syndrome characteristics is the premise of clinic effect; therefore, this paper studies the symptom, syndrome distribution and medication characteristics of wind-warm disease with lung heat through modern literature research, clinic reviewing study and perspective clinic research, and on the basis of the tutor's early stage output, the effective herbal medicine has been worked out, and it is primarily proven to be effective to the clinic intervention of the most common syndrome of phlegm-heat obstructing lung.
[Objective]
1. By means of the reviewing research of modern literatures, from the view of literatures, the symptom, TCM syndrome and syndrome elements distribution of lung inflation based wind-warm disease with lung heat, as well as the medication characteristics of phlegm-heat obstructing lung have been analyzed.
2. By means of the reviewing research on clinic cases, from the view of clinic, the basic data, TCM syndrome and syndrome elements distribution, and the evolution rules of patients suffering from lung inflation based wind-warm disease with lung heat have been analyzed and researched.
3. By way of investigating the cross-section of the patients suffering from lung inflation based wind-warm disease with lung heat, as well as using the method of multi-element statistics, the further research on the TCM syndrome characteristics of this sickness has been carried out.
4. The effective herbal medicine has been summarized, and the clinic intervention and effect observation on phlegm-heat obstructing lung, which is the most common syndrome of lung inflation based wind-warm disease with lung heat have been conducted.
[Methods]
1. Part of reviewing research on modern literatures
Through the searching and sorting on modern literatures relevant to lung inflation based wind-warm disease with lung heat of recent10years, with the application of Excel2010, the symptom database, syndrome database and medicine database have been established separately, and the frequency number and frequency statistics analysis has been conducted with SPSS20.0software.
2. Part of reviewing research on clinic cases
The clinic data collection of patients suffering from lung inflation based wind-warm disease with lung heat in breath branch of Dongzhimen Hospital of Beijing Chinese Medicine University in recent3years (2010-2012) has been performed, database has been established with EXCELL2010, and the statistics analysis has been conducted with SPSS20.0software.
3. Part of perspective research on clinic cases
On the basis of cross-section investigating on clinic epidemiology, the four diagnostic information on the patients up to lung inflation based wind-warm disease with lung heat standards in breath branch of Dongzhimen Hospital of Beijing Chinese Medicine University has been collected, the database has been built up with Epidata3.0software, and statistics analysis has been conducted with SPSS20.0software. The ordinary clinic data are analyzed with descriptive statistics, and are shown on frequency number and percent; the TCM four diagnostic information is mainly used for basic components analysis in combination with cluster analysis.
4. Clinic intervention part
This part has divided60patients suffering from lung inflation based wind-warm disease with lung heat into two groups:treatment group and control group, and both the groups have taken regular basic treatment; the treatment group has taken additional TCM clearing heat and expectoration/detoxification and dissipation blood stasis dosage once per day. The basic compositions are as follows: Trichosanthes (pericarp)15g, Scutellaria12g, Echinps latifolius15g, Forsythia suspense15g, Dahurian Patrinia Herb30g, raw CoixSeed30g, Pinellia ternate10g, Caladium10g, Roast Herba Ephedrae6g, almond10g, Balloon Flower10g, Citrus aurantium10g, peachseed10g, angelica10g, Radix Pseudostellariae30g, zhigancao6g. The treatment course is12days. The clinic intervention has been performed to collect the clinic data of the sixth and twelfth days, database has been established with Epidata3.0, and the statistics analysis has been conducted with SPSS20.0software.
[Results]
1. Part of reviewing research on modern literatures
1.1. Symptom distribution
1.1.1. Symptoms of lung system
The top ten symptoms of lung system are ranked as:asthma, cough, chest obstruction, cough with sputum, viscous sputum, large sputum volume, sputum yellow and thick, breath hard, asthma too hard to prostrate and wheezing due to retention of phlegm in throat.
1.1.2. Constitutional symptoms
The top ten constitutional symptoms are ranked as:fever, lack of force, fear of cold, excessive sweat, spirit fatigue, aversion to cold, spontaneous sweating, aversion to wind, timid low voice and edema.
1.1.3. Head and face symptoms
The top ten head and face symptoms are ranked as:paro xymally cyanosis, puffy swelling of the face, dizziness, running nose, angina, tinnitus, deaf, headache, eyes swelling, itchy pharynx and snuffle.
1.1.4. Complexion
The top five abnormal complexion symptoms are ranked as:somber facial complexion, green-blue or purple facial complexion, white facial complexion, red facial complexion, yellow facial complexion.
1.1.5. Symptoms of chest and rib part
There are totally seven types of chest and rib part symptoms, and they are ranked as follows:heart-throb, shortness of breath, fearful throbbing, rib side lump glomus, hypochondriac pain, rib-side distention and rib-side distending pain.
1.1.6. Symptoms of stomach duct
There are totally nine types of stomach duct symptoms, and they are ranked as follows:abdominal distention, stomach-duct full, nausea, vomit, melanemesis, hydrogaster, eructation, bellyache and pantothenic acid.
1.1.7. Symptoms of waist, back and limb
The top five symptoms of waist, back and limb are ranked as follows:nails cyanotic, limb edema, limb reversal cold, limp aching lumbus and knees and twitch.
1.1.8. Symptoms of skin
There are two types of skin symptoms:skin ecchymosis and skin encrustation, which represent the possibilities of active blood and static blood.
1.1.9. Symptoms of consciousness
The top five consciousness symptoms are ranked as follows:irritation, dizziness, clouded spirit and dilirious speech, lethargy and upset.
1.1.10. Symptoms of diet and taste
The top five diet and taste symptoms are ranked as follows:xerostomia, anepithymia, bitterness in the mouth, dry mouth but no desire for drink and mouth viscidity.
1.1.11. Symptoms of sleeping
The relevant sleeping symptoms are as follows:sleepless and excessive dream.
1.1.12. Symptoms of stool and urine
The top five stool and urine symptoms are ranked as follows:astriction, stool dry, urine fewness, yellow urine and grimy sloppy stool.
1.1.13. Symptoms of andriatrics and gynedology
The Symptoms of andriatrics and gynedology are as follows:libido recession, mankind gonacratia, impotence, woman scant menses or amenorrhea.
1.2. The distribution of syndrome
After the syndromes criteria are extracted from the literatures, the top ten syndromes are ranked as follows:pattern of phlegm-heat congesting the lung, pattern of phlegm turbidity obstructing the lung, pattern of phlegm-stasis obstructing the lung, yang2vacuity water flood pattern, pattern of phlegm confounding the orifices of the heart, pattern of lung-kidney qi4vacuity, phlegm-heat obstructing lung, concurrent blood stasis pattern, exterior cold and interior drink, lung and spleen qi4vacuity pattern and blood stasis pattern.
1.3. The distribution of syndrome elements
The syndrome is further decomposed into syndrome elements, and the top five syndrome elements are ranked as:lung, Phlegm, heat, blood stasis and qi4vacuity, and they account for66.15%of the total frequencies.
1.3.1. The distribution of sickness location type syndrome elements
11sickness location type syndrome elements are ranked as per their occurred frequencies from the highest to the lowest:lung, kidney, spleen, mind, appearance, heart, liver, channels, large intestine, stomach and gallbladder.
1.3.2. The distribution of sickness property type syndrome elements
There are totally24sickness property type syndrome elements, the top ten of them are phlegm, heat, blood stasis, qi4vacuity, yang2vacuity, water stop, yinl vacuity, cold, drink and wind.
1.4. The distribution of medicine for pattern of phlegm-heat congesting the lung
By means of analyzing377TCM modern literatures which have the records of medicine applications, and totally21categories236types of Chinese medicines relevant to pattern of phlegm-heat congesting the lung have been extracted. If the usage frequency of medicines is higher than10times, such medicines shall be sorted according to their purpose, and they are also ranked as per the usage of medicines types。
Clear heat and transform phlegm medicines. totally16types:trichosanthes, platycodon root, Thunberg Fritillary Bulb, Rhizoma Arisaematis Cum bile, Chinese Waxgourd Semen, Unibract Fritillary Bulb, raw coix seed, Pericarpium Trichosanthis, reed stem, Radix Peucedani, clamshell powder, trichosanthes seed, Bamboo Shavings, Semen Plantaginis, Tabasheer and pumex.
heat-clearing medicines, totally12types:Baical Skullcap Root, houttuynia cordata Thunb, raw gypsum, Honeysuckle Flower, Blackberrykiky Rhizome, golden bell, reed root, Common Anemarrhena Rhizome, dandelion, Wild Buckwheat Rhizome, burnt gardenia and Golden Thread. Qi4-supplementing medicinal, totally12types:mix-fried licorice, mix-fried astragalus, Atractylis ovata, Radix Codonopsis, raw licorice, pseudostellaria, Panax, date and raw astragalus.
cough-suppressing pant ing-calming medicines, totally9types:almond, Cortex Mori, descurainiae, perilla, mix-fried ephedra, Flos Farfarae, aster, Radix Stemonae and Ginkgo.
Blood-quickening stasis-transforming medicines, totally6types:Danshen Root, peach seed, Rhizoma Ligustici, Chinese Angelica, red peony and safflower.
2. Part of reviewing research on clinic cases
By means of reviewing researches on the clinic data of524patients, it has been found that the ages of patients suffering from lung inflation based wind-warm disease with lung heat are generally old, and99.24%of the patients are over50years old; the number of male patients is more than that of the female patients,60.31%of the patients are male and39.69%of them are female; through the analysis on366COPD patients who have lung function records, usually, their sickness severity degrees are Ⅱ grade, III grade and IV grade, and the percents are30.05%,33.33%and31.97%separately, whereas the I grade patients are scarce, and only4.64%of patients are Ⅰ grade; most of the patients have onset of illness in spring, which accounts for38.36%, and the sickness rate in autumn is the lowest, and which accounts for16.60%; the vernal equinox is the summit of sickness rate, and the end of heat is the trough of sickness rate. From the view of sickness unset days prior to going to hospital, the periods of within3days,4-7days and over7days account for35.50%,31.87%and32.63%separately, and their distribution is relatively average. From the view of pathogenesis diagnosis, this research shows that the sputum cultures negative rate is49.81%, and among the positive patients of sputum cultures, most of them are mixed-infected by more than two types of germs, which account for13.74%, and the common sickness induced germs are microzyme, Pseudomonas aeruginosa, K. pneumoniae, mildew and acinetobacter baumanii.
Among the general distribution of syndromes, the most common one is complex syndrome, which accounts for89.19%of the syndromes types, among them, the co-existence of two syndromes are75types, and which make up67.57%of the total syndromes types; the co-existence of three syndromes are12types, and which make up10.81%of the total syndromes types. The top5most frequently occurred syndromes are ranked as:pattern of phlegm-heat congesting the lung (75times,14.34%), phlegm-heat obstructing lung, pattern of lung-kidney qi4vacuity (36times,6.88%), phlegm-stasis obstructing the lung, pattern of lung-kidney qi4vacuity (34times6.50%), phlegm-stasis obstructing the lung, pattern of dual vacuity of heart qi4and yinl (32times6.12%), phlegm-heat obstructing lung, pattern qi4vacuity with blood stasis (31times5.93%), among the five syndromes, only pattern of phlegm-heat congesting the lung is simple syndrome, the rest four are complex syndromes, therefore, the pathogenesis of post-wind-warm disease with lung heat patients is complicated, and easy to show the syndrome of vacuity-repletion complex.
From the sickness unset days prior to going to hospital, the patients have been analyzed as per the periods of0.5-3days,4-7days and over7days, and it is known that all the three periods are susceptible to pattern of phlegm-heat congesting the lung, pattern of phlegm-stasis obstructing the lung and pattern of lung-kidney qi4vacuity; during0.5-3days, the sickness rate of dual vacuity of heart qi4and yinl is higher than the late two periods; whereas, during the late two periods, the sickness rate of blood stasis pattern is higher than that of the first period.
The repletion patterns proportions of the three periods are separately66.36%, 61.78%and60.44%, and the vacuity patterns proportions are separately33.64%,38.22%and39.56%; it is obvious that as time goes on, the repletion patterns proportions drop stepwisely and the vacuity patterns proportions increase step by step.
3. Part of perspective research on clinic cases
This part divides the four diagnostic information combination of196patients into19main constituents firstly, then the19main constituents are considered to be new variables and are analyzed with Hierarchical clustering method; totally6symptom groups have been obtained, and they are analyzed with professional knowledge. Among the6symptom groups, two of them are hard to identify their syndrome types, and the rest four are categorized as:similar yin deficiency, similar qi4vacuity with blood stasis, yang2vacuity water stop, similar dual vacuity of the spleen and kidney, and similar pattern of phlegm-heat congesting the lung; the conclusion is basically identical to the results of subjective pattern identification.
4. Clinic intervention part
This part shows that at the end of treatment, the symptom recovery rate presents no obvious different between treatment group and control group, but at the sixth clay, the main symptoms like cough, phlegm rale in the throat, phlegm productive difficult, thrist, bitter taste, green-blue or purple lips and nails, abdominal distent ion and dry stool of treatment group are better than the control group; at the twelfth day, the symptoms like thrist, bitter taste, green-blue or purple lips and nails, abdominal distent ion and dry stool of treatment group are still better than the control group, which shows the advantages of TCM on rapid and consistent improving the patients'symptoms. This research shows the treatment group and control group have no obvious difference on remission laboratory indices, and the remission of symptoms keeps no step with the assisted check indices, therefore, the method of measuring the treatment effect of TCM which is good at macro-think.ing with the micro index of modern medicine is still in question, the only doable way to establish reasonable TCM treatment effect appraisal system is aiming at clinic practices and realizing the combination of macro and micro perspectives.
[目的]
1.通过对现代文献的回顾研究,从文献角度分析肺胀基础上风温肺热病的症状、中医证候、证候要素分布及痰热壅肺证的用药特点。
2.通过对临床病案的回顾性研究,从临床角度对肺胀基础上风温肺热病患者的临床基本资料、中医证候、证素分布及演变规律进行分析研究。
3.通过对肺胀基础上风温肺热病患者的横断面调查,使用多元统计方法,进一步对其中医证候特点进行研究。
4.总结有效方药,对肺胀病人殒患风温肺热病最常见的痰热壅肺证进行临床干预,观察疗效。
[方法]
1.现代文献的回顾研究部分
通过对近10年(2003-2012年)来肺胀基础上的风温肺热病相关文献的检索整理,利用Exce12010分别建立症状数据库、证候数据库、用药数据库,使用SPSS20.0软件进行频数、频率的统计分析。
2.临床病案的回顾性研究部分
通过对近3年(2010-2012年)北京中医药大学东直门医院呼吸科伴有肺胀基础疾病的风温肺热病住院患者的临床资料采集,利用EXCELL2010软件建立数据库,并用SPSS20.0软件进行统计分析。
3.临床病例的前瞻性研究部分
根据临床流行病学横断面调查的方法,在北京中医药大学东直门医院呼吸科住院部对符合纳入标准的肺胀基础上的风温肺热病患者的四诊信息进行采集,应用Epidata3.0软件建立数据库,应用SPSS20.0软件进行统计分析。临床一般资料采用描述性统计分析以频次、百分率形式表示；中医四诊信息应用主成分分析(Principal component analysis,PCA)结合聚类分析(Cluster analysis, CA)进行分析研究。
4.临床干预部分
本部分将60例伴有肺胀基础疾病的风温肺热病患者分为治疗组与对照组两个部分,同时给与规范的基础治疗,治疗组加服中药清热化痰,解毒化瘀中药复方,每日1剂。基本方组成：瓜蒌(皮)15g、黄芩12g、漏芦15g、连翘15g、败酱草30g、生薏米30g、半夏10g、贝母10g、炙麻黄6g、杏仁10g、桔梗10g、炒枳壳10g、桃仁10g、当归10g、太子参30g、炙甘草6g。疗程12天。进行临床干预,采集治疗第六天、第十二天的临床资料,应用Epidata3.0软件建立数据库,应用SPSS20.0软件进行统计分析。
[结果]
1.现代文献的回顾研究部分
1.1.症状分布情况
1.1.1.肺系症状
出现在前十位的肺系症状按出现频次高低依次为：气喘、咳嗽、胸膺满闷、咳痰、痰粘难咯、痰量多、痰黄稠、气短、喘不得卧、喉中痰鸣。
1.1.2.全身症状
出现在前十位的全身症状按出现频次高低依次为：发热、乏力、畏寒、多汗、神疲、恶寒、自汗、恶风、声低气怯、浮肿。
1.1.3.头面部症状
出现在前十位的头面症状按出现频次高低依次为：口唇紫绀、颜面浮肿、头晕、流涕、咽痛、耳鸣、耳聋、头痛、目睛胀突、咽痒、鼻塞。
1.1.4.面色
出现在前五位的异常面色按出现频次高低依次为：面色晦暗、面色青紫、面色咣白、面色红、面色萎黄。
1.1.5.胸胁部症状
胸胁部症状出现七种,按频次高低依次为：心悸、短气、怔忡、胁下痞块、胁痛、胁胀、肋胀。
1.1.6.脘腹部症状
脘腹部症状出现九种,按频次高低依次为：腹胀、胃脘痞满、恶心、呕吐、呕血、腹水、嗳气、腹痛、泛酸。
1.1.7.腰背四肢部症状
出现前五位的腰背部症状按频次高低依次为：爪甲紫绀、肢体浮肿、肢体厥冷、腰膝酸软、抽搐。
1.1.8.皮肤症状
史肤症状有皮肤瘀斑瘀点、肌肤甲错两种,反映出本病有动血、瘀血的可能。
1.1.9.神志症状
排名在前五位的神志症状有：烦躁、神昏嗜睡、神昏谵语、精神萎靡、心烦。
1.1.10.饮食口味症状
出现前五位的饮食口味相关症状有：口干渴、纳差、口苦、口干而不欲饮、口粘腻。
1.1.11.睡眠症状
睡眠相关症状有不寐、多梦。
1.1.12.二便症状
出现在前五位的二便相关症状依次为：大便秘、大便干、小便量少、小便黄、大便溏。
1.1.13.男科及妇科症状
男科及妇科症状有性欲减退、男子遗精、阳痿、女子经少或闭经。
1.2.证候分布情况
从文献中提取证候规范后出现频次前十位的证候有：痰热壅肺证、痰浊阻肺证、痰瘀阻肺证、阳虚水泛证、痰迷心窍证、肺肾气虚证、痰热壅肺,兼血瘀证、表寒里饮证、肺脾气虚证、血瘀证。这10种证候占证候总数的58.29%,可以认为肺胀基础上的风温肺热病常见以上10种证候。
1.3.证素分布情况
将证候进一步分解为证素,排名前五位的证素为：肺、痰、热、血瘀、气虚,占全部证素出现总频次的66.15%
1.3.1.病位类证素分布情况
病位类证素11个按出现频次高低依次为：肺、肾、脾、心神、表、心、肝、经络、大肠、胃、胆。
1.3.2.病性类证素分布情况
病性类证素24个,排名前十位的有痰、热、血瘀、气虚、阳虚、水停、阴虚、寒、饮、风。
1.4.痰热壅肺证用药分布情况
通过对377篇有用药记录的中医药现代文献的分析,共提取出关于痰热壅肺证相关的中药236种,计21类。将用药频次超过10次的药物按用途加以归类,并按使用药物种类多少排名,前五位依次为：
清化热痰药,共有16种：全瓜萎、桔梗、淅贝母、胆南星、冬瓜子、川贝母、生薏苡仁、瓜蒌皮、苇茎、前胡、海蛤粉、瓜蒌仁、竹茹、车前子、天竺黄、海浮石。
清热药,共12种：黄芩、鱼腥草、生石膏、金银花、射干、连翘、芦根、知母、蒲公英、金养麦、焦栀子、黄连。
补气药,共12种：炙甘草、炙黄芪、白术、党参、生甘草、太子参、人参、大枣、生黄芪。
止咳平喘药,共9种：杏仁、桑白皮、葶苈子、苏子、炙麻黄、款冬花、紫苑、百部、白果。
活血化瘀药,共6种：丹参、桃仁、川芎、当归、赤芍、红花。
2.临床病案的回顾性研究部分
通过对524例患者临床资料的回顾性研究,发现肺胀基础上的风温肺热病患者年龄普遍较大,50岁以上人群占总发病人群的99.24%；性别分布上男性多于女性,男性占60.31%,女性占39.69%；通过对366例有肺功能记录的COPD患者的分析,其病情严重程度以Ⅱ级、Ⅲ级、Ⅳ级多见,分别占30.05%、33.33%、31.97%,而Ⅰ级病人少见,仅占4.64%；其发病率以春季最多,占38.36%,秋季最少,占16.60%；春分节气为发病高峰,处暑节气为发病的低谷。在入院前的发病日数方面,3天以内、4-7天、7天以上的各占35.50%、31.87%、32.63%,分布较为平均。在病因诊断方面,本研究显示痰培养阴性率为49.81%,在痰培养阳性患者中,两种以上细菌混合感染的病人最多,占13.74%,其常见致病菌为铜绿假单胞菌、肺炎克雷伯菌、真菌、醋酸钙鲍曼不动杆菌。524例病人经查重后为363人,其中近三年因病情加重住院次数在1次以上的有100例,占总调查人数的27.55%,由此可见,有肺胀基础疾病的病人容易殒患风温肺热病。
其证候总体分布以复合证候最为常见,占证候种类的89.19%,其中两证相兼有75种,占症候种类的67.57%,三证相兼有12种,占10.81%,出现频次前五位的证候分别为痰热壅肺证(75次14.34%)、痰热壅肺,肺肾气虚证(36次6.88%)、痰瘀阻肺,肺肾气虚证(34次6.50%)、痰瘀阻肺,气阴两虚证(32次6.1296)、痰热壅肺,气虚血瘀证(31次5.93%),五种证候中仅有痰热壅肺证为简单证候,其余四种均为复合证候,由此可见肺胀病人殒患风温肺热病后病机较为复杂,容易出现虚实夹杂的证候表现。
将患者按入院前发病时间分为0.5—3天、4—7天、>7天加以分析发现三个时间段均容易表现出痰热壅肺证、痰瘀阻肺证、肺肾气虚证,在0.5-3天时,患者出现气阴两虚的几率较后两个时间段为高；而后两个时间段出现血瘀证的几率则高于第一个时间段。
三个时间段实证的比例各自为66.36%、61.78%、60.44%,虚证的比例各自为33.64%、38·22%、39.56%。可以很明显的看出,随着时间的推移,实证比例逐渐较少,而虚证比例逐渐升高的趋势。
3.临床病例的前瞻性研究部分
通过对196例病人临床资料的前瞻性调查我们发现,本病病人年龄普遍偏大,平均年龄为74.32岁,基础疾病患病时间较长,基础疾病病史在十年以上的病人占总调查人数的67.86%,男性发病率为59.69%,略高于女性40.31%；与回顾性调查结果基本吻合。
196例病人入院时只有1.02%的病人表现为单纯的卫分证,而90.82%的病人表现为气分证,另外,尚有3.57%的病人入院时即表现为营分证,且除新发病病人外,尚有37.24%的病人发病已达1周以上,从一定程度上反映出肺胀病人殒患风温肺热病后,由于基础疾病的存在,导致正气亏虚,无力抗邪于卫分,病邪迅速入里的发病情况,同时患病后病势缠绵难愈的趋势。本次调查的196例病人中,死亡6例,有27例在病程中出现了营分证,占总调查人数的13.78%,并且死亡的6例病人,均包含在这27例病人当中表明肺胀病人殒患风温肺热病后容易出现营分证,一旦出现营分证,病情较重,本次调查显示肺胀基础上的风温肺热病一旦出现营分证候,其死亡率为22.22%。
本部分先用主成分分析法将196例患者的中医四诊信息组合成19个主成分,然后将19个主成分得分作为新变量,应用系统聚类法加以分析,从而得到6个症状群,并应用专业知识加以分析。6个症状群有两个难以判断其证候类型,其余四个可归纳为：类阴虚证、类气虚血瘀,阳虚水停证、类脾肾两虚证、类痰热壅肺证,基本与临床主观辨证结果相吻合。4.临床干预部分
本部分研究显示,虽然在治疗结束时,治疗组与对照组的证候治愈率无明显差异,但是在治疗第六天时,治疗组患者咳嗽、喉中痰鸣、排痰难度、口渴、口苦、唇甲紫绀、腹胀、大便干等主要症状缓解程度明显优于对照组,在治疗第十二天时时,治疗组患者口渴、口苦、唇甲紫绀、腹胀、大便干等症状缓解程度依然优于对照组,显示出中药在迅速而持久的改善患者症状方面的优势。本次研究显示,治疗组与对照组在缓解实验室指标方面无明显差异,症状的缓解与辅助检查指标并不同步,因此,以现代医学微观指标去衡量长于宏观思维的中医疗效这种方式仍然值得商榷,只有从临床实际出发,将宏观与微观有机的结合,才能构建合理的中医疗效评价新体系。
Wind-warm disease with lung heat is one of the most common sicknesses in breath branch, along with the coming of Chinese aging society, the patients often have several basic sicknesses simultaneously, as for breathing system, lung inflation is one of such common basic illnesses. Due to the old age and long-term sickness, the patient suffering from lung inflation is lack of the positive air, and is susceptible to wind-warm disease with lung heat, meanwhile the clinic performance is complex and with its unique syndrome characteristics. The essence of Traditional Chinese Medicine(TCM) lies on treatment based on syndrome differentiation, the accurate control of syndrome characteristics is the premise of clinic effect; therefore, this paper studies the symptom, syndrome distribution and medication characteristics of wind-warm disease with lung heat through modern literature research, clinic reviewing study and perspective clinic research, and on the basis of the tutor's early stage output, the effective herbal medicine has been worked out, and it is primarily proven to be effective to the clinic intervention of the most common syndrome of phlegm-heat obstructing lung.
[Objective]
1. By means of the reviewing research of modern literatures, from the view of literatures, the symptom, TCM syndrome and syndrome elements distribution of lung inflation based wind-warm disease with lung heat, as well as the medication characteristics of phlegm-heat obstructing lung have been analyzed.
2. By means of the reviewing research on clinic cases, from the view of clinic, the basic data, TCM syndrome and syndrome elements distribution, and the evolution rules of patients suffering from lung inflation based wind-warm disease with lung heat have been analyzed and researched.
3. By way of investigating the cross-section of the patients suffering from lung inflation based wind-warm disease with lung heat, as well as using the method of multi-element statistics, the further research on the TCM syndrome characteristics of this sickness has been carried out.
4. The effective herbal medicine has been summarized, and the clinic intervention and effect observation on phlegm-heat obstructing lung, which is the most common syndrome of lung inflation based wind-warm disease with lung heat have been conducted.
[Methods]
1. Part of reviewing research on modern literatures
Through the searching and sorting on modern literatures relevant to lung inflation based wind-warm disease with lung heat of recent10years, with the application of Excel2010, the symptom database, syndrome database and medicine database have been established separately, and the frequency number and frequency statistics analysis has been conducted with SPSS20.0software.
2. Part of reviewing research on clinic cases
The clinic data collection of patients suffering from lung inflation based wind-warm disease with lung heat in breath branch of Dongzhimen Hospital of Beijing Chinese Medicine University in recent3years (2010-2012) has been performed, database has been established with EXCELL2010, and the statistics analysis has been conducted with SPSS20.0software.
3. Part of perspective research on clinic cases
On the basis of cross-section investigating on clinic epidemiology, the four diagnostic information on the patients up to lung inflation based wind-warm disease with lung heat standards in breath branch of Dongzhimen Hospital of Beijing Chinese Medicine University has been collected, the database has been built up with Epidata3.0software, and statistics analysis has been conducted with SPSS20.0software. The ordinary clinic data are analyzed with descriptive statistics, and are shown on frequency number and percent; the TCM four diagnostic information is mainly used for basic components analysis in combination with cluster analysis.
4. Clinic intervention part
This part has divided60patients suffering from lung inflation based wind-warm disease with lung heat into two groups:treatment group and control group, and both the groups have taken regular basic treatment; the treatment group has taken additional TCM clearing heat and expectoration/detoxification and dissipation blood stasis dosage once per day. The basic compositions are as follows: Trichosanthes (pericarp)15g, Scutellaria12g, Echinps latifolius15g, Forsythia suspense15g, Dahurian Patrinia Herb30g, raw CoixSeed30g, Pinellia ternate10g, Caladium10g, Roast Herba Ephedrae6g, almond10g, Balloon Flower10g, Citrus aurantium10g, peachseed10g, angelica10g, Radix Pseudostellariae30g, zhigancao6g. The treatment course is12days. The clinic intervention has been performed to collect the clinic data of the sixth and twelfth days, database has been established with Epidata3.0, and the statistics analysis has been conducted with SPSS20.0software.
[Results]
1. Part of reviewing research on modern literatures
1.1. Symptom distribution
1.1.1. Symptoms of lung system
The top ten symptoms of lung system are ranked as:asthma, cough, chest obstruction, cough with sputum, viscous sputum, large sputum volume, sputum yellow and thick, breath hard, asthma too hard to prostrate and wheezing due to retention of phlegm in throat.
1.1.2. Constitutional symptoms
The top ten constitutional symptoms are ranked as:fever, lack of force, fear of cold, excessive sweat, spirit fatigue, aversion to cold, spontaneous sweating, aversion to wind, timid low voice and edema.
1.1.3. Head and face symptoms
The top ten head and face symptoms are ranked as:paro xymally cyanosis, puffy swelling of the face, dizziness, running nose, angina, tinnitus, deaf, headache, eyes swelling, itchy pharynx and snuffle.
1.1.4. Complexion
The top five abnormal complexion symptoms are ranked as:somber facial complexion, green-blue or purple facial complexion, white facial complexion, red facial complexion, yellow facial complexion.
1.1.5. Symptoms of chest and rib part
There are totally seven types of chest and rib part symptoms, and they are ranked as follows:heart-throb, shortness of breath, fearful throbbing, rib side lump glomus, hypochondriac pain, rib-side distention and rib-side distending pain.
1.1.6. Symptoms of stomach duct
There are totally nine types of stomach duct symptoms, and they are ranked as follows:abdominal distention, stomach-duct full, nausea, vomit, melanemesis, hydrogaster, eructation, bellyache and pantothenic acid.
1.1.7. Symptoms of waist, back and limb
The top five symptoms of waist, back and limb are ranked as follows:nails cyanotic, limb edema, limb reversal cold, limp aching lumbus and knees and twitch.
1.1.8. Symptoms of skin
There are two types of skin symptoms:skin ecchymosis and skin encrustation, which represent the possibilities of active blood and static blood.
1.1.9. Symptoms of consciousness
The top five consciousness symptoms are ranked as follows:irritation, dizziness, clouded spirit and dilirious speech, lethargy and upset.
1.1.10. Symptoms of diet and taste
The top five diet and taste symptoms are ranked as follows:xerostomia, anepithymia, bitterness in the mouth, dry mouth but no desire for drink and mouth viscidity.
1.1.11. Symptoms of sleeping
The relevant sleeping symptoms are as follows:sleepless and excessive dream.
1.1.12. Symptoms of stool and urine
The top five stool and urine symptoms are ranked as follows:astriction, stool dry, urine fewness, yellow urine and grimy sloppy stool.
1.1.13. Symptoms of andriatrics and gynedology
The Symptoms of andriatrics and gynedology are as follows:libido recession, mankind gonacratia, impotence, woman scant menses or amenorrhea.
1.2. The distribution of syndrome
After the syndromes criteria are extracted from the literatures, the top ten syndromes are ranked as follows:pattern of phlegm-heat congesting the lung, pattern of phlegm turbidity obstructing the lung, pattern of phlegm-stasis obstructing the lung, yang2vacuity water flood pattern, pattern of phlegm confounding the orifices of the heart, pattern of lung-kidney qi4vacuity, phlegm-heat obstructing lung, concurrent blood stasis pattern, exterior cold and interior drink, lung and spleen qi4vacuity pattern and blood stasis pattern.
1.3. The distribution of syndrome elements
The syndrome is further decomposed into syndrome elements, and the top five syndrome elements are ranked as:lung, Phlegm, heat, blood stasis and qi4vacuity, and they account for66.15%of the total frequencies.
1.3.1. The distribution of sickness location type syndrome elements
11sickness location type syndrome elements are ranked as per their occurred frequencies from the highest to the lowest:lung, kidney, spleen, mind, appearance, heart, liver, channels, large intestine, stomach and gallbladder.
1.3.2. The distribution of sickness property type syndrome elements
There are totally24sickness property type syndrome elements, the top ten of them are phlegm, heat, blood stasis, qi4vacuity, yang2vacuity, water stop, yinl vacuity, cold, drink and wind.
1.4. The distribution of medicine for pattern of phlegm-heat congesting the lung
By means of analyzing377TCM modern literatures which have the records of medicine applications, and totally21categories236types of Chinese medicines relevant to pattern of phlegm-heat congesting the lung have been extracted. If the usage frequency of medicines is higher than10times, such medicines shall be sorted according to their purpose, and they are also ranked as per the usage of medicines types。
Clear heat and transform phlegm medicines. totally16types:trichosanthes, platycodon root, Thunberg Fritillary Bulb, Rhizoma Arisaematis Cum bile, Chinese Waxgourd Semen, Unibract Fritillary Bulb, raw coix seed, Pericarpium Trichosanthis, reed stem, Radix Peucedani, clamshell powder, trichosanthes seed, Bamboo Shavings, Semen Plantaginis, Tabasheer and pumex.
heat-clearing medicines, totally12types:Baical Skullcap Root, houttuynia cordata Thunb, raw gypsum, Honeysuckle Flower, Blackberrykiky Rhizome, golden bell, reed root, Common Anemarrhena Rhizome, dandelion, Wild Buckwheat Rhizome, burnt gardenia and Golden Thread. Qi4-supplementing medicinal, totally12types:mix-fried licorice, mix-fried astragalus, Atractylis ovata, Radix Codonopsis, raw licorice, pseudostellaria, Panax, date and raw astragalus.
cough-suppressing pant ing-calming medicines, totally9types:almond, Cortex Mori, descurainiae, perilla, mix-fried ephedra, Flos Farfarae, aster, Radix Stemonae and Ginkgo.
Blood-quickening stasis-transforming medicines, totally6types:Danshen Root, peach seed, Rhizoma Ligustici, Chinese Angelica, red peony and safflower.
2. Part of reviewing research on clinic cases
By means of reviewing researches on the clinic data of524patients, it has been found that the ages of patients suffering from lung inflation based wind-warm disease with lung heat are generally old, and99.24%of the patients are over50years old; the number of male patients is more than that of the female patients,60.31%of the patients are male and39.69%of them are female; through the analysis on366COPD patients who have lung function records, usually, their sickness severity degrees are Ⅱ grade, III grade and IV grade, and the percents are30.05%,33.33%and31.97%separately, whereas the I grade patients are scarce, and only4.64%of patients are Ⅰ grade; most of the patients have onset of illness in spring, which accounts for38.36%, and the sickness rate in autumn is the lowest, and which accounts for16.60%; the vernal equinox is the summit of sickness rate, and the end of heat is the trough of sickness rate. From the view of sickness unset days prior to going to hospital, the periods of within3days,4-7days and over7days account for35.50%,31.87%and32.63%separately, and their distribution is relatively average. From the view of pathogenesis diagnosis, this research shows that the sputum cultures negative rate is49.81%, and among the positive patients of sputum cultures, most of them are mixed-infected by more than two types of germs, which account for13.74%, and the common sickness induced germs are microzyme, Pseudomonas aeruginosa, K. pneumoniae, mildew and acinetobacter baumanii.
Among the general distribution of syndromes, the most common one is complex syndrome, which accounts for89.19%of the syndromes types, among them, the co-existence of two syndromes are75types, and which make up67.57%of the total syndromes types; the co-existence of three syndromes are12types, and which make up10.81%of the total syndromes types. The top5most frequently occurred syndromes are ranked as:pattern of phlegm-heat congesting the lung (75times,14.34%), phlegm-heat obstructing lung, pattern of lung-kidney qi4vacuity (36times,6.88%), phlegm-stasis obstructing the lung, pattern of lung-kidney qi4vacuity (34times6.50%), phlegm-stasis obstructing the lung, pattern of dual vacuity of heart qi4and yinl (32times6.12%), phlegm-heat obstructing lung, pattern qi4vacuity with blood stasis (31times5.93%), among the five syndromes, only pattern of phlegm-heat congesting the lung is simple syndrome, the rest four are complex syndromes, therefore, the pathogenesis of post-wind-warm disease with lung heat patients is complicated, and easy to show the syndrome of vacuity-repletion complex.
From the sickness unset days prior to going to hospital, the patients have been analyzed as per the periods of0.5-3days,4-7days and over7days, and it is known that all the three periods are susceptible to pattern of phlegm-heat congesting the lung, pattern of phlegm-stasis obstructing the lung and pattern of lung-kidney qi4vacuity; during0.5-3days, the sickness rate of dual vacuity of heart qi4and yinl is higher than the late two periods; whereas, during the late two periods, the sickness rate of blood stasis pattern is higher than that of the first period.
The repletion patterns proportions of the three periods are separately66.36%, 61.78%and60.44%, and the vacuity patterns proportions are separately33.64%,38.22%and39.56%; it is obvious that as time goes on, the repletion patterns proportions drop stepwisely and the vacuity patterns proportions increase step by step.
3. Part of perspective research on clinic cases
This part divides the four diagnostic information combination of196patients into19main constituents firstly, then the19main constituents are considered to be new variables and are analyzed with Hierarchical clustering method; totally6symptom groups have been obtained, and they are analyzed with professional knowledge. Among the6symptom groups, two of them are hard to identify their syndrome types, and the rest four are categorized as:similar yin deficiency, similar qi4vacuity with blood stasis, yang2vacuity water stop, similar dual vacuity of the spleen and kidney, and similar pattern of phlegm-heat congesting the lung; the conclusion is basically identical to the results of subjective pattern identification.
4. Clinic intervention part
This part shows that at the end of treatment, the symptom recovery rate presents no obvious different between treatment group and control group, but at the sixth clay, the main symptoms like cough, phlegm rale in the throat, phlegm productive difficult, thrist, bitter taste, green-blue or purple lips and nails, abdominal distent ion and dry stool of treatment group are better than the control group; at the twelfth day, the symptoms like thrist, bitter taste, green-blue or purple lips and nails, abdominal distent ion and dry stool of treatment group are still better than the control group, which shows the advantages of TCM on rapid and consistent improving the patients'symptoms. This research shows the treatment group and control group have no obvious difference on remission laboratory indices, and the remission of symptoms keeps no step with the assisted check indices, therefore, the method of measuring the treatment effect of TCM which is good at macro-think.ing with the micro index of modern medicine is still in question, the only doable way to establish reasonable TCM treatment effect appraisal system is aiming at clinic practices and realizing the combination of macro and micro perspectives.
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