失眠症伤寒六经辨治规律探讨及临床研究
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摘要
本文以仲景伤寒六经辨证论治体系为指导,对失眠症在六经的生理、病理机制、发病特点、证候分布、证治规律、临证特色、疗效评价等方面进行探讨,初步建立了较为系统、完整、规范的失眠症六经辨治体系,为临床诊疗提供了新的思维方法和辨证论治思路,显示了六经辨证论治体系有别于其它辨证方法的鲜明特色和整体优势。同时开展了六经辨治失眠症的临床观察,初步揭示了失眠症六经证型的分布规律、辨证要点、治则方药及诊疗优势。
1理论部分
(1)失眠症六经生理病理机制
生理机制：营卫调和为其使,枢机斡旋为其要,阴阳顺接为其果,神出水火,舍主有序,寤寐有常,则保持睡眠休作有时的正常节律,体现“卫主营从”、“枢机为权”的生理特征。病理机制：外感六淫、内伤杂病致六经营卫不和,阴阳失调,枢机不利,气机逆乱,阴阳气不相顺接,心肾不交,神不守舍而发病。“营卫交会-阴阳交接-神舍出入”失调,贯穿失眠症六经疾病转归的始终。
(2)失眠症六经证型特点
伤寒六经邪气所干、脏腑虚损均可导致失眠。太阳病：营卫不和、阳气怫郁、蓄水、蓄血、热郁胸膈证。明阳病：阳明热盛、腑实、蓄血、热郁胸膈、胃强脾弱及胃肾阴伤,水热互结证。少阳病：枢机不利、三焦水火痞结证。太阴病：阳虚寒湿、水气上逆、水郁经气、营卫不和、气血不足、气滞腹胀、气血阴阳两虚、阳复化燥证。少阴病：少阴阳虚证(心肾阳虚、水寒上逆)、少阴阴虚证(阴虚火旺,心肾不交,水热互结)、阴阳两虚、阳复扰心证。厥阴病：血虚寒凝、阳郁失宣、厥阴寒热错杂(肝热脾寒、肺热脾寒、胃热脾寒)证。
(3)失眠症的六经辨治特色
①鲜明的仲景学说理论特色
六经辨治失眠,具有仲景学说鲜明的理论特色。心脑体用,共主神明,共调睡眠。六经实以脏腑、经络为基础,营卫气血为载体,圆周运动为形式,阴阳和合交替为特征,心神、脑神统帅调控为主体,气、血、精、津、液气化、输布、调节为物质基础,协调于六经脏腑神明,归属脑神所总司。营卫不和,阴阳失调是失眠的基础：营卫交会失和,破坏“卫主营从”的基本运行规律,扰乱人体生物效应、人体辉光和暗物质的良性激发,导致阴阳交感失和,神、舍出入失调。胃气不和,枢机不利是失眠的关键：少阳、厥阴两枢相将不相离,既为阳明、太阴之枢,也为阴阳升降出入、交替开阖之枢,对六经有强大的调畅作用。胃气不和,斡旋失职,营卫出入失调,阴阳升降失序,心肾阴阳不交,心脑神明失藏,均不离枢机之矩。六经瘀血是失眠的重要因素：六经皆有瘀血,互为因果。瘀血内阻,血脉不畅,气机郁滞,血不荣心,也是导致失眠的病因之一。
②系统完整和灵活规范的临证特色
临证以六经辨治失眠,首分阴阳,以阴阳分六经。次分经腑,再辨寒热、虚实、表里。表里层次分明,轻重缓急兼顾。既六经分治,又各有兼顾。与其它辨证方法相比,在病因、病性、病位、病势、病程、疾病转归、正邪消长等方面,均可体现出其更显突出的整体性、全局性的辨证优势,以辨应变,知权达变,灵活多变。
和法和通法是六经论治失眠的主要方法：桂枝汤、小建中汤、桂枝甘草龙骨牡蛎汤、当归四逆汤体现“以六经为据,调和营卫,引阳入阴,纳神归舍”的调治之法。小柴胡汤、小陷胸汤、三泻心汤、黄连汤体现“以三阳为寓,和解少阳,通达三焦,调枢安神”的调治之法。乌梅丸、麻黄升麻汤、干姜黄芩黄连人参汤、黄连阿胶汤体现“以三阴为根,燮理升降,交通阴阳,调济安神”的调治之法。白虎汤、三承气汤、桃核承气汤、真武汤体现“通腑散结、利水破瘀”的调治之法。
“大建中州,顾护后天”是六经论治失眠的关键：中州为脾胃中土之地,厥阴枢机斡旋之所,也是胆、三焦循行之地,少阳枢机调和之所。中州建固,营卫复生,交接正常,昼夜有序。上则心阳得温,营阴资足,神有所养。下则肝有所藏,肾有所助,神魂归舍。少阳之枢助阴阳表里出入,营卫交接,通达三焦；厥阴之枢助阴阳上下升降,生发交接,水火交济。少阳、厥阴二枢,对营卫气血由阳入阴、出阴入阳的阴阳交替具有调节、协调作用。通过调畅枢机,调和阴阳,实现自身昼夜交接,体现“枢机为权”的重要性。
“益阴扶阳,三阴并治”是六经论治失眠的根本：太阴辨证须重视“太阴脾虚,营卫不足,心营失养,神不归舍”的病机特点。治宜大建中州,调和营卫。少阴辨证须重视“少阴热化,阴虚火旺,心肾不交,水火失济”的病机特点。少阴阳虚,神失所养,宜温补心阳,潜镇安神。肾阳大伤,神无阳助,宜破阴散结,引阳入阴。少阴阴虚,心肾不交宜滋阴清热,交通心肾。少阴阴阳气血俱虚,宜调补气血阴阳。厥阴辨证须重视“厥阴阳郁,肝阳失用,寒热错杂,阴阳失和”的病机特点。寒热错杂,肝热脾寒,宜清上温下。肺热脾寒,宜发越阳郁,清肺温脾。胃热脾寒,宜清胃温脾,交通阴阳。血虚寒凝,宜温经散寒,养血通脉。阳郁失宣,宜疏肝健脾,开宣郁阳。病在三阴,须重视“三阴并治,注重枢机”的治疗特点。肝肾阳虚,脾土亏耗,卫虚营滞,神机失运,宜补肾暖肝,温建中州。肝肾阴虚,精血不足,水火失济,心神浮越,宜滋肝养阴,补肾填髓,调补阴阳。
(4)失眠症的六经辨治优势
以六经辨证失眠,具有整体全局优势和动态变化特征。三阳初病多实邪,三阴久病多虚损。六经辨证失眠,其病机乃营卫不和,枢机不利,脏腑虚损,阴阳气不相顺接,心神受扰所致。病初在三阳,多营卫不和、枢机不利、胃气不和、热扰胸膈、三焦津气痞结之证。病末在三阴,多寒湿内蕴、气血亏虚、阳虚气浮、阴虚火旺、寒热错杂、相火上逆、阴阳失交等证。三阴病失眠症,三阴挟杂、经脏俱病。失眠六经论治,病在三阳多标实,病在三阴多本虚。六经辨治失眠,以“调和营卫,燮理阴阳,交通上下,安神达志”为标,“固先天,养后天,调肝胆,和枢机”为本,以“三阴并治,重在厥阴”为要,兼顾化痰利水、活血散瘀。
2临床部分
(1)背景
关于失眠症的辨证论治,目前临床基本倾向于八纲辨证、脏腑辨证、气血津液辨证,如与温病相联系,则多选择卫气营血、三焦辨证体系,临证诊疗容易缺乏整体意识和动态变化观念。以六经辨证论治失眠症,临床多以方证辨证为主,缺乏系统、完善、规范的六经证治规律及辨证论治体系。
(2)目的
确立失眠症的六经主要症状、主要证型及证候分布规律,比较经方与舒乐安定治疗失眠症的临床疗效、不良反应差异。
(3)方法
采用《中药新药临床研究指导原则》、《精神疾病分类与诊断标准》纳入观察病例,采用《90项症状自评量表》(SCL-90)排除精神心理疾病所致继发性失眠,采用《失眠症六经证候调查表》记录全部合格观察病例的临床症状、体征及舌脉象,阳性症状采用4级量化指标。根据临床症状的积分频数分布、六经证型的频数分布,确定失眠症六经主证、主要证型的证候分布规律。
对纳入观察的失眠症主要六经证型病例,采用《失眠症六经辨治临床研究报告表》、汉密尔顿焦虑量表(HAMA)、汉密尔顿抑郁量表(HAMD)和匹兹堡睡眠质量指数量表(PSQI),治疗组给予经方辨证治疗,对照组给予舒乐安定,4周药物疗程结束后进行疗效评价。疗效评价为失眠症六经主证及HAMA、HAMD、PSQI指标在治疗前后的量值变化,安全性指标为不良反应。
(4)结果
确定15个失眠症六经主要症状为六经主症：不得眠、烦躁、惊狂、汗出、渴或燥渴、心悸、心中怫郁、胸满或闷、胁满闷或胀、心下痞或硬、腹满或胀、便结或硬、便溏或利、少气肢乏、四逆或逆冷。确定9个失眠症六经主要证型：①阴虚火旺,心肾不交证；②邪壅中焦,气机痞塞证；③少阳枢机不利证；④营卫不和证；⑤厥阴阳郁失宣证；⑥寒热错杂,肝热脾寒,火逆神乱证；⑦血虚寒凝,肝阳失用,阴阳不和证；⑧气血阴阳两虚证；⑨太阴虚寒,气血不足证。15主症与六经证型分布基本一致,烦躁、心中怫郁与不得眠密切相关。9大证型属三阳病3型,三阴病6型,6型与少阳胆、三焦、厥阴肝相关,4型与营卫相关,证型分布偏重三阴及少阳、厥阴枢机。
与西药舒乐安定单纯镇静安眠、抗焦虑比较,采用失眠症六经论治,对于治疗前后临床症状和HAMA、HAMD、PSQI焦虑、抑郁、睡眠质量等指标的改善具有明显优势。①有效改善六经主症：两组治疗后组间比较,“渴或燥渴”、“腹满或胀”症状改善无显著性差异(P＞0.05),其余主症均有显著性差异(P＜0.05或0.01),其中“不得眠”、“心悸”、“少气肢乏”组间比较P＜0.01。两组治疗前后比较,经方组“四逆或逆冷”、对照组“汗出”、“渴或燥渴”、“心悸”、“便结或硬”无显著性差异(P>0.05),其余主症均有显著性差异(P<0.05)。舒乐安定改善“汗出”“渴或燥渴”、“心悸”、“便结或硬”症状较差,经方治疗对于阳气亏虚所致“四逆或逆冷”以外其它六经症状改善尤为显著,提示舒乐安定单纯镇静安眠、抗焦虑,重在治标、弱于治本,经方治疗长于治本和整体改善。②有效改善HAMA、HAMD、PSQI指标：与对照组比较,治疗后经方组HAMA、HAMD、PSQI值变化有显著性差异(P<0.05),PSQI因子评分(睡眠障碍、日间功能、PSQI总分)有显著性差异(P<0.05),其余(睡眠质量、入睡时间、睡眠时间、睡眠效率)无显著性差异(P＞0.05)。失眠六经论治,对于失眠伴焦虑、抑郁、恶梦、发热、易醒、早醒等的改善较好,白天疲倦、神差、烦躁、注意力不集中等改善更好。③近期疗效比较：两组总体有效率相当,经方组“痊愈”、“无效”、“显效痊愈率”有显著性差异(P＜0.05)。经方对轻、中度失眠症疗效较好,显效痊愈率高,舒乐安定对重度患者改善较好,对轻、中度较差,可能与六经临床主要证型、主要症状的整体改善相关。④不良反应、复发率低,无依赖性：两组治疗后比较,严重、中度不良反应(嗜睡、口干、视物模糊、头晕、便秘、腹泻、食欲减退)及不良反应发生率有显著性差异(P<0.05)。经方辨治失眠,药物不良反应较少,无药物依赖性,停药后复发率低。舒乐安定不良反应发生率较高,具有药物依赖性,停药后复发率高。
(5)结论
烦躁、心中怫郁是失眠症的六经主症,与三阴阳气虚弱、营卫气血不足、阴虚火旺、心肾不交、枢机不利、相火上逆等相关。经方辨治失眠症,“三阴并治,善调营卫,注重枢机”,可明显改善烦躁、心中怫郁等精神症状,提高睡眠质量,在临床症状改善、提高患者依从性和生命质量、降低不良反应发生率和停药后复发率等方面具有更好的比较优势。
Under the guidance of differentiation of Liujing coming from Shanghan, this study aimed to explore the physiology, pathological mechanism, character of attack, syndrome distribution, rule of differentiation, clinical characteristics, effect assessment and so on of Liujing for the patients suffering from insomnia. Initially, the systematic, complete, standard system of Liujing Differentiation on insomnia was established. This study provided a new method of thought and ideas of differentiation, displayed the distinct features and holistic advantage from other methods. otherwise, it explored the regular of distribution, the points of differentiation, the principle of therapy and the excellence of diagnose of Liujing differentiation on insomnia under the observation of clinic.
1. The theory
(1) The physiology, pathological mechanism of Liujing on insomnia
The physiology:the harmony between ying and wei is the function, the mediating of the zhongjiao is the key point, and the result is the connection of yin and yang. If the shen coming from the kidney and heart under the runs and humans go to sleep regularly, the rhythms of sleeping will be kept. The physiological characters such as "wei is on the position of master and ying follows", "the function of zhongjiao takes an important position" are reflected. The pathological mechanism:insomnia caused by both the six evils of external and all kinds of diseases from internal which lead the disharmony of ying and wei, imbalance of yin and yang, cardinal adverse in the shaoyang, moving upwards of qi, failure of connection between yin and yang, discordance of heart and kidney and shen fails to take the appropriate position. Throughout the outcome of Liujing disease on insomnia, the imbalance of" Confluence of ying and wei---connection of yin and yang---appropriate position of shen" lasted.
(2) the character of Liujing pattern on insomnia
Insomnia can be caused by all the diseases of liujing attacked by six evils in shanghan and the deficiency of zangfu. Taiyang diseases:the patterns of disharmony of ying and wei, depression of yang-qi, water retardation, blood stagnation, depression of heat in the chest. Yangming diseases:the patterns of excess of heat in yangming, excess syndrome of fu, blood stagnation of yangming, depression of heat in the chest, excess of stomach and deficiency of spleen, consumption of yin in stomach and kidney, coagulation of water and heat. Shaoyang diseases:patterns of cardinal adverse in the shaoyang, stagnation of water and fire of sanjiao. Taiyin diseases:patterns of yang deficiency and cold-damp, adverse of water, stagnation of fluid in the meridians, disharmony of ying and wei, deficiency of qi and blood, qi stagnation and abdominal distension, both deficiency of qi, blood, yin and yang, relapse of yang changes to dryness. Shaoyin diseases:patterns of yang deficiency of shaoyin (eg:yang deficiency of heart and kidney, cold-water goes up), yin deficiency of shaoyin (eg:yin deficiency and fire in excess, disharmony between the heart and kidney, coagulation of water and heat), deficiency of yin and yang, relapse of yang disturbing the heart. Jueyin diseases:blood deficiency and cold coagulation, yang depression and fails to disperse, cold-heat complex in jueyin (eg:liver heat and spleen cold, lung heat and spleen cold, stomach heat and spleen cold).
(3) the character of Liujing differentiation in insomnia
①distinct characteristics of Zhongjing'theory:
Liujing differentiation in insomnia has outstanding character of Zhongjing'theory. Both the heart and the brain share the function of charge the shen and harmonizing the sleeping. Liujing harmonize the shen of zangfu and all of them under the charge of brain, which based on the zangfu, meridians and collaterals, ying, wei, qi and blood as the carrier, the circular motion as the form, connection of yin-yang as the character, heart-shen and brain-shen on the charge and regulate the body as the subject, transformation, distribution and regulation of qi, blood, jing, jin and fluid as the material base. The base of insomnia is the disharmony of ying-wei and yin-yang. The disharmony of ying-wei breaks the basic operation rule of "wei is on the position of master and ying follows". Also destroys the biological effects of human beings, ruins the benign inspire of light and dark material, leads the disharmony of yin-yang and the imbalance of store and spread of shen. The key of insomnia is the disharmony of stomach-qi and cardinal adverse in the shaoyang:shaoyang and jueyin assist but not separate from each other which regulate liujing powerfully. It works as the pivot of yangming and taiyin, the hub of ascending, descending, exit and enter of yin-yang, the hinge of alternate, open and close of yin-yang. All are related to the cardinal adverse, either the disharmony of stomach-qi, failure of mediate, dysfunction of exiting and entering of ying-wei, disorder of ascending and descending of yin-yang, disharmony between the heart and kidney, or failure of store of shen in the heart and brain. Blood stasis of the six channels is an important factor in insomnia:blood stasis exists in six channels and leads to each other. One of the reason is the blood fails to nourish the heat caused by blood stasis which blocking the vessels and leading the stagnation of qi.
②the character of systematic, complete, flexible and standard on clinic:
Separate yin and yang first and then distinguish liujing when using Liujing differentiation on insomnia. Secondly, meridians and zang-fu should be distinguished and also the cold-heat, deficiency-excess and external-internal.Distinguish the external-internal and emergency-chronics. The treatment is different but not separated. Compared with other differentiation system, it has outstanding integral, global advantage in the aspects of pathogen, character, position, condition, history, prognosis and the wane and wax between the vital and evil. Agile and changeable differentiation for changing diseases but sings to the key.
Harmonizing and dredging methods are the main methods for treating insomnia by Liujing differentiation. The decoctions such as Gui Zhi Tang, Xiao Jianzhong tang, Gui Zhigancaolonggumuli Tang and Dang Guisini Tang explain the method of "based on the liujing, harmonizing the ying-wei, leading the yang to yin and guiding the shen to the appropriate position". The decoctions Xiao Chaihu Tang, Xiao Xianxiong Tang, three Xie Xin Tang and Huang Lian Tang explain the method of "sanyang as the apartment, harmonizing shaoyang, dredging sanjiao and regulating the pivot and calming the shen". The decoctions Wu Mei Wan, Ma Huangshengma Tang, Gan Jianghuangqinhuanglianren-shen Tang and Huang Lianejiao Tang explain the method of "sanyin as the basic, balancing the ascending and descending, connecting yin-yang and harmonizing to calm the shen". At last, " dredging the fu and relieving the stagnation, resolving the water and breaking blood stasis" are explained by the decoctions such as Bai Hu Tang, Chen Qi Tang, Tao Hechenqi Tang and Zhen Wu Tang.
"Reinforcing the zhongjiao, tonifying the postnatal" is the key of Liujing differentiation in insomnia. Zongjiao is the place of middle earth belongs to spleen and stomach, where the jueyin mediates, the gallbladder and sanjiao meridians pass through, and the place to harmonize shaoyang. If the zhongjiao is strengthened, ying-wei may be rebuild, the circulation may be regular and day-night in order. Heart yang may be warmed, ying-yin may be moistened and the shen may be nourished in the upper jiao, while liver can be stored, kidney can be assisted and the shen-spirit may be in the appropriate position in the lower jiao. The hub of shaoyang assist the exiting and entering of yin-yang, the connecting of ying-wei and regulation sanjiao. The hinge of jueyin helps the ascending and descending of yin-yang, the intercourse of reproducing and the harmonizing of water and fire. Both shoyang and jueyin have the function of regulating and harmonizing the movement of ying-wei-qi-blood between yin and yang. By regulating the pivot, harmonizing yin and yang, handover of day and night may be achieved, which reflecting importance that "hinge makes the balance"
It's the basic to care insomnia using Liujing differentiation that "nourishing yin and reinforcing yang, treating sanyin at the same time" Differentiation of taiyin should pay attention to the character of pathology that "deficiency of spleen in taiyin causing the deficiency of ying-wei, which makes the failure to nourish heart-ying and the shen fails to be in the appropriate position".The treating method is to strengthen the middle jiao and harmonizing ying and wei. Differentiation of shaoyin should pay attention to the character of pathology that "heat in shaoyin, yin deficiency and fire in excess, disharmony between the heart and kidney, discordance between water and fire". Warming the heart-yang diving down and calming the shen should be provided while yang deficiency in shaoyin and failed to store the shen. Breaking the yin and relieving and stagnation, guiding the yang to yin should be offered while the kidney-yang is badly damaged and failed to assist the shen. Nourishing yin and cleaning the fire, harmonizing the heart and kidney should be supplied while yin deficiency in shaoyin and disharmony between heart and kidney. Deficiency of yin-yang and qi-blood in shaoyin should be treated by replenishing qi, blood, yin and yang. Differentiation of jueyin should pay attention to the character of pathology that "yang depressing of jueyin, failure of the function of liver-yang, cold-heat complex and imbalance of yin-yang". Cold-heat complex, heat in liver and cold in spleen should be treated by cleaning the upper and warming the lower. Heat in lung and cold in spleen should be treated by dispersing the depressing of yang, cleaning the lung and warming the spleen. Heat in stomach and cold in spleen should be treated by cleaning the stomach-heat and warming the spleen, connecting the yin and yang. Deficiency of blood and coagulation of cold should be treated by warming the meridians and expelling the cold, nourishing the blood and dredging the vessels. Failure of expel caused by yang depressing should be treated by smoothing the liver and strengthening the spleen, expelling the depressing yang. While the three yin be attached at the same time, the character of treating" treating the three yin at the same time but hinge at the top position" should pay attention to. Yang deficiency of liver and kidney, deficiency of spleen, deficiency of wei and stagnation of ying and dysfunction of shen should be treated by tonify the kidney and warm the liver, invigorate the middle jiao. Yin Deficiency of both liver and kidney, deficiency of jing and blood, disharmony of water and fire, floating of heart-shen should be treated by moistening liver and nourishing yin, tonify the kidney and replenish the marrow and tonify yin and yang.
(4) the advantage of Liujing differentiation on insomnia
Liujing differentiation on insomnia has the character of holistic advantage and dynamic changes. Most are excess evils at the first step of sanyang diseases while deficiency for the diseases of sanyin with long history. The pathology is disharmony between ying and wei, cardinal adverse in the shaoyang deficiency of zangfu, discordance between yin and yang, disturbing the heart-shen. Sanyang are attached at the first stage, and most are the patterns such as disharmony between ying and wei, cardinal adverse, disharmony of stomach-qi, heat in the chest and stagnation of jing and qi of sanjiao. While sanyin are attached at the end stage, most are the patterns such as coagulation of cold and damp, deficiency of qi and blood, yang deficiency and qi float, yin deficiency and fire in excess, cold-heat complex, kidney fire goes upward and discordance of yin and yang. The three yin are all attached at the same time and neither the meridians nor the zangfu are damaged when the insomnia belongs to sanyin. Mostly, superficies in excess when three yang are attached while origin in deficiency when three yin are attached. It's important in Liujing differentiation on insomnia that "treating the three yin at the same time but jueyin on the first place". "harmonizing ying and wei, balancing yin and yang, regulating the upper and lower and calming shen to smoothing the spirit" is the secondary aspects of Liujing differentiation on insomnia while the primary aspects is "strengthening the prenatal, reinforcing the postnatal, harmonizing the liver and gallbladder, regulating the hinge". Also, eliminating the phlegm and resolving the water, promoting the circulation and resolving the blood stasis.
2.The clinic
(1) The background
At present, most people tend to eight principle differentiation, differentiation of zangfu and differentiation of qi, blood, jing and fluid. Related to warming diseases, wei-qi-ying-blood differentiation and sanjiao differentiation are regularly adopted which leads to lack of whole consciousness and the idea of dynamic changes on the clinic. Formula-pattern differentiation which lack of systematic, perfect and standard rule of differentiation was adopted in the clinic when using the Liujing differentiation on insomnia.
(2) objective
This study aimed to set up the main syndromes, patterns, and the rule of distribution of liujing for insomnia. Comparing the classic formula with Estazolamum on the clinical effect and the differences on side-effect in treating insomnia.
(3) method
The observed cases were admitted following the relevant provisions of Guiding Principles for New Drug Clinical Research of Chinese Medicine and Classification and Diagnostic Criteria for Mental Illness. The secondary insomnia caused by psychosis was excluded by SCL-90. The clinic syndromes, signs, the tongue and the pulse of all the into cases were recorded by the clinical observation form. The positive syndromes were measured by the quantitative index of 4 grades. The main syndromes, patterns and the regularity of distribution were determined by the frequency distribution of syndrome integration and the frequency distribution of liujing patterns.
The cases were recorded by the clinical observation form, HAMA, HAMD and PSQL. Classic formula were supplied to the treatment group while Estazolamum for the control group. After the drug treatment lasted for 4 weeks, the effects were evaluated by the main symptoms and the changes of numerical value from the forms of clinical observation form, HAMA, HAMD and PSQL. Otherwise, the safety index was the side-effect.
(4) results
There were 15 main symptoms in insomnia:hard to fall asleep, restlessness, easy to be frightened and manic psychosis, sweating, thirsty or with dryness, palpitation, depressing sensation in the chest, fullness or oppression in the chest, hypochondriac fullness or oppression, epigastric stuff or distress, abdominal fullness or distension, constipation or dry stools, loose stools or diarrhea, lack of qi and fatigue of the four limbs, cold sensation of the four limbs. There were nine main patterns of liujing in insomnia:①yin defficiency and fire in excess, disharmony between heart and kidney;②evil stagnating in the middle jiao, coagulation of qi;③dysfunction of shaoyang;④disharmony between ying and wei;⑤yang depression and fails to disperse in jueyin;⑥cold-heat complex, liver heat and spleen cold, fire stairs up and confused shen;⑦blood deficiency and cold coagulation, dysfunvtion of liver-yang, disharmony between yin and yang;⑧both deficiency of qi, blood, yin and yang;⑨yang deficiency and cold in taiyin, deficiency of qi and blood. The 15 main syndromes matches up with the patterns of liujing. Restlessness and depressing sensation in the chest were closely related to hard to fall asleep. Three were belongs to sanyang and the other six belongs to sanyin in the nine main patterns. And there were six patterns relating to gallbladder, sanjiao and cardinal of jueyin while four relating to ying-wei. The distribution of patterns emphasised on sanyin, shaoyang and jueyin.
Comparing with the simple sedative hypnotic and anxiolytic of Estazolamum, there were obvious advantages in the clinic syndromes and the improvement of index of anxiety, depression and the quality of sleeping in HAMA、HAMD、PSQI and so on while using Liujing differenciation.①effectively improve the main patterns:After the treatment, compared with the control group, there were no statistical significant difference between the two groups on the syndromes such as "thirsty or with dryness, abdominal fullness or distension" (P> 0.05), but there were statistical significant difference between the two groups on the other main syndromes (P<0.05 or 0.01). "hard to fall asleep, palpitation, lack of qi and fatigue of the four limbs" were difference between the two groups (P<0.01). There were no statistical significant difference between the two groups on the syndromes such as" cold sensation of the four limbs, sweating, thirsty or with dryness, palpation, constipation or dry stools" before and after the treatment (P>0.05), but there were statistical significant difference between the two groups on the other main syndromes (P <0.05). Estazolamum was not good at improving the syndromes such as "sweating, thirsty or with dryness, constipation or dry stools". But the classic formulas were special in improving the syndromes except "cold sensation of the four limbs" caused by yang deficiency. It pointed out that Estazolamum focusing on symptoms but the classic formulas were good at the essence.②effectively improve the index of HAMA、HAMD and PSQI:Compared with the control group, there were statistical significant difference between the two groups on the changes of numerical value from HAMA、HAMD、PSQI (P<0.05). There were statistical significant difference between the two groups on the index of PSQI(disability of sleeping, ability in the day time, total scores of PSQI) (P<0.05), but there were no statistical significant difference between the two groups on the other index (quality of sleeping, time needed to fall to sleep, time of sleeping and the efficiency of sleeping) (P>0.05). The Liujing differentiation were good at the improvement of insomnia with anxiety, depression, nightmare, fever, easy to wake up, early to wake up and so on and better for the insomnia with lassitude in the day time, lack of spirit, restness and inattention.③comparison of curative effect:The overall efficiency was similar, but there were statistical significant difference between the two groups on the "the rate of recovery, invalid and the rate of excellent recovery" (P<0.05). The classic formulars were better for the mild and moderate while Estazolamum was better for the severe. That's probably related to the clinic main patterns of liujing and the overall improvement of main symptoms.④low side-effect, low recurrence rate and non-dependence:There were statistical significant difference between the two groups on the severe and moderate side-effect(somnolence, thirsty, blurred vision, vertigo, constipation, diarrhea and reduced appetite) and the rate of side-effect (P<0.05). Lower side-effect, without dependence and lower relapse rate after stopping the treatment while using the Liujing differentiation. But Estazolamum on the contrary.
(5) conclusion
Restlessness and depressing sensation in the chest which relating to the yang deficiency of sanyin, deficiency of ying, wei, qi and blood, yin deficiency and fire in excess, disharmony between heart and kidney, cardinal adverse in the shaoyang and the minister fire stires up were one of the main syndromes in insomnia.Treating the three yin at the same time but cardinal on the first place and harmonizing ying and wei were the characters of Liujing differentiation. It improved the syndromes of restlessness and depressing sensation in the chest, improved the sleeping quality. And there were compared advantages in the improvement of clinic syndromes, improving the patients' compliance and life quality, reducing the rate of side-effect and the recovering rate after stop the treatment.
1理论部分
(1)失眠症六经生理病理机制
生理机制：营卫调和为其使,枢机斡旋为其要,阴阳顺接为其果,神出水火,舍主有序,寤寐有常,则保持睡眠休作有时的正常节律,体现“卫主营从”、“枢机为权”的生理特征。病理机制：外感六淫、内伤杂病致六经营卫不和,阴阳失调,枢机不利,气机逆乱,阴阳气不相顺接,心肾不交,神不守舍而发病。“营卫交会-阴阳交接-神舍出入”失调,贯穿失眠症六经疾病转归的始终。
(2)失眠症六经证型特点
伤寒六经邪气所干、脏腑虚损均可导致失眠。太阳病：营卫不和、阳气怫郁、蓄水、蓄血、热郁胸膈证。明阳病：阳明热盛、腑实、蓄血、热郁胸膈、胃强脾弱及胃肾阴伤,水热互结证。少阳病：枢机不利、三焦水火痞结证。太阴病：阳虚寒湿、水气上逆、水郁经气、营卫不和、气血不足、气滞腹胀、气血阴阳两虚、阳复化燥证。少阴病：少阴阳虚证(心肾阳虚、水寒上逆)、少阴阴虚证(阴虚火旺,心肾不交,水热互结)、阴阳两虚、阳复扰心证。厥阴病：血虚寒凝、阳郁失宣、厥阴寒热错杂(肝热脾寒、肺热脾寒、胃热脾寒)证。
(3)失眠症的六经辨治特色
①鲜明的仲景学说理论特色
六经辨治失眠,具有仲景学说鲜明的理论特色。心脑体用,共主神明,共调睡眠。六经实以脏腑、经络为基础,营卫气血为载体,圆周运动为形式,阴阳和合交替为特征,心神、脑神统帅调控为主体,气、血、精、津、液气化、输布、调节为物质基础,协调于六经脏腑神明,归属脑神所总司。营卫不和,阴阳失调是失眠的基础：营卫交会失和,破坏“卫主营从”的基本运行规律,扰乱人体生物效应、人体辉光和暗物质的良性激发,导致阴阳交感失和,神、舍出入失调。胃气不和,枢机不利是失眠的关键：少阳、厥阴两枢相将不相离,既为阳明、太阴之枢,也为阴阳升降出入、交替开阖之枢,对六经有强大的调畅作用。胃气不和,斡旋失职,营卫出入失调,阴阳升降失序,心肾阴阳不交,心脑神明失藏,均不离枢机之矩。六经瘀血是失眠的重要因素：六经皆有瘀血,互为因果。瘀血内阻,血脉不畅,气机郁滞,血不荣心,也是导致失眠的病因之一。
②系统完整和灵活规范的临证特色
临证以六经辨治失眠,首分阴阳,以阴阳分六经。次分经腑,再辨寒热、虚实、表里。表里层次分明,轻重缓急兼顾。既六经分治,又各有兼顾。与其它辨证方法相比,在病因、病性、病位、病势、病程、疾病转归、正邪消长等方面,均可体现出其更显突出的整体性、全局性的辨证优势,以辨应变,知权达变,灵活多变。
和法和通法是六经论治失眠的主要方法：桂枝汤、小建中汤、桂枝甘草龙骨牡蛎汤、当归四逆汤体现“以六经为据,调和营卫,引阳入阴,纳神归舍”的调治之法。小柴胡汤、小陷胸汤、三泻心汤、黄连汤体现“以三阳为寓,和解少阳,通达三焦,调枢安神”的调治之法。乌梅丸、麻黄升麻汤、干姜黄芩黄连人参汤、黄连阿胶汤体现“以三阴为根,燮理升降,交通阴阳,调济安神”的调治之法。白虎汤、三承气汤、桃核承气汤、真武汤体现“通腑散结、利水破瘀”的调治之法。
“大建中州,顾护后天”是六经论治失眠的关键：中州为脾胃中土之地,厥阴枢机斡旋之所,也是胆、三焦循行之地,少阳枢机调和之所。中州建固,营卫复生,交接正常,昼夜有序。上则心阳得温,营阴资足,神有所养。下则肝有所藏,肾有所助,神魂归舍。少阳之枢助阴阳表里出入,营卫交接,通达三焦；厥阴之枢助阴阳上下升降,生发交接,水火交济。少阳、厥阴二枢,对营卫气血由阳入阴、出阴入阳的阴阳交替具有调节、协调作用。通过调畅枢机,调和阴阳,实现自身昼夜交接,体现“枢机为权”的重要性。
“益阴扶阳,三阴并治”是六经论治失眠的根本：太阴辨证须重视“太阴脾虚,营卫不足,心营失养,神不归舍”的病机特点。治宜大建中州,调和营卫。少阴辨证须重视“少阴热化,阴虚火旺,心肾不交,水火失济”的病机特点。少阴阳虚,神失所养,宜温补心阳,潜镇安神。肾阳大伤,神无阳助,宜破阴散结,引阳入阴。少阴阴虚,心肾不交宜滋阴清热,交通心肾。少阴阴阳气血俱虚,宜调补气血阴阳。厥阴辨证须重视“厥阴阳郁,肝阳失用,寒热错杂,阴阳失和”的病机特点。寒热错杂,肝热脾寒,宜清上温下。肺热脾寒,宜发越阳郁,清肺温脾。胃热脾寒,宜清胃温脾,交通阴阳。血虚寒凝,宜温经散寒,养血通脉。阳郁失宣,宜疏肝健脾,开宣郁阳。病在三阴,须重视“三阴并治,注重枢机”的治疗特点。肝肾阳虚,脾土亏耗,卫虚营滞,神机失运,宜补肾暖肝,温建中州。肝肾阴虚,精血不足,水火失济,心神浮越,宜滋肝养阴,补肾填髓,调补阴阳。
(4)失眠症的六经辨治优势
以六经辨证失眠,具有整体全局优势和动态变化特征。三阳初病多实邪,三阴久病多虚损。六经辨证失眠,其病机乃营卫不和,枢机不利,脏腑虚损,阴阳气不相顺接,心神受扰所致。病初在三阳,多营卫不和、枢机不利、胃气不和、热扰胸膈、三焦津气痞结之证。病末在三阴,多寒湿内蕴、气血亏虚、阳虚气浮、阴虚火旺、寒热错杂、相火上逆、阴阳失交等证。三阴病失眠症,三阴挟杂、经脏俱病。失眠六经论治,病在三阳多标实,病在三阴多本虚。六经辨治失眠,以“调和营卫,燮理阴阳,交通上下,安神达志”为标,“固先天,养后天,调肝胆,和枢机”为本,以“三阴并治,重在厥阴”为要,兼顾化痰利水、活血散瘀。
2临床部分
(1)背景
关于失眠症的辨证论治,目前临床基本倾向于八纲辨证、脏腑辨证、气血津液辨证,如与温病相联系,则多选择卫气营血、三焦辨证体系,临证诊疗容易缺乏整体意识和动态变化观念。以六经辨证论治失眠症,临床多以方证辨证为主,缺乏系统、完善、规范的六经证治规律及辨证论治体系。
(2)目的
确立失眠症的六经主要症状、主要证型及证候分布规律,比较经方与舒乐安定治疗失眠症的临床疗效、不良反应差异。
(3)方法
采用《中药新药临床研究指导原则》、《精神疾病分类与诊断标准》纳入观察病例,采用《90项症状自评量表》(SCL-90)排除精神心理疾病所致继发性失眠,采用《失眠症六经证候调查表》记录全部合格观察病例的临床症状、体征及舌脉象,阳性症状采用4级量化指标。根据临床症状的积分频数分布、六经证型的频数分布,确定失眠症六经主证、主要证型的证候分布规律。
对纳入观察的失眠症主要六经证型病例,采用《失眠症六经辨治临床研究报告表》、汉密尔顿焦虑量表(HAMA)、汉密尔顿抑郁量表(HAMD)和匹兹堡睡眠质量指数量表(PSQI),治疗组给予经方辨证治疗,对照组给予舒乐安定,4周药物疗程结束后进行疗效评价。疗效评价为失眠症六经主证及HAMA、HAMD、PSQI指标在治疗前后的量值变化,安全性指标为不良反应。
(4)结果
确定15个失眠症六经主要症状为六经主症：不得眠、烦躁、惊狂、汗出、渴或燥渴、心悸、心中怫郁、胸满或闷、胁满闷或胀、心下痞或硬、腹满或胀、便结或硬、便溏或利、少气肢乏、四逆或逆冷。确定9个失眠症六经主要证型：①阴虚火旺,心肾不交证；②邪壅中焦,气机痞塞证；③少阳枢机不利证；④营卫不和证；⑤厥阴阳郁失宣证；⑥寒热错杂,肝热脾寒,火逆神乱证；⑦血虚寒凝,肝阳失用,阴阳不和证；⑧气血阴阳两虚证；⑨太阴虚寒,气血不足证。15主症与六经证型分布基本一致,烦躁、心中怫郁与不得眠密切相关。9大证型属三阳病3型,三阴病6型,6型与少阳胆、三焦、厥阴肝相关,4型与营卫相关,证型分布偏重三阴及少阳、厥阴枢机。
与西药舒乐安定单纯镇静安眠、抗焦虑比较,采用失眠症六经论治,对于治疗前后临床症状和HAMA、HAMD、PSQI焦虑、抑郁、睡眠质量等指标的改善具有明显优势。①有效改善六经主症：两组治疗后组间比较,“渴或燥渴”、“腹满或胀”症状改善无显著性差异(P＞0.05),其余主症均有显著性差异(P＜0.05或0.01),其中“不得眠”、“心悸”、“少气肢乏”组间比较P＜0.01。两组治疗前后比较,经方组“四逆或逆冷”、对照组“汗出”、“渴或燥渴”、“心悸”、“便结或硬”无显著性差异(P>0.05),其余主症均有显著性差异(P<0.05)。舒乐安定改善“汗出”“渴或燥渴”、“心悸”、“便结或硬”症状较差,经方治疗对于阳气亏虚所致“四逆或逆冷”以外其它六经症状改善尤为显著,提示舒乐安定单纯镇静安眠、抗焦虑,重在治标、弱于治本,经方治疗长于治本和整体改善。②有效改善HAMA、HAMD、PSQI指标：与对照组比较,治疗后经方组HAMA、HAMD、PSQI值变化有显著性差异(P<0.05),PSQI因子评分(睡眠障碍、日间功能、PSQI总分)有显著性差异(P<0.05),其余(睡眠质量、入睡时间、睡眠时间、睡眠效率)无显著性差异(P＞0.05)。失眠六经论治,对于失眠伴焦虑、抑郁、恶梦、发热、易醒、早醒等的改善较好,白天疲倦、神差、烦躁、注意力不集中等改善更好。③近期疗效比较：两组总体有效率相当,经方组“痊愈”、“无效”、“显效痊愈率”有显著性差异(P＜0.05)。经方对轻、中度失眠症疗效较好,显效痊愈率高,舒乐安定对重度患者改善较好,对轻、中度较差,可能与六经临床主要证型、主要症状的整体改善相关。④不良反应、复发率低,无依赖性：两组治疗后比较,严重、中度不良反应(嗜睡、口干、视物模糊、头晕、便秘、腹泻、食欲减退)及不良反应发生率有显著性差异(P<0.05)。经方辨治失眠,药物不良反应较少,无药物依赖性,停药后复发率低。舒乐安定不良反应发生率较高,具有药物依赖性,停药后复发率高。
(5)结论
烦躁、心中怫郁是失眠症的六经主症,与三阴阳气虚弱、营卫气血不足、阴虚火旺、心肾不交、枢机不利、相火上逆等相关。经方辨治失眠症,“三阴并治,善调营卫,注重枢机”,可明显改善烦躁、心中怫郁等精神症状,提高睡眠质量,在临床症状改善、提高患者依从性和生命质量、降低不良反应发生率和停药后复发率等方面具有更好的比较优势。
Under the guidance of differentiation of Liujing coming from Shanghan, this study aimed to explore the physiology, pathological mechanism, character of attack, syndrome distribution, rule of differentiation, clinical characteristics, effect assessment and so on of Liujing for the patients suffering from insomnia. Initially, the systematic, complete, standard system of Liujing Differentiation on insomnia was established. This study provided a new method of thought and ideas of differentiation, displayed the distinct features and holistic advantage from other methods. otherwise, it explored the regular of distribution, the points of differentiation, the principle of therapy and the excellence of diagnose of Liujing differentiation on insomnia under the observation of clinic.
1. The theory
(1) The physiology, pathological mechanism of Liujing on insomnia
The physiology:the harmony between ying and wei is the function, the mediating of the zhongjiao is the key point, and the result is the connection of yin and yang. If the shen coming from the kidney and heart under the runs and humans go to sleep regularly, the rhythms of sleeping will be kept. The physiological characters such as "wei is on the position of master and ying follows", "the function of zhongjiao takes an important position" are reflected. The pathological mechanism:insomnia caused by both the six evils of external and all kinds of diseases from internal which lead the disharmony of ying and wei, imbalance of yin and yang, cardinal adverse in the shaoyang, moving upwards of qi, failure of connection between yin and yang, discordance of heart and kidney and shen fails to take the appropriate position. Throughout the outcome of Liujing disease on insomnia, the imbalance of" Confluence of ying and wei---connection of yin and yang---appropriate position of shen" lasted.
(2) the character of Liujing pattern on insomnia
Insomnia can be caused by all the diseases of liujing attacked by six evils in shanghan and the deficiency of zangfu. Taiyang diseases:the patterns of disharmony of ying and wei, depression of yang-qi, water retardation, blood stagnation, depression of heat in the chest. Yangming diseases:the patterns of excess of heat in yangming, excess syndrome of fu, blood stagnation of yangming, depression of heat in the chest, excess of stomach and deficiency of spleen, consumption of yin in stomach and kidney, coagulation of water and heat. Shaoyang diseases:patterns of cardinal adverse in the shaoyang, stagnation of water and fire of sanjiao. Taiyin diseases:patterns of yang deficiency and cold-damp, adverse of water, stagnation of fluid in the meridians, disharmony of ying and wei, deficiency of qi and blood, qi stagnation and abdominal distension, both deficiency of qi, blood, yin and yang, relapse of yang changes to dryness. Shaoyin diseases:patterns of yang deficiency of shaoyin (eg:yang deficiency of heart and kidney, cold-water goes up), yin deficiency of shaoyin (eg:yin deficiency and fire in excess, disharmony between the heart and kidney, coagulation of water and heat), deficiency of yin and yang, relapse of yang disturbing the heart. Jueyin diseases:blood deficiency and cold coagulation, yang depression and fails to disperse, cold-heat complex in jueyin (eg:liver heat and spleen cold, lung heat and spleen cold, stomach heat and spleen cold).
(3) the character of Liujing differentiation in insomnia
①distinct characteristics of Zhongjing'theory:
Liujing differentiation in insomnia has outstanding character of Zhongjing'theory. Both the heart and the brain share the function of charge the shen and harmonizing the sleeping. Liujing harmonize the shen of zangfu and all of them under the charge of brain, which based on the zangfu, meridians and collaterals, ying, wei, qi and blood as the carrier, the circular motion as the form, connection of yin-yang as the character, heart-shen and brain-shen on the charge and regulate the body as the subject, transformation, distribution and regulation of qi, blood, jing, jin and fluid as the material base. The base of insomnia is the disharmony of ying-wei and yin-yang. The disharmony of ying-wei breaks the basic operation rule of "wei is on the position of master and ying follows". Also destroys the biological effects of human beings, ruins the benign inspire of light and dark material, leads the disharmony of yin-yang and the imbalance of store and spread of shen. The key of insomnia is the disharmony of stomach-qi and cardinal adverse in the shaoyang:shaoyang and jueyin assist but not separate from each other which regulate liujing powerfully. It works as the pivot of yangming and taiyin, the hub of ascending, descending, exit and enter of yin-yang, the hinge of alternate, open and close of yin-yang. All are related to the cardinal adverse, either the disharmony of stomach-qi, failure of mediate, dysfunction of exiting and entering of ying-wei, disorder of ascending and descending of yin-yang, disharmony between the heart and kidney, or failure of store of shen in the heart and brain. Blood stasis of the six channels is an important factor in insomnia:blood stasis exists in six channels and leads to each other. One of the reason is the blood fails to nourish the heat caused by blood stasis which blocking the vessels and leading the stagnation of qi.
②the character of systematic, complete, flexible and standard on clinic:
Separate yin and yang first and then distinguish liujing when using Liujing differentiation on insomnia. Secondly, meridians and zang-fu should be distinguished and also the cold-heat, deficiency-excess and external-internal.Distinguish the external-internal and emergency-chronics. The treatment is different but not separated. Compared with other differentiation system, it has outstanding integral, global advantage in the aspects of pathogen, character, position, condition, history, prognosis and the wane and wax between the vital and evil. Agile and changeable differentiation for changing diseases but sings to the key.
Harmonizing and dredging methods are the main methods for treating insomnia by Liujing differentiation. The decoctions such as Gui Zhi Tang, Xiao Jianzhong tang, Gui Zhigancaolonggumuli Tang and Dang Guisini Tang explain the method of "based on the liujing, harmonizing the ying-wei, leading the yang to yin and guiding the shen to the appropriate position". The decoctions Xiao Chaihu Tang, Xiao Xianxiong Tang, three Xie Xin Tang and Huang Lian Tang explain the method of "sanyang as the apartment, harmonizing shaoyang, dredging sanjiao and regulating the pivot and calming the shen". The decoctions Wu Mei Wan, Ma Huangshengma Tang, Gan Jianghuangqinhuanglianren-shen Tang and Huang Lianejiao Tang explain the method of "sanyin as the basic, balancing the ascending and descending, connecting yin-yang and harmonizing to calm the shen". At last, " dredging the fu and relieving the stagnation, resolving the water and breaking blood stasis" are explained by the decoctions such as Bai Hu Tang, Chen Qi Tang, Tao Hechenqi Tang and Zhen Wu Tang.
"Reinforcing the zhongjiao, tonifying the postnatal" is the key of Liujing differentiation in insomnia. Zongjiao is the place of middle earth belongs to spleen and stomach, where the jueyin mediates, the gallbladder and sanjiao meridians pass through, and the place to harmonize shaoyang. If the zhongjiao is strengthened, ying-wei may be rebuild, the circulation may be regular and day-night in order. Heart yang may be warmed, ying-yin may be moistened and the shen may be nourished in the upper jiao, while liver can be stored, kidney can be assisted and the shen-spirit may be in the appropriate position in the lower jiao. The hub of shaoyang assist the exiting and entering of yin-yang, the connecting of ying-wei and regulation sanjiao. The hinge of jueyin helps the ascending and descending of yin-yang, the intercourse of reproducing and the harmonizing of water and fire. Both shoyang and jueyin have the function of regulating and harmonizing the movement of ying-wei-qi-blood between yin and yang. By regulating the pivot, harmonizing yin and yang, handover of day and night may be achieved, which reflecting importance that "hinge makes the balance"
It's the basic to care insomnia using Liujing differentiation that "nourishing yin and reinforcing yang, treating sanyin at the same time" Differentiation of taiyin should pay attention to the character of pathology that "deficiency of spleen in taiyin causing the deficiency of ying-wei, which makes the failure to nourish heart-ying and the shen fails to be in the appropriate position".The treating method is to strengthen the middle jiao and harmonizing ying and wei. Differentiation of shaoyin should pay attention to the character of pathology that "heat in shaoyin, yin deficiency and fire in excess, disharmony between the heart and kidney, discordance between water and fire". Warming the heart-yang diving down and calming the shen should be provided while yang deficiency in shaoyin and failed to store the shen. Breaking the yin and relieving and stagnation, guiding the yang to yin should be offered while the kidney-yang is badly damaged and failed to assist the shen. Nourishing yin and cleaning the fire, harmonizing the heart and kidney should be supplied while yin deficiency in shaoyin and disharmony between heart and kidney. Deficiency of yin-yang and qi-blood in shaoyin should be treated by replenishing qi, blood, yin and yang. Differentiation of jueyin should pay attention to the character of pathology that "yang depressing of jueyin, failure of the function of liver-yang, cold-heat complex and imbalance of yin-yang". Cold-heat complex, heat in liver and cold in spleen should be treated by cleaning the upper and warming the lower. Heat in lung and cold in spleen should be treated by dispersing the depressing of yang, cleaning the lung and warming the spleen. Heat in stomach and cold in spleen should be treated by cleaning the stomach-heat and warming the spleen, connecting the yin and yang. Deficiency of blood and coagulation of cold should be treated by warming the meridians and expelling the cold, nourishing the blood and dredging the vessels. Failure of expel caused by yang depressing should be treated by smoothing the liver and strengthening the spleen, expelling the depressing yang. While the three yin be attached at the same time, the character of treating" treating the three yin at the same time but hinge at the top position" should pay attention to. Yang deficiency of liver and kidney, deficiency of spleen, deficiency of wei and stagnation of ying and dysfunction of shen should be treated by tonify the kidney and warm the liver, invigorate the middle jiao. Yin Deficiency of both liver and kidney, deficiency of jing and blood, disharmony of water and fire, floating of heart-shen should be treated by moistening liver and nourishing yin, tonify the kidney and replenish the marrow and tonify yin and yang.
(4) the advantage of Liujing differentiation on insomnia
Liujing differentiation on insomnia has the character of holistic advantage and dynamic changes. Most are excess evils at the first step of sanyang diseases while deficiency for the diseases of sanyin with long history. The pathology is disharmony between ying and wei, cardinal adverse in the shaoyang deficiency of zangfu, discordance between yin and yang, disturbing the heart-shen. Sanyang are attached at the first stage, and most are the patterns such as disharmony between ying and wei, cardinal adverse, disharmony of stomach-qi, heat in the chest and stagnation of jing and qi of sanjiao. While sanyin are attached at the end stage, most are the patterns such as coagulation of cold and damp, deficiency of qi and blood, yang deficiency and qi float, yin deficiency and fire in excess, cold-heat complex, kidney fire goes upward and discordance of yin and yang. The three yin are all attached at the same time and neither the meridians nor the zangfu are damaged when the insomnia belongs to sanyin. Mostly, superficies in excess when three yang are attached while origin in deficiency when three yin are attached. It's important in Liujing differentiation on insomnia that "treating the three yin at the same time but jueyin on the first place". "harmonizing ying and wei, balancing yin and yang, regulating the upper and lower and calming shen to smoothing the spirit" is the secondary aspects of Liujing differentiation on insomnia while the primary aspects is "strengthening the prenatal, reinforcing the postnatal, harmonizing the liver and gallbladder, regulating the hinge". Also, eliminating the phlegm and resolving the water, promoting the circulation and resolving the blood stasis.
2.The clinic
(1) The background
At present, most people tend to eight principle differentiation, differentiation of zangfu and differentiation of qi, blood, jing and fluid. Related to warming diseases, wei-qi-ying-blood differentiation and sanjiao differentiation are regularly adopted which leads to lack of whole consciousness and the idea of dynamic changes on the clinic. Formula-pattern differentiation which lack of systematic, perfect and standard rule of differentiation was adopted in the clinic when using the Liujing differentiation on insomnia.
(2) objective
This study aimed to set up the main syndromes, patterns, and the rule of distribution of liujing for insomnia. Comparing the classic formula with Estazolamum on the clinical effect and the differences on side-effect in treating insomnia.
(3) method
The observed cases were admitted following the relevant provisions of Guiding Principles for New Drug Clinical Research of Chinese Medicine and Classification and Diagnostic Criteria for Mental Illness. The secondary insomnia caused by psychosis was excluded by SCL-90. The clinic syndromes, signs, the tongue and the pulse of all the into cases were recorded by the clinical observation form. The positive syndromes were measured by the quantitative index of 4 grades. The main syndromes, patterns and the regularity of distribution were determined by the frequency distribution of syndrome integration and the frequency distribution of liujing patterns.
The cases were recorded by the clinical observation form, HAMA, HAMD and PSQL. Classic formula were supplied to the treatment group while Estazolamum for the control group. After the drug treatment lasted for 4 weeks, the effects were evaluated by the main symptoms and the changes of numerical value from the forms of clinical observation form, HAMA, HAMD and PSQL. Otherwise, the safety index was the side-effect.
(4) results
There were 15 main symptoms in insomnia:hard to fall asleep, restlessness, easy to be frightened and manic psychosis, sweating, thirsty or with dryness, palpitation, depressing sensation in the chest, fullness or oppression in the chest, hypochondriac fullness or oppression, epigastric stuff or distress, abdominal fullness or distension, constipation or dry stools, loose stools or diarrhea, lack of qi and fatigue of the four limbs, cold sensation of the four limbs. There were nine main patterns of liujing in insomnia:①yin defficiency and fire in excess, disharmony between heart and kidney;②evil stagnating in the middle jiao, coagulation of qi;③dysfunction of shaoyang;④disharmony between ying and wei;⑤yang depression and fails to disperse in jueyin;⑥cold-heat complex, liver heat and spleen cold, fire stairs up and confused shen;⑦blood deficiency and cold coagulation, dysfunvtion of liver-yang, disharmony between yin and yang;⑧both deficiency of qi, blood, yin and yang;⑨yang deficiency and cold in taiyin, deficiency of qi and blood. The 15 main syndromes matches up with the patterns of liujing. Restlessness and depressing sensation in the chest were closely related to hard to fall asleep. Three were belongs to sanyang and the other six belongs to sanyin in the nine main patterns. And there were six patterns relating to gallbladder, sanjiao and cardinal of jueyin while four relating to ying-wei. The distribution of patterns emphasised on sanyin, shaoyang and jueyin.
Comparing with the simple sedative hypnotic and anxiolytic of Estazolamum, there were obvious advantages in the clinic syndromes and the improvement of index of anxiety, depression and the quality of sleeping in HAMA、HAMD、PSQI and so on while using Liujing differenciation.①effectively improve the main patterns:After the treatment, compared with the control group, there were no statistical significant difference between the two groups on the syndromes such as "thirsty or with dryness, abdominal fullness or distension" (P> 0.05), but there were statistical significant difference between the two groups on the other main syndromes (P<0.05 or 0.01). "hard to fall asleep, palpitation, lack of qi and fatigue of the four limbs" were difference between the two groups (P<0.01). There were no statistical significant difference between the two groups on the syndromes such as" cold sensation of the four limbs, sweating, thirsty or with dryness, palpation, constipation or dry stools" before and after the treatment (P>0.05), but there were statistical significant difference between the two groups on the other main syndromes (P <0.05). Estazolamum was not good at improving the syndromes such as "sweating, thirsty or with dryness, constipation or dry stools". But the classic formulas were special in improving the syndromes except "cold sensation of the four limbs" caused by yang deficiency. It pointed out that Estazolamum focusing on symptoms but the classic formulas were good at the essence.②effectively improve the index of HAMA、HAMD and PSQI:Compared with the control group, there were statistical significant difference between the two groups on the changes of numerical value from HAMA、HAMD、PSQI (P<0.05). There were statistical significant difference between the two groups on the index of PSQI(disability of sleeping, ability in the day time, total scores of PSQI) (P<0.05), but there were no statistical significant difference between the two groups on the other index (quality of sleeping, time needed to fall to sleep, time of sleeping and the efficiency of sleeping) (P>0.05). The Liujing differentiation were good at the improvement of insomnia with anxiety, depression, nightmare, fever, easy to wake up, early to wake up and so on and better for the insomnia with lassitude in the day time, lack of spirit, restness and inattention.③comparison of curative effect:The overall efficiency was similar, but there were statistical significant difference between the two groups on the "the rate of recovery, invalid and the rate of excellent recovery" (P<0.05). The classic formulars were better for the mild and moderate while Estazolamum was better for the severe. That's probably related to the clinic main patterns of liujing and the overall improvement of main symptoms.④low side-effect, low recurrence rate and non-dependence:There were statistical significant difference between the two groups on the severe and moderate side-effect(somnolence, thirsty, blurred vision, vertigo, constipation, diarrhea and reduced appetite) and the rate of side-effect (P<0.05). Lower side-effect, without dependence and lower relapse rate after stopping the treatment while using the Liujing differentiation. But Estazolamum on the contrary.
(5) conclusion
Restlessness and depressing sensation in the chest which relating to the yang deficiency of sanyin, deficiency of ying, wei, qi and blood, yin deficiency and fire in excess, disharmony between heart and kidney, cardinal adverse in the shaoyang and the minister fire stires up were one of the main syndromes in insomnia.Treating the three yin at the same time but cardinal on the first place and harmonizing ying and wei were the characters of Liujing differentiation. It improved the syndromes of restlessness and depressing sensation in the chest, improved the sleeping quality. And there were compared advantages in the improvement of clinic syndromes, improving the patients' compliance and life quality, reducing the rate of side-effect and the recovering rate after stop the treatment.
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