CN117018103A - 一种治疗咽喉反流性疾病肺胃不和证的中药组合物、制剂和应用 - Google Patents
一种治疗咽喉反流性疾病肺胃不和证的中药组合物、制剂和应用 Download PDFInfo
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- Medicines Containing Plant Substances (AREA)
Abstract
本发明涉及治疗咽喉反流性疾病的药物技术领域,具体地说,涉及一种治疗咽喉反流性疾病肺胃不和证的中药组合物、制剂和应用。所述中药组合物的活性成分原料以重量份计包括以下原料:射干8份,西青果10份,木蝴蝶8份,炒黄连6份,制吴茱萸3份,姜半夏9份,制厚朴15份,白螺蛳壳20份,灵芝20份,六月雪30份。本发明的有益效果为:本发明中药组合物能有效治疗咽喉反流性疾病肺胃不和证,且具有较高的安全性,无明显不良反应,能改善患者的部分咽喉症状和中医证候。
Description
技术领域
本发明涉及治疗咽喉反流性疾病的药物技术领域,具体地说,涉及一种治疗咽喉反流性疾病肺胃不和证的中药组合物、制剂和应用。
背景技术
咽喉反流性疾病(laryngopharyngeal reflux disease,LPRD)是胃内容物、胃酸、胃蛋白酶和结合胆汁酸反流至上呼吸道及消化区域所引起的咽喉不适。它包括一系列症状,不局限于咳嗽、声音嘶哑、咽球感、喉咙痛、吞咽困难、鼻后滴漏和慢性重复清嗓等症状。且许多黏膜改变都与咽喉反流有关,包括声门上水肿和红斑、咽后壁鹅卵石、声带溃疡、内侧肌壁水肿和声带肉芽肿。疾病进展可导致溃疡性疾病、肉芽肿、声门下狭窄和喉癌。咽喉反流(laryngopharyngeal reflux,LPR)即胃内容物反流到喉部、咽部的过程,咽喉反流性疾病与胃食管反流病(gastroesophageal reflux disease,GERD)的食管外综合征之间存在关联。越来越多的消化科医生、肺科专家和耳鼻喉科外科医生日渐关注到咽喉部位不适的症状。现有数据已经表明,高达60%的GERD患者咽喉症状的患病率日益增加,可能会增加喉癌的发生风险。
咽喉反流性疾病的发病机制与胃十二指肠内容物(如胃蛋白酶,胆盐和其他胃肠道蛋白)回流到上呼吸消化道粘膜有关。尤其是胃蛋白酶的沉积会导致黏膜损伤、炎症反应、黏液干燥、上皮增厚和微创伤。黏膜刺激会导致粘液产生和脱水;粘稠粘液的积聚诱发鼻后滴漏、癔球感、清嗓子、吞咽困难和咳嗽。根据患者的黏膜敏感性,急慢性咽喉反流性疾病患者都可能出现不同程度的症状。
反流理论认为咽喉反流性疾病是由酸,胆汁酸和胃蛋白酶的微误吸引起的。这些酸,胆汁酸和胃蛋白酶可直接损伤喉部并引起症状。咽喉反流性疾病患者唾液胃蛋白酶和胆汁酸水平升高的发现支持了这一点。即使是轻微的胃蛋白酶反流到达喉部也可能是有害的,因为喉部水平的微环境对侮辱的保护作用较差,这可以解释为什么有些患者对PPI没有单独反应。此外,反射理论提出食管远端酸性胃内容物反流会刺激迷走神经进而诱发喉部症状。咽喉反流性疾病可能伴有或不伴有胃食管疾病的典型症状。目前有三种机制来解释这一点。首先,酸性胃内容物对更敏感的咽部和喉部的直接作用会引起刺激。其次,胃内容物反流到食管远端刺激迷走神经反射导致慢性咳嗽,进而诱发咽喉反流性疾病症状。最后,非酸性胃内容物反流也会引起喉损伤。而防御反流的主要机制受损可能是反酸的主要原因。若食管动力以及LES和UES压力减弱,理论上会导致食管咽反流事件增加。此外,咽喉反流性疾病被怀疑与许多流行疾病有关,如帕金森病,肺纤维化,慢性阻塞性肺疾病,系统性硬化症等疾病,上述疾病呼吸、消化或吞咽生理学方面的相关损害可能与反流风险增加有关。同样,服用一些药物如苯二氮卓类,抗抑郁药,抗胆碱能药,钙拮抗剂,利多卡因和前列腺素等,都会增加LRPD的风险。
由于缺少确切、有效的治疗方案疗法,在真实世界中PPI被广泛用于咽喉反流性疾病的治疗。对疑似咽喉反流性疾病患者目前仍然推荐经验性得使用大剂量PPI治疗。因此,尽管PPI疗法是当下治疗咽喉反流性疾病的热门一线方案,但PPI治疗存在潜在的危害。长期使用PPI长期以来一直被怀疑与不良事件有关,例如矿物质和维生素吸收改变,骨折,骨科损伤,急性冠脉综合征,结肠炎,感染风险和死亡风险增加。另外,PPI的过度处方,特别是在老年患者中,对医疗保健系统的成本产生了巨大影响,使反流成为管理成本最高的疾病之一。因此,对于咽喉反流性疾病,我们需要优先考虑中医中药这种具有安全性和成本效益的治疗方法。近年来,大量研究已经表明辨证治疗下中药治疗咽喉反流性疾病疗效显著,一定程度上可以消除和缓解患者的临床症状,并减少PPI的副作用,因此咽喉反流性疾病可采用中医中药的治疗。
中医药对咽喉反流性疾病具有独特的认识及疗效,咽喉反流缺乏与之完全对应的病名记载,中医认识咽喉反流性疾病多为“咽胃相关”“胃咽合病”,认为咽部疾病常与胃部的病变密不可分,根据其临床表现,常常将其归于“噎膈”“梅核气”等,如果胃肠道症状明显,也可根据“反酸”“烧心”“胃痞”“胃脘痛”等病进行治疗。祖国医学对咽喉反流性疾病最早的相关论述见于《金匮要略·妇人杂病脉证并治篇》曰:“妇人咽中如有炙脔,半夏厚朴汤主之。”一般认为这是关于论治“梅核气”的最早记载。宋代《仁斋直指方·梅核气》最早出现了梅核气这一命名,临床表现为咽中如有物阻,吐之不出,吞之不下,胁肋胀满,或咳或呕,舌苔白润或白滑,脉弦缓或弦滑。此外,中医认为食管胃受纳食物之通道,属胃气所主;胃主纳腐,中焦升降之间,可使饮食精微得以无碍运化输布,水谷糟粕得以顺畅下行。若中焦升降功能乖常,气机阻滞不畅,升降失序,酸水可上犯至咽喉,引起一系列咽喉不适,包括咳嗽、噎膈、喑哑等症状。若胃内容物进到食管,误吸人肺,酸性内容物造成损伤性感染;或者由于用反流后,刺激食管,继发神经调节的支气管收缩,而出现呛咳、支气管炎喘样发作、吸入性肺炎甚或窒息等。金元四大家之一的李东垣言吞酸、吐酸病性为寒,认为“杂病醋心,浊气不降,欲为中满,寒药岂能治之乎?”而丹溪认为“吞酸者,湿热郁积于肝而出,伏于肺胃之间”,又说“《素问》言热,言其本也,东垣言寒,言其末也”。在治疗上,主张以黄连为君,用炒吴茱萸反佐之。肺为清肃之脏,一物不容,胃内容物误入气道,即导致肺气失宣,肺气上逆而不下降,甚或痰浊阻肺,使本病形成更复杂的病机,此时应降肺和胃降逆,通降肺胃,甚或健脾益肺,补土生金,益气通阳,提高治疗效果。
咽喉反流性疾病的病因病机及证型可大致归纳如下:①外邪犯胃:寒、暑、湿、浊之气犯胃,胃失和降,胃液随胃气上逆于膈,如《素问·举痛论》言“寒气客于肠胃,厥逆上气。”《素问·至真要大论》言“厥阴之胜……胃膈如寒化而为热,胃脘当心而痛……鬲咽不通……少阳之胜,热客于胃,烦心心痛……呕酸善饥……太阴之胜火气内郁……心痛热格……湿气内郁”胃中湿气郁而成积,则湿中生热从木化而吐酸。②饮食失节:可致食滞胃膈,胃气上逆,上泛咽喉,反伤于咽。多食胃闷,胃痞难消。若嗜食油炸辛辣甜腻等刺激之物,可致肥甘厚味滋生火热,甘壅中热积胃。或因热食消耗脾胃津液,致干涸虚热。③情志失调:忧思困顿,肝气不畅横逆犯胃,胃气酸水上泛于咽。心神暗耗,劳伤脾血,脾失健运,纳入不化,可致脾不能升清,咽喉失于濡养。④体质差异:若患者素有脾胃虚寒、胸阳不足,外邪可进一步损伤脾胃,使脾胃升降失常,上下不通,浊气上逆,嗳气吞酸,上犯咽喉,致咽喉不适;而胃气失和,上逆胸膈,寒郁化热,则膈脘灼热。胸为极易受邪,因胸空旷,一旦胸中阳微,阴寒病邪可挟痰涎上逆结于咽喉,故胸中气机升降不利则咽喉不爽。
总之,咽喉反流性疾病病位在上脘和咽喉,“喉间嗳噫,是名吞酸,病在上脘最高之处”。在“中焦胃脘之间时多呕恶,所吐皆酸”,唯或偶因呕吐所出,或酸或苦及诸不堪之味,乃肠胃中痰饮积聚所化”,提示这种反流物可侵袭咽喉五官致一系列咽喉不适。
目前咽喉反流性疾病的中医证型研究较少。李云英从肝郁气滞、肝胃郁热、气郁痰阻、中虚气逆、瘀血阻络五种证型辩证治疗咽喉反流性疾病。钟秀婷等人调查195例咽喉反流性疾病患者,归纳总结了7种常见的咽喉反流性疾病证型,她的观察群体中以肝胃不和证及肝郁脾虚证为多,脾胃虚弱证、肝胃郁热证、痰气交阻证,胃阴亏虚证及气滞血瘀证相对次之。李平等人将咽喉反流性疾病中医证型归纳以下五个证型:肝脾不和,气郁痰阻、肝火犯胃、湿阻中焦、肺胃不和以及胃阴亏虚。蔡燕文等人在临床中归纳得到咽喉反流性疾病的三个中医证型——气滞痰凝、肺胃湿热及肺胃阴虚。刘铁陵等人同样在临床观察中总结出三种证型——气滞痰凝,肺胃湿热,肺胃阴虚。
以下列举几个常见证型:①痰气交阻,临床表现:咽部异物感、胸闷、腹胀、嗳气,偶有反酸,烧心,病情轻重及发作往往与情绪有关。常以疏肝理气、化痰降气为法,可用四逆散合半夏厚朴汤加减。咽部异物感明显者,多有咽部滤泡增生,伴咳嗽者可加用射干、木蝴蝶、桔梗;咽干有痰可加用麦冬、浙贝母;痰多可加莱菔子、浙贝母等。②脾胃虚弱,临床表现:咽部异物感,稍微劳作或发声过度即声音嘶哑,面色黄而无光泽,腹胀纳少,嗳气反酸,偶有烧心,大便不成形或量少,舌苔薄白。治疗:以健脾益气,疏肝和胃为主。此型患者以肥胖者居多,现代医学认为,肥胖后腹腔压力增大,是胃食管反流的主要原因之一。从中医的角度来看,脾主肌肉,脾虚失其职则出现肌肉无力或松弛。③脾胃湿热,临床表现:咽部异物感,甚至灼热感,腹胀口干口苦,胸腹痞闷不适,偶心烧心嗳气,大便不爽或便秘,小便黄赤。治疗:以清热利湿、疏肝和胃为主。可用半夏泻心汤合四逆散加减。肝气犯胃明显者,则嗳气频频,两胁胀闷不适;晨起有眼眵者,可加桑叶、菊花;大便不爽或便秘明显者,可加重虎杖、蒲公英,以清热燥湿通便。④肺胃津伤:胸脘灼热,嘈杂或嗳气频频,咽干涩,口干口苦,善饥喜饮,大便燥结或干,舌红少苔,不润,脉细数。外感燥热,耗伤膈胃津液,情志不畅,气郁化火,劫灼胃阴,津少不濡,胸脘灼热而痛。治宜养阴增液利咽。中药可选木蝴蝶、南沙参、麦冬、生地、玉竹、石斛、芦根清养肺胃,利咽润喉,牡丹皮、炒黄连、竹茹清热兼以和胃降逆抑酸。
三、对肺胃不和证咽喉反流性疾病的认识
何梦瑶有言:“饮食入胃,脾为运行精英之气,虽日周而诸腑,实先上输于肺,肺先受其益,是为脾土生肺金。肺受脾之益,则气愈旺化水下降,泽及百脉”。肺与脾胃从五行角度讲,肺属金,脾胃属土,土生金。肺居上焦,脾胃居中焦;肺主降,脾主升。肺主通调水道,脾主运化水湿。肺同脾胃两者相生。脾胃是肺的母脏,肺可以主气而脾可以益气,由此可见肺之气最终来源于脾,即脾胃运化水谷所产生的精气,第一步来到了肺并充养了肺。鉴于此,大多脾胃的升降或运化失常会率先影响到肺的生理、病理状态。肺胃两者是子母脏腑的关系,生理上肺胃互为依赖,相辅相成。肺主诸气,五脏六腑皆有赖于肺气以维持自身正常生理功能的正常运转,同时物脏六腑之的精微也都通过肺的宣发功能而得到补充,胃也是其中之一,它也收到肺气的调控而进行运化。因此肺气盛则胃气得到补充亦可强盛,反之肺气衰则胃气同步衰弱。以上说明肺胃息息相关。临床大量事实能证明肺胃密切相关,且《素问·咳论篇》中有描述“脾咳不已则胃受之。胃咳之状,咳而呕,呕甚则长虫出”。此系肺脏受邪,误治失治,邪舍于胃,胃气上逆而致既咳且呕。这种“胃咳”临床的确屡见不鲜。而在治胃方中参以治肺之药,上述症状却可逐渐消失。这不是个别和偶然现象。因为肺胃经脉相连,胃足阳明之脉与肺手太阴之脉会于咽喉,故胃病也表现出咽部不适症状,即本于胃,标于肺,二者同病。诸如此类,胃病与肺相关相因的现象还可列出若干。古今医家善于从肺治胃者不乏其人。清代陈修园即为代表,他创用的“百合乌药汤”治疗胃脘痛,久用不衰。陈修园自谓:“百合其色白而入肺,肺主气,肺气降则诸气皆调”。由此可见,从调理肺气入手治疗胃病不是毫无根据的。治疗咽喉反流性疾病患者,可从清肺、降胃、利咽入手。
在前期临床观察中发现,随着人们生活习惯、饮食结构改变,反流性疾病的发病率逐年增高,同时咽喉反流性疾病的发病率也随之增高。《素问·金匮真言论》中有言:“夫言人脏腑中阴阳,则藏者为阴,府者为阳……”脾为藏,胃为府,故脾乃阴土,胃乃阳土。胃为阳土,具有偏爱滋润、厌恶燥烈的特性,又有胃为燥土、阳明燥土之称,得阴自安,胃中具有充分的津液,才可以将水谷消化,才能使其通降下行的作用得以维持。作为清虚之体,肺对清润比较偏爱,如果饮食不节制、不和理,对辛辣刺激性的食物比较偏爱,就会对肺胃造成熏灼影响,就会在一定程度上对肺胃津液耗损影响,导致虚火上炎,使肺胃之气消损,使肺丧失清肃功能,导致肺气逆转向上,进而发展成反流或咳嗽、咽痒。咽属肺,肺胃不和证在南方地区极为常见。对此,可将肺胃不和证咽喉反流性疾病总体病机概括为:“肺胃不和,胃气不降,虚热内生,挟胃内容物上犯于肺,引起咽喉异物感、慢性咳嗽等症状”。咽喉反流性疾病的病位在咽喉,与肺胃关系密切,南方地区病性多责之于虚火、津亏、湿阻。
中国发明专利(公开号:CN114177269B,公开日:2023.03.21)公开了一种治疗反流性咽喉炎的中药组合物,所述中药组合物由以下重量份的原料药制成:旋覆花10-14份,煅赭石13-17份,半夏10-14份,厚朴10-14份,茯苓13-17份,紫苏叶10-14份,生姜1-5份,甘草7-11份,桔梗7-11份,射干7-11份,黄连1-5份,吴茱萸1-5份,煅瓦楞28-32份,海螵蛸18-22份,威灵仙13-17份。该发明针对的是气郁痰阻证咽喉反流性疾病,症状改善程度和临床疗效优于雷贝拉唑钠肠溶胶囊治疗反流性咽喉炎。
发明内容
本发明针对现有技术的不足,提供了一种治疗咽喉反流性疾病肺胃不和证的中药组合物。本发明中药组合物能有效治疗咽喉反流性疾病肺胃不和证,且具有较高的安全性,无明显不良反应,能改善患者的部分咽喉症状和中医证候。
为了实现上述的目的,本发明采用了以下的技术方案:
一种治疗慢性胆囊炎肝郁胆热证的中药组合物,所述中药组合物的活性成分原料以重量份计包括以下原料:射干4-12份,西青果5-15份,木蝴蝶4-12份,炒黄连2-10份,制吴茱萸1-5份,姜半夏5-15份,制厚朴10-20份,白螺蛳壳15-25份,灵芝15-25份,六月雪25-35份。
作为优选,所述中药组合物的活性成分原料以重量份计包括以下原料:射干8份,西青果10份,木蝴蝶8份,炒黄连6份,制吴茱萸3份,姜半夏9份,制厚朴15份,白螺蛳壳20份,灵芝20份,六月雪30份。
作为优选,所述中药组合物的活性成分原料以重量份计还包括以下原料:
桔梗2-10份,延胡索5-15份;
或,炒白术15-25份,茯苓10-20份,白扁豆5-15份;
或,陈皮2-10份,砂仁2-10份;
或,炒鸡内金15-25份,炒麦芽10-20份,炒稻芽10-20份;
或,煅牡蛎15-25份,煅瓦楞子15-25份。
作为优选,所述中药组合物的活性成分原料以重量份计还包括以下原料:
桔梗6份,延胡索9份;
或,炒白术20份,茯苓15份,白扁豆9份;
或,陈皮6份,砂仁6份;
或,炒鸡内金20份,炒麦芽15份,炒稻芽15份;
或,煅牡蛎20份,煅瓦楞子20份。
作为优选,所述中药组合物还包括适量添加其它中药提取物和/或添加其它原料。
进一步,本发明还公开了一种治疗咽喉反流性疾病肺胃不和证的中药组合物制剂,所述中药组合物制剂包括所述的中药组合物和/或添加药用辅料、和/或添加食品添加剂。
作为优选,所述中药组合物制剂为片剂、咀嚼片、粉剂、散剂、颗粒剂、冲剂、胶囊剂、膏剂、丸剂或液体制剂。
再进一步,本发明还公开了所述的中药组合物和中药组合物制剂在制备治疗咽喉反流性疾病肺胃不和证药物中的应用。
本发明配方设计的原理:
本发明中药组合物以西青果,木蝴蝶为君药:二药合用,其润肺宁咽之功更显著。射干、六月雪利咽和胃、一寒一热诚能加强君药之功效,共为方中之臣药。制吴茱萸反佐炒黄连清降虚火;姜半夏、制厚朴燥湿化痰,降逆止呕,消痞散结,佐白螺蛳壳化湿止流、和胃止痛,最后加入灵芝益气血,安心神,健肺胃,全方共奏利咽降胃,润肺清火之功,使肺胃气机得以畅通,则虚火可除,反流可缓,咽喉不适可消,这是对于单纯西药质子泵抑制剂治疗咽喉反流性疾病较好的补充和调整。
射干归于肺、肝两经,性味苦寒,有小毒,具有清热解毒,降火消痰,散血散结的作用,可治疗咽喉痹痛,喘咳上气,壅痰瘰疬,经闭、反酸等疾患。
西青果归肺经、大肠经,性平,味苦、微甘、涩,主治清热生津、利咽解毒。
木蝴蝶归肺、肝、胃经,味微苦、甘、性微寒,具有利咽润肺;疏肝和胃;敛疮生肌功效,可主咽痛喉痹、声音嘶哑、咳嗽等症。
黄连入心、肝、胃、大肠经,性味苦,寒,具有泻火,燥湿,解毒,治热毒,伤寒痞满呕逆,吐、衄百日咳,咽喉肿痛,口疮等症。
吴茱萸归肝、脾、胃、肾经,性味辛、苦,热,有小毒。主治散寒止痛,降逆止呕,助阳止泻,可用于呕吐吞酸,五更泄泻,与黄连共用为经典反佐之法。
半夏归脾、胃、肺经,性味辛温,有毒,可燥湿化痰,降逆止呕,消痞散结,古有仲景名方“半夏厚朴汤”用,是治疗痰气交阻梅核气的要药,可改善咳喘壅痰,咽喉不爽,呕吐反胃,中焦痞闷等证候。
厚朴归脾、胃、肺、大肠经,性味苦、辛,温,主治燥湿消痰,下气除满,用于痰饮喘咳,湿滞伤中,脘痞吐泻,食积气滞,腹胀等症。
白螺蛳壳归经肺、心、胃经,性味甘淡,平,可化痰,散结,止痛,敛疮,治热痰咳嗽,反胃,胃痛,吐酸等症。
灵芝归心、肺、肝、肾经,性味甘,平。功能主治补气安神,止咳平喘,用于心悸气短,虚劳咳喘等症。
六月雪入肝经、脾经,味淡、微辛,凉,主治疏风解表,清热利湿,舒筋活络,可用于感冒,咳嗽,急性扁桃体炎,咽喉炎等症。
本发明配方单味药药理学原理:
射干:射干煎剂或浸剂在体外对外感及咽喉疾患中的某些病毒,有抑制或延缓作用,对粘膜渗出亦有抑制作用。射干的醇或水提取物口服或注射,能促进家兔唾液分泌。此外,它还有雌激素样作用。
西青果:西青果成分中含20%~40%的鞣质,其中以诃子酸、诃黎勒酸,鞣云实素,原诃子酸,鞣花酸及没食子酸为主要成分。《全国中草药汇编》中记录西青果2~3枚治聊咽喉不适肿痛有奇效,具体方法可采用西青果磨汁,常温下慢慢吞咽,尽量在咽喉部长时间停留起效。
木蝴蝶:木蝴蝶的茎皮和种子都含黄芩甙元,具有有抗炎、抗免疫异常反应、同时可以利小便、利胆道,降低血管胆固醇,减少粥样硬化的作用。除了黄芩甙元外,木蝴蝶同时含有白杨素这类成分,对鼻咽癌细胞的化疗具有增效减毒作用。
炒黄连:黄连具有广谱抗菌作用。小檗碱对多种细菌、病毒均有抑制作用。低浓度抑菌,高浓度杀菌。小檗碱对急、慢性炎症均有抑制作用。黄连和小檗碱增强白细胞的吞噬功能,小檗碱降低减少炎性介质的生产。
吴茱萸:煎剂对霍乱弧菌、絮状表皮癣菌有较强抑制效力。大量吴茱萸对中枢有兴奋作用,并可引起视力障碍、错觉等。日本产吴茱萸醇提物有镇痛作用,镇痛效力和安替匹林或氨基比林大致相等。其生物碱,其盐酸盐对小鼠有镇静催眠作用。
半夏:生半夏、姜半夏、姜浸半夏和明矾半夏的煎剂对咳嗽有明显的镇咳作用,且可维持5小时以上。抑制腺体分泌,有一定的镇吐作用。
厚朴:厚朴的水煎剂在多种细菌具有抑菌作用,是强效的抑菌中药之一。在抑菌效果之外,厚朴的水煎剂对低浓度时可使得胃肠蠕动出现兴奋,而高浓度时则为表现为抑制作用。
白螺蛳壳:白螺蛳壳主要成分为碳酸钙,本品具有止咳化痰、健胃消食、敛疮消炎的效果。可达到止咳化痰作用,用于治疗肺热和肺燥所引起的咳嗽症状,能够缓解咳嗽,痰多和痰液黏稠,同时对于排痰困难以及咳嗽不止也能起到效果。
灵芝:灵芝的醇提取液具有抑制中枢神经的作用,对镇静剂戊巴比妥钠具有协同作用。此外,灵芝的水煎液具有抗惊厥功效,能抑制小鼠自发活动,同时具有一定的镇痛作用。
六月雪:六月雪含有苷类、鞣质、植物甾醇、少量生物碱、糖和脂肪酸等有效成分,其水煎液能对多种细菌、病毒起到相当的抑制作用。且在临床实践中,发现六月雪同时具有防病抗衰,增强体力及身体免疫力等多种作用。
本发明的有益效果为:1)本发明中药组合物能有效治疗咽喉反流性疾病肺胃不和证,且具有较高的安全性,无明显不良反应;2)本发明中药组合物能改善患者的部分咽喉症状,尤其在红斑/充血、声带水肿、后连合增生、肉芽肿、喉内黏稠黏液附着方面效果较佳;3)本发明中药组合物能改善患者的中医证候。
附图说明
图1为两组病例完成情况比较(n)。
图2为两组患者性别比较(n)。
图3为两组患者年龄比较。
图4为两组患者病程比较。
图5为两组治疗前RFS评分比较。
图6为两组治疗前RSI评分比较。
图7为两组治疗前中医证候积分比较。
图8为两组患者总体疗效比较(n)。
图9为两组治疗后RFS总评分比较。
图10为两组治疗后RSI总评分比较。
图11为两组患者中医证候疗效比较(n)。
图12为两组治疗后中医证候积分比较图。
图13为两组受试者不良反应情况比较(n)。
具体实施方式
下面结合本发明实施例,将实施例中的技术方案进行清楚、完整地描述,显然,所描述的实施例仅是本发明一部分实施例,而不是全部的实施例。基于本发明中的实施例,本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例,都属于本发明保护范围。
实施例1
一种治疗慢性胆囊炎肝郁胆热证的中药组合物,所述中药组合物的活性成分原料以重量份计包括以下原料:射干8份,西青果10份,木蝴蝶8份,炒黄连6份,制吴茱萸3份,姜半夏9份,制厚朴15份,白螺蛳壳20份,灵芝20份,六月雪30份。煎服即可,其中白螺蛳壳先煎。
实施例2
一种治疗慢性胆囊炎肝郁胆热证的中药组合物,所述中药组合物的活性成分原料以重量份计包括以下原料:射干8份,西青果10份,木蝴蝶8份,炒黄连6份,制吴茱萸3份,姜半夏9份,制厚朴15份,白螺蛳壳20份,灵芝20份,六月雪30份,桔梗6份,延胡索9份。煎服即可,其中白螺蛳壳先煎。
实施例3
一种治疗慢性胆囊炎肝郁胆热证的中药组合物,所述中药组合物的活性成分原料以重量份计包括以下原料:射干8份,西青果10份,木蝴蝶8份,炒黄连6份,制吴茱萸3份,姜半夏9份,制厚朴15份,白螺蛳壳20份,灵芝20份,六月雪30份,炒白术20份,茯苓15份,白扁豆9份。煎服即可,其中白螺蛳壳先煎。
实施例4
一种治疗慢性胆囊炎肝郁胆热证的中药组合物,所述中药组合物的活性成分原料以重量份计包括以下原料:射干8份,西青果10份,木蝴蝶8份,炒黄连6份,制吴茱萸3份,姜半夏9份,制厚朴15份,白螺蛳壳20份,灵芝20份,六月雪30份,陈皮6份,砂仁6份。煎服即可,其中白螺蛳壳先煎,砂仁后下。
实施例5
一种治疗慢性胆囊炎肝郁胆热证的中药组合物,所述中药组合物的活性成分原料以重量份计包括以下原料:射干8份,西青果10份,木蝴蝶8份,炒黄连6份,制吴茱萸3份,姜半夏9份,制厚朴15份,白螺蛳壳20份,灵芝20份,六月雪30份,炒鸡内金20份,炒麦芽15份,炒稻芽15份。煎服即可,其中白螺蛳壳先煎。
实施例6
一种治疗慢性胆囊炎肝郁胆热证的中药组合物,所述中药组合物的活性成分原料以重量份计包括以下原料:射干8份,西青果10份,木蝴蝶8份,炒黄连6份,制吴茱萸3份,姜半夏9份,制厚朴15份,白螺蛳壳20份,灵芝20份,六月雪30份,煅牡蛎20份,煅瓦楞子20份。煎服即可,其中白螺蛳壳、煅牡蛎和煅瓦楞子先煎。
本发明有益效果研究:
一、研究资料与方法
(一)研究资料
1.研究对象
本研究所纳入的患者均为2021年10月~2023年1月的门诊病例,来源于临海市中医院。诊断上符合咽喉反流性疾病的西医标准和肺胃不和的中医辨证标准。
2.诊断标准与辨证标准
2.1西医诊断标准
参考2020年《咽喉反流性疾病诊断和治疗研究进展》中关于咽喉反流性疾病的诊断标准,通过详细的询问病史和喉镜检查,评价患者咽喉反流体征评分量表(refluxfinding score,RFS)和咽喉反流症状指数评分量表(reflux symptomindex,RSI)。
RFS评分量表:①假声带沟,无记0分,存在记2分;②喉室消失,无记0分,部分存在记2分,完全存在记4分;③红斑/充血,无记0分,局限于杓状软骨记2分,弥漫记4分;④声带水肿,无记0分,轻度记1分,中度记2分,重度记3分,堵塞记4分;⑤弥漫性喉水肿,无记0分,轻度记1分,中度记2分,重度记3分,堵塞记4分;⑥后连合增生,无记0分,轻度记1分,中度记2分,重度记3分,堵塞记4分;⑦肉芽肿,无记0分,存在记2分;⑧喉内黏稠黏液附着无记0分,存在记2分。
RSI评分量表:①声嘶或发音障碍;②存在持续清嗓;③痰过多或鼻涕倒流;④吞咽食物、水或药片不利;⑤饭后或躺下后咳嗽;⑥呼吸不畅或反复窒息发作;⑦烦人的咳嗽;⑧咽喉异物感;⑨烧心胸痛胃痛。患者根据自己症状的严重程度作出评分,0分代表无症状,5分代表非常严重。
若RFS>7分和(或)RSI>13分,可将此患者诊断为疑似咽喉反流性疾病。
2.2中医辨证标准
参照《咽喉反流性疾病中医证型与症状分布规律研究》研究结果,结合临床,本研究拟定本病“肺胃不和证”标准如下:
主症:①咽部异物感或吞咽不利;②咳嗽、清嗓或伴咳痰;③咽干咽痒或伴咽痛;④声音嘶哑。
次症:①口咽黏腻感;②胃脘胀满;③纳差。
舌脉:①舌红苔薄黄或黄腻;②脉虚数。
具备2项主症,兼具2项及以上次症,参照舌脉,即可诊断。
3.纳入标准
①符合上述咽喉反流性疾病西医诊断标准;
②符合肺胃不和证的中医辨证标准;
③符合年龄区间位于18至60周岁之间;
④同意参与本研究并由本人亲笔签署知情同意书;
⑤未服用对咽喉反流性疾病有治疗作用的任何药物或虽有服用但在入组之前已停用2周以上。
4.排除标准
①合并其他消化道疾病或五官科疾病或者伴有肝、肾等器官功能不全者;
②对本研究所用药物(包括本发明中药组合物和奥美拉唑胶囊)过敏者;
③备孕期、哺乳期或妊娠期妇女;
④伴有器质性病变,如喉癌、食管癌、鼻咽癌等患者;
⑤因各种原因不遵医嘱,不配合治疗者;
⑥因各种原因在研究过程中脱落者;
⑦有酗酒、滥用药物病史者;
⑧在同时参与其他临床研究,或在服用其他药物,以及研究者判断不适合纳入标准的其它情况。
5.剔除标准
①错误纳入者;
②纳入后未按医师所嘱要求服药者;
③观察期间资料收集不全等无法进行疗效和安全性评估者。
6.脱落标准
①患者发生并发症不可耐受;
②在研究过程中发现其他疾病;
③患者失访,主动要求退出等。
7.终止临床试验标准
①为保障患者健康,研究过程中出现严重不良反应的患者,应及时予以终止试验。
②主动要求终止此临床研究者。
(二)研究方法
1.样本量估计
本研究为随机、平行、对照试验,以试验组和对照组的总有效率作为观测的结局指标,采用的样本量计算公式为:
其中n代表每组所需要的样本量,值代表双侧检验值,设双侧=0.05,把握度为80%,则Zα=0.96,Zβ=1.28。P1和P2分别对应的是预估的试验组、对照组的总有效率,p代表P1和P2的均值,q代表1-P1和1-P2的均值。通过查阅咽喉反流性疾病的相关临床试验文献,发现本研究试验组总有效率可能在90%左右,对照组的有效率可能在60%左右,即P1=0.9,P2=0.6。依据上述公式计算得到n=44例。以脱落率不超过10%进行计算,最终计算得n1=n2=48(例)。
2.分组方法
依据入组后的就诊顺序,所有患者依次被标记成1-96号编号,采用统计软件SPSS25.0进行随机分组,最终将96名患者平均标记为编号0和1,各48名。在和患者就诊编号相对应的前提下,将编号为0的患者列为试验组,编号为1的患者列为对照组。
3.治疗方案
3.1中药试验组
中药试验组用本发明中药组合物(药物组成如下:射干8g,西青果10g,木蝴蝶8g,炒黄连6g,制吴茱萸3g,姜半夏9g,制厚朴15g,白螺蛳壳20g(先煎),灵芝20g,六月雪30g)为主治疗。咽痛甚加桔梗6g,延胡索9g;口咽黏腻感重加炒白术20g,茯苓15g,白扁豆9g;胃脘胀满加陈皮6g,砂仁6g(后下);纳差加炒鸡内金20g,炒麦芽15g,炒稻芽15g;感嗳气、反酸、烧心者,加煅牡蛎20g(先煎),煅瓦楞子20g(先煎);上述中药材由中药房代煎或自煎,每次煎服200毫升,早晚各煎服一次;2周为一个疗程,一共治疗2个疗程。
3.2西药对照组
奥美拉唑肠溶胶囊(批准文号:国药准字H19991118,产品批号:JA2205005B。生产企业:浙江金华康恩贝生物制药有限公司)20mg,饭前口服,早晚各一次。2周为一个疗程,一共治疗2个疗程。
疗程及随访:两组的治疗疗程均为4周,在疗程结束4周后进行随访。
4.观测指标
4.1病例人口学资料
详细、准确记录患者姓名、性别、年龄、病程等资料。
4.2安全性观测指标
一般体检项目:血压、心率、心律、呼吸、体重。
相关检查:血、尿、大便常规化验;肝、肾功能检查;心电图。治疗前和治疗后4周各检查1次。观察患者服用药物后是否有毒副作用。
4.3疗效判定指标
4.3.1总体疗效判定方法
依据《咽喉反流性疾病规范化诊断和治疗》:
显效为患者咽部、喉部症状消失,电子喉镜下黏膜充血完全消失,或溃疡愈合,RSI评分≤13分;
有效为患者各项症状明显缓解,炎症减轻,电子喉镜下粘膜病变好转,RSI评分>13分,但低于治疗前;
无效为患者症状和喉镜下体征均无改善,RSI评分未降低。RFS评分表和RSI评分表可参见西医诊断标准。
4.3.2中医证候疗效判定方法
参照《中药新药临床研究指导原则》制定如下疗效判定标准:中医证候改善百分率=(治疗前积分-治疗后积分)/治疗前积分×100%。
显效为中医症状、体征基本消失,中医证候改善百分率≥80%;
有效为中医症状、体征改善50%以上,即50%≤中医证候改善百分率<80%;
无效为中医症状、体征无好转,中医证候改善百分率<50%。
4.4安全性判定方法
准确记录患者不良反应的情况,并统计各组出现的个数。评价标准依据《中药新药临床研究指导原则》制定:
①Ⅰ级:安全,治疗期间无不良反应发生;
②Ⅱ级:较安全,若出现不良反应,无需任何特殊处理,可进行后续给药治疗;
③Ⅲ级:有安全问题,试验过程中出现一定不良反应,采取相应处理后可进行后续试验;
④Ⅳ级:出现严重不良反应,需结束临床试验。
(三)统计学方法
采用SPSS25.0统计软件进行统计分析。计数资料采用卡方检验,符合正态分布或者近似正态分布的数据采用t检验。治疗前后比较采用配对t检验,组间比较采用两独立样本t检验,用均数±标准差表示,P<0.05表示差异具有统计学意义。
二、结果
(一)病例完成情况
共纳入96名患者,根据随机数字表中分组,随机分为试验组和对照组,n1=n2=48(例)。在试验中途,试验组、对照组中各有因未定期复诊而导致脱落的患者2例,此外对照组中有1例患者因私自服用影响研究的药物(泮托拉唑)而予以剔除,试验组有另有1例因准备怀孕而中止试验。最终试验组招募到45例患者、对照组招募到45例患者完整完成了此次研究方案,总脱落率为6.67%。参见下表1和图1:
表1两组病例完成情况比较(n)
组别 | 纳入例数 | 剔除病例 | 脱落病例 | 完成病例 |
试验组 | 48 | 0 | 3 | 45 |
对照组 | 48 | 1 | 2 | 45 |
(二)病例基线情况比较
1.性别比较
试验组中有18例男性,占试验组人数的40%,27例女性占比60%;对照组中有19例男性,占对照组人数的57.8%,26例女性占比42.2%。两组患者的性别比较无统计学差异(P>0.05),两组可比。参见下表2、图2:
表2两组患者性别比较(n)
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2.年龄比较
在符合纳入标准的的90例患者中,试验组患者年龄在22~54岁之间,平均年龄(38.89±9.83)岁;对照组患者年龄在年龄在25~54岁之间,平均年龄(40.36±8.27)岁。试验组和对照组患者年龄均接近正态分布。故比较采用独立样本t检验。两组的年龄比较无统计学差异(P>0.05)。具体见表3、图3。
表3两组患者年龄比较
3.两组病程比较
在符合纳入标准的90例受试群体中,试验组患者病程在5~47(月);对照组病程在6~46(月)。两组患者病程近似正态分布,两者比较采用独立样本t检验。两组的年龄比较无统计学差异(P>0.05)。具体见表4、图4。
表4两组患者病程比较
4.两组治疗前RFS评分比较
对符合纳入标准的90例患者RFS评分进行统计,试验组与对照组治疗前单项症状评分呈接近正态分布,比较采用两独立样本t检验,差异无统计学意义(P>0.05),提示两组患者治疗前单项症状比较无明显差异,具有可比性。具体见表5、图5。
表5两组治疗前RFS评分比较
5.两组治疗前RSI评分比较
对符合纳入标准的90例患者RSI评分进行统计,试验组与对照组治疗前单项症状积分呈近似正态分布,比较采用两独立样本t检验,除持续清嗓外,其余各项差异无统计学意义(P>0.05),提示两组患者治疗前单项症状比较无明显差异,两组可比。具体见表6、图6。
表6两组治疗前RSI评分比较
6.两组治疗前中医证候积分比较
对符合纳入标准的90例患者中医证候进行评分,试验组与对照组治疗前单项症状积分呈近似正态分布,比较采用两独立样本t检验,差异无统计学意义(P>0.05),提示两组患者治疗前单项中医证候比较无明显差异,具有可比性。具体见表7、图7。
表7两组治疗前中医证候积分比较
(三)疗效比较
1.总体疗效比较
经过4周治疗后,试验组本发明中药组合物治疗咽喉反流性疾病总有效率为88.88%,对照组奥美拉唑治疗咽喉反流性疾病总有效率为62.22%。经卡方检验后,两组总有效率比较差异具有统计学意义(P<0.01)。参见表8、图8:
表8两组患者有效率比较(n)
2.两组治疗前后RFS评分比较
对90例患者治疗完成后再次进行RFS评分,对治疗前后RFS单项症状比较采用配对样本t检验,结果提示:除假声带沟、喉室消失、肉芽肿外,其余各项均具有统计学意义(P<0.05)。且两组患者在红斑/充血等该项中,本发明中药组合物具有治疗效果(P<0.05),而PPI疗效欠佳(P>0.05)。具体见表9、图9。
表9两组治疗前后RFS评分比较
3.两组治疗前后RSI评分比较
治疗结束后对两组患者再次进行RSI评分,治疗后较治疗前单项症状积分比较采用配对样本t检验,试验组中除吞咽不利、呼吸不畅或反复窒息发作外,其余各项均具有统计学意义(P<0.05),对照组仅痰过多或鼻涕倒流、烦人的咳嗽、烧心胸痛胃痛具有统计学意义(P<0.05)。见表10、图10。
表10两组治疗前后RSI评分比较
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4.治疗前后中医证候疗效比较
经过4周治疗后,本发明中药组合物治疗咽喉反流性疾病总有效率为80.00%,PPI治疗咽喉反流性疾病总有效率为48.89%,本发明中药组合物和PPI总有效率比较差异具有统计学意义(P<0.05)。参见表11、图11:
表11两组患者中医证候疗效有效率比较(n)
5.两组治疗前后中医证候积分比较
对90例患者试验结束后进行中医证候的结果再次进行统计,两组治疗后较治疗前单项症状比较采用配对样本t检验,试验组各项均具有统计学意义(P<0.05),对照组在咽部异物感或吞咽不利、口咽黏腻感、胃脘胀满具有统计学意义(P<0.05)。具体见表12、图12。
表12两组治疗前后中医证候积分比较
(四)安全性比较
经过试验后,两组受试者的生命体征均在正常范围内,治疗前后的血常规、尿常规、大便常规及常规心电图检查结果均未见明显异常。但在研究过程中对照组头晕3例,腹泻8例,肝功能异常3例,治疗组头晕0例,口苦2例。两组不良反应率存在统计学差异(P<
0.01)。参见表13,图13。
表13两组受试者不良反应情况比较(n)
三、研究结果分析
(一)病例人口学资料分析
共纳入96例肺胃不和证咽喉反流性疾病患者,最终90例完成本次研究,其中男性37例,女性53例。虽然两组之间男女比例无统计学差异(P>0.05),但女性数量明显多于男性,这可能与女性易受压力、心理因素影响引起胃酸反流有关。本研究试验组患者平均年龄为(38.89±9.83)岁,对照组患者平均年龄为(40.36±8.27)岁。两组的年龄比较无统计学差异(P>0.05),发病年龄区间位于中青年,可能与三甲医院就诊优势群体有关。本研究中试验组的平均病程(28.40±12.79)月,对照组的平均病程(27.84±13.46)月,说明咽喉反流性疾病病程绵长,对患者带来和生活压力和经济压力较大。但是本研究样本量小,样本来源单一,因此并不能代表咽喉反流性疾病患者整体的人口学特征情况。
(二)治疗前后临床疗效、中医证候疗效结果分析
经过4周治疗后,试验组咽喉反流性疾病总有效率为88.88%,对照组为62.22%,两组总有效率比较差异具有统计学意义(P<0.05)。试验组咽喉反流性疾病中医证候有效率为80.00%,对照组为48.89%,两组中医证候有效率比较差异具有统计学意义(P<0.05)。其间PPI治疗的有效率并不令人十分满意,可以从以下观点解释:尽管目前反流病与咽喉症状之间的关联已得到充分认可,超过一半的接诊医生在治疗中使用PPI,但是导致咽喉反流性疾病的病理学确切机制尚不清楚,即咽喉反流性疾病可能是由于多种复杂因素造成的,这使得经验性PPI治疗的成功率较低。目前,PPI是咽喉反流性疾病治疗的首选,有研究表明但高达40%的咽喉反流性疾病患者PPI不能缓解症状,这与我们的结果相似,故关于PPI对咽喉反流性疾病的有效性缺乏实质性临床证据。鉴于咽喉反流性疾病的症状和机制的复杂性以及PPIs的疗效值得怀疑,中医药治疗咽喉反流性疾病更具有优势。咽喉反流性疾病的患者既有咽喉隐痛、干燥,如异物梗阻状,咳之不出,吞之不下,或仅能咯出少许白色粘痰,咽及胸部憋闷梗噎,噫气难除,嗳之则舒,甚则喉及胸部有灼热刺激感症状外,还常伴有胃脘痞满疼痛、腹胀、嗳气、嘈杂、纳差。其类似“梅核气”,按传统疗法从痰气互结论治,予疏肝理气化痰之品如半夏厚朴汤一类,每难于奏效。申请人创制本发明中药组合物治疗肺胃不和证咽喉反流性疾病,着眼于患者症状,切合南方群体病机,故而临床疗效显著。
(三)治疗前后RFS、RSI评分结果分析
RSI量表评分和RFS量表评分是目前广泛使用的咽喉反流性疾病的诊断工具。RSI、RFS可用作评估以量化患者的身体症状和咽喉反流性疾病的严重程度。RSI评分>13被认为是咽喉反流性疾病的可靠诊断指标,这些患者经常进行喉镜检查,以使用RFS进一步量化其咽喉反流性疾病。RFS旨在根据内镜检查结果对患者进行评分,评分为7分或更高通常被认为具有咽喉反流性疾病的诊断意义。经过4周的不同方案治疗后,每组患者的“红斑/充血”“声带水肿”“后连合增生”“肉芽肿”“喉内黏稠黏液附着”的前后对比均具有统计学意义(P<0.05),这提示PPI和本发明中药组合物对两组患者的上述几项各项均有治疗效。但在“弥漫性喉水肿”,试验组P<0.05,对照组P>0.05,提示中药能改善咽喉反流性疾病患者的弥漫性喉水肿体征,但PPI治疗疗效受限。软式鼻咽喉镜检查,直接观察咽部和喉部,咽喉反流性疾病镜下常见典型的发炎外观,包括咽黏膜内膜干燥伴浓稠分泌物或黏液,黏膜鹅卵石外观,声带、声门上水肿、红斑。咽喉反流性疾病患者声门后可出现增厚和水肿,可延伸至声门下,导致狭窄,在声门、声门下或声门上区域亦可出现肉芽肿。根据声带肉芽肿的大小和位置,声带可能活动受限,内收可能受损。故“喉室消失”“假声带沟”两者的P>0.05是由于这两个体征在咽喉反流性疾病患者本身就十分少见。其中治疗后红斑/充血试验组和对照组存在统计学差异(P<0.05),提示中医治疗在该体征的改善上更具有优势。这提示我们临床中遇到红斑/充血明显的咽喉反流性疾病患者,应用本发明中药组合物可能有比PPI治疗有更好效果。RSI评分结果分析,试验组中除吞咽不利、呼吸不畅或反复窒息发作外,其余各项均具有统计学意义(P<0.05),这提示本发明中药组合物对大部分咽喉反流性疾病症状都有效,吞咽不利、呼吸不畅或反复窒息发作改善不佳的原因可能在于该类患者病程较久,症状严重,且数量较少,难以得出统计学阳性结果;而对照组仅痰过多或鼻涕倒流、烦人的咳嗽、烧心胸痛胃痛具有统计学意义(P<0.05),这提示PPI改善咽喉反流性疾病患者症状的能力有限,且烧心胸痛胃痛同时作为胃肠道疾病的相关症状,可能对PPI治疗的反应率更高。总体而言,临床中遇到持续声嘶或者发音障碍、清嗓明显、饭后或躺下后咳嗽、咳嗽、咽喉异物感的咽喉反流性疾病患者,应用本发明中药组合物可能有比PPI治疗有更好效果。
(四)治疗前后中医证候积分结果分析
治疗后中医证候资料结果分析,试验组在中医证候各项均具有统计学意义(P<0.05),对照组仅仅在咽部异物感或吞咽不利、口咽黏腻感、胃脘胀满具有统计学意义(P<0.05)。在本发明中药组合物中,理论上射干,西青果,木蝴蝶润肺宁咽,六月雪,制吴茱萸反佐炒黄连清降虚火;姜半夏、制厚朴燥湿化痰,降逆止呕,消痞散结,佐白螺蛳壳化湿止流、和胃止痛,最后加入灵芝益气血,安心神,健肺胃,全方共奏利咽降胃,润肺清火之功,使肺胃气机得以畅通,则虚火可除,反流可缓,咽喉不适可消。研究结果来看,本发明中药组合物确实具有改善咽喉反流性疾病中医证候的作用。但在舌脉上不甚明显,可能是由于舌脉的病情深浅的体现不及症状来得迅捷。总体来看,PPI治疗对中医证候改善不明显,原因可能在于老年人群中UES压力和食管体动力对反流和反流后残留的反应降低,食管裂孔疝的存在造成的顽固性咽喉反流性疾病有关。而PPI能够治疗胃脘胀满也是由于胃脘痞满同时作为胃肠道疾病的相关症状,可能对PPI治疗的反应率更高。
(四)安全性分析
研究过程对照组出现头晕3例,腹泻8例,肝功能异常3例,治疗组头晕0例,口苦2例。两组不良反应率存在统计学差异(P<0.05)。这体现了中医中药治疗的安全性。
以上为对本发明实施例的描述,通过对所公开的实施例的上述说明,使本领域专业技术人员能够实现或使用本发明。对这些实施例的多种修改对本领域的专业技术人员来说将是显而易见的。本文中所定义的一般原理可以在不脱离本发明的精神或范围的情况下,在其它实施例中实现。因此,本发明将不会被限制于本文所示的这些实施列,而是要符合与本文所公开的原理和新颖点相一致的最宽的范围。
Claims (8)
1.一种治疗咽喉反流性疾病肺胃不和证的中药组合物,其特征在于,所述中药组合物的活性成分原料以重量份计包括以下原料:射干4-12份,西青果5-15份,木蝴蝶4-12份,炒黄连2-10份,制吴茱萸1-5份,姜半夏5-15份,制厚朴10-20份,白螺蛳壳15-25份,灵芝15-25份,六月雪25-35份。
2.根据权利要求1所述的一种治疗咽喉反流性疾病肺胃不和证的中药组合物,其特征在于,所述中药组合物的活性成分原料以重量份计包括以下原料:射干8份,西青果10份,木蝴蝶8份,炒黄连6份,制吴茱萸3份,姜半夏9份,制厚朴15份,白螺蛳壳20份,灵芝20份,六月雪30份。
3.根据权利要求1或2所述的一种治疗咽喉反流性疾病肺胃不和证的中药组合物,其特征在于,所述中药组合物的活性成分原料以重量份计还包括以下原料:
桔梗2-10份,延胡索5-15份;
或,炒白术15-25份,茯苓10-20份,白扁豆5-15份;
或,陈皮2-10份,砂仁2-10份;
或,炒鸡内金15-25份,炒麦芽10-20份,炒稻芽10-20份;
或,煅牡蛎15-25份,煅瓦楞子15-25份。
4.根据权利要求3所述的一种治疗咽喉反流性疾病肺胃不和证的中药组合物,其特征在于,所述中药组合物的活性成分原料以重量份计还包括以下原料:
桔梗6份,延胡索9份;
或,炒白术20份,茯苓15份,白扁豆9份;
或,陈皮6份,砂仁6份;
或,炒鸡内金20份,炒麦芽15份,炒稻芽15份;
或,煅牡蛎20份,煅瓦楞子20份。
5.根据权利要求1-4任意一个权利要求所述的一种治疗咽喉反流性疾病肺胃不和证的中药组合物,其特征在于,所述中药组合物还包括添加其它中药提取物和/或添加其它原料。
6.一种治疗咽喉反流性疾病肺胃不和证的中药组合物制剂,其特征在于,所述中药组合物制剂包括权利要求1-5任意一项权利要求所述的中药组合物和/或添加药用辅料、和/或添加食品添加剂。
7.根据权利要求6所述的一种治疗咽喉反流性疾病肺胃不和证的中药组合物制剂,其特征在于,所述中药组合物制剂为片剂、咀嚼片、粉剂、散剂、颗粒剂、冲剂、胶囊剂、膏剂、丸剂或液体制剂。
8.权利要求1-5任意一个权利要求所述的中药组合物或权利要求6-7任意一个权利要求所述的中药组合物制剂在制备治疗咽喉反流性疾病肺胃不和证药物中的应用。
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