功能失调性子宫出血常见中医证候规范化研究
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摘要
背景功能失调性子宫出血(简称功血)是妇科常见的疑难重症,其发病率占妇科门诊的10%,出血机理十分复杂,出血的临床表现多种多样,严重影响妇女的身心健康。中医药对“调经”和“止血”效果显著,但是由于功血中西医病名对应性差,辨证论治复杂多样,无统一的标准,这就急需要对功血的中医证候进行科学合理的规范化研究以发挥中医药治疗功血优势。
     目的通过古今文献调研,对功血相关中医证候进行全面分析,探讨功血古今中医证候规律。探索运用合适的统计方法建立功血常见中医证型及其主症规范,为最终建立一套科学、合理、实用的功血中医证候规范体系提供依据和方法学参考。
     方法本研究应用文献研究方法,通过查阅古今相关文献,获得功血相关中医证候的全面信息,再通过证型的频数分布和症状的聚类分析建立功血中医证候数据库,并拟定调查的证型,初步规范常见证型中的主要症状和次要症状。采用Delphi专家咨询法对拟定的功血中医证型以及与经期、经量相关的主症指标体系进行评判。通过三轮专家咨询表的信度、效度以及专家的积极系数、权威系数和协调程度等指标对本研究的可靠性进行分析;运用综合指数法、界值法筛选指标;运用秩和比法和改良的比例分配法确定各指标的权重。
     结果本研究共检出59种古籍书和2082篇现代期刊文献,对符合纳入标准的324条古籍信息和42篇现代期刊文献进行统计分析后制定专家咨询表进行了三轮专家咨询。结果显示:①古籍中与功血相关的中医证型有83种次,整合后有证型18种(血热证、脾气虚证、肾阴虚证、肾气虚证、肝郁脾虚证、肝郁化火证、心脾两虚证、脾气下陷证、肝气郁结证、肾阳虚证、湿热蕴结证、气滞血瘀证、脾阳虚证、痰湿证、气虚血瘀证、血虚证、血热瘀结证、阴虚血瘀证),分解成病位证素12种(脾、肝、冲任、肾、胃、肝经、脾经、胞宫、阴虚、心、血海、血室)及病性证素17种(气虚、气滞/郁、阴虚、血虚、血热、血瘀、火、气陷、郁热、湿热、虚、阳虚、痰湿、热、怒、气乱、血寒);现代期刊文献与功血相关的中医证型有53种次,整合后有证型16种(脾气虚证、肾阴虚证、肾阳虚证、肝气郁结证、气滞血瘀证、血热证、心脾两虚证、气虚血瘀证、肾气虚证、肝郁血热证、肝郁脾虚证、血热瘀结证、.肝郁化火证、寒凝胞宫证、湿热蕴结证、气阴两虚证),分解成病位证素6种(脾、肾、肝、冲任、胞宫、心)及病性证素10种(气虚、血瘀、血热、阴虚、气滞、阳虚、血虚、热、湿热、火)。其中常见证型中的主要症状和次要症状均采用聚类分析获得。②三轮专家咨询的克朗巴赫α系数分别为0.9134,0.9062,0.9379;咨询表均具有较好的表面效度和内容效度;三轮专家咨询的积极系数分别为92%,95%,93%;第一、二轮的协调系数分别为0.76,0.80;第三轮的协调系数分别为脾气虚证0.81,肾气虚证0.75,肾阴虚证0.81,血热证0.90,血热瘀结证0.63,气虚血瘀证0.78;本研究的专家权威系数为0.881和0.887。③功血中医证型经第一、二轮专家咨询后得出功血常见6个常见中医证型为脾气虚证、气虚血瘀证、血热瘀结证、肾阴虚证、血热证、肾气虚证。④经过第三轮专家咨询,脾气虚证中与经期、经量相关的主症指标的权重排序分别为经期提前0.2049、经量偏多0.2049、或崩或漏0.2049>或多或少0.1966>经期延长0.1888;肾气虚证中与经期、经量相关的主症指标的权重排序分别为经期提前0.1446、经量偏多0.1446、或崩或漏0.1446>或多或少0.1401>时下时止0.1297;肾阴虚证中与经期、经量相关的主症指标的权重排序分别为经期延长0.2594、经量偏多0.2594>经间出血0.2376>或崩或漏0.2437;血热证中与经期、经量相关的主症指标的权重排序分别为经期提前0.2193、经量偏多0.2193>或崩或漏0.2133>经间出血0.1910>或多或少0.1572;血热瘀结证中与经期、经量相关的主症指标的权重排序分别为经期提前0.2210>经量偏多0.2137>经间出血0.1851>或多或少0.1475>经期延长0.1292>经来无期0.1033;气虚血瘀证中与经期、经量相关的主症指标的权重排序分别为或多或少0.2222>或崩或漏0.2047>时下时止0.2005>经来无期0.2000>经期延长0.1726。各证型中主症指标排序与文献研究中的聚类分析结果相近似。
     结论通过文献调研,聚类分析以及Delphi评价法所建立的功血常见中医证型以及与经期、经量相关的常见症状规范符合临床证治规律,具有一定的科学性,为进一步的临床流行病学调查乃至功血中医证候规范体系的最终建立提供了科学依据,奠定了方法学基础。
Background Dysfunctional uterine bleeding (DUB) is a common gynopathic stubborn disease, and its morbidity constitutes 10% of the gynopathic OPD. The mechanism of bleeding is very complicated and its clinic manifestation varies, badly influencing the health of women's body and heart. The theory of traditional Chinese medicine and herbs has an obvious therapeutic effect on "regulating menstruation" and "hemostasis". However, not only the lower corresponding degree of DUB in traditional Chinese medicine and Western medicine, but the syndrome differentiation and treatment is complex, without unified standard as well. It is necessary to carry out scientifically regular research into the traditional Chinese medical syndrome of DUB in order to take advantages of the treatment under the theory of traditional Chinese medicine and herbs.
     Objective By referring to the ancient and present literatures, we have a multi-analysis in DUB associated with the traditional Chinese medicine, and discuss the syndrome regulations of DUB in ancient and present traditional Chinese medicine. We try to use suitable statistical method to build the regulations of familiar DUB types of syndrome and its main syndrome, so as to build a series of scientific, rational and practical systems in the end, providing guilds and technology to refer to.
     Methods The research uses methods of studying literatures by consulting associated literatures of ancient and present times. We have obtained fullscale information of traditional Chinese medical syndrome associated with DUB and built a database of it. This paper adopts methods of Delphi experts consultation to value the supposed types of syndromes in traditional Chinese medicine and a system of main symptoms index associated with cycle of menstruation and quantity of menstruation. We analyze the reliability of our study by some index such as three rounds experts'consultative papers'reliability and validity as well as experts' Cronbach's coefficient, kendall coefficient and authoritative coefficient, using synthetic index method and critical value method to bolt index, using RSR method and distribution according to proportion method to confirm the weight of every index.
     Results The study totally selects 59 ancient books and 2082 modern journal literatures. After statistical analyzing 324 pieces of ancient information and 42 modern journal literatures which are qualified for the internalized standards, we establish experts'consultative paper to consult experts. The result shows:
     1. There were 85 kinds of traditional medicine syndrome associated with DUB in ancient books, and about 18 types of syndromes (syndrome of blood stasis, syndrome of qi asthenia of spleed, syndrome of yin asthenia of kidney, syndrome of qi asthenia of kidney, syndrome of liver depression and spleen asthenia, syndrome of liver depression transforming into fire, syndrome of simultaneous asthenia of heart and spleen, syndrome of downward of spleen qi, syndrome of qi stagnation of liver, syndrome of yang asthenia of kidney, syndrome of accumulation of damp-heat, syndrome of qi stagnation and blood stasis, syndrome of yang asthenia of spleen, syndrome of phlegm-dampness, syndrome of qi asthenia and blood stasis, syndrome of blood asthenia, syndrome of blood heat and stasis, syndrome of yin asthenia and blood stasis) and 11 key points of the types of syndromes of place of disease (spleen, liver, thoroughfare and conception, kidney, stomach, liver meridian, spleen meridian, uterus, heart, sea of blood, room of blood) and 19 key points of the types of syndromes of nature of disease(qi asthenia, qi stagnation, yin asthenia, blood asthenia, blood heat, blood coat, fire, downward of qi, depression-heat, damp-heat, asthenia, yang asthenia, phlegm-dampness, heat, angry, disorder of qi, blood-coat) in gathering; in present journal literatures, there are 53 kinds of traditional medicine syndromes associated with DUB, and 16 types of syndromes of nature of disease(syndrome of qi asthenia of spleed, syndrome of yin asthenia of kidney, syndrome of yang asthenia of kidney, syndrome of qi stagnation of liver, syndrome of qi asthenia and blood stasis, syndrome of blood heat, syndrome of simultaneous asthenia of heart and spleen, syndrome of qi asthenia and blood stasis, syndrome of qi asthenia of kidney, yndrome of liver depression and blood heat, syndrome of liver depression and spleen asthenia, syndrome of blood heat and stasis, syndrome of liver depression transforming into fire, syndrome of cold coagulation in uterus, syndrome of accumulation of damp-heat, syndrome of asthenia of qi and yin) and 6 key points of the types of syndromes of place of disease(spleen, kidney, liver, thoroughfare and conception, uterus, heart) and 10 key points of nature of disease(qi asthenia, blood stasis, blood heat, yin asthenia, qi stagnation, yang asthenia, blood asthenia, heat, damp-heat, fire) in gatherting.
     2. Each Cronbach's alpha coefficients of three rounds experts' consultation are respectively 0.9134,0.9062,0.9379; the consultative paper has a good face validity and content validity; cronbach's coefficients of three-round experts'consultation are 92%,95%and 93%; the authoritative coefficient of the first round and the second round are 0.76,0.80; the authoritative coefficient of the third round respectively are 0.81 in Syndrome of qi asthenia of spleed,0.75 in Syndrome of qi asthenia of kidney,0.81 in Syndrome of yin asthenia of kidney,0.90 in Syndrome of predominant yang and blood heat,0.63 in Syndrome of qi blood heat and blood stasis,0.78 in Syndrome of qi asthenia and blood stasis; the expert weight coefficient of this study are 0.881 and 0.887.
     3. After the first and the second round of experts'consultation, we totally delete 10 index of type of syndrome and get the common TCM syndromes of DUB are Syndrome of qi asthenia of spleed, Syndrome of qi asthenia and blood stasis, Syndrome of blood heat and blood stasis, Syndrome of yin asthenia of kidney, Syndrome of predominate yang and blood heat, Syndrome of qi asthenia of kidney.
     4. After the third experts'consultation, the collating sequence of weight coefficient of main syndrome associated with cycle and quantity of menstruation in the Syndrome of qi asthenia of spleed respectively are early menstruation 0.2049, profuse menorrhea 0.2049, metrorrhagis or metrostaxis 0.2049> irregularity of menstrual quantity 0.1966> menostax is 0.1888; the collating sequence of weight coefficient of main syndrome associated with cycle and quantity of menstruation in the Syndrome of qi asthenia of kidney respectively are early menstruation 0.1446, profuse menorrhea 0.1446, metrorrhagia or metrostaxis 0.1446> irregularity of menstrual quantity 0.1401> occasional bleeding 0.1297; the collating sequence of weight coefficient of main syndrome associated with cycle and quantity of menstruation in the Syndrome of yin asthenia of kidney respectively are are menostax is 0.2594, scanty menses 0.2594> intermenstrual bleeding 0.2376> metrorrhagia or metrostaxis 0.2437; the collating sequence of weight coefficient of main syndrome a ssociated with cycle and quantity of menstruation in the Syndrome of predominant yang and blood heat respectively are early menstrualtion 0.2193, profuse menorrhea 0.2193> metrorrhagia or metrostaxis 0.2133 > intermenstrual bleeding 0.1910> irregularity of menstrual quantity 0.1572; the collating sequence of weight coefficient of main syndrome a ssociated with cycle and quantity of menstruation in the Syndrome of blood heat and blood stasis respectively are early menstrualtion 0.2210> profuse menorrhea 0.2137> intermenstrual bleeding 0.1851> irregularity of menstrual quantity 0.1475> menostaxis 0.1292> irregularity of menstrual cycle 0.1033; the collating sequence of weight coefficient of main syndrome associated with cycle and quantity of menstruation in the Syndrome of qi asthenia and blood stasis respectively are irregularity of menstrual quantity 0.2222> metrorrhagia or metrostaxis0.2047> occasional bleeding 0.2005> irregularity of menstrual cycle 0.2000> menostaxis 0.1726.
     Conclusions By referring to literatures, evaluation Clustering analysia and Delphi evaluation, we establish the regulations of common DUB types of syndrome and main syndrome associated with cycle of menstruation and quantity of menstruation, which suit for clinical regulations of syndrome differentiation and treatment and have a certain science. It provides scientific guides and serve a base of technology for next clinical epidemiologic survey and even for building a series of DUB systems in the end.
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