感冒后咳嗽证候类型与方证效相关性研究
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摘要
研究目的
1.分析和总结近十年文献所涉及的感冒后咳嗽症状、证候分布情况,为临床研究以及制定专家问卷和信息采集表提供参考依据。
2.考察感冒后咳嗽中医证候分布特点,并采用多种数据分析方法,对中医证候与症状信息进行挖掘,探讨感冒后咳嗽常见症状、中医证候规律以及二者之间的相关关系。
3.对临床常见证候进行疗效的分析和比较,验证中医辨证论治的临床疗效,阐释证候的客观存在性以及方证的相关性。
研究方法
1.理论研究
对近10年感冒后咳嗽(或感染后咳嗽)证候相关的文献进行收集与整理,纳入合格文献,建立文献信息提取表,应用SPSS13.0软件,对文献中涉及的中医症状、证候信息及文献的基本信息等采用频率、频次的统计分析方法。
2.临床研究
2.1证候类型研究：在文献研究所得到证候、症状分布情况的基础上,结合多轮专家共识的结果,制定中医四诊信息调查问卷对信息进行全面采集；并输入临床信息采集与分析系统。采用前瞻,多中心,开放式,有监督与无监督相结合的观察性研究方法,共收集研究病例503例,其中西医病例84例,中医病例419例。运用SPSS13.0软件,对419例中医病例所涉及的症状、证候等信息分别进行构成比分析、因子分析、聚类分析和回归分析。
2.2方证效相关性研究：首先进行中药辨证论治与单纯西药的疗效比较,在中药辨证论治具有疗效优势的基础上,选择四种临床常见证候,并纳入其中具有共性治法和方药的临床病例,应用SPSS13.0软件进行组间和组内的疗效分析比较。
结果
1.理论研究结果
共纳入248篇合格文献,所涉及到的证候经规范化后共计106种,总频率大于5%的证候7个,分别为风寒袭肺证、风邪恋肺证、痰热蕴肺证、痰浊阻肺证、肺气虚证、风热犯肺证、肺脾气虚证。
中医症状经规范化后共计100个(未包括舌脉象)。主要症状中排在前十位的分别是干咳、咽痒、阵发性咳嗽、白痰、痰少、质粘稠、质稀薄、咽干/燥、口干、咳嗽诱发因素为冷风；其它相关症状中排在前五位的是乏力、自汗食欲不振、胸闷和头痛。涉及的舌象共34种,常见的(频率>5%)为红舌、淡舌、淡红舌、白苔、黄苔、薄苔、腻苔；涉及的脉象经规范化后共计17种,常见脉象(频率>5%)为细脉、数脉、浮脉、弦脉、滑脉和弱脉。
2.临床流行病学调查结果
419例感冒后咳嗽患者中男性患者132例,女性患者287例,女性患者数量为男性的2.17倍。患者的平均年龄为47.67±15.49岁,患者群以中青年人为主。
主要症状(频率>10%)25个,分别为：有痰,咯白痰或干咳无痰或咯黄痰；痰质稀薄或粘稠,痰量少或痰量多或痰量一般；咳嗽声低无力、咳声重浊或咳声阵发；咳嗽加重无明显时间区别、夜晚、晨起或白天；咳嗽诱发因素为冷风油烟,异味或说话过多和空气污染；嗓音嘶哑,胸闷,气短,动则气喘。
常见的伴随症状(频率>10%)共计23个,分别为：咽痒、咽痛或咽部异物感,口干、口苦、口渴多饮,怕冷、怕风、乏力和平素易感冒,鼻塞、打喷嚏、流清涕,头痛,自汗,皮肤过敏,大便稀溏或便干,食欲减退、腹胀,烦躁,失眠/多梦,偶尔有腰膝酸软。
常见舌象(频率>10%)和脉象(频率>5%)共计15个,分别为：舌色鲜红暗红、淡暗,白苔、薄苔、黄苔,少津,厚苔、腻苔,舌体胖大/齿痕；脉象依次为弦脉、细脉、沉脉、滑脉和弱脉。
感冒后咳嗽最常见的中医证候(频率>5%)8个：风邪恋肺证,肺气虚证肺热炽盛证,痰浊阻肺证,风热犯肺证,肺脾气虚证,肺气阴两虚证,痰热蕴肺证
3.通过因子分析,将47个感冒后咳嗽常见症状分成了十九类,该疾病可能涉及的一些证候类别分别为风邪恋肺、肺气虚、风寒束表、肺热、阴虚、肺卫气虚、痰浊、脾虚、表虚、肝火犯肺、肺肾两虚、肺热津亏；不便于归纳为某一证候类型的,直接对其进行分类处理,如：咳嗽的诱发因素类、咳嗽加重时间类、痰质类、皮肤症状类
4.通过聚类分析,得到感冒后咳嗽相关的一般症状14类,舌脉相关症状5类,综合两者结果,提示感冒后咳嗽的证候可能有风邪恋肺、肺气虚、阴津亏虚、脾虚、肺热、痰浊、痰热、风寒袭表、肺卫亏虚、肝火上炎和肾虚。
5.通过Logistic回归分析,我们得到了与证候密切相关的症状表现。风邪恋肺证：咳声阵发、痰量少、痰质稀薄和咳嗽加重时间为白天；肺气虚证：咳嗽声低无力和怕风；肺热炽盛证：咯黄痰、口渴多饮、咽痛、嗓音嘶哑；风热犯肺证：咯黄痰、咽痛、口渴多饮、以及喷嚏。
回归结果显示,当咳嗽时间<3周时,常见的证候为肺热炽盛证和风热犯肺证,而肺脾气虚证少见；当咳嗽时间持续3-8周时,风邪恋肺证与痰浊阻肺证出现的可能性较大,而肺热炽盛证较少见；当咳嗽时间>8周时,肺脾气虚证与肺气阴两虚证是出现可能性较大的两个证候。
6.中医辨证论治与西药疗效比较结果
在总体疗效上,西药组显效率和有效率分别为22.64%、84.91%,中药辨证组为43.23%和95.83%,均高于西药组,两组显效率、有效率比较有非常显著统计学差异(P<0.01),说明中药辨证论治在提高感冒后咳嗽患者显效率和有效率方面明显优于西药。
中药辨证论治在改善咳嗽症状积分方面明显优于西药组(P<0.01)。在视觉模拟评分中,白天评分的改善,两组并未见显著差异(P>0.05)；在改善夜间评分上,中药辨证论治组效果明显优于西药组(P<0.01)。两组治疗前后自身比较结果显示,无论中药辨证论治组还是西药组,在上述指标的改善方面,均有显著性疗效(P<0.01)。
LCQ结果表明中药辨证组在生理维度、心理维度以及总得分方面均优于西药组(P<0.05)；在社会维度方面,两组得分未见显著区别(P>0.05)。治疗前后组内比较发现,无论西药还是辨证论治中药均能增加各个维度得分,且均有统计学差异；但在心理维度,西药治疗组前后差异性分值<0.8分,提示西药在心理领域疗效不明显。
7.四种常见证候间的疗效比较结果
选择四组常见证候(频率>10%)—风邪恋肺证、肺气虚证、肺热炽盛证、痰浊阻肺证进行进一步的疗效观察。
四组之间的显效率、有效率无统计学差异(P>0.05),总体疗效相当
四组之间在咳嗽症状积分上未见显著差异(P>0.05)。在视觉模拟评分方面,肺气虚组白天症状评分得分最高,说明症状改善不明显,并与风邪恋肺组、痰浊阻肺组有显著差异(P<0.01、P<0.05)；夜间症状评分,四组之间疗效无明显差别(P>0.05)。治疗前后组内比较发现,四组治疗后各症状均比治疗前有显著改善(P<0.01),说明辨证论治疗效确切。
LCQ结果分析发现,四组经治疗后,肺气虚组在生理维度、心理维度以及总分均低于其它组别；其中在生理维度以及总分的得分上,明显低于风邪恋肺组(P<0.01)；在心理维度得分上,亦低于风邪恋肺组和肺热炽盛组(P<0.05)。四组之间在社会维度的比较无明显差异(P>0.05)。治疗前后组内比较,有非常显著统计学差异(P<0.01),说明辨证论治各组均有疗效。结论
1.通过理论研究,得到了感冒后咳嗽症状、证候分布规律,反映了该疾病研究的基本现状。
2.本研究采用前瞻,多中心,开放式的观察性临床研究方法,较为全面的获得了感冒后咳嗽患者的基本信息以及症状、证候分布情况,与文献研究结果基本一致；并采用因子分析、聚类分析和回归分析等多元分析方法,有监督与无监督相结合的考察感冒后咳嗽临床常见证候类型以及证候与症状的相关关系,为辨证论治提供客观、可信依据。
3.综合疗效评价来看,中药辨证论治疗效明显优于单纯的西药治疗；不同中医证候经辨证治疗后均取得显著疗效,验证了方证的相关性；本研究发现肺气虚证在综合疗效评价方面不如风邪恋肺证、肺热炽盛证和痰浊阻肺证,说明不同证候之间的疗效在某种程度上可能存在着一定的差异性
Objective
1. By analyzing the literature of the past decade, the research will analyze the distribution of symptomsand syndromes of post-infectious cough (PIC) to provide a reference for clinical research and questionnaire.
2. On the basis of theliterature and expert consensus results, using the methods of clinical epidemiology to research the syndrome distribution characteristics of PIC. A variety of data analysis methods will be used to mine the information of TCM syndrome and symptom,in order to discuss the common symptoms and TCM syndrome of PIC andthe relationship between them.
3.Analyzing and comparing the clinical efficacy of common syndromes,toverify the clinical efficacy of TCM syndrome differentiation,and to explain the objective existence of syndrome and the correlation between formula and syndrome.
Methods
1.Theory research
The researchcollected literature related to PICof the past decade and selected qualified literature to establish an information extraction table. SPSS13.0statistics software was used to analyze the frequency of the involved TCM symptoms, syndromes and basic information of literature.
2. Clinical research
2.1The research of syndrome types:On the basis of the literature results which involved the syndromes and symptoms,combined with the results of several rounds of expert consensus, the research drew a questionnaire to collect the information of four examinations and input the information into a collection andanalysis system.Observational study methods of prospective, multicentric, open, the combination of supervised and unsupervised were adopted.84Western medicine cases and419TCM cases were collected. The research applied SPSS13.0software to analyze the419TCM cases by using ratio analysis, factor analysis, cluster analysis and regression analysis.
2.2The research of formula-syndrome and effectrelationship:First, comparing the efficacy between TCM syndrome differentiation and western medicine. On the basis of traditional Chinese medicine had advantage on efficacy, the research selected four common clinical syndromes which had similar therapy and formula to analyze and compare the inter-group and intra-group efficacy by applying SPSS13.0software.
Results
1. The results of theory research
248qualified articles were included in the theory research, and there were106kinds of TCM syndromes through the process of standardization. There were7syndromes of which frequency was more than5%, including wind-cold attacking the lung syndrome, wind restraining the lung syndrome, phlegm-heat obstructing the lung syndrome, phlegm-dampness obstructing the lung syndrome, lung qi deficiency syndrome, wind-heat attacking the lung syndrome, lung-spleen qi deficiency.
There were100TCM symptoms totally after normalization(not including tongue and pulse). The top ten main symptoms were dry cough,itchy throat,paroxysmal cough, white sputum, little sputum, sticky sputum, thin sputum, dry throat, dry mouth, cough-induced factors for the cold. The top five related symptoms were fatigue, spontaneous sweating, loss of appetite, chest tightness, and headache. There were34kinds of tongue characteristics, the common tongue (frequency>5%) including red tongue, pale tongue, pale-red tongue, white coating, yellow coating, thin coating, thick coating. And there were17kinds of pulse conditions, the common pulse (frequency>5%) including thready pulse, rapid pulse, floating pulse, wiry pulse, slippery pulse, weak pulse.
2.The results of clinical epidemiology research
There were132male and287female patients in419PIC cases. The number of female was2.17times of the male. The patients'average age was47.67±15.49years old and main component of the patients were young and middle-aged people.
There were25kinds of main symptoms(frequency>10%), including sputum, white sputum or cough without sputum or slightly yellow sputum, sticky or thinsputum,sputum less or phlegm or sputum volume in general, coughing. with faint and low sound or with heavy sound, paroxysmal coughing,cough aggravating at night or in the morning, cough aggravating at day time or no significant time difference, inducing agent of the cough included cold-wind, fumes, odor, talk too much and air pollution, hoarse voice, chest tightness, shortness of breath and asthma while moving were all common symptoms.
There were23kinds of associated symptoms(frequency>10%), as follows: itchy throat,painful throat, pharyngeal foreign body sensation, dry mouth, bitter taste, thirst with a desire to drink water, afraid of cold, afraid of wind, fatigue, easy to catch a cold, stuffy nose, sneezing, watery discharge, headache,spontaneous sweating,skin allergies, loose stools or dry tools, loss of appetite, abdominal distension, restlessness, insomnia and dream disturbed sleep,weakness in the lower back and knees occasionally.
The common tongue characteristics(frequency>10%) and pulse conditions (frequency>5%)were totally15kinds, including bright red tongue,dark red tongue, pale-dark tongue, white coating, thin coating, yellow coating, dry coating, thick coating, greasy coating, enlarged and tooth-marked tongue. The pulse conditions included wiry pulse, thready pulse, deep pulse, slippery pulse and weak pulse.
There were8kinds of TCM syndromes that were the most common to see(frequency>5%):wind restraining the lung syndrome,lung qi deficiency syndrome, accumulated heat in the lung syndrome, phlegm-dampness obstructing the lung syndrome,wind-heat attacking the lung syndrome,lung-spleen qi deficiency,lung qi and yin deficiency syndrome,phlegm-heat obstructing the lung syndrome.
3. Through factor analysis, we divided47kinds of common symptoms into19classes. There were a series of syndrome classes that might be involved in the disease, including wind restraining the lung, lung qi deficiency, wind-cold attacking the lung, accumulated heat in the lung, yin deficiency, lung-defense qi deficiency, phlegm-dampness, spleen deficiency, exterior deficiency, qi stagnation, liver fire invasion of the lung, lung-kidney deficiency, lung heat and body fluid deficiency, defense qi deficiency. There were some symptoms that did not belong to any classes, such as the class of cough inducing factors, the time of cough aggravation, the characteristics of the sputum, the symptoms of the skin.
4.Through cluster analysis, we got14categories of general symptoms and5categories of tongue and pulse related symptoms.Combiningboth of the results, the syndromes of PIC wereprompted, including wind restraining the lung, lung qi deficiency,yin and body fluid deficiency, spleen deficiency,accumulated heat in the lung,phlegm-dampness, phlegm-heat, wind-cold attacking the lung, lung-defense deficiency, liver heat hyperactivity and kidney deficiency.
5. Through logistic regression analysis, we got a series of symptoms that related to the syndromes closely.Wind restraining the lung syndrome:paroxysmal coughing, sputum less, thinsputum, cough aggravating at day time.Lung qi deficiency syndrome:coughing with faint and low sound, afraid of wind. Accumulated heat in the lung syndrome:yellow sputum, thirst with a desire to drink water, painful throat, hoarse voice. Wind-heat attacking the lung:yellow sputum, painful throat, thirst with a desire to drink water and sneezing.
The regression results showed that when cough lasted for less than3weeks, the common syndromes were accumulated heat in the lung and wind-heat attacking the lung, while lung-spleen qi deficiency was rare to see. When the cough lasted for3-8weeks, wind restraining the lung syndrome and phlegm-dampness obstructing the lung syndrome had more possibilities to exist, while accumulated heat in the lung syndrome was rare to see. When the cough lasted for more than8weeks, lung-spleen qi deficiency and lung qi and yin deficiency were the syndromes more possible to appear.
6. The results of the efficacy comparison between syndrome differentiation and western medicine
On the overall efficacy, the significant efficiency rate and effective rate were22.64%and84.91%respectively, while those of the TCM group were43.23%and95.83%, higher than the western medicine group. There was significant difference (P<0.01) between the two groups in efficiency rates. The results showed that TCM syndrome differentiation was obviously superior to western medicine in promoting the efficiency rate of PIC.
TCM groupwas significantly better than the western medicine group in improving the cough symptom score (P<0.01). In the visual analogue scale, there was no significant difference in the improvement of the daytime assessment (P>0.05), while compared with western medicine, TCM group had significant difference in the improvement of the nighttime assessment (P<0.01). The results of before-and-after showed that there were significant effect on the improvement in these indicators in both TCMgroup and western medicine group (P<0.01).
The LCQ results showed that TCM group was better than the western medicine group in the physical dimension, psychological dimension as well as the total score (P<0.05). In the social dimension, the two groups had no significant difference (P>0.05). The results of before-and-after showed that both TCMgroup and western medicine group could increase the scores of each dimension and had statistical differentiation. But in the psychological dimension, the scoresof before-and-after in western medicine group was less than0.8, which suggested that the efficacy of western medicine in the psychological domain wasnot significant.
7. The results of the efficacy comparison among the four common syndromes
Four groups of common syndrome (frequency>10%)-wind restraining the lung syndrome, lung qi deficiency syndrome, accumulated heat in the lung syndrome and phlegm-dampness obstructing the lung syndrome were chosen to have a further observation of efficacy.
On the overall efficacy, there were no significant differences among the four syndromes on both significant efficiency rate and effective rate(P>0.05). It indicated that the efficacy of the four groups were equal.
There were no significant differences among the four groups on cough symptom score(P>0.05).In the visual analogue score, we found that lung qi deficiency group had the highest score in daytime assessment. It indicated that its improvement of the symptoms was the worst, and it had significant differences compared with wind restraining the lung syndrome group and phlegm-dampness obstructing the lung syndrome group (P<0.01, P<0.05). There were no significant differences among the four groups on nighttimesymptom score(P>0.05). The results of before-and-after showed that symptomsof the four groupsafter treatment significantly improved(P<0.01), indicating there was exactefficacy in syndrome differentiation.
The LCQ results showed thatthe group of lung qi deficiency had the lowest scores in physical dimension, the psychological dimension, as well as the total score. Its scores were much lower than the wind restraining the lung syndrome group both in physiological dimension and the total score(P<0.01).It was lower than the lung syndrome group and accumulated heat in the lung syndrome in psychological dimension (P<0.05). There was no significant differenceamong the four groups in the social dimension(P>0.05).There was significant difference between before-and-after (P<0.01). It indicated thatthere was exactefficacy in syndrome differentiation.
Conclusion
1. Through theory research, we got the distribution law of syndromes and symptoms of PIC. The research revealed the basic status of the disease.
2. The research adopted observational study methods of prospective, multicentric and open to acquire the basic information of PIC patients as well as the distribution of its symptoms and syndromes roundly. The results were basically consistent with the literature findings. Multivariate analysis methods such as factor analysis, cluster analysis and regression analysis were used in the research. The combination of supervised and unsupervised methods was used to investigate the common clinical syndromes and the correlation between syndromes and symptoms. The results of the research provided an objective and credible basis for syndrome differentiation.
3. From an overall perspective, TCMsyndrome differentiationwas more effective than western medicine alone. After the syndrome differentiation therapy, the patients of different groups were improved significantly in efficacy, which proved the correlation between formula and syndrome. But it showed that qi deficiency syndrome is less effective than wind restraining the lung syndrome, accumulated heat in the lung syndrome and phlegm-dampness obstructing the lung syndrome in comprehensive efficacy, indicating there might be some differences in efficacy among different syndromes in a way.
1.分析和总结近十年文献所涉及的感冒后咳嗽症状、证候分布情况,为临床研究以及制定专家问卷和信息采集表提供参考依据。
2.考察感冒后咳嗽中医证候分布特点,并采用多种数据分析方法,对中医证候与症状信息进行挖掘,探讨感冒后咳嗽常见症状、中医证候规律以及二者之间的相关关系。
3.对临床常见证候进行疗效的分析和比较,验证中医辨证论治的临床疗效,阐释证候的客观存在性以及方证的相关性。
研究方法
1.理论研究
对近10年感冒后咳嗽(或感染后咳嗽)证候相关的文献进行收集与整理,纳入合格文献,建立文献信息提取表,应用SPSS13.0软件,对文献中涉及的中医症状、证候信息及文献的基本信息等采用频率、频次的统计分析方法。
2.临床研究
2.1证候类型研究：在文献研究所得到证候、症状分布情况的基础上,结合多轮专家共识的结果,制定中医四诊信息调查问卷对信息进行全面采集；并输入临床信息采集与分析系统。采用前瞻,多中心,开放式,有监督与无监督相结合的观察性研究方法,共收集研究病例503例,其中西医病例84例,中医病例419例。运用SPSS13.0软件,对419例中医病例所涉及的症状、证候等信息分别进行构成比分析、因子分析、聚类分析和回归分析。
2.2方证效相关性研究：首先进行中药辨证论治与单纯西药的疗效比较,在中药辨证论治具有疗效优势的基础上,选择四种临床常见证候,并纳入其中具有共性治法和方药的临床病例,应用SPSS13.0软件进行组间和组内的疗效分析比较。
结果
1.理论研究结果
共纳入248篇合格文献,所涉及到的证候经规范化后共计106种,总频率大于5%的证候7个,分别为风寒袭肺证、风邪恋肺证、痰热蕴肺证、痰浊阻肺证、肺气虚证、风热犯肺证、肺脾气虚证。
中医症状经规范化后共计100个(未包括舌脉象)。主要症状中排在前十位的分别是干咳、咽痒、阵发性咳嗽、白痰、痰少、质粘稠、质稀薄、咽干/燥、口干、咳嗽诱发因素为冷风；其它相关症状中排在前五位的是乏力、自汗食欲不振、胸闷和头痛。涉及的舌象共34种,常见的(频率>5%)为红舌、淡舌、淡红舌、白苔、黄苔、薄苔、腻苔；涉及的脉象经规范化后共计17种,常见脉象(频率>5%)为细脉、数脉、浮脉、弦脉、滑脉和弱脉。
2.临床流行病学调查结果
419例感冒后咳嗽患者中男性患者132例,女性患者287例,女性患者数量为男性的2.17倍。患者的平均年龄为47.67±15.49岁,患者群以中青年人为主。
主要症状(频率>10%)25个,分别为：有痰,咯白痰或干咳无痰或咯黄痰；痰质稀薄或粘稠,痰量少或痰量多或痰量一般；咳嗽声低无力、咳声重浊或咳声阵发；咳嗽加重无明显时间区别、夜晚、晨起或白天；咳嗽诱发因素为冷风油烟,异味或说话过多和空气污染；嗓音嘶哑,胸闷,气短,动则气喘。
常见的伴随症状(频率>10%)共计23个,分别为：咽痒、咽痛或咽部异物感,口干、口苦、口渴多饮,怕冷、怕风、乏力和平素易感冒,鼻塞、打喷嚏、流清涕,头痛,自汗,皮肤过敏,大便稀溏或便干,食欲减退、腹胀,烦躁,失眠/多梦,偶尔有腰膝酸软。
常见舌象(频率>10%)和脉象(频率>5%)共计15个,分别为：舌色鲜红暗红、淡暗,白苔、薄苔、黄苔,少津,厚苔、腻苔,舌体胖大/齿痕；脉象依次为弦脉、细脉、沉脉、滑脉和弱脉。
感冒后咳嗽最常见的中医证候(频率>5%)8个：风邪恋肺证,肺气虚证肺热炽盛证,痰浊阻肺证,风热犯肺证,肺脾气虚证,肺气阴两虚证,痰热蕴肺证
3.通过因子分析,将47个感冒后咳嗽常见症状分成了十九类,该疾病可能涉及的一些证候类别分别为风邪恋肺、肺气虚、风寒束表、肺热、阴虚、肺卫气虚、痰浊、脾虚、表虚、肝火犯肺、肺肾两虚、肺热津亏；不便于归纳为某一证候类型的,直接对其进行分类处理,如：咳嗽的诱发因素类、咳嗽加重时间类、痰质类、皮肤症状类
4.通过聚类分析,得到感冒后咳嗽相关的一般症状14类,舌脉相关症状5类,综合两者结果,提示感冒后咳嗽的证候可能有风邪恋肺、肺气虚、阴津亏虚、脾虚、肺热、痰浊、痰热、风寒袭表、肺卫亏虚、肝火上炎和肾虚。
5.通过Logistic回归分析,我们得到了与证候密切相关的症状表现。风邪恋肺证：咳声阵发、痰量少、痰质稀薄和咳嗽加重时间为白天；肺气虚证：咳嗽声低无力和怕风；肺热炽盛证：咯黄痰、口渴多饮、咽痛、嗓音嘶哑；风热犯肺证：咯黄痰、咽痛、口渴多饮、以及喷嚏。
回归结果显示,当咳嗽时间<3周时,常见的证候为肺热炽盛证和风热犯肺证,而肺脾气虚证少见；当咳嗽时间持续3-8周时,风邪恋肺证与痰浊阻肺证出现的可能性较大,而肺热炽盛证较少见；当咳嗽时间>8周时,肺脾气虚证与肺气阴两虚证是出现可能性较大的两个证候。
6.中医辨证论治与西药疗效比较结果
在总体疗效上,西药组显效率和有效率分别为22.64%、84.91%,中药辨证组为43.23%和95.83%,均高于西药组,两组显效率、有效率比较有非常显著统计学差异(P<0.01),说明中药辨证论治在提高感冒后咳嗽患者显效率和有效率方面明显优于西药。
中药辨证论治在改善咳嗽症状积分方面明显优于西药组(P<0.01)。在视觉模拟评分中,白天评分的改善,两组并未见显著差异(P>0.05)；在改善夜间评分上,中药辨证论治组效果明显优于西药组(P<0.01)。两组治疗前后自身比较结果显示,无论中药辨证论治组还是西药组,在上述指标的改善方面,均有显著性疗效(P<0.01)。
LCQ结果表明中药辨证组在生理维度、心理维度以及总得分方面均优于西药组(P<0.05)；在社会维度方面,两组得分未见显著区别(P>0.05)。治疗前后组内比较发现,无论西药还是辨证论治中药均能增加各个维度得分,且均有统计学差异；但在心理维度,西药治疗组前后差异性分值<0.8分,提示西药在心理领域疗效不明显。
7.四种常见证候间的疗效比较结果
选择四组常见证候(频率>10%)—风邪恋肺证、肺气虚证、肺热炽盛证、痰浊阻肺证进行进一步的疗效观察。
四组之间的显效率、有效率无统计学差异(P>0.05),总体疗效相当
四组之间在咳嗽症状积分上未见显著差异(P>0.05)。在视觉模拟评分方面,肺气虚组白天症状评分得分最高,说明症状改善不明显,并与风邪恋肺组、痰浊阻肺组有显著差异(P<0.01、P<0.05)；夜间症状评分,四组之间疗效无明显差别(P>0.05)。治疗前后组内比较发现,四组治疗后各症状均比治疗前有显著改善(P<0.01),说明辨证论治疗效确切。
LCQ结果分析发现,四组经治疗后,肺气虚组在生理维度、心理维度以及总分均低于其它组别；其中在生理维度以及总分的得分上,明显低于风邪恋肺组(P<0.01)；在心理维度得分上,亦低于风邪恋肺组和肺热炽盛组(P<0.05)。四组之间在社会维度的比较无明显差异(P>0.05)。治疗前后组内比较,有非常显著统计学差异(P<0.01),说明辨证论治各组均有疗效。结论
1.通过理论研究,得到了感冒后咳嗽症状、证候分布规律,反映了该疾病研究的基本现状。
2.本研究采用前瞻,多中心,开放式的观察性临床研究方法,较为全面的获得了感冒后咳嗽患者的基本信息以及症状、证候分布情况,与文献研究结果基本一致；并采用因子分析、聚类分析和回归分析等多元分析方法,有监督与无监督相结合的考察感冒后咳嗽临床常见证候类型以及证候与症状的相关关系,为辨证论治提供客观、可信依据。
3.综合疗效评价来看,中药辨证论治疗效明显优于单纯的西药治疗；不同中医证候经辨证治疗后均取得显著疗效,验证了方证的相关性；本研究发现肺气虚证在综合疗效评价方面不如风邪恋肺证、肺热炽盛证和痰浊阻肺证,说明不同证候之间的疗效在某种程度上可能存在着一定的差异性
Objective
1. By analyzing the literature of the past decade, the research will analyze the distribution of symptomsand syndromes of post-infectious cough (PIC) to provide a reference for clinical research and questionnaire.
2. On the basis of theliterature and expert consensus results, using the methods of clinical epidemiology to research the syndrome distribution characteristics of PIC. A variety of data analysis methods will be used to mine the information of TCM syndrome and symptom,in order to discuss the common symptoms and TCM syndrome of PIC andthe relationship between them.
3.Analyzing and comparing the clinical efficacy of common syndromes,toverify the clinical efficacy of TCM syndrome differentiation,and to explain the objective existence of syndrome and the correlation between formula and syndrome.
Methods
1.Theory research
The researchcollected literature related to PICof the past decade and selected qualified literature to establish an information extraction table. SPSS13.0statistics software was used to analyze the frequency of the involved TCM symptoms, syndromes and basic information of literature.
2. Clinical research
2.1The research of syndrome types:On the basis of the literature results which involved the syndromes and symptoms,combined with the results of several rounds of expert consensus, the research drew a questionnaire to collect the information of four examinations and input the information into a collection andanalysis system.Observational study methods of prospective, multicentric, open, the combination of supervised and unsupervised were adopted.84Western medicine cases and419TCM cases were collected. The research applied SPSS13.0software to analyze the419TCM cases by using ratio analysis, factor analysis, cluster analysis and regression analysis.
2.2The research of formula-syndrome and effectrelationship:First, comparing the efficacy between TCM syndrome differentiation and western medicine. On the basis of traditional Chinese medicine had advantage on efficacy, the research selected four common clinical syndromes which had similar therapy and formula to analyze and compare the inter-group and intra-group efficacy by applying SPSS13.0software.
Results
1. The results of theory research
248qualified articles were included in the theory research, and there were106kinds of TCM syndromes through the process of standardization. There were7syndromes of which frequency was more than5%, including wind-cold attacking the lung syndrome, wind restraining the lung syndrome, phlegm-heat obstructing the lung syndrome, phlegm-dampness obstructing the lung syndrome, lung qi deficiency syndrome, wind-heat attacking the lung syndrome, lung-spleen qi deficiency.
There were100TCM symptoms totally after normalization(not including tongue and pulse). The top ten main symptoms were dry cough,itchy throat,paroxysmal cough, white sputum, little sputum, sticky sputum, thin sputum, dry throat, dry mouth, cough-induced factors for the cold. The top five related symptoms were fatigue, spontaneous sweating, loss of appetite, chest tightness, and headache. There were34kinds of tongue characteristics, the common tongue (frequency>5%) including red tongue, pale tongue, pale-red tongue, white coating, yellow coating, thin coating, thick coating. And there were17kinds of pulse conditions, the common pulse (frequency>5%) including thready pulse, rapid pulse, floating pulse, wiry pulse, slippery pulse, weak pulse.
2.The results of clinical epidemiology research
There were132male and287female patients in419PIC cases. The number of female was2.17times of the male. The patients'average age was47.67±15.49years old and main component of the patients were young and middle-aged people.
There were25kinds of main symptoms(frequency>10%), including sputum, white sputum or cough without sputum or slightly yellow sputum, sticky or thinsputum,sputum less or phlegm or sputum volume in general, coughing. with faint and low sound or with heavy sound, paroxysmal coughing,cough aggravating at night or in the morning, cough aggravating at day time or no significant time difference, inducing agent of the cough included cold-wind, fumes, odor, talk too much and air pollution, hoarse voice, chest tightness, shortness of breath and asthma while moving were all common symptoms.
There were23kinds of associated symptoms(frequency>10%), as follows: itchy throat,painful throat, pharyngeal foreign body sensation, dry mouth, bitter taste, thirst with a desire to drink water, afraid of cold, afraid of wind, fatigue, easy to catch a cold, stuffy nose, sneezing, watery discharge, headache,spontaneous sweating,skin allergies, loose stools or dry tools, loss of appetite, abdominal distension, restlessness, insomnia and dream disturbed sleep,weakness in the lower back and knees occasionally.
The common tongue characteristics(frequency>10%) and pulse conditions (frequency>5%)were totally15kinds, including bright red tongue,dark red tongue, pale-dark tongue, white coating, thin coating, yellow coating, dry coating, thick coating, greasy coating, enlarged and tooth-marked tongue. The pulse conditions included wiry pulse, thready pulse, deep pulse, slippery pulse and weak pulse.
There were8kinds of TCM syndromes that were the most common to see(frequency>5%):wind restraining the lung syndrome,lung qi deficiency syndrome, accumulated heat in the lung syndrome, phlegm-dampness obstructing the lung syndrome,wind-heat attacking the lung syndrome,lung-spleen qi deficiency,lung qi and yin deficiency syndrome,phlegm-heat obstructing the lung syndrome.
3. Through factor analysis, we divided47kinds of common symptoms into19classes. There were a series of syndrome classes that might be involved in the disease, including wind restraining the lung, lung qi deficiency, wind-cold attacking the lung, accumulated heat in the lung, yin deficiency, lung-defense qi deficiency, phlegm-dampness, spleen deficiency, exterior deficiency, qi stagnation, liver fire invasion of the lung, lung-kidney deficiency, lung heat and body fluid deficiency, defense qi deficiency. There were some symptoms that did not belong to any classes, such as the class of cough inducing factors, the time of cough aggravation, the characteristics of the sputum, the symptoms of the skin.
4.Through cluster analysis, we got14categories of general symptoms and5categories of tongue and pulse related symptoms.Combiningboth of the results, the syndromes of PIC wereprompted, including wind restraining the lung, lung qi deficiency,yin and body fluid deficiency, spleen deficiency,accumulated heat in the lung,phlegm-dampness, phlegm-heat, wind-cold attacking the lung, lung-defense deficiency, liver heat hyperactivity and kidney deficiency.
5. Through logistic regression analysis, we got a series of symptoms that related to the syndromes closely.Wind restraining the lung syndrome:paroxysmal coughing, sputum less, thinsputum, cough aggravating at day time.Lung qi deficiency syndrome:coughing with faint and low sound, afraid of wind. Accumulated heat in the lung syndrome:yellow sputum, thirst with a desire to drink water, painful throat, hoarse voice. Wind-heat attacking the lung:yellow sputum, painful throat, thirst with a desire to drink water and sneezing.
The regression results showed that when cough lasted for less than3weeks, the common syndromes were accumulated heat in the lung and wind-heat attacking the lung, while lung-spleen qi deficiency was rare to see. When the cough lasted for3-8weeks, wind restraining the lung syndrome and phlegm-dampness obstructing the lung syndrome had more possibilities to exist, while accumulated heat in the lung syndrome was rare to see. When the cough lasted for more than8weeks, lung-spleen qi deficiency and lung qi and yin deficiency were the syndromes more possible to appear.
6. The results of the efficacy comparison between syndrome differentiation and western medicine
On the overall efficacy, the significant efficiency rate and effective rate were22.64%and84.91%respectively, while those of the TCM group were43.23%and95.83%, higher than the western medicine group. There was significant difference (P<0.01) between the two groups in efficiency rates. The results showed that TCM syndrome differentiation was obviously superior to western medicine in promoting the efficiency rate of PIC.
TCM groupwas significantly better than the western medicine group in improving the cough symptom score (P<0.01). In the visual analogue scale, there was no significant difference in the improvement of the daytime assessment (P>0.05), while compared with western medicine, TCM group had significant difference in the improvement of the nighttime assessment (P<0.01). The results of before-and-after showed that there were significant effect on the improvement in these indicators in both TCMgroup and western medicine group (P<0.01).
The LCQ results showed that TCM group was better than the western medicine group in the physical dimension, psychological dimension as well as the total score (P<0.05). In the social dimension, the two groups had no significant difference (P>0.05). The results of before-and-after showed that both TCMgroup and western medicine group could increase the scores of each dimension and had statistical differentiation. But in the psychological dimension, the scoresof before-and-after in western medicine group was less than0.8, which suggested that the efficacy of western medicine in the psychological domain wasnot significant.
7. The results of the efficacy comparison among the four common syndromes
Four groups of common syndrome (frequency>10%)-wind restraining the lung syndrome, lung qi deficiency syndrome, accumulated heat in the lung syndrome and phlegm-dampness obstructing the lung syndrome were chosen to have a further observation of efficacy.
On the overall efficacy, there were no significant differences among the four syndromes on both significant efficiency rate and effective rate(P>0.05). It indicated that the efficacy of the four groups were equal.
There were no significant differences among the four groups on cough symptom score(P>0.05).In the visual analogue score, we found that lung qi deficiency group had the highest score in daytime assessment. It indicated that its improvement of the symptoms was the worst, and it had significant differences compared with wind restraining the lung syndrome group and phlegm-dampness obstructing the lung syndrome group (P<0.01, P<0.05). There were no significant differences among the four groups on nighttimesymptom score(P>0.05). The results of before-and-after showed that symptomsof the four groupsafter treatment significantly improved(P<0.01), indicating there was exactefficacy in syndrome differentiation.
The LCQ results showed thatthe group of lung qi deficiency had the lowest scores in physical dimension, the psychological dimension, as well as the total score. Its scores were much lower than the wind restraining the lung syndrome group both in physiological dimension and the total score(P<0.01).It was lower than the lung syndrome group and accumulated heat in the lung syndrome in psychological dimension (P<0.05). There was no significant differenceamong the four groups in the social dimension(P>0.05).There was significant difference between before-and-after (P<0.01). It indicated thatthere was exactefficacy in syndrome differentiation.
Conclusion
1. Through theory research, we got the distribution law of syndromes and symptoms of PIC. The research revealed the basic status of the disease.
2. The research adopted observational study methods of prospective, multicentric and open to acquire the basic information of PIC patients as well as the distribution of its symptoms and syndromes roundly. The results were basically consistent with the literature findings. Multivariate analysis methods such as factor analysis, cluster analysis and regression analysis were used in the research. The combination of supervised and unsupervised methods was used to investigate the common clinical syndromes and the correlation between syndromes and symptoms. The results of the research provided an objective and credible basis for syndrome differentiation.
3. From an overall perspective, TCMsyndrome differentiationwas more effective than western medicine alone. After the syndrome differentiation therapy, the patients of different groups were improved significantly in efficacy, which proved the correlation between formula and syndrome. But it showed that qi deficiency syndrome is less effective than wind restraining the lung syndrome, accumulated heat in the lung syndrome and phlegm-dampness obstructing the lung syndrome in comprehensive efficacy, indicating there might be some differences in efficacy among different syndromes in a way.
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46.吕予,张群莹.加味止嗽散治疗感染后咳嗽36例.陕西中医,2007,28(8)：951-952
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50.于瑞萍,李新民,马慧.止嗽散加减治疗感冒后咳嗽80例.长春中医药大学学报,2009,25(4)：524-525
51.高小林.止嗽散加味治疗感冒后咳嗽32例.黑龙江中医药,2008,(6)：26-27
52.潘红斌.止嗽散加味治疗感冒后咳嗽65例.浙江中医杂志,2009,44(3)：195
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74.戴珍.固本宣肺汤治疗感冒后咳嗽56例.陕西中医,2009,30(8)：954
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